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      • id1212
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      • abstract_of_study<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><b><span lang=\"EN-US\" style=\"line-height: 17.12px;\">Background</span></b></span></span><b><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></b></p>\n<p class=\"BodyText12\" style=\"margin: 0cm 0cm 12pt; text-align: justify; line-height: 17.6px; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\">At the end of December 2021, 68% of PLHIV globally had achieved virological suppression against the UNAIDS target of 95%. Virologic suppression is primarily dependent on adherence to antiretroviral therapy (ART). Simplifying treatment and overcoming the need for daily pill taking is an important step in increasing treatment compliance, improving quality of life and reducing the death and disability caused by HIV treatment failure. Long-acting (LA) injectable therapy offers a greatly reduced dosing frequency that may be a better option for patients with a history of sub-optimal adherence as it may result in reduced stigma, improved adherence and greater treatment satisfaction.</span></span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p class=\"BodyText12\" style=\"margin: 0cm 0cm 12pt; text-align: justify; line-height: 17.6px; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\">This study will build upon data provided by the ongoing Cabotegravir (CAB) and Rilpivirine (RPV) Efficacy and Safety (CARES) study in Uganda, Kenya, and South Africa that aims to determine whether the antiviral effect of switching to injectable cabotegravir and rilpivirine is non-inferior to continuation of first-line ART in virologically suppressed PLHIV.</span></span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><b><span lang=\"EN-US\" style=\"line-height: 17.12px;\">Methods</span></b></span></span><b><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></b></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">This is a randomized, open-label multicenter, interventional study of 540 virologically suppressed (HIV-1 VL <200 c/mL) HIV-1 infected adults (18 years or older) who have a history of, or are at high risk of, sub-optimal adherence to daily oral ART and/or engagement in HIV care.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">The study will take place in Kenya, Uganda and South Africa. In Kenya, 160 participants will be enrolled into the study, 80 each at Kenyatta National Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital. Participants will be randomized 1:1 to continue daily oral ART or switch to LA CAB / RPV, and will be followed for 24 months.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">HIV-1 RNA viral load will be measured at months 2/3, 6, 8/9, 12 18 and 24. CD4 count, complete blood count,</span><span class=\"NoneA\"><span lang=\"EN-US\"> </span></span><span lang=\"EN-US\" style=\"line-height: 17.12px;\">renal and liver function tests, glycated haemoglobin, fasting lipids, urinalysis and patient satisfaction will be measured at baseline and during follow up, along with other safety investigations. Procedures to minimize risk of COVID-19 infection amongst participants and staff will be implemented.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none; text-align: justify;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.12px;\">The primary efficacy endpoint of virologic response (HIV-1 RNA <50 copies/ml at 12 months) will be analysed for non-inferiority using the FDA snapshot method.</span></span></span><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></p>\n<p class=\"Body\" style=\"margin: 0cm 0cm 8pt; line-height: 15.6933px; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); border: none;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><b><span lang=\"IT\" style=\"line-height: 17.12px;\">Conclusion</span></b></span></span><b><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 17.12px;\"><o:p></o:p></span></b></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">The results of this study will establish whether LA injectable therapy is an effective treatment option for PLHIV with a history of sub-optimal ART adherence or engagement in care.</span></span></span></p>\n
      • study_title<p>\n Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV-1 Control in Sub-Saharan Africa: A Pragmatic Phase 3b Open-Label Randomized Controlled Trial</p>\n
      • laymans_summary<p align=\"center\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV-1 Control in Sub-Saharan Africa: A Pragmatic Phase 3b Open-Label Randomized Controlled Trial</strong></span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Background: </strong>At the end of December 2021, only 2 out of 3 people living with HIV (PLHIV) had achieved viral suppression which means there was control of the amount of HIV virus in their blood. Internationally, the goal is to have 95% of PLHIV being virally suppressed. The main driver to successful HIV treatment and control is taking medication as per the instructions of the healthcare providers. Simplifying treatment and overcoming the need for daily pill taking is an important step in making it easier to take medication correctly. This will also improve the quality of life and reduce the death and disability caused by HIV treatment failure. Monthly or 2-monthly injectable drugs offer a greatly reduced dosing frequency. This dosing plan may be a better option for patients who find it difficult to take medication as prescribed and it may result in reduced stigma and greater treatment satisfaction.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">This research will build upon data provided by the ongoing Cabotegravir (CAB) and Rilpivirine (RPV) Efficacy and Safety (CARES) study in Uganda, Kenya, and South Africa that aims to determine whether the injectable HIV-1 drugs are as good as the current oral drugs in controlling the amount of HIV virus in PLHIV.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Objective: </strong>We would like to determine if changing to 2-monthly injections of the drugs CAB and RPV is as good as continuing on the current recommended daily oral antiretrovirals over a 12-month period in PLHIV who have in the past had difficulty in taking their medication as prescribed or had difficulty in engaging in care.</span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Participants and Methods: </strong>We will enroll 540 participants in 3 countries: Kenya, Uganda and South Africa. In Kenya, a total of 160 participants will be recruited from HIV clinics at Kenyatta National Hospital in Nairobi and Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu, 80 at each site. After providing written informed consent, participants will be evaluated for eligibility for up to 3 months. Thereafter, half of them will have their HIV treatment changed to 2-monthly injectable treatment while the other half will remain on the treatment they have been using; this choice will be made randomly at the time each person is enrolled onto the study. Thereafter, each person will be followed up for 24 months. During this time, the amount of HIV virus in blood will be checked on months 2/3, 6, 8/9, 12, 18 and 24 alongside other laboratory and radiological tests assessing for safety. Procedures to minimize risk of COVID-19 infection amongst participants and staff will be implemented.</span></span></p>\n
      • short_titleIMPALA Study
      • protocol_noECCT/23/01/05
      • version_noAmendment-1
      • date_of_protocol30-09-2022
      • study_drugCabotregavir and Rilpivirine
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVocabria/Rekambys/Edurant
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name2 NRTIs (TDF and 3TC) plus INSTI (DTG)
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
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      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDR LOICE ACHIENG OMBAJO
      • declaration_date125-01-2023
      • declaration_principal_investigatorDR LOICE ACHIENG OMBAJO
      • declaration_date225-01-2023
      • placebo_presentNo
      • study_objectives<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">Primary Obective:</span></strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">To demonstrate the non-inferior efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long acting (LA) plus rilpivirine (RPV) LA compared with continuation of daily oral ART over 12 months in people living with HIV-1 (PLHIV1) with a history of, or at risk of, sub-optimal ART adherence or engagement in care.</span></span></span></p>\n<p>\n  </p>\n<p>\n <strong><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-US\" style=\"color: rgb(0, 0, 0);\">Secondary Objectives:</span></span></span></strong></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To demonstrate the antiviral activity and the impact on retention in HIV care of switching to Q2M CAB LA + RPV LA compared with continuation of daily oral ART over 12 and 24 months in PLHIV1 with a history of, or at risk of, sub-optimal ART adherence or engagement in care</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To demonstrate the immunological activity of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To evaluate the safety and tolerability of switching to Q2M CAB LA + RPV LA compared to continuation of daily oral ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess genotypic viral resistance in participants experiencing protocol-defined CVF (confirmed plasma HIV-1 RNA ≥200 c/mL on 2 consecutive tests) and its impact on future treatment options including proportion who resuppress on dolutegravir</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To evaluate the effect of Q2M CAB LA + RPV LA on health-related quality of life</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess treatment satisfaction</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess preference for Q2M CAB LA + RPV LA compared to daily oral ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To measure participants' medical resource utilization under Q2M CAB LA + RPV LA compared to daily oral ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To assess programmatic acceptability of Q2M CAB LA + RPV LA</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">To evaluate adherence to treatment</span></span></li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">18 years of age and above</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV-1 infection confirmed in clinic records or by study tea,</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Two consecutive HIV-1 VL <200 copies/ml ≥3 months apart prior to randomization</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">On an oral regimen of 2NRTI + DTG as part of first-line ART</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Is identified as a participant with a history of sub-optimal ART adherence or engagement in care</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">A female participant is eligible to participate if she is not pregnant, not lactating, and either has non-reproductive potential of if has reproductive potential, agrees to to a highly effective method of avoiding pregnancy from 30 days prior to the first dose of study medication</span></span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">Male partidcipants are advised to wear a condim during sexual intercourse</span></span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">Must sign informed consent form </span>indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">Willing and able to attend all clinic appointments</span></span></span></li>\n</ol>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\">For more details, see section 5.1 of the protocol (pages 31 to 33)</span></span></span></p>\n
      • principal_exclusion_criteria<ol>\n <li>\n Not virologically suppressed (VL <200c/ml) for ≥3 months at the end of the screening process</li>\n <li>\n Previous use, or intention to use, protease inhibotor-based ART at any time</li>\n <li>\n Evidence of prior HIV-1 resistance test with NNRTI drug resistance mutations (other than K103N) and/or INSTI drug resistance mutations</li>\n <li>\n Unwillingness to receive 2 injections on a 2-monthly basis</li>\n <li>\n Unwilling to use a form of contraception</li>\n <li>\n Pregnant, breastfeeding or planning to become pregnant during the study period</li>\n <li>\n Requires tuberculosis therapy or other drug with clinically relevant drug interaction </li>\n <li>\n High risk of seizures, including participants with an unstable or poorly controlled seizure disorder</li>\n <li>\n Has active TB or other mycobacterial disease and requires treatment</li>\n <li>\n Advance liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or assymptomatic gallstones) or history of cirrhosis</li>\n</ol>\n<p>\n <span style=\"font-family: arial, helvetica, sans-serif;\">For more details, see section 5.2 of the protocol (pages 33 to 35)</span></p>\n
      • primary_end_points<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span lang=\"EN-GB\" style=\"color: rgb(0, 0, 0);\">Proportion with plasma HIV-1 viral load (VL) <50 c/mL at 12 months (by Food and Drug Administration [FDA] snapshot algorithm)</span></span></span></p>\n
      • scope_diagnosis0
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      • trial_other0
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      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</strong></p>\n<p>\n Kenyatta National Hospital Comprehensive Care Centre (CCC) was established in December 2002 as the pioneer care and treatment centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS), Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs, and the Center for International Health, Education, and Biosecurity (CIHEB) - Kenya. It has evolved over time to be a centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  </p>\n<p>\n The CCC offers a one-stop-shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.</p>\n<p>\n  The services offered at the Comprehensive Care Centre include the following:</p>\n<p style=\"margin-left:36.75pt;\">\n 1.     Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co-morbidities</p>\n<p style=\"margin-left:36.75pt;\">\n 2.     Anti-Retroviral Therapy both 1^st line; 2^nd line and 3^rd line regimens as per the WHO guidelines</p>\n<p style=\"margin-left:36.75pt;\">\n 3.     Laboratory monitoring and evaluation of the patients - The centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Flow Cytometry </p>\n<p style=\"margin-left:72.75pt;\">\n ·       Hematology </p>\n<p style=\"margin-left:72.75pt;\">\n ·       Chemistry </p>\n<p style=\"margin-left:72.75pt;\">\n ·       TB Diagnosis </p>\n<p style=\"margin-left:72.75pt;\">\n ·       HIV EID </p>\n<p style=\"margin-left:72.75pt;\">\n ·       HIV Viral Load </p>\n<p style=\"margin-left:36.75pt;\">\n 4.     Research: Since its inception the centre has actively been involved in research which has informed HIV/AIDS national policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with international partners include: </p>\n<p style=\"margin-left:72.75pt;\">\n ·       A clinical trial with almost 400 participants at the site to determine the efficacy of a switch to DTG-based ART from the standard PI/r-based ART for PLHIV on second-line ART</p>\n<p style=\"margin-left:72.75pt;\">\n ·       A clinical trial with over 300 participants evaluating the effectiveness of switching older PLHIV on first-line ART to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF)</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Optimizing Pediatric HAART Study</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya</p>\n<p style=\"margin-left:72.75pt;\">\n ·       Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic</p>\n<p style=\"margin-left:36.75pt;\">\n 5.     Training of undergraduate and postgraduate students in the departments of Clinical Medicine and Therapeutics and Pediatrics and Child Health at the University of Nairobi</p>\n<p style=\"margin-left:36.75pt;\">\n 6.     Adherence Counseling</p>\n<p style=\"margin-left:36.75pt;\">\n 7.     Nutritional Counseling</p>\n<p style=\"margin-left:36.75pt;\">\n 8.     Social Work Support</p>\n<p style=\"margin-left:36.75pt;\">\n 9.     Physiotherapy services</p>\n<p style=\"margin-left:36.75pt;\">\n 10.  Supportive Counseling</p>\n<p>\n  </p>\n<p>\n The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9,400 with 8,150 on first-line regimens and 1,230 on second-line regimens and 20 patients on third-line regimens. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the CCC. With the experience of the staff working in the CCC and the high number of patients including those with history of sub-optimal adherence to treatment and/or care, the KNH Comprehensive Care Centre is best suited to undertake this research study.</p>\n<p>\n <strong>CAPABILITY STATEMENT FOR JOOTRH TO CONDUCT CLINICAL RESEARCH</strong></p>\n<p>\n Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. </p>\n<p>\n The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). </p>\n<p>\n JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and Rift Valley with a population of more than 7 million people. It has a bed capacity of 530. </p>\n<p>\n The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. </p>\n<p>\n It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. </p>\n<p>\n The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as on 1st June 2019.</p>\n<p>\n JOOTRH Patient Support Centre (PSC) was started in the year 2002 and has ever enrolled approximately 28,000 clients. Current active on care is 6,842 by the end of June 2019. Total number of clients on first-line are 6,203, on second-line are 600, and 11 clients are on third-line. </p>\n<p>\n Out of the 154 staff employed by the CDC-funded implementing partner at the site, 39 are stationed at the PSC and 6 are MOH staff. There is 1 medical officer, 1 pharmacist, 8 nurses, 7 clinical officers, 3 pharmaceutical technologists, 2 social workers, 4 adherence councilors, 8 peer educators, 3 health records information officers, 5 data clerks, 1 nutritionist and 1 laboratory technician. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the PSC.</p>\n<p>\n The daily workload of the clinic is between 250 to 300 per regular clinic day (Monday, Tuesday and Friday) comprising adults 35 years old and above. 180 to 250 youths are seen on Wednesday (youth day age 20- 35 yrs) and 70 to 150 adolescents are seen on Thursdays.</p>\n<p>\n The CCC also runs viremia clinics for patient with high viral loads on first-line therapy every Wednesday while Fridays are reserved for clients failing second-line treatment.</p>\n<p>\n The medical officer is the in-charge of the clinic and works closely with the matron and the pharmacist in charge of the PSC Pharmacy. </p>\n<p>\n The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. </p>\n<p>\n JOOTRH is also the hub center for the regional Nyanza-Western technical working group meetings held every 2^nd Monday of the month. It is also the spokes hub for ECHO sessions held every Thursday at 3pm.</p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n The sites in South Africa are making a similar application to the South African Health Products Regulatory Authority. The sites in South Africa are Caprisa and Desmond Tutu.</p>\n
      • other_details_regulatory_approved<p>\n National Drug Authority in Uganda; Date of approval is 7th November 2022; Number of sites is 4 (Entebbe Hospital, Joint Clinical Research Centre in Lubowa, Joint Clinical Reserach Centre in Fort Portal, and Infectious Diseases Institute in Kampala)</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration3 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator2 NRTIs + DTG
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites2
      • multi_country_listUganda, South Africa and Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site80 at KNH and 80 at JOOTRH
      • total_participants_worldwide540
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_nameAchieng
      • investigator1_family_nameOmbajo
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants160
      • notification
      • approval_date14-03-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-01-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments responded to adequately.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-07-15 18:17:08
      • created2023-01-19 08:09:40
      • total_sites(null)
      • ecitizen_invoice321010
    • InvestigatorContact(array)
      • 0(array)
        • id882
        • application_id1212
        • given_nameLoice
        • middle_nameAchieng
        • family_nameOmbajo
        • qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
        • professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2023-01-19 08:42:43
        • modified2023-01-25 15:38:14
    • SiteDetail(array)
      • 0(array)
        • id1393
        • application_id1212
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressComprehensive Care Centre, Hospital Road, Nairobi
        • contact_detailsP.O. Box 20723 - 00202, Nairobi
        • contact_personDr Loice Achieng Ombajo
        • site_capacity(null)
        • misc(null)
        • created2023-01-19 08:42:43
        • modified2023-01-25 15:38:14
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1394
        • application_id1212
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressPatient Support Centre, Jomo Kenyatta Highway, Kaloleni, Kisumu
        • contact_detailsP.O. Box 849 - 40100, Kisumu
        • contact_personDr Florentius Ndinya
        • site_capacity(null)
        • misc(null)
        • created2023-01-19 10:31:11
        • modified2023-01-25 15:38:14
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id629
        • application_id1212
        • sponsorUniversity of Nairobi
        • sponsor_typeResearch Institution
        • contact_personProf Erastus Amayo
        • addressP.O. Box 19676 - 00202 Nairobi, Kenya
        • telephone_number+254204915041
        • fax_number
        • cell_number+254733611557
        • email_addresserastus.amayo@uonbi.ac.ke
        • created2023-01-19 08:42:43
        • modified2023-01-25 15:38:14
      • 1(array)
        • id633
        • application_id1212
        • sponsorLondon School of Hygiene and Tropical Medicine
        • sponsor_typeResearch Institution
        • contact_personFiona Cresswell
        • addressKeppel Street, London, WC1E 7HT, United Kingdom
        • telephone_number+44 (0)20 7636 8636
        • fax_number
        • cell_number+254769080859
        • email_addressFiona.Cresswell@lshtm.ac.uk
        • created2023-01-24 11:07:28
        • modified2023-01-25 15:38:14
  • 1(array)
    • Application(array)
      • id32
      • user_id38
      • trial_status_id8
      • abstract_of_study<p>\n ACTs are effective and today are considered by World Health Organization to be the best anti-malarials in terms of efficacy and a lower propensity to resistance. However, resistance to the recommended anti-malarial drugs has become a challenge and is a public health problem. Efforts are required to secure new therapies (single or in combination), which could be an alternative to standard treatment.</p>\n<p>\n The combination of AS and MQ, whether in loose or fixed combination, was the first of the artemisinin-based combinations, used extensively in Asia and Latin America, however there is very limited data on its efficacy and safety in young children in Africa.  ASMQ has a simple schedule of administration with single daily doses of one to two tablets per day according to an age-based categories, rather than weight. It is available on paediatric formulation and field-adapted packaging with 3 years of stability.</p>\n<p>\n  The proposed study will evaluate a new product, Farmanguinhos Artesunate-Mefloquine, a fixed-dosed combination of Artesunate-Mefloquine in the treatment of uncomplicated P. falciparum malaria and will also add to the scarce knowledge on efficacy, safety and pharmacokinetics of the combination in young children in Africa.  The target population in the study is under-5 children, the primary victims of malaria in the continent, with the highest burden of the disease, and which had been documented to have increased rates of vomiting with mefloquine monotherapy</p>\n
      • study_title<p>\n Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine Combination for the Treatment of Uncomplicated Falciparum Malaria in African Children versus Artemether-Lumefantrine</p>\n
      • laymans_summary(null)
      • short_titleASMQ Study
      • protocol_noECCT/10/11/03
      • version_noAmendment Version 2
      • date_of_protocol10-06-2011
      • study_drugASMQ
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameartesunate-mefloquine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicant+254722299438
      • declaration_date113-02-2013
      • declaration_principal_investigator+254733966065
      • declaration_date213-02-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n <ol>\n <li>\n Age between 6 to 59 months.</li>\n <li>\n Presence of acute uncomplicated <em>P. falciparum</em> mono-infection confirmed by:</li>\n </ol>\n <ol style=\"list-style-type: lower-alpha;\">\n <li>\n Axillary temperature ³37.5° C <strong>and,</strong></li>\n <li>\n Positive microscopy of <em>P. falciparum</em> with parasite density between 2,000 and 200,000 asexual parasites/µl</li>\n </ol>\n <ol>\n <li value=\"3\">\n Written informed consent from parent/guardian</li>\n </ol>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ul>\n <li>\n Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000</li>\n <li>\n Weight < 5kg</li>\n <li>\n Inability to tolerate oral medication (presence of any of the following danger signs: unable to drink or breastfeed, severe vomiting, recent history of convulsions, lethargic or unconscious state, unable to sit or stand up)</li>\n <li>\n Mixed Plasmodium infection.</li>\n <li>\n Presence of febrile conditions caused by diseases other than malaria.</li>\n <li>\n Known history of hypersensitivity, allergic or serious adverse reactions to Mefloquine, Quinine, Quinidine, Artesunate or other Artemisinins.</li>\n <li>\n History of use of any anti-malarial agent within 2 weeks prior to start of the study (except mefloquine and piperaquine within 4 weeks).</li>\n <li>\n Prior participation to a therapeutic trial within 3 months.</li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n Cure Rate as determined by PCR-corrected adequate clinical and parasitological response (ACPR) on Day 63.</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 1 Medical Doctor</p>\n<p>\n 1 Pharmacist</p>\n<p>\n 1 pharm technicians</p>\n<p>\n 3 Laboratory technicians</p>\n<p>\n 1 Clinical Research Coordinator</p>\n<p>\n 4 Nurses</p>\n<p>\n 1 Clinical Officers/Physician Assistants</p>\n<p>\n 3 Field Officers</p>\n
      • other_details_explanation<p>\n As stated in the study title, the objective of this study is to<span new=\"\" style=\"line-height: 115%; font-family: ;\" times=\"\"><font color=\"#000000\"> compare the efficacy and safety of the fixed-dose combination of ASMQ with AM-LM in under 5 children with uncomplicated falciparum malaria in <st1:place w:st=\"on\">Africa.</st1:place></font></span></p>\n<p>\n <span new=\"\" style=\"line-height: 115%; font-family: ;\" times=\"\"><font color=\"#000000\">This is an efficacy and safety study of uncomplicated Malaria treatment. There is no Malaria in the host country so it not possible to do such a study in the host country</font></span></p>\n
      • other_details_regulatory_notapproved<p>\n 0</p>\n
      • other_details_regulatory_approved<p>\n 0</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration63 days for each participant
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-Lumefantrine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThe Kenya Medical Research Institute (KEMRI), Kisumu, Kenya
      • single_site_physical_addressAlong Kisumu Nairobi Road adjacent Ahero Town
      • single_site_contact_personDr Bernhards Ogutu
      • single_site_telephone+254733812613
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listGhana\nKenya\nTanzania\nBukina Faso
      • data_monitoring_committeeYes
      • total_enrolment_per_site300
      • total_participants_worldwide940
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_nameOgutu
      • investigator1_family_nameRagama
      • investigator1_qualificationMBChB, MMed(Peds), PhD
      • investigator1_professional_address54-40100 Kisumu
      • investigator1_telephone+254733812613
      • investigator1_emailbogutu@wrp-ksm.org
      • organisations_transferred_No
      • number_participants400
      • notification
      • approval_date07-02-2011
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-11-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-02-10 00:29:27
      • created2013-02-13 13:15:44
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id22
        • application_id32
        • given_nameBearnhards
        • middle_nameOgutu
        • family_nameRagama
        • qualificationMBChB, MMed(Peds), PhD
        • professional_address54-40100 Kisumu
        • telephone+254733812613
        • emailbogutu@wrp-ksm.org
        • created2013-02-13 13:43:26
        • modified2013-11-03 19:04:28
    • SiteDetail(array)
      • 0(array)
        • id33
        • application_id32
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-02-13 13:43:26
        • modified2013-11-03 19:04:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id16
        • application_id32
        • sponsorDNDi, 15 Chemin Louis Dunant.
        • sponsor_type(null)
        • contact_personGwenaelle CARN
        • address1202 GENEVA Switzerland
        • telephone_number+41 22 906 9230
        • fax_number
        • cell_number+41 22 906 9230
        • email_addressgcarn@dndi.org
        • created2013-02-13 13:43:26
        • modified2013-11-03 19:04:28
  • 2(array)
    • Application(array)
      • id1389
      • user_id567
      • trial_status_id6
      • abstract_of_study<p>\n <strong>Background</strong></p>\n<p>\n Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression. However, they are associated with various adverse events including renal and bone disease, anemia, mitochondrial toxicity, and possible association with increased cardiovascular events. Data from the ongoing BFTAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more, hence the need for safe treatment options. Two drug regimens (2DR) have demonstrated non-inferiority to three drug regimens in patients who are treatment naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity, fewer adverse drug events and a lower drug burden.</p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years old or more.</p>\n<p>\n <strong>Methods</strong></p>\n<p>\n This is a phase 3b, multi-center, open-label, single arm clinical trial over 96 weeks. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH) and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels). A target of 240 participants from the ongoing BFTAF Elderly Switch Study will be enrolled. Eligible participants will be switched from B/F/TAF to DTG/3TC at enrollment and followed up for 96 weeks. The primary endpoint will be the proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48. Analysis of the primary endpoint will be performed for the ITT-E population using the FDA snapshot method.</p>\n<p>\n Data Management: The collection and processing of personal data from s enrolled in this study will be limited to those data that are necessary to investigate the primary and secondary objectives. These data will be collected using electronic Case Report Forms and processed with adequate precautions to ensure confidentiality and compliance with data privacy and protection laws and regulations</p>\n<p>\n <strong>Study Utility</strong></p>\n<p>\n The Kenyan national HIV program currently recommends tenofovir disoproxil fumarate (TDF) as the preferred nucleoside reverse transcriptase inhibitor (NRTI). TDF is associated with both renal and bone toxicity and in the absence of safer tenofovir pro-drugs such as tenofovir alafenamide (TAF), it is important to consider regimens that exclude the toxic NTRIs such as the two-drug regimen of lamivudine and dolutegravir, especially in populations that are at risk of multiple comorbidities. This will provide useful data to inform policy and programming.</p>\n
      • study_title<p>\n Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya</p>\n
      • laymans_summary<p align=\"center\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: center; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya</span></strong><span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"> <o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Background: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">The standard treatment for HIV comprises three or four drugs in order to achieve viral suppression. However, the use of some of these drugs may affect the kidneys, bone and other body systems. For example, an ongoing study in Kenya has demonstrated high rates of kidney and bone disease in older persons living with HIV aged 60 years old or more.<o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Recent studies have shown that two-drug regimens such as a combination of dolutegravir (DTG) and lamivudine (3TC) may achieve the same rates of viral suppression after switching from other treatment regimens containing three drugs. The use of a two-drug regimen means that there will be a lower drug burden that may have less harmful effects including improving bone health and kidney function.</span><span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"> </span><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p style=\"margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Objective: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">The purpose of the study is to determine whether older persons living with HIV (60 years old or above) who are currently virally suppressed on their first line antiretroviral regimen containing bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) can safely be switched to a two-drug regimen of dolutegravir (DTG) and lamivudine (3TC).<o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Participants and Methods: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">We will enroll 240 participants in two sites in Kenya: Kenyatta National Hospital in Nairobi and Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu. After providing written informed consent, participants will be evaluated for eligibility. Those who are enrlled will have their treatment regimen changed to a combined pill containing DTG and 3TC taken once daily for the duration of the study. Thereafter, each person will be followed up for 96 weeks (about two years). All participants will have scheduled visits at weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96. During follow-up, the amount of HIV virus in blood will be checked alongside other laboratory and radiological tests assessing for safety.<o:p></o:p></span></p>\n
      • short_titleB/F/TAF to DTG/3TC Switch Stud
      • protocol_noECCT/24/04/01
      • version_no1.2
      • date_of_protocol07-03-2024
      • study_drugDolutegravir (DTG) and Lamivudine (3TC)
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameAvridela
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Loice Achieng Ombajo
      • declaration_date103-04-2024
      • declaration_principal_investigatorDr Loice Achieng Ombajo
      • declaration_date203-04-2024
      • placebo_presentNo
      • study_objectives<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">Primary Objective</span></b></span><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></b></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the maintenance of virologic suppression of DTG/3TC at Week 48 post-switch from BIC/FTC/TAF</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"None\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"> </span></span></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">Secondary Objectives</span></b></span><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></b></p>\n<ul>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the antiviral activity, immunologic effects, and incidence of disease progression (HIV-associated conditions, AIDS and death) of DTG/3TC over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess viral resistance in participants experiencing protocol-defined virologic failure over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the safety and tolerability of DTG/3TC over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the efficacy and immunologic response of DTG/3TC by participant characteristics subgroups (e.g., demographic factors, Baseline CD4, CD4 nadir) and pre-specified target population (≥65 years old, CV risk, women, co-medication) over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate renal (in urine and blood) biomarkers over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate cardiovascular risk over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate fasting lipids over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate weight and body morphology evolution over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess health-related quality of life</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess patient treatment satisfaction</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Able and willing to understand and comply with the protocol requirements, instructions and restrictions</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Able and willing to give informed consent</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study.  Participant should be on B/F/TAF until day 1 of entry into the current study</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)</span></span></p>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load < 50 copies/ml</li>\n <li>\n Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative (see Section 5.2. under Prohibited medications and non-drug therapies)</li>\n <li>\n Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:\n <ul>\n <li>\n a) Participants positive for HBsAg are excluded;</li>\n <li>\n b) Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;</li>\n <li>\n c) Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.</li>\n </ul>\n </li>\n <li>\n Has AST and/or ALT at least 5-times greater than the upper limit of normal</li>\n <li>\n Severe hepatic impairment (Class C) as determined by Child-Pugh classification</li>\n <li>\n Has a CrCl below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)</li>\n <li>\n Documented opportunistic infection within 4 weeks prior to the study enrolment</li>\n <li>\n Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study</li>\n <li>\n Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.</li>\n <li>\n History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.</li>\n <li>\n Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.</li>\n <li>\n Participants who in the investigator’s judgment, poses a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk</li>\n <li>\n Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation</li>\n</ol>\n<div>\n  </div>\n
      • primary_end_points<p>\n Participants with plasma HIV-1 RNA ≥ 50 copies/mL (snapshot algorithm) at week 48</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" times=\"\">\n <strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</span></strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Kenyatta National Hospital Comprehensive Care Centre (CCC) was established in December 2002 as the pioneer care and treatment centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS), Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs, and the Center for International Health, Education, and Biosecurity (CIHEB) - Kenya. It has evolved over time to be a centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC offers a one-stop-shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> The services offered at the Comprehensive Care Centre include the following:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">1.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co-morbidities<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">2.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Anti-Retroviral Therapy both 1^st line; 2^nd line and 3^rd line regimens as per the WHO guidelines<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">3.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Laboratory monitoring and evaluation of the patients - The centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">a.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Flow Cytometry <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">b.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Hematology <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">c.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Chemistry <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">d.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">TB Diagnosis <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">e.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">HIV EID <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">f.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">HIV Viral Load <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">4.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Research: Since its inception the centre has actively been involved in research which has informed HIV/AIDS national policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with international partners include: <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">a.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">A clinical trial with almost 400 participants at the site to determine the efficacy of a switch to DTG-based ART from the standard PI/r-based ART for PLHIV on second-line ART<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">b.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">A clinical trial with over 300 participants evaluating the effectiveness of switching older PLHIV on first-line ART to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF)<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">c.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">d.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Optimizing Pediatric HAART Study<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">e.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">f.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">g.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">h.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">5.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Training of undergraduate and postgraduate students in the departments of Clinical Medicine and Therapeutics and Pediatrics and Child Health at the University of Nairobi<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">6.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Adherence Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">7.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Nutritional Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">8.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Social Work Support<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">9.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Physiotherapy services<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">10.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">    </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Supportive Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9,400 with 8,150 on first-line regimens and 1,230 on second-line regimens and 20 patients on third-line regimens. There are 4 co-investigators in the B/F/TAF to 2DR Switch Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the CCC. The site currently has 138 PWH aged 60 years or older on B/F/TAF.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> </span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">CAPABILITY STATEMENT FOR JOOTRH TO CONDUCT CLINICAL RESEARCH</span></strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and Rift Valley with a population of more than 7 million people. It has a bed capacity of 530. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as on 1st June 2019.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH Patient Support Centre (PSC) was started in the year 2002 and has ever enrolled approximately 28,000 clients. Current active on care is 6,842 by the end of June 2019. Total number of clients on first-line are 6,203, on second-line are 600, and 11 clients are on third-line. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Out of the 154 staff employed by the CDC-funded implementing partner at the site, 39 are stationed at the PSC and 6 are MOH staff. There is 1 medical officer, 1 pharmacist, 8 nurses, 7 clinical officers, 3 pharmaceutical technologists, 2 social workers, 4 adherence councilors, 8 peer educators, 3 health records information officers, 5 data clerks, 1 nutritionist and 1 laboratory technician. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the PSC.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The daily workload of the clinic is between 250 to 300 per regular clinic day (Monday, Tuesday and Friday) comprising adults 35 years old and above. 180 to 250 youths are seen on Wednesday (youth day age 20- 35 yrs) and 70 to 150 adolescents are seen on Thursdays.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC also runs viremia clinics for patient with high viral loads on first-line therapy every Wednesday while Fridays are reserved for clients failing second-line treatment.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The medical officer is the in-charge of the clinic and works closely with the matron and the pharmacist in charge of the PSC Pharmacy. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH is also the hub center for the regional Nyanza-Western technical working group meetings held every 2^nd Monday of the month. It is also the spokes hub for ECHO sessions held every Thursday at 3pm.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">There are 4 co-investigators in the B/F/TAF to 2DR Switch Study who are based at the site and 3 site-based study staff (2 study nurse/counsellors and a study clinical officer) have been engaged and are currently working at the CCC. The site currently has 105 PWH aged 60 years or older on B/F/TAF.<o:p></o:p></span></p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2.5 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site105 at JOOTRH and 135 in KNH
      • total_participants_worldwide240
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_nameAchieng
      • investigator1_family_nameOmbajo
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_professional_addressMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants240
      • notification
      • approval_date02-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-04-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed adequately.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-07-07 11:12:43
      • created2024-03-14 10:26:11
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1049
        • application_id1389
        • given_nameLoice
        • middle_nameAchieng
        • family_nameOmbajo
        • qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
        • professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
    • SiteDetail(array)
      • 0(array)
        • id1685
        • application_id1389
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressPatient Support Centre, Jomo Kenyatta Highway, Kaloleni, Kisumu
        • contact_detailsP.O. Box 849 - 40100, Kisumu
        • contact_personDr Florentius Ndinya
        • site_capacity(null)
        • misc(null)
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1686
        • application_id1389
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressComprehensive Care Centre, Hospital Road, Nairobi
        • contact_detailsP.O. Box 20723 - 00202, Nairobi
        • contact_personDr Loice Achieng Ombajo
        • site_capacity(null)
        • misc(null)
        • created2024-03-14 11:48:06
        • modified2024-04-03 13:18:57
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id733
        • application_id1389
        • sponsorUniversity of Niarobi
        • sponsor_typeResearch Institution
        • contact_personProf Erastus Amayo
        • addressP.O. Box 19676 - 00202 Nairobi, Kenya
        • telephone_number+254204915041
        • fax_number
        • cell_number+254733611557
        • email_addresserastus.amayo@uonbi.ac.ke
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
  • 3(array)
    • Application(array)
      • id278
      • user_id127
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong> According to KDHS 2008/9 the under 5-mortality rate has dropped from 115 per 1000 in 2003 KDHS, to 74 per 1000 in 2008, this represents an annual decline rate of 0.9%. Unless this rate is accelerated to at least 4.5%, Kenya is unlikely to meet MDG 4 by 2015. Integrated community case management (iCCM) coupled together with the administration of vitamin A supplements (VAS), is an important and viable option of reducing the mortality of children under the age of five <em>due to pneumonia, malaria and diarrhea</em>. Implementation of the iCCM in Kenya still remains inadequate. The main challenges to implementation include: inadequate training among the CHWs including little follow up post training in iCCM.</p>\n<p>\n <strong>The main objective</strong> is to determine whether trained, supervised and well supplied community health workers in hard to reach areas such as Homabay County can administer Vitamin A Supplements (VAS) and correctly perform iCCM and increase the proportion of children under five years receiving antibiotics for pneumonia, artementher-lumefantrine for malaria and zinc and oral rehydration therapy for diarrhoea by 20% compared to the baseline. On the other hand, despite efforts to improve vitamin A status among children through supplementation, advocacy for dietary diversification, bio fortification, industrial and home fortification of essential food commodities, VAD still remains a major public health problem in Kenya.  Studies have shown that about 42% of children under the age of five years in Sub Saharan Africa are at risk of VAD with Kenya at 76%. Achievement of Millennium Development Goal 4 of reducing under five mortality by two third by 2015, requires addressing or enhancing factors that contribute to child survival and development. Such factors include vitamin A supplementation and the integration of iCCM which will go a long way in reducing both maternal and child deaths.</p>\n<p>\n <strong>Methodology: </strong>The study will employ a pre and post design to compare iCCM and VAS health and process outcomes in Homabay County in Nyanza Province, Kenya during the intervention period, with those during a pre-intervention period. We will implement iCCM and VAS in a stepwise manner using a four-prong approach. The four prongs are 1) Sensitization of national, district, health center and community teams on iCCM and VAS 2) Training of the Community Health Extension Workers (CHEWS), CHWs and health care workers 3) Supervision and motivation of CHWs and 4) Commodity provision and accountability.</p>\n
      • study_title<p>\n Evaluating integrated community case management of pneumonia, malaria and diarrhoea among children under 5 years in Homabay County, Kenya.</p>\n
      • laymans_summary(null)
      • short_title Integrated community case management
      • protocol_noECCT/14/02/02
      • version_no1.4
      • date_of_protocol19-12-2013
      • study_drugAmoxicillin dispersible tablets [New formulation]
      • disease_conditionPneumonia
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameAmoxicillin dispersible tablets
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmaricianah@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPO BOX 614-40100 Kisumu, Tel No. +254 732 390 992 email: maricianah@yahoo.com
      • declaration_date123-02-2014
      • declaration_principal_investigatorDr. Onono Maricianah - Principal Investigator
      • declaration_date223-02-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n -Children aged 2months- 5 years<br />\n -Children suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • principal_exclusion_criteria<p>\n -Adults<br />\n -Children less than 2 months or over 5 years</p>\n<p>\n Children not suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • primary_end_points<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"732\">\n <tbody>\n <tr>\n <td style=\"width:160px;height:14px;\">\n <p>\n <strong>Primary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Proportion of children under 5 years with pneumonia who receive appropriate antibiotic treatment, compared to baseline</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:70px;\">\n <p>\n Proportion of CHWs who are able to rationally use antibiotics for treatment of pneumonia</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:83px;\">\n <p>\n Proportion of CHWs who appropriately account for supplied commodities</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use antimalarials</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use ORS and zinc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of mothers of children under 5 years who have symptoms of pneumonia or malaria who seek care from an appropriate provider</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children aged 6 to 59 months who received VAS on a semi-annual basis.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to correctly administer VAS, defined as giving vitamin A supplementation to children aged 6 to 59 months on a semi-annual basis in the County</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n <strong>Secondary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children treated for pneumonia who do not respond to treatment (experience treatment failure or relapse</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <br />\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Dr. Onono Maricianah:</strong> M.B.Ch.B, MSc Clinical Research  Global Health Fellowship- Principal Investigator<br />\n <strong>Dr. Bukusi Elizabeth:</strong> MBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics) - Co-Investigator<br />\n <strong>Akama Eliud:</strong> BSc, Diploma Community Health Nursing - Co-Investigator<br />\n <strong>Owuor Kevin</strong>: MSc Research Methods, BSc. Statistics - Co-Investigator/Statistician</p>\n<p>\n  </p>\n<p>\n <strong>Strength of the research team and f</strong><strong>easibility of project completion: </strong>The researchers in the study are part of the Kenya Medical Research Institute (KEMRI). Kenya Medical Research Institute (KEMRI) is a state corporation responsible for carrying out health research in Kenya. Since it's inception, KEMRI has developed a critical mass of scientists and technical personnel, to enable it mount a competitive research infrastructure to rank as a leading centre of excellence in health research both in Africa as well as globally. The researchers on this project have experience working in Nyanza province, specifically the Mbita district, in collaboration with the Ministries of Health in implementing a large scale HIV/AIDS program – the Family AIDS Care and Education Services (FACES). KEMRI will build on its experience and institutional knowledge gained from working in Homabay County. In Homabay County, KEMRI has over the years: 1) spearheaded community mobilization and built community linkages in alignment with the Government of Kenya (GoK) Community Strategy; 2) achieved rapid decentralization of services in underserved communities through family-based comprehensive HIV service provision; 3) improved the health system capacity in Mbita through training, mentorship, ongoing supervision, lab and pharmacy support, and logistics development; 4) successfully conducted clinical research including Microbicide research in partnership with the International Partnership for Microbicides (IPM); 5) established partnerships with GoK and other local institutions working in the area; and 6) attracted philanthropic support to help fund projects in the area e.g. the construction of the Comprehensive Care Clinic in Sindo District hospital (Steinberg building) and the Kar Geno Centre, Suba.7) Established the Fishermen hotline that allows the fishermen to dial in to be referred to the nearest health facilities providing antiretroviral therapy and the  <em>Uliza!</em> clinicians’ hotline hosted by Safaricom. The <em>Uliza!</em> hotline provides an opportunity for care providers in the periphery to call and receive mentorship from qualified medical doctors in the care of HIV patients. 8) KEMRI has already developed a robotic text messaging software built upon the RapidSMS platform. The software has been extensively tested and refined for the automated delivery of pre-defined text messages at specified times and in any preferred language. The proposed will use a similar platform and benefit from the expertise acquired.</p>\n<p>\n <strong>Organization</strong></p>\n<p>\n The study will have a study coordinator (clinical) and assistant coordinator (nutritionist), monitoring and evaluation specialist and a programmer. There will also be 6 sub-county coordinators in charge of the 6 sub counties in Homabay county. Further the study will employ 21 diploma nurses to do follow up for all pneumonia cases seen in the community</p>\n<p>\n The study will utilise existing community units in Homabay county. The community units must be actively reporting on a monthly basis as per records from the county health management team.</p>\n<p>\n The study will have a hotline number +254734919191 in which every time a community health worker sees a suspected pneumonia case, s/he will send a message which will trigger systems for the case to be verified by a trained nurse</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n<p>\n The trial will be conducted in Kenya which is the host country of the applicant. Both WHO and UNICEF which are the sponsors have country offices in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n -Kenya Medical Research Institute Ethical Research Committee (KEMRI- ERC) 21st May 2013 Homabay County</p>\n<p>\n <br />\n -World Health Organisation Research Ethics Review Committee (WHO ERC) 6th January 2014 Homabay County</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration24 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHomabay County
      • single_site_physical_addressLumumba Health Center, Agoi Street, PO BOX 614-40100 Kisumu-Kenya
      • single_site_contact_personDr. Maricianah Onono
      • single_site_telephone+254 732 390 992
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site888
      • total_participants_worldwideN/A
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren under 5years.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB MMed OBGYN MPH PHD
      • investigator1_professional_addressP.O Box 19464- 00202 ,Nairobi
      • investigator1_telephone+254 720 617 503
      • investigator1_emailebukusi@kemri.org
      • organisations_transferred_Yes
      • number_participants888
      • notification<p>\n Dear Reviewers</p>\n<p>\n Rationale for Amoxicillin Dispersible Tablets (DTs) for Pneumonia in children</p>\n<p>\n The overall study is designed to determine whether CHWs can correctly diagnose pneumonia and treat them using Amoxicillin (suspension or dispersible tablets). As investigators we felt that given the evidence already existing for DTs that within the context of this implementation research project, we were best placed to use this amoxicillin DTs as they became available and measure outcomes at day 4 and 6 as per protocol. Currently the trained CHWs are already diagnosing and treating diarrhoea and malaria using Zinc DTs and Coartem DTs. They are also successfully diagnosing and treating pneumonia using Amoxicillin suspension in the community. A total of 192 children have been diagnosed and treated adn treatment confirmed by trained nurses. Given the success in use of DTs and in diagnosing and treating pneumonia, we believe now is the time to introduce the Amoxicllin DTs.</p>\n<p>\n Tablets and capsules can be difficult to swallow, and if perceived as bitter or unpleasant are often refused by childrenespecially when ill (WHO 2008). To overcome these problems, many paediatric medicines are given as liquid suspensions or syrups, with the taste masked by fruity or sweet flavourings. Effective drug administration in children requires formulations which allow for accurate weight or age- based dosing. With syrups and suspensions this is often done as full, half, or quarter spoonfuls, which has been shown to be inaccurate (Grießmann 2007). An alternative is to dispense measured syringes alongside medications. In a position statement on the preferred dosage forms for use in children, the World Health Organization now recommend that where available dispersible tablets should be chosen above suspensions due to advantages in dosing, storage, and transportation (WHO 2009). Dispersible amoxicillin has been identified as a priority medicine for the treatment of pneumonia; formulated as scored tablets of 250mg and 500mg, and packaged in blister packs of 10 (WHO/UNICEF 2010a ). Dispersible amoxicillin offers significant benefits over suspensions in terms of cost, product stability and ease of transport. Further, dispersable tablets have other advantages over the suspension such as 1) Dose accuracy: Dosing of liquids by spoon is unreliable. 2) Storage: Long shelf-life and no need for refridgeration 3) Transport: Less bulky and less susceptible to high temperatures. Paediatric dispersible tablets are already in use in Kenya for malaria, and well tolerated. Additionaly, based on WHO price lists, dispersible tablets could represent a cost saving compared to suspensions. (WHO/UNICEF 2010b).</p>\n<p>\n <strong>References</strong></p>\n<p>\n WHO 2008. The pathway to better medicines for children. 2008. Available at: http://www.who.int/childmedicines/Pathway.pdf</p>\n<p>\n Grießmann K, Breitkreutz J, Schubert-Zsilavecz et al. Dosing accuracy of measuring devices provided with antibiotic  oral suspensions. <em>Paediatric and Perinatal Drug Therapy</em><em>. </em>2007; <strong>8: </strong>61-70.</p>\n<p>\n <em>WHO technical report series; 958</em><em>. </em><em>The selection and use of essential medicines: report of the WHO Expert Committee, March 2009</em>. Geneva, World Health Organization, 2009.</p>\n<p>\n WHO/UNICEF 2010a. Priority essential medicines for child survival. 2010. Available at: http://www.who.int/childmedicines/progress/Unicef_prioriry_meds_child_survival.pdf</p>\n<p>\n WHO/UNICEF 2010b. Sources and prices of selected medicines for children including therapeutic food, dietary vitamin and mineral supplementation. 2010. Second edition. Available at: http://www.who.int/medicines/publications/essentialmedicines/Sources_Prices2010.pdf</p>\n
      • approval_date21-05-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n  </p>\n<h1>\n Operationalization of integrated community case management in Homabay County, Kenya</h1>\n<h1>\n Executive summary</h1>\n<p>\n In a Kenya Ministry of Health and WHO-supported exercise in 2011, Kenyan experts (academics, clinicians and policy-makers) generated and systematically scored research questions for maternal, newborn and child health interventions to reduce child mortality in Kenya using Child Health and Nutrition Research Initiative methodology. During this exerciseintegrated community case management (iCCM), which included pneumonia home case management was identified as a top priority for research in Kenya. To address this gap, in 2013, the Ministry of Health mandated the Kenya Medical Research Institute (KEMRI) with support from UNICEF and WHO to demonstrate the feasibility and effectiveness of training Community health workers (CHWs) and supplying them with Oral Rehydration Salts (ORS), zinc, rapid diagnostic tests (RDTs) for malaria, artemether-lumefantrin (AL) and amoxicillin to treat diarrhoea, malaria and pneumonia at the community level as envisaged in iCCM. This report describes the implementation strategies, processes and outcomes of an iCCM programme in Homabay County in western Kenya as part of large-scale countywide implementation. In addition, the report examines: i) concordance in identification and classification of lower chest indrawing between CHWs and nurses; ii) acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets versus oral suspension in treatment of children aged 2-59 months with pneumonia; iii)patient level costs of treating childhood pneumonia at home versus in the health facility; iv) quality of care provided by facility based health care workers vs. community health workers for pneumonia in sick children under 5 years; and v) the association between adherence and multiple drug prescription for pneumonia, malaria and diarrheal in children under five years of age by CHWs</p>\n<p>\n  </p>\n<p>\n <strong>Methods: </strong></p>\n<p>\n This was a prospective observational implementation research project. CHWs in Homabay County, Kenya were trained, equipped and supervised to implement iCCM for sick children aged 2-59 months. Implementation was conducted using a five-pronged approach which involved: i) sensitization of national, county, sub-county, health facility and community teams; ii) training of CHWs, community health extension workers and health care workers; iii) commodity provision and accountability; iv) supervision of CHWs; and v) monitoring and evaluation. Mobile phones were used to ascertain correct management of pneumonia by CHWs, monitoring and evaluation of service level statistics and commodity tracking.</p>\n<p>\n <strong>Key findings:</strong></p>\n<p>\n <strong>Service level statistics: </strong>A total of 2604 CHWs and 200 community health extension workers (CHEWs) from 242 community units received training in iCCM. Between October 2013 and March 2015, 170 079 children were assessed and classified by the CHWs. CHWs treated 11 693 pneumonia, 9869 malaria and 26 713 diarrhoea cases in the community, referred 8906 children to a health facility for immunization, and gave age-appropriate doses of vitamin A supplementation to 137 585 children. </p>\n<p>\n <strong>Concordance in identification and classification of lower chest indrawing pneumonia between CHWs and nurses:</strong>CHWs were able to identify, classify and treat lower chest in-drawing pneumonia in children aged 2-59 months with a five-day course of oral amoxicillin with low treatment failure rates in a real programme setting in Kenya. The concordance for classification of lower chest indrawing between CHWs and nurses was high (88.7% agreement) and the observed treatment failure rate was low (2.1%). The concordance for classification of fast breathing pneumonia between CHWs and nurses was high (97% agreement) with an inter-rater difference of only 2 breaths/count.  CHWs were more likely to misclassify lower chest indrawing in children with co-morbidities such as malaria and diarrhoea, those with moderate malnutrition or those whose caregivers delayed care seeking. This subset of children likely represents sicker children for whom extra care is needed in disease assessment and classification. </p>\n<p>\n <strong>Acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets:</strong>When compared to Amoxicillin oral suspension, Amoxicillin dispersible tablets had better treatment adherence among the sick children. Amoxicillin dispersible tables were also just as acceptable and as effective as the amoxicillin oral suspension in the treatment of pneumonia in children aged 2-59 months.</p>\n<p>\n <strong>Perceived quality of care provided by facility based health care workers vs. CHWs for pneumonia in sick children under 5 years: </strong>Caregivers rated the quality of CHW provided home-based management for childhood pneumonia to be higher than facility based health workers (FBHW) provided care.  We used the Primary Care Assessment Survey (PCAS), a patient-completed questionnaire that operationalizes formal definitions of primary care. The PCAS measures seven domains of care through 11 summary scales: accessibility (organizational, financial), continuity (longitudinal, visit-based), comprehensiveness (contextual knowledge of patient, preventive counseling), integration, clinical interaction (clinician-patient communication, thoroughness of physical examinations), interpersonal treatment, and trust.</p>\n<p>\n Caregivers rated CHWs higher in regards to ease of access (geographic and financial). This is likely because of both the spatial distribution of CHWs, as they live in the community and therefore are closer to clients, and the fact that CHWs don’t charge user fees for care or medications. CHWs were rated more highly than FBHWs in their ability to communicate with caregivers and instill trust. Patients answered positively when asked about the integrity, friendliness and support in decision-making by CHWs. Even in regards to clinical skills, the area in which FBHWs have a clear advantage, caregivers rated CHWs and FBHWs equally. One explanation could be that CHWs simply spend more time with the patients and are therefore able to perform a more thorough evaluation. In terms of overall satisfaction, CHWs were preferred to FBHWs when examining either a self-reported satisfaction score or a summary score that was calculated as the mean across all PCAS domains indicating acceptability</p>\n<p>\n <strong>Patient level costs of treating childhood pneumonia at home versus in the health facility. </strong>The estimated costs associated with treatment of a pneumonia episode in under-five children can be divided into direct and indirect out-of-pocket expenses incurred by the household for an episode of pneumonia.Direct medical costs are the actual amount paid by the households for consultation, investigations such as radiology, hospital admissions and medicines. Direct non-medical costs are incurred for transportation and meals for caregivers at the health facility. Indirect costs are the opportunity cost of caregiver time and fore gone wages during the time of seeking care for the child.The average total household cost of treatment of pneumonia was KSh. 194.36($2.04) and KSh 2201.64 ($23.18) for the caregivers that sort care from the CHW and health facility respectively. This is an 11-fold difference in cost of treatment. The cost of treatment of pneumonia has significant influence on subsequent health seeking behaviour as caregivers tend to subsequently seek care where it’s deemed cheaper for them. </p>\n<p>\n <strong>Effect of multiple drug prescription for pneumonia, malaria and diarrhoea on adherence in children under five years of age by CHWs: </strong>Among children classified as having pneumonia plus additional diarrhoea and or malaria, the treatment with combinations of anti-malarial, antibiotics and/ORS and zinc sulphate did not lower adherence compared to antibiotic alone. In addition, there was no difference in treatment failure in the two arms. </p>\n<p>\n  </p>\n<p>\n It is anticipated that with the evidence provided by this project, the Kenyan Ministry of health as well as the county health management teams will begin to adopt these practical solutions for iCCM regarding training, supplies and supervision.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Summary of recommendations:  </strong></p>\n<p>\n This large-scale implementation of iCCM in Homabay demonstrated practical approaches and models of providing services, linking community and health facility commodity management and strengthening the capacity of CHWs to manage common childhood illnesses in a community setting. The project established that when CHWs are trained, supervised and supported, they are able to have adequate knowledge, skills and competency to provide quality services including treatment of sick children. </p>\n<p>\n             The experience of this implementation project has important implications for expansion of iCCM in Kenya. We propose the following recommendations </p>\n<p style=\"margin-left:.25in;\">\n 1.    CHWs in this project demonstrated high competency rates and outranked facility based health care workers in terms of perceived quality of care and overall satisfaction. We therefore recommend that CHWs and iCCM be a key component of increasing access to treatment of childhood illnesses such as diarrhoea malaria and pneumonia to address child survival in Kenya </p>\n<p style=\"margin-left:.25in;\">\n 2.    Mechanisms of performance review and clinical accreditation of skills after basic training are needed in order to produce and maintain competency among CHWs; </p>\n<p style=\"margin-left:.25in;\">\n 3.    Availability of commodities to CHWs coupled with strong health facility-community linkages are crucial to success.</p>\n<p style=\"margin-left:.25in;\">\n 4.    Because CHWs experienced some challenge in classification of sicker children particularly those with moderate malnutrition, training curricula, needs to emphasize prompt identification and referral for all cases of moderate and severe malnutrition. CHWs should be able to identify and refer children with any danger sign and those with malnutrition. Additionally, caregivers need to be educated and motivated to seek appropriate care early</p>\n<p style=\"margin-left:.25in;\">\n 5.    Given the higher adherence rates and equivalence in effectiveness and acceptability, we recommend that Amoxicillin dispersible tablet be preferentially prescribed over the oral suspension for the treatment of pneumonia in children aged 2-59 months.</p>\n<p style=\"margin-left:.25in;\">\n 6.    Given that the household costs of iCCM of pneumonia were eleven times lower than facility based pneumonia treatment, we recommend the scale up of pneumonia treatment with oral amoxicillin at community level. Pneumonia home case management can significantly reduce household cost, improve access and better treatment outcomes to the underprivileged population, preventing many child deaths. It also has potential to decrease economic burden on the families besides decreasing pressure and cost on the already overburdened public health system.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-15 16:39:47
      • created2014-02-23 05:46:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id194
        • application_id278
        • given_nameMaricianah
        • middle_nameAtieno
        • family_nameOnono
        • qualificationMBChB MSC-Clinical Research Global health fellowship
        • professional_addressP.O Box 614 Postal Code 40100, Kisumu-Kenya
        • telephone+254 732 390 992
        • emailmaricianah@yahoo.com
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
    • SiteDetail(array)
      • 0(array)
        • id240
        • application_id278
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id152
        • application_id278
        • sponsorUNICEF
        • sponsor_type(null)
        • contact_personDr. Ketema Aschenaki Bizuneh
        • addressUNICEF, Kenya Country Office, P.O. Box 44145-00100,
        • telephone_number254 (20) 762 2209
        • fax_number254 (20) 762 27 46
        • cell_number+254 719 390 115
        • email_addresskbizuneh@unicef.org
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
      • 1(array)
        • id153
        • application_id278
        • sponsorWorld Health Organization
        • sponsor_type(null)
        • contact_personDr. Shamim Qazi
        • address20 Avenue Appia, Geneva 27, 1211 Switzerland
        • telephone_number(+41-22) 791-2547
        • fax_number(+41-22) 791-4853
        • cell_number(+41-22) 791-2547
        • email_addressqazis@who.int
        • created2014-02-23 06:06:38
        • modified2014-02-23 08:35:23
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    • Application(array)
      • id1518
      • user_id729
      • trial_status_id(null)
      • abstract_of_study<div>\n In a phase 2 clinical trial performed in Vietnam, 400 mg imatinib mesylate (IM) in combination with the standard of care (SOC), which at the time was 120 mg dihydroartemisinin (DHA) and 960 mg piperaquine (PPQ) per day, was shown to be safe and well tolerated in male patients aged 16-55, infected with P. falciparum malaria. Additionally, IM+DHA+PPQ was shown to reduce the parasite density and pyrexia in patients infected with P. falciparum malaria faster than in patients treated with the SOC (DHA+PPQ) alone.</div>\n<div>\n This protocol will expand upon the initial results obtained in Vietnam, to evaluate the safety, tolerability, and efficacy of the use of the combination of Artemether + Lumefantrine + Imatinib mesylate (ALIM), and its ability to eliminate the parasites after 2 days of dosing in Kenya. It shall also evaluate this triple combination in a broader age group, compared to the initial trials, to eventually include a 12-60 months children age group which together with the 1-5yr age group are the most affected by malaria morbidity and mortality, accounting for 80% of the burden.</div>\n<div>\n The implementation of the study shall be in three incremental parts:</div>\n<div>\n Part 1: This shall be an adaptive trial design that will seek to ensure no serious adverse events occur when IM is added to the SOC (AL) during the standard 3 days of dosing and the adequate dose, if possible, that can effectively treat malaria in a 2 dose regimen. During this part of the trial, study participants will be followed-up over 35 days, to determine adequate clinical and parasitic response. IM dosing will begin at 600mg/day in cohort 2a for three days. If no parasites are observed via microscopy/PCR corrected analysis between days 7 and 35 (i.e., no recrudescence), then 600mg IM + AL will be administered for only 2 days in cohort 2b and recrudescence determined on samples collected between days 7- and 35-days post admission. If no significant increase in recrudescence is observed, then the dose of imatinib will be reduced to 400mg/day and the procedure will be repeated. However, if parasites are detected in the initial 600mg/day group or a significant increase in recrudescence is observed after 2-day dosing, the dose of IM will be escalated to 800mg/day.</div>\n<div>\n Part 2: The amount of IM that eliminates all viable parasites after 2 days of dosing will have been identified in the previous Part 1. Using this dose, a larger sample of 516 participants above the age of 18 years will be split evenly between three groups: a control (AL for 3 days), a cohort 1 (AL+IM for 3 days) and a cohort 2 (AL+IM for 2 days). This part of the trial will confirm the effectiveness in larger numbers.</div>\n<div>\n Part 3: Based upon the proven efficacy of ALIM in adults, an age de-escalation, dose escalation trial shall evaluate the safety, tolerability and efficacy of ALIM in the following age groups:</div>\n<div>\n -10-17yrs age group</div>\n<div>\n -5-9yrs age group</div>\n<div>\n -12-60 months age group</div>\n<div>\n In each of these age groups cohorts, we shall recruit 90-150 children, which shall include 30 participants on the SOC (AL for 3 days), an intervention group (30 participants) on treatment for 3 days receiving the standard dose of AL (calculated by weight) with IM at a lower dose of 260mg/m2/day, and another group (30 participants) on the AL+IM treatment for 2 days. If after 35 days of follow up malaria parasites are found, we shall recruit another intervention cohort on treatment for 2 days that will receive AL + IM at a higher dose of 340 mg/m2/day.</div>\n<div>\n <div>\n In all three parts of the study, measurements such as parasite density, body temperature, and adverse events will also be collected at the time intervals as indicated in the study methodology section.</div>\n <div>\n All trial activities and associated tests will be performed using site SOPs and internationally accepted guidelines. </div>\n</div>\n
      • study_title<p>\n Evaluating the safety and efficacy of Imatinib in combination with Artemether and Lumefantrine for the treatment of Uncomplicated Malaria: a three-part trial.</p>\n
      • laymans_summary<div>\n 1.Why should you do this study?</div>\n<div>\n Treatment options for malaria are continuously being challenged. The P. falciparum parasite has been found to take longer to eliminate during the standard three-day treatment, and in some cases be totally resistant to medication, even Artemisinin combined therapies (ACT), which are currently the gold standard of treatment. An initial trial in Vietnam found that the drug Imatinib, when used in combination with ACT, greatly improved the treatment of malaria, eliminating the parasite and improving the fever experienced by patients.</div>\n<div>\n 2. What questions are we trying to answer?</div>\n<div>\n We propose to use Imatinib in combination with ACTs to treat malaria, while evaluating if this combination is safe and effective in adults and all childhood age groups above 12 months of age. Furthermore, we would like to know if indeed, when imatinib is used with ACTs, the malaria parasite can be eliminated in 2 days.</div>\n<div>\n 3. Where is the study taking place?</div>\n<div>\n This study in going to take place in public health facilities in western Kenya, located in the Kisumu, Busia and/or Siaya counties.</div>\n<div>\n <div>\n 4. How many participants does it involve and how will they be selected?</div>\n <div>\n The study will be conducted in three parts:</div>\n <div>\n 1)</div>\n <div>\n In Part 1, to establish in a small number of adult study participants the safest, and effective dose of Imatinib to use in combination with ACTs we will enroll 30 participants in the control (standard of care) group and 120 (4 groups of 30) participants in the (AL+IM) treatment groups in the first Part of the study.</div>\n <div>\n 2)</div>\n <div>\n In Part 2, we anticipate recruiting an additional 516 adult participants (172 in each of three cohorts) (i.e. a control, a 3-day ALIM treatment cohort and a 2-day ALIM treatment cohort).</div>\n <div>\n 3)</div>\n <div>\n In Part 3, like Part 1, we shall evaluate the safety, and efficacy of ALIM in each of three age groups i.e., 10-18yrs, 5-9yrs and 12-60 months at two different IM concentrations. In each of these three age-groups we shall recruit a control cohort (30 children on AL for 3 days), an intervention group (30 children) on treatment for 3 days and another group (30 children) on treatment for 2 days. Part 3 will only begin recruitment after Part 1 is successfully completed.</div>\n <div>\n Study participants shall be recruited from the health facilities when they present for treatment of uncomplicated Malaria. We shall request informed consent from the approached participants. Participation is voluntary. We shall approach both adult male patients (18-55 years old) and adult female patients (18-55 years old) that are either postmenopausal (defined as amenorrhea for the last consecutive 12 months), actively on birth control, and/or test negative on a pregnancy test. In the case of post-pubertal girls below the age of 18yrs, we shall also require a negative pregnancy test.</div>\n <div>\n 5. What does the study involve for those taking part?</div>\n <div>\n Study participants will be treated with ACTs (Artemether & Lumefantrine) alone or in combination with Imatinib and monitored for treatment.</div>\n <div>\n <div>\n In Part 1 of the trial (involving adults), we shall ask the participants to be admitted at the study hospital for at least 1-2 days. To determine the elimination of the malaria parasite, we shall draw blood samples of the participants at the following intervals:</div>\n <div>\n i. 0hrs, 4hrs, 6hrs, 12hrs, 18hrs (on Day 0)</div>\n <div>\n ii. 24hrs, 36hrs (on Day 1)</div>\n <div>\n iii. 48hrs, 60hrs (on Day 2)</div>\n <div>\n iv. 72hrs (on Da7 4)</div>\n <div>\n v. Day 7 follow up</div>\n <div>\n vi. Day 21 follow up</div>\n <div>\n vii. Day 35 follow up</div>\n <div>\n  </div>\n <div>\n In Part 2 of the trial (involving adults), we shall also ask participants to be admitted at the hospital for 1-2 days. We shall draw blood samples from the participants at the following intervals:</div>\n <div>\n i. 0hrs, 12hrs (on the first day, Day 0)</div>\n <div>\n ii. 24hrs, 36hrs (on Day 1)</div>\n <div>\n iii. 48hrs, 60hrs (on Day 2)</div>\n <div>\n iv. Day 7 follow up</div>\n <div>\n v. Day 21 follow up</div>\n <div>\n vi. Day 35 follow up</div>\n <div>\n  </div>\n <div>\n In Part 3 (involving children), we shall withdraw the samples at 0hr, 48hrs and 72hrs during which time they will be admitted at the study hospital, and during follow up on days 7, 21 and 35.</div>\n <div>\n  </div>\n <div>\n <div>\n 6. What are the risks and benefits of taking part?</div>\n <div>\n Risks: It is the first time we are combining Imatinib with Artemether and Lumefantrine. Hence there may be previously unknown side effects, much as these individual drugs are quite safe at the dose and duration we intend to administer them.</div>\n <div>\n Benefits: Potential benefits include a shorter duration of illness, accelerated elimination of the parasite, faster resolutions of symptoms with lower chances of illness caused by the same parasite’s recrudescence (as would be the case when it is not totally eliminated)</div>\n <div>\n  </div>\n <div>\n 7. How will the study benefit society?</div>\n <div>\n Imatinib as an additional option to the drugs used to treat malaria will greatly strengthen the available treatment interventions. Uniquely, unlike all other malaria drugs, the mode of action of Imatinib targets the red blood cell which the malaria parasite cannot mutate. Hence it is difficult (if ever possible) for the parasite to develop resistance to Imatinib.</div>\n <div>\n  </div>\n <div>\n 8. When does the study start and finish?</div>\n <div>\n We intend to start this recruitment into this study in the first quarter of 2025 and complete it by fourth quarter of 2027. The duration of the trial shall ultimately depend on study participant recruitment.</div>\n </div>\n </div>\n</div>\n
      • short_titleALIM STUDY
      • protocol_noECCT/25/03/03
      • version_no1.0
      • date_of_protocol26-11-2024
      • study_drugImatinib
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameImatinib
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameArtemether/Lumefantrine
      • comparator_registeredYes
      • comparator_countriesSub-Saharan Africa\nNigeria\nDemocratic Republic of Congo\nUganda\nKenya\nTanzania\nGhana\nMozambique\nMalawi\nZambia\nCameroon\nCôte d\'Ivoire\nSouth Africa\n\nSoutheast Asia: \nThailand\nVietnam\nCambodia\nMyanmar (Burma)\nLaos\nIndonesia\nMalaysia\n\nSouth Asia:\nIndia\nBangladesh\nPakistan\n\nLatin America:\nBrazil\nColombia\nEcuador\n\nMiddle East and North Africa:\nEgypt\nSudan\n\nOther regions:\nPapua New Guinea\nPhilippines\nHaiti
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressQAWORI@GMAIL.COM
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
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      • applicant_financial_declaration1
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      • applicant_indemnity_cover1
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      • applicant_detailed_budget1
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      • applicant_practice_license1
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      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDR. QUENTIN AWORI
      • declaration_date120-03-2025
      • declaration_principal_investigatorDR. QUENTIN AWORI
      • declaration_date220-03-2025
      • placebo_presentNo
      • study_objectives<div>\n General Objective</div>\n<div>\n The general objective of the trial is to evaluate the safety, tolerability, and efficacy of AL+IM in the treatment of uncomplicated malaria in adults and pediatric (above 12months) age groups.</div>\n<div>\n  </div>\n<div>\n <div>\n Specific Objective</div>\n <div>\n The primary objectives of this study are elaborated below:</div>\n <div>\n i. To determine if the triple combination AL+IM (ALIM) exhibits non-inferior safety and tolerability as compared to the SOC (AL) alone</div>\n <div>\n in adults, and all age groups above 12 months</div>\n <div>\n ii. To determine if the addition of IM to AL allows for the complete clearance of P. falciparum after only 2 days of dosing in adults and pediatric age groups above 12 months</div>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n For Part 1 and 2 of the study design, all individuals must meet all the inclusion criteria below:</div>\n<div>\n a. Patients diagnosed with symptomatic mild to moderate P. falciparum malaria with a parasite density of >= 5000 parasites/μl</div>\n<div>\n b. Adult male, age 18-55 years old or</div>\n<div>\n Adult female, age 18-55 years that are post-menopausal, actively on birth control, or test negative on a pregnancy test.</div>\n<div>\n c. Provision of informed consent and agrees to hospital admission for at least 1-2 days</div>\n<div>\n d. Good health condition other than malaria</div>\n<div>\n e. The patient has not taken anti-malarial drugs in the past 4 weeks</div>\n<div>\n  </div>\n<div>\n For Part 3 of the trial, all individuals must meet all the inclusion criteria below:</div>\n<div>\n a. Patients diagnosed with symptomatic mild to moderate P. falciparum malaria and a parasite density of >= 5000 parasites/μl</div>\n<div>\n b. Age 12 months to below 18 years</div>\n<div>\n c. In the case of post pubertal females, only non-pregnant (either actively on birth control and/or test negative on a pregnancy test)</div>\n<div>\n d. Presented by parent or legally accepted representative (LAR) who has consented to the participation of the child in the trial</div>\n<div>\n e. Hb levels > 5mg/dL</div>\n<div>\n f. Child has not taken anti-malarial drugs in the past 6 weeks.</div>\n
      • principal_exclusion_criteria<div>\n a) unable to provide informed consent</div>\n<div>\n b) symptoms and signs of severe or complicated malaria including:</div>\n<div>\n ⇀ significant confusion or impaired consciousness (including unarousable coma)</div>\n<div>\n ⇀ multiple convulsions (more than two episodes within 24 hours),</div>\n<div>\n ⇀ respiratory distress</div>\n<div>\n ⇀ circulatory collapse (systolic blood pressure <80mm Hg with evidence of impaired perfusion)</div>\n<div>\n ⇀ clinical jaundice plus evidence of other vital organ dysfunction</div>\n<div>\n ⇀ simultaneous infection of unrelated origin</div>\n<div>\n c) parasite density > 200,000 parasites /μl</div>\n<div>\n d) other neurological or psychiatric symptoms or disorders</div>\n<div>\n e) abnormal bleeding</div>\n<div>\n f) resting heart rate lower than 55 or higher than 100 bpm</div>\n<div>\n <div>\n g) history of cardiac disease</div>\n <div>\n h) signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system</div>\n <div>\n i) Abnormal blood chemistry:</div>\n <div>\n ⇀ hemoglobin < 9.0 g/dL in adults or < 5.0 g/dL in children 12 months-18 years</div>\n <div>\n ⇀ WBC not in the range of 4800-10,000/mm3</div>\n <div>\n ⇀ RBC if < 4.0x106/ mm3</div>\n <div>\n ⇀ Platelet < 1.3x105/ mm3</div>\n <div>\n ⇀ ALAT not in the normal range (4 to 36 U / l)</div>\n <div>\n ⇀ ASAT not in the normal range (8 to 33 U / l)</div>\n <div>\n ⇀ Total bilirubin 0.1 to 1.2 mg / 100 ml</div>\n <div>\n ⇀ Serum protein if < 5.5 g/dL</div>\n <div>\n j) symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.</div>\n <div>\n k) patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption.</div>\n <div>\n l) concomitant infection by plasmodium species other than P. falciparum</div>\n <div>\n m) inability to attend/meet study staff on follow up visits</div>\n <div>\n <div>\n n) concomitant use of medicines, including:</div>\n <div>\n ⇁ medicines used to treat high cholesterol (such as atorvastatin, lovastatin, simvastatin);</div>\n <div>\n ⇁ medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);</div>\n <div>\n ⇁ medicine used to treat HIV (antiretroviral medicines) including protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);</div>\n <div>\n ⇁ medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);</div>\n <div>\n ⇁ medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;</div>\n <div>\n ⇁ medicines used to prevent/treat epileptic seizures including barbiturates (such as phenobarbital), carbamazepine or phenytoin;</div>\n <div>\n ⇁ medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);</div>\n <div>\n ⇁ nefazodone (used to treat depression);</div>\n <div>\n ⇁ aprepitant (used to treat nausea);</div>\n </div>\n</div>\n<div>\n  </div>\n
      • primary_end_points<div>\n The primary endpoints of this study are:</div>\n<div>\n i. Number and severity of adverse events of AL+IM when compared to AL alone</div>\n<div>\n ii. Identification of an IM dose that eliminates all viable parasites after 2 days of dosing</div>\n<div>\n iii. Non-inferiority of 2-day dosing of AL+IM compared to 3-day dosing of AL as determined by the rate of recrudescence of parasites at the 35-day time point.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The sites have adequate staffing including investigators, study coordinators and all other roles needed for study conduct who are experienced and well trained. The facilities are well equiped including emergency facilities. There is robust infrastructure to support clinical trials.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Kisumu County, Kenya, has a population of about 1,155,574 (Kenya National Bureau of Statistics, 2019 Census). The land area of Kisumu County totals 2085.9 km2. The county has a shoreline on Lake Victoria, occupying northern, western and a part of the southern shores of the Winam Gulf. Several institutions that are either private or government funded provide health services in Kisumu County. There is one teaching and referral hospital, 5 County referral hospitals, 14 sub-county hospitals, 74 dispensaries and 18 health centers in the county . The Kisumu County Referral Hospital (KCRH) is a level 4 facility designed to provide preventive and curative care for patients and has the capacity for regulated clinical trials. It has a clinical laboratory including hematology, chemistry and microbiology capability. The site has a pharmacy, study drug administration area, clinical assessment area, data entry area, internal quality control and registration area and adequate space where monitoring can be done. The hospital will serve as a clinical research site and primary storage facility for both vaccines and biological samples. Homabay County, is located in the former Nyanza Province in Kenya. Its capital and largest town is Homa Bay. The county has a population of 1,131,950 (Kenya National Bureau of Statistics, 2019 Census) and an area of 3,154.7 km2. Lake Victoria is a major source of livelihood for Homa Bay County. The population in the study area is primarily black African, and the languages spoken are Luo (predominant ethnic group), Kiswahili and English. The Rachuonyo County Hospital (RCH) is designed as a primary care facility to provide preventive and curative care for patients. It has a clinical laboratory including hematology, and chemistry capability. The site has a pharmacy, study drug administration area, clinical assessment area, data entry area, internal quality control and registration area and adequate space where monitoring can be done. The hospital will serve as a satellite clinical research site for the Kisumu site. The site will be used for recruitment, screening, vaccination and follow up activities. Given that VIBRI has access to a well-developed health system coupled with a strong collaborative network with the county ministries of health as well as easy accessibility of patients through the hospital networks in Kisumu County, Homabay County among others, it is anticipated that the study will be able to screen and enroll participants into the study with minimal challenges. The research team will work closely with personnel working in the Ministry of Health facilities within the study area. Trained study staff will assist with study activities conducted in the field including follow up of study participants using demographic and locator information obtained at the clinical research site</p>\n
      • other_details_explanation<p>\n N/A. Investigator- initiated protocol.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 YEARS
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether/ Lumefantrine
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaVICTORIA BIOMEDICAL RESEARCH INSTITUTE
      • single_site_physical_address7180-40100. Located in Kisumu County Referral Hospital
      • single_site_contact_personDr. Quentin Awori
      • single_site_telephone+254722913616
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A, single site study.
      • total_participants_worldwide1116
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren below 12 years of age; Parent(s) or legal guardian(s) will sign the parent/ guardian consent form on behalf of this age group.\nChildren from 12 to 17 years will sign an assent form and additionally parent(s) or legal guardian(s) will sign the parental/guardian consent form.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Quentin
      • investigator1_middle_name
      • investigator1_family_nameAwori
      • investigator1_qualificationMBChB, MPH
      • investigator1_professional_address7180-40100
      • investigator1_telephone+254722913616
      • investigator1_emailQAWORI@GMAIL.COM
      • organisations_transferred_Yes
      • number_participants1116
      • notification
      • approval_date27-10-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-03-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted20-03-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
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      • quantity_imported(null)
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      • final_date(null)
      • modified2025-10-27 11:13:56
      • created2025-02-19 13:48:55
      • total_sites1
      • ecitizen_invoice357147
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        • given_nameDr. QUENTIN
        • middle_name
        • family_nameAWORI
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        • professional_address7180-40100
        • telephone+254722913616
        • emailQAWORI@GMAIL.COM
        • created2025-02-19 13:48:55
        • modified2025-06-16 16:27:57
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        • created2025-02-19 14:06:42
        • modified2025-06-16 16:27:57
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        • id811
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        • sponsorPURDUE UNIVERSITY
        • sponsor_typeOthers
        • contact_personKarson Putt
        • address610 Purdue Mall, West Lafayette, IN 47907, United States
        • telephone_number+1765-494-4600
        • fax_number
        • cell_number+1765-494-4600
        • email_addressputtk@purdue.edu
        • created2025-02-19 14:06:42
        • modified2025-06-16 16:27:57
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      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php