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      • id1175
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      • abstract_of_study<p align=\"center\" style=\"margin-left:224.7pt;\">\n <strong>Ab</strong><strong>stract of </strong><strong>the  study: </strong></p>\n<p style=\"margin-left:5.9pt;\">\n <strong>B</strong><strong>a</strong><strong>c</strong><strong>k</strong><strong>g</strong><strong>r</strong><strong>o</strong><strong>und</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n Sickle cell disease (SCD) is a serious and life-threatening inherited hemoglobin (Hb) disorder caused by a single amino acid substitution in the beta (β)-globin gene (β s c.20A>T; rs334). Sickle cell disease affects millions of people worldwide. The homozygous form (HbSS) occurs in most cases and represents approximately 88% to 96% in certain areas of Africa. Preliminary data indicate that mitapivat may reduce Hemoglobin S polymerization, sickling, and hemolysis. Therefore, in this study mitapivat is a therapeutic candidate for the treatment of adult patients with SCD with the potential to provide clinical benefit by both improvement of anemia and reduction in sickle cell pain crises (SCPCs).</p>\n<p style=\"margin-left:5.9pt;\">\n The only current curative treatment approach for some patients with SCD is bone marrow transplant. However, a lack of histocompatible donors, concerns about transplantrelated morbidity and mortality, and pre-existing conditions (organ dysfunction or alloimmunization) often preclude patients from pursuing this treatment option. For decades, hydroxyurea was the only disease-modifying therapy available for patients with SCD. Hydroxyurea is indicated to reduce the frequency of painful crises; however, its use  is limited by its safety profile, which includes myelosuppression (neutropenia and thrombocytopenia) and gastrointestinal toxicity. Reduced fertility has been reported as a longterm adverse effect.</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>J</strong><strong>u</strong><strong>s</strong><strong>t</strong><strong>i</strong><strong>f</strong><strong>i</strong><strong>c</strong><strong>a</strong><strong>t</strong><strong>i</strong><strong>o</strong><strong>n</strong><strong>/</strong><strong>R</strong><strong>a</strong><strong>t</strong><strong>i</strong><strong>o</strong><strong>n</strong><strong>a</strong><strong>l</strong><strong>e</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n The use  of curative options for SCD is currently limited to a small subgroup of patients who are deemed fit for bone marrow transplantation and have available donors. The treatment options for SCD are not universally effective or globally available, tend to address only a single component of the disease, or are limited by their safety profile. Therefore, a significant unmet medical need exists for safe and effective therapies for the treatment of SCD that result in both an improvement in anemia and reduction in sickle cell–related crises.</p>\n<p style=\"margin-left:5.9pt;\">\n Mitapivat is a small molecule, oral activator of wild-type (WT) and mutant forms of the RBC-specific form of pyruvate kinase (PKR). Activation of PKR has potential application in the treatment of hemolytic anemias, including SCD, which are characterized by increased metabolic demands or by defects in glycolysis that contribute to the shortened life span of the RBC. Decreases in PKR function, exemplified in patients with pyruvate kinase deficiency, leads to dysfunctional RBCs that are characterized by defective glycolysis, including a build-up of 2,3-DPG and PEP with decreased levels of ATP. However, there is evidence that the activation of the normal (WT) PKR enzyme can play a role in other hemolytic anemias such  as SCD.</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>Ma</strong><strong>in </strong><strong>O</strong><strong>b</strong><strong>j</strong><strong>e</strong><strong>c</strong><strong>t</strong><strong>i</strong><strong>v</strong><strong>e</strong><strong>s</strong>: <strong>Pha</strong><strong>se </strong><strong>2</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n 1. To determine the recommended Phase 3 dose of mitapivat by evaluating the effect of 2 dose levels of mitapivat versus placebo on:</p>\n<p style=\"margin-left:5.9pt;\">\n • Anemia in subjects with sickle cell disease (SCD)</p>\n<p style=\"margin-left:5.9pt;\">\n • Safety</p>\n<p style=\"margin-left:5.9pt;\">\n Phase 3: 1. To determine the effect of mitapivat versus placebo on:</p>\n<p style=\"margin-left:5.9pt;\">\n • Anemia in subjects with sickle cell disease (SCD)</p>\n<p style=\"margin-left:5.9pt;\">\n • Sickle cell pain crises (SCPCs) in subjects with SCD</p>\n<p style=\"margin-left:5.9pt;\">\n Secondary objectives:</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>Pha</strong><strong>se </strong><strong>2</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n 1. To evaluate the effect of 2 doses of mitapivat versus placebo on:</p>\n<p style=\"margin-left:29.9pt;\">\n <img height=\"4\" src=\"file:///C:/Users/kimettjc/AppData/Local/Temp/msohtmlclip1/01/clip_image001.gif\" width=\"4\" />Anemia</p>\n<p style=\"margin-left:29.9pt;\">\n <img height=\"4\" src=\"file:///C:/Users/kimettjc/AppData/Local/Temp/msohtmlclip1/01/clip_image002.gif\" width=\"4\" />Markers of hemolysis and erythropoiesis</p>\n<p style=\"margin-left:29.9pt;\">\n <img height=\"4\" src=\"file:///C:/Users/kimettjc/AppData/Local/Temp/msohtmlclip1/01/clip_image003.gif\" width=\"4\" />Patient-reported fatigue</p>\n<p style=\"margin-left:29.9pt;\">\n <img height=\"4\" src=\"file:///C:/Users/kimettjc/AppData/Local/Temp/msohtmlclip1/01/clip_image004.gif\" width=\"4\" />Sickle cell pain crises (SCPCs)</p>\n<p style=\"margin-left:5.9pt;\">\n 2. To evaluate the pharmacokinetic and pharmacodynamic effects of mitapivat.</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>Pha</strong><strong>se </strong><strong>3</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n 1. To evaluate the effect of mitapivat versus placebo on:</p>\n<p style=\"margin-left:5.9pt;\">\n • Anemia in subjects with SCD</p>\n<p style=\"margin-left:5.9pt;\">\n • Markers of hemolysis</p>\n<p style=\"margin-left:5.9pt;\">\n • Markers of erythropoiesis</p>\n<p style=\"margin-left:5.9pt;\">\n • Patient-reported fatigue</p>\n<p style=\"margin-left:5.9pt;\">\n • Additional clinical efficacy measures related to SCPC</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>M</strong><strong>e</strong><strong>t</strong><strong>h</strong><strong>o</strong><strong>d</strong><strong>s</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n <strong>Ove</strong><strong>rall Study </strong><strong>d</strong><strong>e</strong><strong>s</strong><strong>i</strong><strong>g</strong><strong>n</strong></p>\n<p style=\"margin-left:5.9pt;\">\n This is a Phase 2/3, double-blind, randomized, placebo-controlled, global, multicenter study evaluating the efficacy and safety of mitapivat versus placebo in subjects with SCD using an operationally seamless design. The Phase 2 portion is a double-blind, randomized, placebo-controlled, dose-finding study evaluating 2 dose levels of mitapivat (50 mg BID and 100 mg BID) versus placebo to select the dose of mitapivat to be evaluated in the Phase 3 portion. The Phase 3 portion is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of mitapivat at the selected Phase 3 dose versus placebo. Subjects who complete the Double-blind Period in eitherthe Phase 2 or Phase 3 portion will have the option to receive mitapivat in the Open-label Extension Period. A total of 267 subjects (69 in Phase 2 and 198 in Phase 3)</p>\n<p style=\"margin-left:5.9pt;\">\n will be randomized in this study. The initiation of the Phase 3 portion will be based on prespecified go/no-go criteria and dose selection criteria. Subjects who participate in the</p>\n<p style=\"margin-left:5.9pt;\">\n Phase 2 portion of the study are not eligible to participate in the Phase 3 portion of the study.</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>S</strong><strong>tudy </strong><strong>o</strong><strong>u</strong><strong>tc</strong><strong>o</strong><strong>m</strong><strong>e</strong><strong>s</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n The primary outcome, or endpoint, for the phase 2 study is hemoglobin (Hb) response, defined as a ≥1.0 g/dL increase in average Hb concentration from Week 10 through Week 12 compared with baseline and safety defined as adverse events (AEs) and serious adverse events (SAEs). The primary outcome for the phase 3 study is Hemoglobin (Hb) response, defined as a ≥1.0 g/dL increase in average Hb concentration from Week 24 through Week 52 compared with baseline and annualized rate of sickle cell pain crises (SCPCs) in subjects with SCD.</p>\n<p style=\"margin-left:5.9pt;\">\n <strong>S</strong><strong>tudy </strong><strong>du</strong><strong>r</strong><strong>a</strong><strong>t</strong><strong>i</strong><strong>o</strong><strong>n</strong><strong>:</strong></p>\n<p style=\"margin-left:5.9pt;\">\n The duration of participation of a subject in the Phase 2 portion is up to 4.5 years (236 weeks). The duration of participation of a subject in the Phase 3 portion is up to 5.3 years (276 weeks). The end of the study is defined as the time at which all subjects complete all study visits, are lost to follow-up, have withdrawn consent for further participation in the study, or when the Sponsor terminates the study.</p>\n<p>\n  </p>\n
      • study_title<p>\n A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease. Mitapivat - AG348-C-020</p>\n
      • laymans_summary<p>\n Sickle cell disease (SCD) is an inherited blood disorder where the red blood cells, which carry oxygen around the body, develop abnormally and become rigid and shaped like a crescent (sickle shape). Sickle cell disease affects millions of people worldwide and is very common in certain areas of Africa. This study will look at a possible drug for treatment of Sickle cell disease called Mitapivat. Results from earlier studies with mitapivat shows that it may reduce the change of shape in red blood cells which makes them look like a sickle and causes the red blood cells to be destroyed resulting in a person with sickle cell disease getting low blood level (anemia). Therefore, in this study mitapivat is a drug candidate for the treatment of adult patients with sickle cell disease with the potential to provide clinical benefit by both improvement of anemia and reduction in sickle cell pain crisis.</p>\n<p>\n  </p>\n<p>\n This study has both a Phase 2 and a Phase 3. The main aim of the Phase 2 portion of the study is to define how mitapivat works in the short term, how safe it is and the right dose which will be selected for the Phase 3 portion of the study. The aim of the Phase 3 portion of the study is to assess the how well the selected dose of mitapivat works for treatment and how safe it when used in patients with sickle cell disease. This portion of the study is intended to show the extent to which mitapivat treatment reduces painful crisis because of blocked blood vessels and reduces anemia in sickle cell disease. In this Phase2/3 study, both the participant and most study staff including the doctors don’t know which treatment has been given to the participant (referred to as doubleblind). One group of study participants called the treatment group will receive the mitapivat and another group called the control group will receive a study treatment with no active ingredient called a placebo.</p>\n<p>\n  </p>\n<p>\n The study is being done in different countries around the world, in multiple study centers in participants with SCD. The Phase 2 portion dose-finding study will assess 2 dose levels of mitapivat (50 mg twice a day and 100 mg twice a day) versus placebo to select the dose of mitapivat to be evaluated in the Phase 3 portion. The Phase 3 portion is a double-blind, randomized, placebo-controlled study evaluating how effective and safe mitapivat is at the selected Phase 3 dose versus placebo. Participants who complete the Double-blind Period in the Phase 2/3 portion will have the option to receive mitapivat in the non-blinded (Open label) Extension Period. Approximately 267 participants (69 in Phase 2 and 198 in Phase 3) are planned to be enrolled in this study worldwide. In Kenya there are 7 sites ,3 sites in Nairobi,1 in western and 3 in Nyanza. Enrollment is competitive world wide. Abstract</p>\n
      • short_titleAgios Study
      • protocol_noECCT/22/10/02
      • version_noAmendment 1 (V1.0)
      • date_of_protocol09-03-2022
      • study_drugMitapivat _ Dr Oyieko Janet
      • disease_conditionSickle Cell Disease
      • 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_nameMitapivat
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.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_countries(null)
      • applicant_addendum1
      • 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_applicantMillicent Aketch
      • declaration_date114-10-2022
      • declaration_principal_investigatorDr Ogutu Bernhards
      • declaration_date214-10-2022
      • placebo_presentYes
      • study_objectives<p>\n * Main objective:</p>\n<p>\n <strong>Phase 2:</strong></p>\n<p>\n 1. To determine the recommended Phase 3 dose of mitapivat by evaluating the effect of 2 dose levels of mitapivat versus placebo on</p>\n<p>\n : • Anemia in subjects with sickle cell disease (SCD). and</p>\n<ul>\n <li>\n Safety </li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Safety Phase 3:</strong></p>\n<p>\n 1. To determine the effect of mitapivat versus placebo on</p>\n<p>\n : • Anemia in subjects with sickle cell disease (SCD)</p>\n<p>\n • Sickle cell pain crises (SCPCs) in subjects with SCD</p>\n<p>\n <strong>Secondary objectives:</strong></p>\n<p>\n <strong>Phase 2</strong>:</p>\n<p>\n 1. To evaluate the effect of 2 doses of mitapivat versus placebo on:</p>\n<p>\n Anemia</p>\n<p>\n Markers of hemolysis and erythropoiesis</p>\n<p>\n Patient-reported fatigue</p>\n<p>\n Sickle cell pain crises (SCPCs)</p>\n<p>\n 2. To evaluate the pharmacokinetic and pharmacodynamic effects of mitapivat.</p>\n<p>\n <strong>Phase 3</strong>:</p>\n<p>\n 1. To evaluate the effect of mitapivat versus placebo on:</p>\n<p>\n Anemia in subjects with SCD</p>\n<p>\n Markers of hemolysis Markers of erythropoiesis</p>\n<p>\n Patient-reported fatigue</p>\n<p>\n Additional clinical efficacy measures related to SCPC</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:5.9pt;\">\n 1. Age ≥16 years; subjects age 16 or 17 years must physically have completed puberty.</p>\n<p style=\"margin-left:5.9pt;\">\n 2. Documented diagnosis of SCD (HbSS, HbSC, HbS/β0-thalassemia, HbS/β+ thalassemia, or other sickle cell syndrome variants).</p>\n<p>\n  3. At least 2 sickle cell pain crises (SCPCs) and no more than 10 SCPCs in the past 12 months.</p>\n<p>\n  4. Hemoglobin ≥5.5 and ≤10.5 g/dL.</p>\n<p>\n  5. If taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days before starting study drug.</p>\n<p>\n  6. Women capable of becoming pregnant and men with partners who are women that are capable of becoming pregnant must agree to use  2 forms of contraception.</p>\n<p>\n 7. Other protocol-defined inclusion criteria may apply</p>\n
      • principal_exclusion_criteria<p style=\"margin-left:5.9pt;\">\n 1. Pregnant or breastfeeding.</p>\n<p style=\"margin-left:5.9pt;\">\n 2. Receiving regularly scheduled transfusions.</p>\n<p>\n  3. Hepatobiliary disorders including but not limited to significant liver disease or gallbladder disease.</p>\n<p>\n  4. Severe kidney disease.</p>\n<p>\n  5. Prior exposure to gene therapy or prior bone marrow or stem cell transplantation.</p>\n<p>\n  6. Currently receiving treatment for SCD (eg, voxelotor, crizanlizumab, L glutamine), with the exception of hydroxyurea. The last dose of such  therapies must have been administered at least 90 days before starting study drug.</p>\n<p>\n  7. Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered at least 90 days before starting study drug.</p>\n<p>\n  8. Received treatment on another investigational trial within 90 days prior to start of study drug or plans to participate in another investigational drug trial.</p>\n<p>\n  9. Taking medications that are strong inhibitors of CYP3A4/5 or strong inducers of CYP3A4 that cannot be stopped in an acceptable timeframe before starting study drug (timeframe will be discussed with your doctor).</p>\n<p>\n 10. Other protocol defined exclusion criteria may apply</p>\n
      • primary_end_points<p>\n <strong>Phase 2 Primary Endpoints</strong>:</p>\n<p>\n 1. Percentage of participants with hemoglobin (Hb) response</p>\n<p>\n 2. Percentage of participants with treatment emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs)</p>\n<p>\n <strong>Timepoint(s) of evaluation of this end point:</strong></p>\n<p>\n Phase 2 primary endpoint of percentage of participants with Hb response: Week 12</p>\n<p>\n Phase 2 primary endpoint of percentage of participants with treatment emergent AEs and treatment emergent SAEs: Up to Week 12</p>\n<p>\n <strong>Phase 3 Primary Endpoints</strong>:</p>\n<p>\n 1. Percentage of participants with hemoglobin (Hb) response</p>\n<p>\n 2. Annualized rate of Sickle Cell Pain Crises (SCPCs)</p>\n<p>\n <strong>Timepoint(s) of evaluation of this end point</strong>:</p>\n<ul>\n <li>\n Phase 3 primary endpoint of percentage of participants with Hb response: Week 52</li>\n <li>\n Phase 3 primary endpoint of annualized rate of sickle cell pain crises:Up to Week 52</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence1
      • 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>\n Kombewa Clinical Research Centre</p>\n<p>\n The KEMRI/WRP Kombewa Clinical Research Center (KCRC) is designed for large clinical trials and has a full clinical laboratory including microbiology capability. KCRC is part of The Walter Reed Project (WRP), which is a 40-year collaboration between the Kenya Medical Research Institute, (KEMRI) and the Walter Reed Army Institute of Research (WRAIR).</p>\n<p>\n The US Army Medical Research Unit in Kenya (USAMRU-K) is a WRAIR attachment stationed in Kenya with headquarters in Nairobi and field stations in Kericho and Kisumu. WRP-Kisumu conducts a wide spectrum of field and laboratory work including numerous clinical research trials. The study will be conducted at the KCRC and recruitment will occur at the Kombewa County hospital as well as in the surrounding health facilities. </p>\n<p>\n The KEMRI/WRP Clinical Research Centre in Kombewa is staffed by KEMRI/WRP qualified research personnel, some of whom will be involved with recruitment of study subjects and conduct of the study. The KCRC is located opposite the Kombewa County Hospital in Kisumu West District of Nyanza Province in Western Kenya. It is located about 40 kilometres west of Kisumu town and has previously been used as a site for many clinical trials and epidemiological studies involving both adults and children on malaria, trypanosomiasis, leishmaniasis, entomology, HIV/AIDS and arboviruses.</p>\n<p>\n INVESTIGATORS AND COORDINATORS: ROLES AND RESPONSIBILITIES</p>\n<p>\n Dr. Janet Oyieko, Principal Investigator Kombewa Clinical Research Centre: will be responsible for the overall conduct of the trial at this study site, administrative actions between WRP, Institutional Review Boards, and the sponsor, oversight of field activities and care accorded to participants. She contributed to the site protocol addendum development and may contribute to the writing of the scientific report(s). </p>\n<p>\n Dr. Jack Hutter, Associate Investigator: will be responsible for the site administrative conduct of the trial, oversight of field activities. He contributed to the protocol addendum development and may contribute to writing of scientific report(s).</p>\n<p>\n Dr. Walter Otieno, Associate Investigator: will be responsible for the clinical conduct of the trial, the care provided to participants, oversight of field activities. He contributed to the protocol addendum development and may contribute to the writing of scientific report(s).</p>\n<p>\n Dr. Valentine Sing’oei, Associate Investigator: will be responsible for the clinical conduct of the trial, the care provided to participants, oversight of field activities. She may contribute to the writing of scientific report(s).</p>\n<p>\n Dr. Michal Ohaga, Associate Investigator: will be responsible for the clinical conduct of the trial, the care provided to participants, oversight of field activities. She may contribute to the writing of scientific report(s).</p>\n<p>\n Irene Onyango- Regulatory Affairs oversight will be responsible for communication with IRBs and ECs.</p>\n<p>\n Millicent Achola - Clinical Research Coordinator; responsible for overall study coordination while working in a team environment under the direction of the investigators. Coordinating the recruiting, screening, and enrolling of study participants; arranging follow-up visits; completing and ensuring the accuracy of CRFs and regulatory documents; and ensuring the adherence to GCP guidelines.</p>\n
      • other_details_explanation<p>\n <strong>N/A</strong>, trial is being conducted in the USA</p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:186px;height:13px;\">\n <p>\n Kenya </p>\n </td>\n <td style=\"width:153px;height:13px;\">\n <p>\n 01 Sep  2022 </p>\n </td>\n <td style=\"width:61px;height:13px;\">\n <p>\n 2 additional sites submitted </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Regualtory</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Approval Date</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Number of site per Country</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Canada</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 16 Nov  2021</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n United Kingdom</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 13 Sep 2021</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Belgium</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 16 Feb 2022</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n France</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 27 Jan 2022</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Germany</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 07 Apr 2022</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:110px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Italy</p>\n </td>\n <td colspan=\"2\" style=\"width:103px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 23 Feb 2022</p>\n </td>\n <td colspan=\"2\" style=\"width:186px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 8</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Regulatory Authority</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Approved Date</p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Number of site per country</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Netherlands</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 23 Dec 2021</p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Brazil</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 21 Jan 2022</p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 8</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n Israel</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 09 Aug 2021</p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n United States of America</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 26 May 2022</p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p style=\"margin-left:.55pt;\">\n 23</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p>\n Turkey</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p>\n 04 Jul 2022 </p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:148px;height:13px;\">\n <p>\n Saudia Arabia</p>\n </td>\n <td colspan=\"2\" style=\"width:90px;height:13px;\">\n <p>\n 06Sep 2022</p>\n </td>\n <td style=\"width:161px;height:13px;\">\n <p>\n 3</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Nigeria _ 22 Aug 2022 - sites _6 </p>\n<p>\n Kenya _ 06 Sep  2022 _ sites approved 2 out of 7 .</p>\n
      • other_details_regulatory_rejected<p style=\"margin-left:5.9pt;\">\n No Regulatory authority nor Ethics Committee has rejected this trial</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration9 years 10 months 0 days
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyThere is an open label extension period following completion of the double blind period.
      • design_controlled_comparatorplacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • 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_states17
      • number_of_sites7
      • multi_country_listBelgium Brazil Canada Egypt France Germany Israel Italy Kenya Lebanon Netherlands Nigeria Oman Saudi Arabia Turkey\nUnited Kingdom United States\n
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNo maximum nor minimum enrolment per site as enrolment is competitive world wide
      • total_participants_worldwide267 for both phases(69 in Phase 2 and 198 in Phase 3)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • 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_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyFor subjects under 18 Years of age written informed assent/consent will be obtained from parents and child assent. It must be obtained before any study-related procedures are conducted
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_nameRagama
      • investigator1_family_nameOgutu
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressStrathmore University Medical Centre_CREATES Madaraka Estate, Ole Sangale Road P.O Box 59857-00200 Nairobi
      • investigator1_telephone+254 733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participantsEnrolment is competitive world wide
      • notification
      • approval_date10-02-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted14-10-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments have been reviewed internally and considered adequate.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-13 00:32:25
      • created2022-09-27 09:23:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id852
        • application_id1175
        • given_nameJanet
        • middle_nameN
        • family_nameOyieko
        • qualificationPediatrician
        • professional_addressKEMRI_CCR
        • telephone+254721996988
        • emailJanet.Oyieko@gmail.com
        • created2022-09-27 09:24:50
        • modified2022-10-14 14:51:43
    • SiteDetail(array)
      • 0(array)
        • id1315
        • application_id1175
        • county_id42
        • site_name Kombewa Clinical Research Centre
        • physical_addressKombewa, Opposite Kombewa Sub-County Hospital
        • contact_details +254721996988
        • contact_personDr Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 09:24:50
        • modified2022-10-14 14:51:43
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1316
        • application_id1175
        • county_id42
        • site_nameVictoria Biomedical Research Institute
        • physical_addressButere County Hospital, Postal Code 40100, Kisumu, Kenya
        • contact_detailsTel: +254 720 597654 P.O. Box 7180
        • contact_personDr. Lucas Otieno Tina
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 12:42:07
        • modified2022-10-14 14:51:43
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1317
        • application_id1175
        • county_id47
        • site_nameKEMRI/CRDR
        • physical_address Kenyatta National Hospital Off Hospital Road, CRDR
        • contact_detailsTel:+254790484654, P.O Box 47855-00100
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 12:42:07
        • modified2022-10-14 14:51:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id1318
        • application_id1175
        • county_id41
        • site_nameKEMRI Siaya Clinical Research Annex
        • physical_address KEMRI Clinical research Annex,Siaya County Hospital,
        • contact_detailsTel: +254722205901, P.O Box 144-40600
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 12:42:07
        • modified2022-10-14 14:51:43
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 4(array)
        • id1319
        • application_id1175
        • county_id47
        • site_nameGertrude’s Children’s Hospital
        • physical_addressGertrude’s Children’s Hospital, 34 Muthaiga Road
        • contact_details+254 721245721
        • contact_personProf. Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 12:42:07
        • modified2022-10-14 14:51:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 5(array)
        • id1320
        • application_id1175
        • county_id42
        • site_nameKEMRI Kondele Children\'s Hospital
        • physical_addressKondele Children\'s Hospital
        • contact_details+254714481488
        • contact_personDr Godfrey Allan Otieno
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 12:42:07
        • modified2022-10-14 14:51:43
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 6(array)
        • id1321
        • application_id1175
        • county_id47
        • site_nameStrathmore University Medical Centre
        • physical_addressStrathmore University Medical Centre, Ole Sangale Rd
        • contact_details+254733813613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-09-27 12:42:07
        • modified2022-10-14 14:51:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id606
        • application_id1175
        • sponsorAgios Pharmaceuticals, Inc.
        • sponsor_typeIndustry
        • contact_personJamie Cohen
        • address88 Sidney Street Cambridge, MA 02139-4169 USA
        • telephone_number+1 617-844-6657
        • fax_number+1 617-588-0455
        • cell_number+1 617-844-6657
        • email_addressJamie.cohen@agios.com
        • created2022-09-27 09:24:50
        • modified2022-10-14 14:51:43
  • 1(array)
    • Application(array)
      • id1173
      • user_id667
      • trial_status_id6
      • abstract_of_study<h1>\n ABSTRACT </h1>\n<p>\n HIV incidence rates remain unacceptably high for adolescent girls and young women (AGYW). Pre-exposure prophylaxis (PrEP) HIV prevention tools are promising with tenofovir (TFV)-based daily oral PrEP and the dapivirine vaginal ring (DPV-VR) recommended by WHO for cisgender women at-risk for HIV. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP access with AGYW as a priority group. Our team pioneered integrated PrEP delivery in family planning (FP) clinics in Kenya; yet 40% of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by facility-based PrEP platforms. Retail pharmacies can increase options for reaching at-risk individuals with PrEP and efforts are underway to define pathways for pharmacy-delivered PrEP in Kenya. We adapted our FP clinic-based PrEP model and piloted PrEP delivery facilitated by nurse-navigators for AGYW seeking contraception at pharmacies. AGYW offered daily oral PrEP frequently initiated, planned to continue use, and were willing to pay for PrEP at pharmacies. Pill burden was a common reason for declining oral PrEP and could be addressed by offering DPV-VR. Through close collaboration with the Kenya Ministry of Health both, national- and county-level, we propose a Cluster Random Controlled Trial( cRCT() at 20 pharmacies in Kisumu, Kenya-a region with an HIV prevalence of up to 28% among women -to test the effectiveness of utilizing nurse-navigators at retail pharmacies to enhance AGYW PrEP use. We will expand on our successful pilot to offer both daily oral PrEP and the DPV-VR and prospectively ascertain PrEP outcomes (initiation, persistence, adherence) among AGYW. This effectiveness-implementation hybrid RCT is designed to expedite translation into practice by evaluating clinical effectiveness alongside implementation and cost outcomes. We hypothesize that combining nurse-navigators with pharmacy-based PrEP will provide a cost-effective strategy for delivering novel HIV prevention tools to AGYW in HIV high-burden settings. Aim 1 will determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model through a 2-arm cluster RCT among HIV-negative AGYW at 20 retail pharmacies in Kisumu, Kenya. AGYW seeking contraception will be offered PrEP and self-select daily oral PrEP or the DPV-VR. Primary outcomes will be proportion of AGYW accessing contraception that initiate PrEP, persist with use at 6 months, and adhere (quantified by TFV or DPV hair levels). Secondary outcomes will include PrEP selection (PrEP pills vs. DPV-VR), STI incidence, and adherence cofactors. Aim 2 will identify potential barriers and facilitators to acceptability, feasibility, and sustainability of nurse-navigators and DPV-VR delivery for AGYW accessing PrEP at retail pharmacies through a qualitative evaluation guided by Proctor et al. Aim 3 will estimate the cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators. This will be the first study aiming to improve PrEP access for AGYW using a pharmacy-based model and will prime pharmacies to deliver novel PrEP agents in the pipeline.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Enhancing PrEP outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform</strong></p>\n<p>\n  </p>\n
      • laymans_summary<div>\n <p>\n <strong>LAY SUMMARY</strong></p>\n <p>\n Pre- exposure prophylaxis (PrEP) is a HIV prevention method available in both a daily oral form (tenofovir) or a monthly vaginal ring (dapivirine), PrEP works when used as recommended. Increasing locations where PrEP is dispensed may make it easier for adolescent girls and young women (AGYW) to access PrEP. To date, PrEP is available at public health clinics, yet there are major barriers to accessing PrEP at clinics which includes stigma, long waiting times, staffing costs, and healthcare providers’ unfamiliarity with PrEP. In Kenya, people often go to retail pharmacies first access to treatment of urgent and prolonged conditions. AGYW frequently obtain contraception at pharmacies without attending a health facility. Potential PrEP users may prefer pharmacy-delivered PrEP due to convenience and privacy. Additionally, the presence of nurses to provide tailored counselling on PrEP use and related topics in pharmacies can facilitate PrEP use. We will offer PrEP to AGYW  at pharmacies with and without nurses to assess if nurse-navigators effect PrEP use and determine the costs of PrEP delivery in pharmacies.</p>\n</div>\n<p>\n  </p>\n
      • short_titleAGYW Pharmacy PrEP Delivery
      • protocol_noECCT/22/10/01
      • version_no1.0
      • date_of_protocol21-03-2021
      • study_drugDapivirine
      • disease_conditionHuman Immunodeficiency Virus (HIV)
      • 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_nameDapivirine
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameTenofovir Emtricitabine
      • comparator_registeredyes
      • comparator_countriesKenya, Zambia, Botswana, Zimbabwe
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.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_countries(null)
      • applicant_addendum1
      • 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_applicantGreshon Rota
      • declaration_date104-10-2022
      • declaration_principal_investigatorElizabeth Bukusi
      • declaration_date204-10-2022
      • placebo_presentNo
      • study_objectives<p>\n Our overarching aim is to determine the effectiveness of utilizing nurse navigators at retail pharmacies to enhance the use of pre-exposure prophylaxis (PrEP) use for HIV prevention among adolescent girls and young women. We propose to determine the effect of nurse navigators vs. standard of care (i.e., pharmacy provider-delivered PrEP), in a 2-armed cluster randomized controlled trial (RCT). </p>\n<p>\n  </p>\n<p>\n <u>The primary objectives of this evaluation are to:</u></p>\n<p>\n  </p>\n<ol>\n <li>\n To determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among HIV-negative AGYW (age 14-24 years) seeking contraception by comparing pharmacy-based PrEP delivery models with and without nurse-navigators at 20 retail pharmacies in Kisumu, Kenya.\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <u>Secondary objectives:</u>\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n To compare PrEP selection (pills vs. DPV-VR), STI incidence and adherence cofactors (e.g. depression, relationship climate) by randomization arm.</li>\n <li>\n To describe HIV incidence, quality of care measures and long-acting reversible contraceptive use.</li>\n </ol>\n </li>\n </ol>\n </li>\n <li>\n To evaluate implementation outcomes (acceptability, feasibility, and client satisfaction) of incorporating nurse-navigators and DPV-VR into pharmacy-based PrEP delivery for AGYW by conducting a qualitative evaluation at the individual, provider, and system-level to inform scale up guided by the Proctor model.¹</li>\n <li>\n To estimate the costs and cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators compared to standard pharmacy-based PrEP by conducting micro-costing and time-and-motion observation to estimate costs.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<h3>\n 5.3 Eligibility Criteria </h3>\n<p>\n  </p>\n<ol>\n <li>\n <strong>AGYW (PrEP screening) </strong></li>\n</ol>\n<ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n</ol>\n<ul>\n <li>\n Female gender </li>\n <li>\n Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between ≥14 and <25 years old </li>\n <li>\n Willingness to receive PrEP screening per national guidelines including HIV testing </li>\n <li>\n Not currently taking PrEP </li>\n <li>\n Able and willing to provide informed consent for participation </li>\n</ul>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n <strong>AGYW (PrEP offer per NASCOP guidelines) </strong></li>\n</ol>\n<ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n</ol>\n<ul>\n <li>\n Meets NASCOP PrEP eligibility criteria. PrEP is offered to sexually active HIV-negative individuals who are at significant risk of acquiring HIV infection. Clients must meet ALL of the following criteria before initiating PrEP: </li>\n</ul>\n<ol>\n <li>\n At high risk for acquiring HIV, by meeting ANY of the following indications </li>\n</ol>\n<ul>\n <li>\n Sexual partner is known HIV positive and: not on ART, or on ART < 6 months, or suspected poor adherence to ART, or most recent viral load is detectable </li>\n <li>\n Sexual partner/s are of unknown HIV status and are at high-risk for HIV infection (has multiple sexual partners, has had STIs, engages in transactional sex, injects drugs, from high HIV burden settings) </li>\n <li>\n Engaging in transactional sex </li>\n <li>\n History of recent sexually transmitted infection </li>\n</ul>\n<ul>\n <li>\n Recurrent use of post-exposure prophylaxis </li>\n <li>\n History of sex whilst under the influence of alcohol or drugs  </li>\n <li>\n Inconsistent or no condom use or unable to negotiate condom use during intercourse with persons of unknown HIV status </li>\n <li>\n Injection drug use where needles and syringes are shared </li>\n <li>\n Sero-discordant couples trying to conceive </li>\n</ul>\n<ol>\n <li value=\"2\">\n Additionally, the following criteria must almost be met for PrEP initiation: </li>\n</ol>\n<ul>\n <li>\n Confirmed HIV negative (rapid antibody testing following the HTS algorithm on the day of PrEP initiation is adequate confirmation of HIV-negative status) </li>\n <li>\n Does not have a current or recent (within past one month) illness consistent with acute HIV infection (fever, sore throat, muscle or joint pains, swollen glands, diarrhoea or headache) in combination with a preceding high-risk exposure for HIV </li>\n <li>\n Assessed as ready to adhere to PrEP and willing to attend follow-up evaluations including repeat HIV testing and monitoring for side effects </li>\n <li>\n No contraindication to use of TDF +/- FTC/3TC </li>\n</ul>\n<p>\n  </p>\n<ol>\n <li value=\"3\">\n <strong>AGYW (FGDs) </strong>\n <ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n </ol>\n </li>\n</ol>\n<ul>\n <li>\n Female gender </li>\n <li>\n Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between ≥14 and <25 years old </li>\n <li>\n Willingness to receive PrEP screening per national guidelines including HIV testing </li>\n <li>\n Not currently taking PrEP </li>\n <li>\n Able and willing to provide informed consent for participation </li>\n <li>\n Randomized to the nurse-navigator arm</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li>\n <strong>AGYW (PrEP screening) </strong></li>\n <br />\n <li value=\"2\">\n <strong><em>Exclusion criteria</em></strong></li>\n</ol>\n<ul>\n <li>\n Male gender </li>\n <li>\n Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between <14 or >24 years old  </li>\n <li>\n Not willing to receive PrEP screening per national guidelines or not willing  to receive HIV testing </li>\n <li>\n Currently taking PrEP </li>\n <li>\n Not able or willing to provide informed consent for participation </li>\n</ul>\n<ol>\n <li value=\"2\">\n <strong>AGYW (Focused Group Discussions (FDGs)) </strong></li>\n</ol>\n<ol>\n <li value=\"2\">\n <strong><em>Exclusion criteria</em></strong></li>\n</ol>\n<ul>\n <li>\n Male gender </li>\n <li>\n Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between <14 or >24 years old  </li>\n <li>\n Not willing to receive PrEP screening per national guidelines or not willing  to receive HIV testing </li>\n <li>\n Currently taking PrEP </li>\n <li>\n Not able or willing to provide informed consent for participation </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n Testing HIV Positive</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImplementation Science
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>FACILITY</u></strong></p>\n<p>\n  </p>\n<ol>\n <li>\n <strong>The main study site is:</strong></li>\n</ol>\n<p>\n KEMRI-RCTP</p>\n<p>\n KEMRI CIS Building</p>\n<p>\n Lumumba Sub-County Hospital</p>\n<p>\n Along Ondiek Highway</p>\n<p>\n P.O Box 614-40100</p>\n<p>\n Kisumu</p>\n<p>\n  </p>\n<p>\n The facility has</p>\n<ol>\n <li>\n Reception and waiting bay</li>\n <li>\n Six Clinic rooms</li>\n <li>\n Pharmacy</li>\n <li>\n Laboratory</li>\n <li>\n Data room</li>\n <li>\n Administration office</li>\n <li>\n Open Office</li>\n <li>\n Washrooms</li>\n</ol>\n<p>\n  </p>\n<p>\n All rooms are equipped with relevant furniture, equipment, and materials to facilitate the activities conducted in the rooms.</p>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n There will be <strong>20 retail pharmacies</strong> across Kisumu County based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms). The selection of these pharmacies is currently ongoing.</li>\n</ol>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p>\n <strong><u>PERSONNEL </u></strong></p>\n<p>\n  </p>\n<p>\n <strong>Elizabeth Bukusi, MBchB, MMed, PhD, Principal Investigator                                           </strong></p>\n<p>\n Prof. Bukusi leads the KEMRI research site in Kisumu, Kenya. In addition to her appointment at KEMRI, she is jointly appointed as a Research Associate Professor at the University of Washington. She will provide substantial oversight of all activities that take place at the Kisumu site. As the site Principal Investigator (PI) for the KEMRI team leading activities, she will work closely with the coordinating center and provide oversight of implementation of all research components, including study and intervention design, preparation of data collection instruments, intervention implementation, data collection and management, statistical analyses, as well as fiscal and administrative management of the study.</p>\n<p>\n <strong>Josephine Odoyo, Project Director   KRCHN, MPH                                                              </strong></p>\n<p>\n Josephine Odoyo is a trained nurse by profession and has wide experience in HIV research having coordinated earlier clinical trials at the Kisumu site. She has hands on experience in working in the clinic, training of staff and serves as a quality management officer for KEMRI, responsible for research studies implemented in collaboration with KEMRI. Was involved in among others Pharmacy PrEP Pilot study, the site coordination and execution of Partners PrEP study, Partners Demonstration study and the ongoing Partners Scale up Project.  She will be assisting the Principal investigators in the planning and implementation stage of the project and offering regulatory services ensuring quality is maintained throughout the study implementation.</p>\n<p>\n <strong>Dr. Zachary Kwena, MA, PhD, Qualitative Researcher   -Co-investigator                                                            </strong></p>\n<p>\n Dr. Zachary Kwena will take lead in all aspects of qualitative research of the study. He has a wealth of experience in qualitative work having conducted various qualitative studies in KEMRI.</p>\n<p>\n <strong>TBD, Coordinator                                                               </strong></p>\n<p>\n The coordinator will be responsible for the smooth functioning of the research project, coordinating communications with regulatory boards, staff and investigators, assisting investigators with implementation, planning and problem-solving to ensure project goals are met. The coordinator will be in charge of the day to day running of the site on behalf of the site PI and supervision of site personnel, development of standard operating procedures including preparation and study results dissemination to the relevant regulatory review boards.</p>\n<p>\n <strong>TBD, Study Nurses                                                               </strong></p>\n<p>\n The study nurses will be responsible for guiding of the participants in HIV counselling and testing and administering PrEP study drugs as well as collecting any sample that may be required for further analysis in the lab.</p>\n<p>\n <strong>TBD, Research Assistants</strong></p>\n<p>\n The research assistants will be responsible for mobilizing of the study participants for enrolment and making up follow ups as needed. They will also assist in the qualitative aspects of the study.</p>\n<p>\n <strong>TBD, Laboratory Technician                                                           </strong></p>\n<p>\n The Lab Technologist will be responsible for performing all the lab tests required for the participants, maintaining and charting of the temperature logs in the laboratory, preparing samples for archiving and shipment .and ensuring proper storage is done.</p>\n<p>\n <strong>TBD, Data Manager</strong></p>\n<p>\n The data manager will be responsible for overall management of the study data ensuring all the needed data bases are created and reports generated on timely basis as needed for each data base. Ensuring confidentiality of participants data by creating link log between the participants study ID and participants name which will be kept separately under double locked cabinets</p>\n<p>\n <strong>Dr. Greshon Rota, Pharmacist of Records                                                                     </strong></p>\n<p>\n The Pharmacist of records will be involved in all matters pertaining to the Pharmacy and Poisons Board (PPB) in regard to the registration of the protocol and act as a linkage between the Study and PPB.</p>\n<p>\n <strong>TBD, Qualitative Interviewer                                                           </strong></p>\n<p>\n The Qualitative Interviewer will be responsible for conducting the qualitative interviews of the study and transcribing them. This will be done in the fourth year of the study.</p>\n<p>\n <strong>TBD, Driver Nairobi</strong></p>\n<p>\n The driver based in Nairobi will assist with project driving and delivery needs especially since the PI is based in Nairobi. He will be given a 20% FTE. He will also be responsible for vehicle maintenance and keeping track of vehicle work tickets / logs.</p>\n<p>\n <strong>TBD, Administrator                                                                                 </strong></p>\n<p>\n This administrator will be responsible for assisting in overall planning for the project in liaison with the coordinator, PI and the Chief Finance Administrator and assist in budget preparation, maintaining of proper audit trail for study funds and expenditures, generate monthly invoices, and other financial reports as required in the subcontract. He will also be responsible for the handling and accounting for the field advance given to the project.</p>\n<p>\n <strong>TBD, Office Assistant</strong></p>\n<p>\n The office assistant will be responsible for delivering messages for study needs and ensure that there is a clean environment for working. She will liaise with the administrator in sending and receiving parcels and courier services. She will also clean the office area, washrooms, building surrounding and maintenance of study clinic grounds.</p>\n<p>\n <strong>Rachel Mwakisha-PA to the Principal Investigator                                                   </strong></p>\n<p>\n The PA to the principal Investigator ensures that the calendar for Prof. Bukusi is updated and that her appointments are scheduled efficiently and convenient for the operations of the project.</p>\n<p>\n <strong>Grace Waititu, Finance & Admin Manager-Nairobi                                                         </strong></p>\n<p>\n The Finance & Admin Manager is based in Nairobi. She is instrumental in terms of procurement of equipment and fast tracking of project payments to suppliers. She forwards letters to the headquarters and follow up payments on behalf of the Kisumu site. She also facilitates staff contracts, subcontracts and petty cash advances. In collaboration with the Study Coordinator and the PI she will ensure timely sub-contract agreements; budget preparation and monitoring of line items to ensure they conform to budgets.</p>\n<p>\n <strong>Denis Ochola, HRM </strong></p>\n<p>\n The Human Resource Manager is responsible for the recruitment of personnel and all staff related issues such as disciplinary, medical insurance, salaries and remuneration among others. </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study is seeking to address persistent drivers of HIV transmission in Africa so as to reduce rate of HIV infection inorder to achieve the UNAIDS “90-90-90” strategy which calls for 90% of HIV-infected individuals to be diagnosed by 2020, 90% of whom will be on anti-retroviral therapy (ART) and 90% of whom will achieve sustained virologic suppression.</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration2 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_comparatorTenofovir/Emtricitabine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI RCTP Lumumba, Kisumu
      • single_site_physical_addressKEMRI-CMR building, P.O Box 614-40100, Agoi street Lumumba Sub-County Hospital, Kisumu
      • single_site_contact_personJosephine Odoyo
      • single_site_telephone+254733276275
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site1900
      • total_participants_worldwide1900
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB,MMed,PHD
      • investigator1_professional_addressKenya Medical Research Institute PO Box 54840,-00200, Nairobi, Kenya
      • investigator1_telephone+254 733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_Yes
      • number_participants1900
      • notification
      • approval_date23-12-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-10-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonAll reviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-10 12:23:50
      • created2022-09-09 09:17:55
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id851
        • application_id1173
        • given_nameELIZABETH
        • middle_name
        • family_nameBUKUSI
        • qualificationMBChB,MMed,PHD
        • professional_addressKenya Medical Research Institute PO Box 54840,-00200, Nairobi, Kenya
        • telephone+254 733617503
        • emailebukusi@rctp.or.ke
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
    • SiteDetail(array)
      • 0(array)
        • id1314
        • application_id1173
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id605
        • application_id1173
        • sponsorNational Institute of Health
        • sponsor_typeResearch Institution
        • contact_person
        • address9000 Rockville ,PIKE, Bethesda, Maryland 2892
        • telephone_number+1 3014964000
        • fax_number
        • cell_number+1 3014964000
        • email_addressgrantsinfo@nih.gov
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
  • 2(array)
    • Application(array)
      • id1167
      • user_id667
      • trial_status_id8
      • abstract_of_study<p>\n <strong>Title: </strong>A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (SAPPHIRE)</p>\n<p>\n <strong>Sample Size</strong>:</p>\n<p style=\"margin-left:13.5pt;\">\n <strong><em>Phase A</em></strong>:  3,200 participants (2,100 HIV-negative participants, 650 HIV-positive participants, 450 hypertensive participants ≥15 years of age)</p>\n<p style=\"margin-left:13.5pt;\">\n <strong><em>Phase B</em></strong>:  32 communities of ~10,000 persons each, for a total of ~160,000 adults (≥15 years of age)</p>\n<p>\n <strong>Participating Sites</strong>:  44 communities in rural western Kenya and rural western Uganda (12 in Phase A, 32 in Phase B), that: a) are geopolitical units (i.e. parish in Uganda, or sub-location in Kenya) of ~10,000 persons each (5,000 ≥15 years) within the catchment area of government health clinics; b) have HIV prevalence similar to the region using Ministry of Health data; c) have a letter of commitment to the study from the local political leader; and d) are of sufficient distance from each other to avoid contamination.</p>\n<p>\n <strong>Overall Objective</strong>: Our overall objective is to determine to reduce HIV incidence and to improve community health with multi-sector, scalable interventions.</p>\n<p>\n <strong>Primary Objective</strong>: Reduce HIV incidence using innovative strategies for HIV prevention and treatment to simultaneously reach “persistent driver” populations.</p>\n<p>\n <strong>Secondary Objectives:</strong></p>\n<p style=\"margin-left:38.25pt;\">\n 1.    Evaluate and optimize individual intervention component effects, alone (Phase A) and in combination (Phase B), versus control conditions on prevention coverage and HIV viral suppression</p>\n<p style=\"margin-left:38.25pt;\">\n 2.    Assess the effect of the intervention package on other health outcomes (all-cause mortality, tuberculosis, hypertension linkage and control, heavy alcohol use and mother-to-child HIV transmission) in Phase B</p>\n<p style=\"margin-left:38.25pt;\">\n 3.    Evaluate behavioral and other mechanistic pathways for intervention effects on proximal mediators of HIV incidence in Phase B</p>\n<p style=\"margin-left:38.25pt;\">\n 4.    Assess the reach, effectiveness, patient and provider adoption, and fidelity and the maintenance of intervention components in Phase B</p>\n<p style=\"margin-left:38.15pt;\">\n 5.    Use final study data to inform a strategic and sustainable investment model that maximally reduces HIV incidence and improves community health for the combination interventions tested in Phase B</p>\n<p>\n <strong>Study Design</strong>: This study will consist of 2 phases:</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Phase A, in which randomized trials and pilot studies will assess effectiveness, fidelity and cost and improve context-specific “fit” of prevention and treatment interventions. Combining effectiveness with implementation, costing and modelling outcomes, Phase A will optimize intervention packages with context specific adaptations in structured consultation with stakeholders.</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Phase B, which will evaluate the effects of these optimized dynamic prevention and treatment packages, alone and in combination, on prevention coverage, population-level suppression, and HIV incidence, as well as other health outcomes, in a balanced, community randomized 2x2 factorial design.</p>\n<p>\n <strong>Interventions in Phase A</strong>:</p>\n<p style=\"margin-left:36.0pt;\">\n ●     Dynamic Prevention: We are evaluating ways to optimize dynamic prevention delivery with the following interventions: Provision of Dynamic Prevention intervention at 1) outpatient health centers, 2) antenatal/family planning clinics, 3) youth multisector events and  4) via village health workers interacting at households.</p>\n<p style=\"margin-left:36.0pt;\">\n ●     Dynamic Treatment: We are evaluating services to improve HIV and hypertension care in difficult to reach populations: mobile population services; alcohol use intervention for heavy alcohol users, and hypertension interventions.</p>\n<p>\n <strong>Study Endpoints:  </strong></p>\n<p>\n <strong>Phase A: </strong>The primary endpoints in Phase A are: Prevention coverage (uptake and persistence of PrEP or PEP) and viral suppression (HIV RNA <400 c/mL).  For hypertension intervention, the primary endpoints are  linkage to care and hypertension control.</p>\n<p>\n <strong>Phase B</strong>: The primary and secondary endpoints in Phase B are:</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Prevention coverage (uptake and persistence of PrEP and PEP)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Viral suppression (HIV RNA <400 c/mL)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         HIV incidence (cumulative 3 year)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Mortality (cumulative 3 year)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Tuberculosis (annual incidence rate)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Hypertension control (<140/90 mmHg)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Heavy alcohol use</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Mother-to-child HIV transmission (infant HIV free survival at 3 years)</p>\n<p>\n  </p>\n<p>\n <strong>Study Duration</strong>: The study’s Phase A and Phase B components will be conducted over a 5-year period.</p>\n<p>\n <strong>Sample Size and Power, Phase A</strong></p>\n<p>\n  </p>\n<p>\n <strong>Dynamic Prevention: </strong>Assuming a standard deviation in covered time of 35% (based on SEARCH), a two-sided hypothesis test (a=0.05), and conservatively ignoring precision gains from stratified randomization and covariate adjustment, a trial with 200 evaluable persons per arm will have 80% power to detect an approximately 10% absolute effect size (corresponding, for example, to an increase in covered time from 30% to 40%). For primary endpoint measurement for the trials at clinics, we will thus enroll up to 300 participants per arm meeting PrEP/PEP eligibility criteria (1,200 total).  We also enroll up to 250 participants per arm from 16 areas serviced by village health workers (total N=500 HIV-negative persons).  For the youth intervention single arm pilots, we will enroll up to 100 persons/pilot-site to examine feasibility in primary analyses and prevention coverage in secondary analyses.</p>\n<p>\n  </p>\n<p>\n <strong>Dynamic Treatment</strong>: Assuming approximately 40% suppression (or 50% linkage in the hypertension trial) in the control arm and a two-sided hypothesis test (a=0.05), a trial of 100 persons per arm will be powered at 80% to detect a 20% increase in suppression (or linkage in the hypertension trial).  For the alcohol intervention trial, we will enroll up to 200 participants living with HIV per arm, for the mobility intervention trial we will enroll 125 participants living with HIV per arm, and for the hypertension linkage intervention we will enroll 125 participants per arm. For the hypertension treatment trial, we will enroll up to 200 participants (100/arm) based on assuming 40% control in the non-intervention group for 80% power to detect an 20% or greater increase in control.   </p>\n<p>\n  </p>\n<p>\n <strong>Sample Size and Power, Phase B</strong>:</p>\n<p>\n Assuming an HIV- Cohort of approximately 1,175 persons per community, 90% follow up, mean 10% prevention covered time in the control arm, within-cluster standard deviation of 35%, and a coefficient of variation (k) of 0.15 (conservatively based on SEARCH), with 16 communities per arm we will be powered at 90% to detect a relative increase in covered time of approximately 24%. Assuming approximately 124 HIV-positive persons with year 3 HIV RNA level measured per community, 70% viral suppression at year 3 in the control arm, and k=0.10 (conservatively based on SEARCH), with 16 communities per arm we will be powered to detect a relative increase in suppression of approximately 15%. Under some but not all scenarios, this design will also have power >80% to detect an effect of combined Dynamic Prevention and Treatment on three-year cumulative HIV incidence compared to standard-of-care. Assuming a 3-year cumulative HIV incidence of 1.7% in the control arm of the study, k= 0.17 (informed by SEARCH), HIV test sensitivity of 95% and specificity of 99.9%, and 90% follow up of the HIV- Cohort (total N ~17,000 in primary analysis), we estimate >80% power to detect a relative reduction of at least 35% in the full intervention (N=8 communities) vs. control (N=8 communities) arms of the study.</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n
      • study_title<p align=\"center\" class=\"Default\" style=\"text-align:center\">\n <b><span lang=\"EN-US\" style=\"font-size:16.0pt;font-family:"Arial",sans-serif\">A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa<o:p></o:p></span></b></p>\n
      • laymans_summary<p>\n <strong>HIV incidence in Sub-Saharan Africa (SSA) remains well above global elimination targets.</strong><strong>¹</strong>Despite an increasingly large, evidence-based toolkit to prevent HIV transmission, there were over 1 million new HIV infections in SSA in 2018.¹We know from SEARCH²and three other recent SSA population-level studies^3-5that reaching (and exceeding) <em><u>the UNAIDS 2020 population-level viral suppression target of 73%</u></em><em><u>⁶</u></em><em><u>is insufficient to achieve epidemic control</u></em> (<strong>Table 1</strong>). We also know that key sub-populations, in particular youth,^{4, 7-10}men,^{2, 4, 10-12}mobile populations,^13-15and persons with heavy alcohol use^{16, 17}continue to fall short of viral suppression targets, putting them at higher risk for HIV complications, mortality, and onward HIV transmission. Finally, pre-exposure prophylaxis (PrEP), an intervention that has reduced incidence in affected populations in some areas where high rates of viral suppression were already present,^{18, 19}has not been effectively deployed in high risk populations (such as young women) in SSA.^{20, 21}To achieve control of the HIV epidemic and mitigate its consequences, <u>we need <strong>new and scalable</strong> interventions to improve delivery of prevention and treatment to <strong>vital segments of the population that contribute to persistence of new infections.</strong></u>  We describe below why previous approaches that were effective for the majority of people in the ART roll-out <u>do not work</u> for subsets of these “persistent-driver” populations, our proposed solutions, and how a multi-component intervention trial can effectively inform stakeholders on programming and resource allocation to accelerate reductions in HIV incidence.</p>\n<p>\n <strong>Barriers to effective HIV prevention and treatment outcomes among key, persistent-driver populations fall into three major themes </strong>based on epidemiologic and qualitative data from SEARCH on seroconversions (N=704), PrEP utilization (3,489 starts²²), viral suppression sub-group analyses (N=13,529^{2, 10, 16}), and other published literature. <u>First</u>, the majority of new infections are in youth, and in this growing, at-risk population, <u>social and economic concerns</u> often far outweigh health concerns on a day-to-day basis (individual barriers).^23-26<em><u>There has been insufficient recognition that at any given moment in time, health is not a preeminent concern,</u> particularly for youth. </em>Indeed, poverty itself may increase “present bias” – the tendency  for short term considerations to outweigh long term ones – contributing to decision-making that harms health.^27-30<u>Second</u> and <u>third,</u> <u>lack of flexibility</u> in how prevention and treatment services, respectively, have been offered to people whose needs and behavior vary from mainstream community members (e.g. mobile populations, drinkers) and may be continually changing (systems barriers) have impeded uptake and impact of these services.^31-35</p>\n<p>\n <strong>Modelling and phylogenetic studies suggest that further progress will require simultaneous and coordinated approaches in HIV treatment and prevention among persistent driver populations. </strong>Individual, “narrow” focused interventions (PrEP) for adolescent girls are important, but alone will not reach HIV elimination levels. Persistent driver populations are minority subsets of demographic populations of considerable size (e.g. while men are at elevated risk of non-suppression, most HIV-infected men are suppressed); some of the barriers they face (e.g. inflexible health systems) are shared across the demographic groups and can be integrated into a personalized public health approach that combines i) <u>foundational changes in health care delivery systems</u> that are scalable and affordable (e.g., re-structuring treatment visits for youth to prioritize non-health concerns) with ii) <u>the option to access more intensive services</u> for the targeted group of persons for whom basic one-size-fits all approaches are insufficient (e.g. intensified alcohol counseling for heavy drinkers and “travel packs” for mobile populations). Assumptions that strategies to reach these populations will be prohibitively expensive or too complex for programs to implement are unsubstantiated, and stakeholders need well-designed studies incorporating multiple interventions for persistent driver populations, and integrating intensification based on choice, to understand what works and inform resource allocation as they move beyond the “90-90-90” era towards HIV elimination.    </p>\n<p>\n <strong>To address these barriers for persistent driver populations to increase prevention coverage for HIV- persons and viral suppression for HIV-infected persons, we used <u>the empirically-validated PRECEDE model</u></strong><strong>³⁶</strong>where health decision-making and health-seeking behaviors can be influenced via interventions that predispose, enable, and reinforce desired engagement with prevention and treatment services (see <strong>Section 8</strong>, below for comprehensive description of our PRECEDE intervention framework). </p>\n<p>\n  </p>\n<p>\n <strong><u>Dynamic HIV prevention</u></strong>: Our 3 Dynamic Prevention components address barriers we identified in offering PrEP to >10,000 persons with risk factors for HIV acquisition in the region (Table 2). First, we will engage youth in HIV prevention and reproductive health services by generating demand for these services within existing life skills and vocational programs (BRAC youth development clubs in Uganda and micro-finance clubs in Kenya) via integration of key health and socio-economic services. For youth, embedding HIV services within a broader, multi-sector strategy for individual and community empowerment via economic and social advancement can lead to better decision-making and also increase <u>demand for and engagement with</u> HIV services. Similar approaches have been used in diverse settings and may overcome present bias and other barriers faced by youth living in poverty by generating demand for services while improving future expectations and decision-making via increased opportunity.^37-44Despite a strong evidence base that these interventions can impact self-reported behaviors, and in some cases unintended pregnancies and STIs, and recent encouraging evidence from the DREAMS program (HIV incidence reduction in <u>non-randomized longitudinal analyses</u><u>⁴⁵</u>), there is little rigorous evidence that these interventions can reduce HIV incidence (as noted in a systematic review of income generation interventions for HIV prevention³⁷) or impact biomedical prevention (e.g. PrEP, PEP, condom use) uptake or adherence <u>from randomized studies.</u> We provide a comprehensive review of key completed and ongoing studies in Table 3. Thus our approach to engage young women and men through these <u>existing programs</u> that <u>offer life skills and vocational training opportunities for economic and social advancement, along with embedded HIV and reproductive health education and expedited referrals for HIV prevention is different and complimentary to the DREAMS program and a potentially efficient way to engage youth that has not been rigorously tested.</u></p>\n<p>\n  </p>\n<p>\n <br />\n <strong>HIV prevention services that offer <u>choice</u> of delivery options (PrEP & PEP) and <u>flexibility</u> in their use and <u>location of delivery</u> over time allow for a dynamic, patient-centered model of prevention. This approach is responsive to the reality of an individual’s changing needs, thereby facilitating <u>continued engagement</u>. </strong>In SEARCH, PrEP use declined over time in spite of initial enthusiasm and uptake by early adopters.⁵⁴<em>In multiple settings, poor adherence to PrEP remains its Achilles’ heel.</em><em>^{55, 56}</em>Rather than presenting PrEP in a similar framework to ART (i.e. lifelong use with 100% adherence for efficacy with delivery at HIV clinic), approaches that incorporate flexibility in choice and delivery location, akin to contraception options for women in developed countries, may prove more successful. Indeed, over the past four decades, increased choice in contraception and flexibility in access have been directly associated with increased use.^{57, 58}Framing prevention in the context of healthy choices, rather than an assessment of risk, may also reduce the association of PrEP with “risky” behavior or promiscuity. Offering PEP – an event-driven option that does not require accurate prediction of risk before a potential HIV exposure (akin to a “morning after” pill), and which additionally provides protection for those with less sexual agency – is a critical innovation in flexible access to prevention services. PEP can also act as a “gateway” to PrEP and other prevention modalities (<strong>Figure 1</strong>), providing infrastructure to add new prevention options as they become available (e.g. the PrEP vaginal ring^{59, 60}). </p>\n<p>\n  </p>\n<p>\n <strong><u>Dynamic HIV Treatment</u></strong><strong>: offering choice and flexibility in HIV clinical care and ART access </strong>that is tailored to the needs of key populations – including youth, men, mobile, and heavy alcohol-using populations – may result in <u>increased care engagement and viral suppression rates</u> among these populations, compared to differentiated care models as currently conceptualized. We have identified key barriers and facilitators for engagement in treatment for each of these groups, obtained via quantitative surveys and focus group discussions among persons who have not engaged, dropped out of care or not achieved viral suppression in SEARCH and via existing literature (Table 4).^{33, 61-67}Treatment outcomes are most likely to be effective when these barriers are overcome. For example in youth, using the PRECEDE framework we have piloted our proposed intervention that combines (i) a “life stage” assessment framework that addresses the many dynamic changes in relationships, school and employment present in youth (PREDISPOSING) (ii) flexible clinic access (ENABLING) and (iii) rapid viral load feedback (REINFORCING). Details on treatment interventions for other key driver populations are in the protocol (see Section 8, below).   </p>\n<p>\n  </p>\n<p>\n <strong>The HIV epidemic will unnecessarily claim and continue to adversely affect millions of lives unless we deploy innovative strategies that extend the gains beyond those of universal testing and ART. </strong>Universal ART must be followed by dynamic prevention and treatment paradigms that allow for heterogeneity in patient need and preference, as well as changing preferences over time – while targeting interventions to those at greatest risk of incident and uncontrolled HIV. Furthermore,<strong> <u>HIV cannot be addressed in a vacuum and must be coupled with health services that are seen by community members as a priority</u> - </strong>including evaluation and treatment for diseases such as hypertension,^68-70diabetes,⁷¹and heavy alcohol use⁷², delivered in an environment that harnesses human capital among youth (the largest segment of the population in SSA⁷³). In our proposal, we postulate that within this broader framework, we can successfully reduce HIV incidence, population viral load and mortality, while improving community health outcomes. We will rigorously evaluate these effects and their costs using a 2-stage optimization and factorial cluster randomized design.</p>\n
      • short_titleSAPPHIRE STUDY
      • protocol_noECCT/22/09/04
      • version_no5.0
      • date_of_protocol25-05-2022
      • study_drug Long-acting injectable Cabotegravir (CAB-LA) 600mg
      • disease_conditionHIV/AIDS
      • 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_nameCabotegravir
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameTenofovir/Emtricitabine (TDF/FTC)
      • comparator_registeredYes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.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_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • 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_applicantGreshon Rota
      • declaration_date112-09-2022
      • declaration_principal_investigatorElizabeth Bukusi
      • declaration_date212-09-2022
      • placebo_presentNo
      • study_objectives<h2>\n Primary Objective</h2>\n<p>\n To reduce HIV incidence using innovative strategies for HIV prevention and treatment to simultaneously reach “persistent driver” populations.</p>\n<h2>\n Secondary Objectives</h2>\n<p style=\"margin-left:36.0pt;\">\n 1.    Evaluate and optimize individual intervention component effects, alone (Phase A) and in combination (Phase B), versus control conditions on prevention coverage and HIV viral suppression.</p>\n<p style=\"margin-left:36.0pt;\">\n 2.    Assess the effect of the intervention package on other health outcomes (all-cause mortality, tuberculosis, hypertension control, heavy alcohol use and mother-to-child HIV transmission) in Phase B.</p>\n<p style=\"margin-left:36.0pt;\">\n 3.    Evaluate behavioral and other mechanistic pathways for intervention effects on proximal mediators of HIV incidence in Phase B.</p>\n<p style=\"margin-left:36.0pt;\">\n 4.    Assess the reach, effectiveness, patient and provider adoption, and fidelity and the maintenance of intervention components in Phase B.</p>\n<p style=\"margin-left:36.0pt;\">\n 5.    Use final study data to inform a strategic and sustainable investment model that maximally reduces HIV incidence and improves community health for the combination interventions tested in Phase B.</p>\n
      • principal_inclusion_criteria<p>\n <u>Outpatient and antenatal/FP clinics</u></p>\n<p style=\"margin-left:18.0pt;\">\n 1.     Age ≥15 years</p>\n<p style=\"margin-left:18.0pt;\">\n 2.     HIV-negative</p>\n<p style=\"margin-left:18.0pt;\">\n 3.     Current or anticipated sexual activity with partner(s) with known HIV-infection or unknown HIV status</p>\n<p>\n  </p>\n<p>\n <u>VHT households </u></p>\n<p style=\"margin-left:18.0pt;\">\n 1.     Age <u>></u>15 years</p>\n<p style=\"margin-left:18.0pt;\">\n 2.     HIV-negative</p>\n<p style=\"margin-left:18.0pt;\">\n 3.     Current or anticipated sexual activity with partner(s) with known HIV-infection or unknown HIV status</p>\n<p>\n  </p>\n<p>\n <u>Youth multi-sector interventions</u></p>\n<p style=\"margin-left:18.8pt;\">\n 1.     Age ≥15 to ≤25 years</p>\n<p style=\"margin-left:18.8pt;\">\n 2.     HIV-negative</p>\n<p style=\"margin-left:18.8pt;\">\n 3.     Current or anticipated sexual activity with partner(s) with known HIV-infection or unknown HIV status</p>\n<p style=\"margin-left:36.0pt;\">\n At least one of the following risk factors: School drop-out, prior pregnancy, transactional sex, orphanhood, work in sector associated with higher HIV risk (e.g. boda boda driver), drink alcohol or STI history</p>\n
      • principal_exclusion_criteria<p>\n <u>Outpatient and antenatal/FP clinics</u></p>\n<p style=\"margin-left:18.8pt;\">\n 1.     <15 years of age</p>\n<p style=\"margin-left:18.8pt;\">\n 2.     Unable to provide consent or parental co-consent as per country guidelines</p>\n<p style=\"margin-left:18.8pt;\">\n 3.     Participation in another Phase A RCT intervention component</p>\n<p style=\"margin-left:18.8pt;\">\n  </p>\n<p>\n <u>VHT households </u></p>\n<p style=\"margin-left:18.0pt;\">\n 1       <15 years of age</p>\n<p style=\"margin-left:18.8pt;\">\n 2       unable to provide consent or parental co-consent as per country guidelines</p>\n<p style=\"margin-left:18.8pt;\">\n 3      Participation in another Phase A RCT intervention component</p>\n<p>\n  </p>\n<p>\n <u>Youth multi-sector interventions  </u></p>\n<p style=\"margin-left:18.8pt;\">\n 1.     <15 or >25 years of age</p>\n<p style=\"margin-left:18.8pt;\">\n 2.     Unable to provide consent or parental co-consent as per country guidelines</p>\n<p style=\"margin-left:18.8pt;\">\n 3.     Participation in another Phase A RCT intervention component</p>\n
      • primary_end_points<p>\n <strong>Study Endpoints:  </strong></p>\n<p>\n <strong>Phase A: </strong>The primary endpoints in Phase A are: Prevention coverage (uptake and persistence of PrEP or PEP) and viral suppression (HIV RNA <400 c/mL).  For hypertension intervention, the primary endpoints are  linkage to care and hypertension control.</p>\n<p>\n <strong>Phase B</strong>: The primary and secondary endpoints in Phase B are:</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Prevention coverage (uptake and persistence of PrEP and PEP)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Viral suppression (HIV RNA <400 c/mL)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         HIV incidence (cumulative 3 year)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Mortality (cumulative 3 year)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Tuberculosis (annual incidence rate)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Hypertension control (<140/90 mmHg)</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Heavy alcohol use</p>\n<p style=\"margin-left:36.0pt;\">\n ·         Mother-to-child HIV transmission (infant HIV free survival at 3 years)</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Principal Investigator - Prof Elizabeth Bukusi</p>\n<p>\n Co-investigator - Dr. James Ayieko</p>\n<p>\n Pharmacist - Dr. Greshon Rota</p>\n<p>\n Study Coordinators - 1. Freddie Opel, 2. Norton Sang, 3. Marilyn Nyabuti</p>\n<p>\n Study Clinicians - 4 </p>\n<p>\n Study Nurses - 4</p>\n<p>\n Study Administrators - 3</p>\n<p>\n Retention coordinator - 1</p>\n<p>\n Lab coordinator - 1</p>\n<p>\n Lab tech - 3</p>\n<p>\n Pharm tech - 1</p>\n<p>\n Data manager - 1</p>\n<p>\n ICT Coordinator - 1</p>\n<p>\n Research assistants - 6</p>\n<p>\n Study drivers - 4</p>\n<p>\n Human resource manager - 1</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study is seeking to address persistent drivers of HIV transmission in Africa so as to reduce rate of HIV infection inorder to achieve the UNAIDS “90-90-90” strategy which calls for 90% of HIV-infected individuals to be diagnosed by 2020, 90% of whom will be on anti-retroviral therapy (ART) and 90% of whom will achieve sustained virologic suppression.</p>\n
      • other_details_regulatory_notapproved<p>\n Uganda National Drug Authority - 26 August 2022</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration5 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_comparatorTenofovir/Emtricitabine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-SEARCH SAPPHIRE
      • single_site_physical_addressSUBA SUBCOUNTY HOSPITAL - SINDO
      • single_site_contact_personJames Ayieko
      • single_site_telephone0720925262
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listUganda and Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site1050
      • total_participants_worldwide2100
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
      • investigator1_professional_addressP.O Box 54840, Nairobi, Kenya
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@kemri.go.ke
      • organisations_transferred_Yes
      • number_participants1050
      • notification
      • approval_date09-12-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-09-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer queries have been resolved.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-01-30 13:36:20
      • created2022-09-05 15:39:42
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id848
        • application_id1167
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
        • professional_addressP.O Box 54840, Nairobi, Kenya
        • telephone0733617503
        • emailebukusi@kemri.go.ke
        • created2022-09-05 16:04:19
        • modified2022-09-12 14:00:48
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        • site_capacity(null)
        • misc(null)
        • created2022-09-05 16:04:19
        • modified2022-09-12 14:00:48
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id602
        • application_id1167
        • sponsorNational Institutes of Health (NIH)
        • sponsor_typeResearch Institution
        • contact_personPhillip De Biase
        • address9000 Rockville Pike Bethesda, Maryland 20892
        • telephone_number+1-301-496-4000
        • fax_number
        • cell_number+1-301-496-4000
        • email_addressgrantsinfo@nih.gov
        • created2022-09-05 16:04:19
        • modified2022-09-12 14:00:48
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      • user_id780
      • trial_status_id(null)
      • abstract_of_study<div>\n ABSTRACT</div>\n<div>\n  </div>\n<div>\n One-third to two-thirds of operated patients in low-income countries acquire surgical site infection (SSI),</div>\n<div>\n which is nine times higher when compared to developed countries. Caesarean section (CS) account for</div>\n<div>\n most of recorded cases of SSI compared to other surgical procedures both in developed and low-income</div>\n<div>\n countries. In African countries, women giving birth still face substantial risks to their own life and that of</div>\n<div>\n their baby and sepsis remains the greatest contributor to maternal morbidity and mortality. Even though</div>\n<div>\n the impact of antibiotic prophylaxis in both emergency and elective caesarean sections has been</div>\n<div>\n highlighted in previous studies, it is not clear whether there exists any significant difference in prevention</div>\n<div>\n of surgical site infection when single dose compared to extended dose antibiotic is used. This study aims</div>\n<div>\n to evaluate differences in occurrence of surgical site infection when extended versus single dose</div>\n<div>\n antibiotics are provided among women undergoing elective caesarean section. The specific objectives of</div>\n<div>\n this study are (i) to compare the occurrence of post caesarean SSI when using extended versus single dose</div>\n<div>\n prophylactic antibiotics. (ii) to determine patient factors associated with surgical site infection among</div>\n<div>\n women undergoing elective caesarean section. (iii) to determine the rational use of antibiotics among</div>\n<div>\n women randomized for single dose prophylactic antibiotics in Elective caesarean section. This will be an</div>\n<div>\n institutional based, un-blinded randomized control study to be carried out at JaramogiOgingaOdinga</div>\n<div>\n Teaching and Referral Hospital (JOOTRH), Kisumu County, Kenya because (i) the hospital has a 600-</div>\n<div>\n bed capacity making it be among those hospitals with higher projected rates of SSIs. (ii)Approximately</div>\n<div>\n 300 caesarean sections are carried out quarter yearly. (iii)The hospital has no existing antibiotic protocol</div>\n<div>\n for use in women undergoing caesarean deliveries. (iv) Antibiotic use in surgical patients is high in</div>\n<div>\n JOOTRH (v) The number of reported Surgical site infections are high at JOOTRH. The study population</div>\n<div>\n will comprise of women aged 18 – 49 years admitted for elective CS at JOOTRH .150 women scheduled</div>\n<div>\n for elective caesarean section will be randomized in two groups, namely the control group and the</div>\n<div>\n intervention group. Those in control group will get extended doses of antibiotics while those in</div>\n<div>\n intervention group shall get single dose antibiotic. Both groups will be followed up for 28 days for signs</div>\n<div>\n and symptoms off SSIs using a close-ended questionnaire on days 2, 14 and 28 after surgery. Collected</div>\n<div>\n data will be summarized using frequency counts and percentages. Inferential analysis will be employed to</div>\n<div>\n analyze the collected data. Pearson’s Chi-square test of independence and Fisher’s exact test will be used</div>\n<div>\n to assess the association of variables. All covariates with p-value &lt;=0.05 at bivariate analysis will be</div>\n<div>\n included in multivariate logistic regression. The expected outcome of the study is to provide data that will</div>\n<div>\n be used in formulating protocol on antibiotic use in caesarean section in JOOTRH. This study is</div>\n<div>\n envisioned to be a preamble to even a wider study on caesarean section care of women in western Kenya.</div>\n<div>\n The participants will not directly benefit from the study results since by the time of analysis all of them</div>\n<div>\n will have exited the study.</div>\n
      • study_title<div>\n <strong>_{EFFECTIVENESS OFSINGLE-DOSE ANTIBIOTIC USE IN ELECTIVE CAESAREANSECTION IN PREVENTION OF SURGICAL SITE INFECTION AT JARAMOGI}</strong></div>\n<div>\n <strong>_{OGINGA ODINGA TEACHING AND REFERRAL HOSPITAL, KISUMU COUNTY,KENYA: A RANDOMIZED CONTROL TRIAL.}</strong></div>\n
      • laymans_summary<p>\n This study aims to compare two groups of women who are scheduled to undergo elective caesarean section at JOOTRH. One group will be randomized to get extended dose of antibiotics while the othr group will be randomized to get single dose of antbiotics.</p>\n<p>\n  The two gruops will be closely followed up after discharge on day 7 , 14 and 28  and surgical site monitored for any infections.</p>\n<p>\n  This comes after the realization that despite literature to support use of single dose antibiotics many medical practioners are still reluctant and always give extended doses of antibitics to this group of patients.</p>\n
      • short_titleSINGLE DOSE VERSUS EXTENDED DO
      • protocol_noECCT/22/09/03
      • version_no1
      • date_of_protocol09-09-2022
      • study_drugCeftriaxone, metronidazole and amoxicillin
      • disease_conditionsurgical site infection
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameCetfriaxone , metronidazone , amoxicillin
      • product_type_medical_device_nameSAFE
      • comparatorNo
      • comparator_nameNONE
      • comparator_registeredN/A
      • comparator_countriesN/A
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdrjuma2022@gmail.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_countries(null)
      • applicant_addendum1
      • 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_applicant0727535519
      • declaration_date124-09-2022
      • declaration_principal_investigatorSTEVEN ODHIAMBO JUMA
      • declaration_date224-09-2022
      • placebo_presentNo
      • study_objectives<div>\n Objectives of the study</div>\n<div>\n  BROAD OBJECTIVE</div>\n<div>\n To assess the effectiveness of single dose antibiotic use in elective caesarean section for SSI prevention.</div>\n<div>\n  </div>\n<div>\n SPECIFIC OBJECTIVE</div>\n<div>\n 1. To compare the occurrence of post CS surgical site infection when using extended antibiotics versus single dose prophylactic antibiotics.</div>\n<div>\n 2. To determine patient factors associated with surgical site infection among women undergoing elective caesarean section.</div>\n<div>\n 3. To determine the rational use of antibiotics among women randomized for single dose prophylactic antibiotics in Elective caesarean section</div>\n
      • principal_inclusion_criteria<div>\n INCLUSION CRITERIA</div>\n<div>\n • Women of the ages of 18 and above.</div>\n<div>\n • Women admitted at JOOTRH for elective caesarean section .</div>\n<div>\n • Indication for elective caesarean section at term.</div>\n<div>\n • Patients shall have consented to participate in the study.</div>\n
      • principal_exclusion_criteria<div>\n EXCLUSION CRITERIA</div>\n<div>\n • Recent antibiotic use.</div>\n<div>\n • Immunosuppressive condition / therapy.</div>\n<div>\n • Allergy to Ceftriaxone (antibiotic prophylaxis)</div>\n<div>\n • Indication for emergency caesarean section.</div>\n<div>\n • Signs and symptoms of active infection.</div>\n
      • primary_end_points<p>\n The study hypothesizes that a single dose prophylactic antibiotic use is as effective as extended antibiotic course in surgical site infection prevention.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyThis will be an un-blinded randomized control study to assess effectiveness of single dose antibiotic use in elective caesarean sections.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n PRINCIPAL INVESTIGATOR - MASTERS STUDENT AT MASENO UNIVERSITY - OBSTETRICS AND GYNECOLOGY</p>\n<p>\n RESEARCH ASSISTANT- SARAH NASAMBU - CLINICAL OFFICER AT JOOTRH</p>\n
      • other_details_explanation<p>\n STUDY IS TO BE DONE IN KENYA , THE PRIINCIPAL INVESTIGATOR IS A KENYAN STUDENT AT MASENO UNIVERSITY PERSUING MASTERS IN OBSTETRICS AND GYNECOLOGY.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n MASENO UNIERSITY ETHICS REVIEW COMMITTEE 01 MARCH ,2022</p>\n<p>\n NACOSTI APPROVAL ON 25TH MARCH , 2022</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration6 MONTHS
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNON INTERVENTION GROUP
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyCEFTRIAXONE, AMOXICILLIN AND METRONIDAZOLE
      • single_site_member_stateYes
      • location_of_areaJARAMOGI OGINGA ODINGA TEACHING AND REFERRAL HOSPITAL
      • single_site_physical_addressKISUMU- KAKAMEGA ROAD
      • single_site_contact_personDr. Juma Steven
      • single_site_telephone0727535519
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site150 women scheduled for elective caesarean section at Jaramogi Oginga Odinga Teaching and Referral Hospital
      • total_participants_worldwide150
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_nameN/A
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emaildrjuma2022@gmail.com
      • organisations_transferred_No
      • number_participants150 participants
      • notification<p>\n none</p>\n
      • approval_date26-09-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-09-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThis is a postgraduate academic study
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-09-26 14:28:04
      • created2022-09-07 14:49:51
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id849
        • application_id1170
        • given_nameSTEVEN
        • middle_nameODHIAMBO
        • family_nameJUMA
        • qualificationMBCHB
        • professional_addressREGISTRAR OBSTETRICS AND GYNECOLOGY MASENO UNIVERSITY
        • telephone0727535519
        • emaildrjuma2022@gmail.com
        • created2022-09-07 15:05:13
        • modified2022-09-24 11:27:04
    • SiteDetail(array)
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        • id1312
        • application_id1170
        • county_id(null)
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        • physical_address
        • contact_details
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        • site_capacity(null)
        • misc(null)
        • created2022-09-07 15:05:13
        • modified2022-09-24 11:27:04
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id603
        • application_id1170
        • sponsorSTUDENT SELF SPONSORED
        • sponsor_typeLocal Kenyan Investigator
        • contact_personJUMA STEVEN ODHIAMBO
        • address3275- 40100 MASENO
        • telephone_number0727535519
        • fax_number
        • cell_number0727535519
        • email_addressdrjuma2022@gmail.com
        • created2022-09-07 15:05:13
        • modified2022-09-24 11:27:04
  • 4(array)
    • Application(array)
      • id1141
      • user_id745
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Introduction:</strong></p>\n<p>\n Anemia among women of reproductive age is a stubborn problem in resource-poor countries.  Approximately 38% and 41% of non-pregnant women in Africa and SE Asia, respectively, are anemic (1).  In the two regions combined, this sums to approximately 270 million cases.  At least half of anemia cases are due to iron deficiency.  Iron deficiency is estimated to be the cause of 18% of maternal deaths worldwide (2); a 10g/L increase in hemoglobin reduces maternal mortality by 29% (3).  Ministries of Health in many resource-poor countries have established programs such as iron supplementation, improving diets, and preventing infectious and communicable diseases that lead to anemia.  Still, the labor-intensive programs and interventions have limited reach and are thus ineffective for hundreds of millions of women.  Multi-prong approaches are needed (4).</p>\n<p>\n The proposed study will take place in Nairobi, Kenya, which is a metropolis with more than three million inhabitants.  Nairobi has large slum areas with poor health conditions that are typical of many large capital cities in sub-Saharan Africa (5).  The national prevalence of anemia, iron-deficiency (corrected for inflammation), and iron-deficiency anemia among non-pregnant women in Kenya is 21.9%, 21.3%. and 14.0%, respectively (6).  In the lowest wealth quintiles of Kenyan society, characteristic of slum areas, the levels are 34.6%, 27.5%, and 20.8%, respectively.</p>\n<p>\n The scientific premise for the proposed work is that a contraceptive technology (the levonorgestrel intrauterine system- LNG IUS) has been shown to reduce menstrual blood loss and consequently, increase hemoglobin and serum ferritin levels in broad populations of non-anemic women (7).  Given what is known about the delicate balance between intake of dietary iron, iron absorption, and iron losses from menstruation, it is highly plausible that retention of iron from using the LNG IUS can become another prong in the strategies to help alleviate anemia.  Both the US Centers for Disease Control and Prevention and the World Health Organization confirm that women with iron deficiency anemia can safely use the LNG IUS (Category 1 on Medical Eligibility Criteria) (8, 9). </p>\n<p>\n <strong>Objectives:</strong></p>\n<p>\n The primary objective is t<span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif;\">o compare hemoglobin changes over time in the randomized arms: LNG IUS versus a </span><span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif; font-size: 11pt;\">Combined oral contraceptives (</span><span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif;\">COC) with ferrous fumarate tablets. </span><span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif;\">The secondary objectives are (1) </span>To compare serum ferritin changes over time in the randomized arms (2) <span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif; text-align: justify;\">To correlate changes in hemoglobin and serum ferritin to reported changes in menstrual blood loss (3) </span><span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif; text-align: justify;\">To assess and compare participants’ satisfaction with the two contraceptive products and (4) </span><span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif; text-align: justify;\">To monitor incidence of progression to severe anemia and compare randomized arms</span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-align: justify; line-height: 12.45pt;\">\n  </p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-align: justify; line-height: 12.45pt;\">\n <span lang=\"EN-US\"><o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-align: justify;\">\n <span lang=\"EN-US\"><o:p></o:p></span></p>\n<p>\n <strong>Methods:</strong></p>\n<p>\n  </p>\n<p>\n This randomized controlled trial will examine and compare changes in hemoglobin among anemic women randomized to either the LNG IUS or an LNG/EE/ferrous fumarate COC.  The equal-allocation, open label study will be conducted at a single site in Nairobi, Kenya.  The primary hypothesis that the mean change in hemoglobin in the group assigned to the LNG IUS will be superior to the COC/ferrous fumarate (control) group by at least 4 g/L after 18-months of product use.  The study products are approved for use only as contraceptives and are available in Kenya; this study is not seeking regulatory approval for a new indication. </p>\n<p>\n Clinic staff will recruit approximately 600 anemic women aged 18-50 who are seeking contraception and have regular menses.  Participation will require two low hemoglobin values (87 to 126 g/L, inclusive) taken approximately 2-4 weeks apart.  After randomization, each participant will be followed for 18 months; blood samples will be collected at enrollment and every six months for measuring hemoglobin, serum ferritin and other markers.  Intention-to-treat principles and per protocol analyses will be used to measure and compare mean change in hemoglobin (primary endpoint) and serum ferritin (secondary endpoint) in the randomized groups.  All results will be examined in relation to incidence of acute inflammation, changes in menstruation, and any non-study use of supplemental iron.</p>\n<p>\n <strong>Utility: </strong></p>\n<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif;\">This study aims to determine whether the LNG IUS can raise hemoglobin and serum ferritin levels in a marginalized, anemic population</span></p>\n<p>\n  </p>\n<p>\n  </p>\n
      • study_title<p>\n <span lang=\"EN-US\" style=\"color: rgb(0, 0, 0); font-size: 16pt; font-family: Calibri, sans-serif;\">Levonorgestrel intrauterine system effects on hemoglobin and serum ferritin among anemic women in Kenya: An open label randomized trial to compare with an oral contraceptive regimen that provides supplemental ferrous fumarate tablets</span></p>\n
      • laymans_summary<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Calibri, sans-serif; font-size: 21.3333px;\">Levonorgestrel intrauterine system effects on hemoglobin and serum ferritin among anemic women in Kenya</span></p>\n
      • short_titleLISA Trial
      • protocol_noECCT/22/09/02
      • version_no3.0
      • date_of_protocol03-03-2022
      • study_druglevonorgestrel, ethinyl estradiol and ferrous fumarate
      • disease_conditionAnemia
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_namelevonorgestrel, ethinyl estradiol and ferrous fumarate
      • product_type_medical_device_namelevonorgestrel-releasing intrauterine system
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfthuita@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)
      • 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 Faith Thuita
      • declaration_date101-09-2022
      • declaration_principal_investigatorDr Faith Thuita
      • declaration_date201-09-2022
      • placebo_presentNo
      • study_objectives<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); line-height: 12.45pt;\">\n <strong><span lang=\"EN-US\">Primary Objective:</span></strong><span lang=\"EN-US\"><o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); line-height: 12.45pt;\">\n <span lang=\"EN-US\">To compare hemoglobin changes over time in the randomized arms: LNG IUS versus COCs</span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); line-height: 12.45pt;\">\n <span lang=\"EN-US\"><o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); line-height: 12.45pt;\">\n  </p>\n<p class=\"TableParagraph\" style=\"margin: 0cm; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); line-height: 12.45pt;\">\n <strong><span lang=\"EN-US\">Secondary Objectives:</span></strong><span lang=\"EN-US\"><o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-indent: -18pt; line-height: 12.45pt;\">\n <span lang=\"EN-US\" style=\"font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span lang=\"EN-US\">To compare serum ferritin changes over time in the randomized arms<o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-indent: -18pt; line-height: 12.45pt;\">\n <span lang=\"EN-US\" style=\"font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span lang=\"EN-US\">To </span><span lang=\"EN-US\">correlate changes in hemoglobin and serum ferritin to changes in self-reported menstrual blood loss<o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-indent: -18pt; line-height: 12.45pt;\">\n <span lang=\"EN-US\" style=\"font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span lang=\"EN-US\">To </span><span lang=\"EN-US\">assess and compare participants’ satisfaction with the two contraceptive products<o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(0, 0, 0); text-indent: -18pt; line-height: 12.45pt;\">\n <span lang=\"EN-US\" style=\"font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span lang=\"EN-US\">To monitor incidence of progression to severe anemia and compare randomized arms<o:p></o:p></span></p>\n
      • principal_inclusion_criteria<p>\n Prospective participants must meet the following main criteria:</p>\n<ol>\n <li>\n Provide sequential oral and written consents to screen for eligibility and enroll</li>\n <li>\n Female, aged 18-50</li>\n <li>\n Desire to use contraception or possibly switch methods</li>\n <li>\n Initial hemoglobin of <u><</u> 126 g/L</li>\n <li>\n Possession of a cell phone and willingness to be contacted</li>\n <li>\n Confirmatory low hemoglobin (minimum of 87 g/L and maximum of 126 g/L) taken 1 to 4 weeks after the initial test</li>\n <li>\n Regularly menstruating (at least once every 35 days)</li>\n <li>\n At least 6 weeks postpartum</li>\n <li>\n Willingness to agree to study procedures</li>\n <li>\n Willingness to be randomized to treatment</li>\n <li>\n Willingness to use assigned hormonal contraceptive for 18 months</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n An individual who has any of the following will be excluded from participation in this study:</p>\n<ol>\n <li style=\"margin-left: 69pt;\">\n Severe anemia (hemoglobin <u><</u> 86 g/L), based on the second rapid test</li>\n <li style=\"margin-left: 69pt;\">\n Currently pregnant based on urine pregnancy test and failure to rule out possible pregnancy according to WHO guidelines</li>\n <li style=\"margin-left: 69pt;\">\n Surgically sterilized or had a hysterectomy</li>\n <li style=\"margin-left: 69pt;\">\n Participated previously in this study by being randomized to contraceptive</li>\n <li style=\"margin-left: 69pt;\">\n Currently using a subdermal contraceptive implant and does not wish to have it removed</li>\n <li style=\"margin-left: 69pt;\">\n Currently using an LNG IUS</li>\n <li style=\"margin-left: 69pt;\">\n Currently receiving treatment for anemia</li>\n <li style=\"margin-left: 69pt;\">\n Any of the following previously diagnosed disorders: hemosiderosis, hemochromatosis, hemolytic anemia</li>\n <li style=\"margin-left: 69pt;\">\n Known allergic reactions to oral contraceptives or LNG IUS</li>\n <li style=\"margin-left: 69pt;\">\n Currently receiving an investigational (unapproved) drug in another study</li>\n <li style=\"margin-left: 69pt;\">\n Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe</li>\n <li style=\"margin-left: 69pt;\">\n ntending to become pregnant in the next 18 months</li>\n <li style=\"margin-left: 69pt;\">\n Mucopurulent cervicitis</li>\n <li style=\"margin-left: 69pt;\">\n Pelvic inflammatory disease</li>\n <li style=\"margin-left: 69pt;\">\n Other medical contraindications to treatment, according to WHO Medical Eligibility Criteria (categories 3 or 4)</li>\n</ol>\n
      • primary_end_points<p>\n <span lang=\"EN-US\" style=\"color: rgb(0, 0, 0); font-size: 11pt; font-family: Calibri, sans-serif;\">Hemoglobin levels of participants measured at 6, 12, and 18 months</span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Facilities</strong></p>\n<p>\n 1. A customized fully equiped fabricated project container installed within field site at Kangemi health centre comprising of:</p>\n<ul style=\"margin-left: 40px;\">\n <li>\n Reception area with lockable cabinets, shelves and necessary materials for record keeping and receiving study participants</li>\n <li>\n Laboratory room with a fridge for storage of samples pending transportation to UNITID-UoN main laboratory</li>\n <li>\n Procedure room equiped with a nursing station, examination couch, sink and relevant equipment for counselling and dispensing study products to eligible study particoipants by the study nurse.</li>\n <li>\n Data room equipped with a working desk for the data entry clerk, photocopie/scanner and lockable cabinets for filing hard copies of study tools</li>\n <li>\n Study coordinators room - lockable cabinet</li>\n <li>\n Reception area - Comfortable seating are for study participants</li>\n</ul>\n<p>\n 2. Health facility Pharmacy - Spacious well stocked pharmacy manned by a Pharmacy Tecnologist. Study products will be stored at this pharmacy with product records, handling and overall conditions monitored by the study pharmacist.</p>\n<p>\n 3. Incinerator for disposal of clinical waste</p>\n<p>\n 4. Generator accesible from KAVI-UoN through internal collaborative arrangements</p>\n<p>\n <strong>Project Staff </strong></p>\n<p style=\"margin-left: 40px;\">\n 1. Study cordinator: Shortlisting on-going to recruit an individual with academic background in a health related course at degree level & strong experience cordinating research activities preferably in a health related grant project.</p>\n<p style=\"margin-left: 40px;\">\n 2. Study Nurse; Jeremiah Kagongo, Registered Community Health Nurse, 8 years expeience in clinical and reserach clinic settings</p>\n<p style=\"margin-left: 40px;\">\n 3. Assistant Lab tecnician: Beryl Masinde, Lab tecnologist, over 8 years experience in reserach and linical labs</p>\n<p style=\"margin-left: 40px;\">\n 4.Data Manager - Agnes Ndirangu, Bsc Statistics & Posgraduate training in Monitoring and Evaluation, over 7years experience as a data manager in large health related reserach projects incuding KEMRI</p>\n<p style=\"margin-left: 40px;\">\n 5. Study Admin/Accountant: Dennis Wanyonyi, B.com, Accounting: Experienced, Former Finance and Fiscal Manager, KEMRI, Thika Project</p>\n<p style=\"margin-left: 40px;\">\n 6. Data entry clerk: In process of recuitment</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"caret-color: rgb(51, 51, 51); color: rgb(51, 51, 51); font-family: \" text-size-adjust:=\"\" trebuchet=\"\">This is a single country trial where FHI 360 is the trial sponsor</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration5 years - Overall duration inclusive of time for all preparatory activities and report writting. Actual follow-up of participants is 18 months.
      • 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_comparatorStandard intervention
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKangemi Health Centre
      • single_site_physical_addressKangemi - Waiyaki Way, Nairobi
      • single_site_contact_personSarah Wachuka
      • single_site_telephone0726105764
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site600 - Kangemi Health Centre and surrounding community
      • total_participants_worldwide600
      • 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_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid
      • investigator1_middle_name
      • investigator1_family_nameHubacher
      • investigator1_qualificationPhD, Senior Epidemiologist
      • investigator1_professional_addressFHI 360, 359 Blackwell Street, Suite 200 | Durham, NC 27701
      • investigator1_telephone+19193213459
      • investigator1_emailDHubacher@fhi360.org
      • organisations_transferred_Yes
      • number_participants600
      • notification
      • approval_date23-02-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted14-02-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe PI has responded to the Reviewer comments and proposed amendment done.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-10-14 09:43:18
      • created2022-05-06 14:55:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id820
        • application_id1141
        • given_nameFaith
        • middle_nameMugure
        • family_nameThuita
        • qualificationPhD, Senior Nutrition and Public health Lecturer and researcher
        • professional_addressP. O. BOX 19676 – 00202, Department of Public and Global Health, Kenyatta National Hospital Campus, Nairobi, Kenya
        • telephone+254722639719
        • emailfthuita@uonbi.ac.ke
        • created2022-05-09 09:04:00
        • modified2023-02-14 14:31:55
    • SiteDetail(array)
      • 0(array)
        • id1276
        • application_id1141
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-05-09 09:04:00
        • modified2023-02-14 14:31:55
        • County(empty)
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      • 0(array)
        • id590
        • application_id1141
        • sponsorFHI 360
        • sponsor_typeOthers
        • contact_personDavid Hubacher
        • addressFHI 360, 359 Blackwell Street, Suite 200 | Durham, NC 27701
        • telephone_number+19193213459
        • fax_number +19195447261
        • cell_number+19193213459
        • email_addressDHubacher@fhi360.org
        • created2022-05-09 09:04:00
        • modified2023-02-14 14:31:55
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PHP Environment

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