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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id917
      • user_id639
      • trial_status_id7
      • abstract_of_study<p>\n  </p>\n<p>\n  </p>\n<p>\n The ultimate goal of this research is to develop a means to safely administer iron supplements to infants in settings with high infection burden. The hypothesis underlying this project is that promoting development of a beneficial, protective gut microbiota by co-administration of prebiotic galacto-oligosaccharides (GOS) and iron-sequestering bovine lactoferrin (bLF) during iron supplementation will prevent iron-induced increases of opportunistic enteropathogens that cause infection and inflammation. The proposed research will extend our established strategy of conjoining investigations <em>in vivo</em> [1-3]with intestinal fermentation and cellular models <em>in vitro </em>[4-9]. We will conduct a randomized clinical trial in 6-month-old Kenyan infants in conjunction with mechanistic microbiota studies using our established long-term continuous polyfermenter platform inoculated with immobilized fecal microbiota from Kenyan infants.</p>\n<p>\n The period from about 6-12 months of age is vital both for iron nutrition [10-13]and for the establishment of a healthy gut microbiome that promotes immune system development, local immune homeostasis and limits pathogen colonization [14-19]. Oral iron supplements are associated with a significant 15% increase in the rate of diarrhea in children in malaria-endemic areas. Our most recent studies have shown that prebiotic GOS can provide partial amelioration of the adverse effects (AEs) of iron-induced dysbiosis by enhancing the growth of barrier populations of bifidobacteria and lactobacilli [20].  We hypothesize that the combination of prebiotic GOS with bLF has iron sequestration, antimicrobial and immunomodulatory activities [21-26]and will provide virtually complete protection against the AEs of added iron on the intestinal microbiota. This research has two specific aims:</p>\n<ol>\n <li>\n To conduct a randomized, controlled double-blind 9-month clinical trial in 6-month old Kenyan infants comparing the effects on gut microbiome composition among groups receiving in-home fortification for 6 months with micronutrient powders (MNPs) containing 5 mg iron (as ferrous fumarate [FeFum]) and (i) GOS (7.5 g), (ii) bLF (1 g), (iii) GOS (7.5 g) and bLF (1 g), and (iv) no GOS or bLF. Each infant will then be followed for an additional 3 months to determine the longer-term effects of the treatments.</li>\n <li>\n To examine mechanisms of prebiotic GOS and bLF on microbiota composition, enteropathogen development, microbiota functions and metabolic activity, and inflammatory potential <em>in vitro</em> with treatments paralleling those in Specific Aim 1, using immobilized fecal microbiota from Kenyan infants to inoculate our established long-term continuous polyfermenter intestinal model (PolyFermS) to mimic Kenyan infant colon conditions, together with cellular studies. </li>\n</ol>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p>\n <span lang=\"EN-GB\" style=\"font-size:9.0pt;font-family:"Arial",sans-serif;\ncolor:#222222;background:white;mso-ansi-language:EN-GB\">Prebiotic galacto-oligosaccharides and lactoferrin for beneficial gut microbiota with iron supplements: an intervention trial in infants in Msambweni, Kwale County, southern coastal Kenya</span></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n  </p>\n<p style=\"margin-left:1.45pt;\">\n Young children being breastfed and starting to eat solid foods are at risk of having diarrhea. In our digestive system (in adults but also in infants) live many bacteria that can be good or bad for health. In some cases, the good intestinal bacteria grow poorly and bad bacteria are more numerous. This can cause diarrhea.</p>\n<p style=\"margin-left:1.45pt;\">\n With this project, we want to study the effects of adding vitamins and minerals, plus a dietary fiber, called a prebiotic, and a small protein, which is found in breast milk, called lactoferrin, to maize porridge. We want to see if giving these nutrients can improve your child’s nutrition, in particular iron, which is essential for ‘good blood’ and healthy growth and development.</p>\n<p style=\"margin-left:1.45pt;\">\n In many countries, flours and cereals already have iron, zinc and vitamins added, and these have been shown to improve health and development in children taking the foods. We need to know if making these additions to food is helpful and whether they cause good or bad intestinal bacteria to grow, and whether they can reduce diarrhea. Therefore, we will be looking at whether feeding infants porridge with these nutrients will improve their health, and also reduce the risk for diarrhea.</p>\n<p style=\"margin-left:1.45pt;\">\n The study duration is 9 months, where the participants will be visited weekly and be delivered a micronutrient powder for 6 months, which contains the vitamins, minerals and nutrients, together with 2 kg maize flour for use in the preparation of all porridge fed to the infant. Some infants will receive vitamins and minerals (plus iron), another group will additionally receive the prebiotic, a third group will additionally receive the special lactoferrin protein and a fourth group will additionally receive both the prebiotic and the lactoferrin together. Neither the participants or their caregivers nor the team working in Msambweni will know which infants are in which group. However, a committee of scientists will be receiving health reports on the children and will know which children have received the additional nutrients. If there is any reason to believe that the nutrient powder is affecting the children badly they will stop the study. After the child receives the micronutrient powders for 6 months, he/she will be followed up for 3 months to determine the long-term effects.</p>\n<p style=\"margin-left:1.45pt;\">\n The child’s health will be checked at the start of the study and regularly during the study (weekly) and we also want to measure the child’s height/length and weight. At the beginning of the study (Day 1), after 1 month (Day 30), after 6 months (Day 180) (after the child finished taking the micronutrient powder) and at the end of the study (Day 270) (9 months), the child will be asked to give a small sample of blood (the amount in a small spoon) which will be used to see if the child has enough iron in his blood. Enough iron makes a child strong. We will also look at the bacteria in child’s intestine. Caregivers will be therefore asked to collect the child’s stool sample at the beginning (Day 1), after 1 month (Day 30), after 6 months (Day 180) and at the end of the study (Day 270). Caregivers will be shown how these samples have to be collected and stored in a container adding a sachet. These samples will be tested for which bacteria are present. This will help us to observe any changes caused by the nutrient powders.</p>\n<p>\n In some of the infants, we will collect a stool sample prior to study start (Day -1). This sample will be sent to the university in Zurich, Switzerland, where we will run tests on the bacteria.</p>\n<p>\n  </p>\n
      • short_titleNIH_PREFER
      • protocol_noECCT/20/08/03
      • version_no2
      • date_of_protocol13-02-2020
      • study_drugmicronutrient powder with 5 mg of iron (nutritional supplement)
      • disease_conditionnone
      • 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_namemicronutrient powder
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressnicole.stoffel@hest.ethz.ch
      • 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)
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      • applicant_stability_data0
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      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
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      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantProf. Simon Karanja
      • declaration_date120-08-2020
      • declaration_principal_investigatorProf. Simon Karanja
      • declaration_date220-08-2020
      • placebo_presentNo
      • study_objectives<p>\n  </p>\n<p style=\"text-align:justify;line-height:150%\">\n <span lang=\"EN-GB\" style=\"font-family:\">1. To compare the effects on gut microbiome composition among infants receiving in-home fortification for 6 months with micronutrient powders containing 5 mg iron  and (i) GOS; 7.5 g, (ii) bLF, 1.0 g, (iii) GOS (7.5 g) and bLF (1.0 g), and (iv) no GOS or Blf.</span></p>\n<p style=\"text-align:justify;line-height:150%\">\n <span lang=\"EN-GB\" style=\"font-family:\">2. To examine mechanisms of iron, prebiotic GOS and iron-sequestering bLF on microbiota composition, enteropathogen development, microbiota functions and metabolic activity, and inflammatory potential in vitro with treatments paralleling those in Specific Aim 1.</span></p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n Inclusion criteria will be:</p>\n<p style=\"margin-left:18.0pt;\">\n (i) vaginal or cesarean delivery,</p>\n<p style=\"margin-left:18.0pt;\">\n (ii) an infant age of 6 months (±3 weeks),</p>\n<p style=\"margin-left:18.0pt;\">\n (iii) mother ≥15 years of age,</p>\n<p style=\"margin-left:18.0pt;\">\n (iv) infant still breastfeeding, and</p>\n<p style=\"margin-left:18.0pt;\">\n (v) anticipated residence in the area for the study duration.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n Exclusion criteria will be:</p>\n<p style=\"margin-left:18.0pt;\">\n (i) inability to provide informed consent,</p>\n<p style=\"margin-left:18.0pt;\">\n (ii) hemoglobin < 70 g/L,</p>\n<p style=\"margin-left:18.0pt;\">\n (iii) Z scores for weight-for-age (WAZ) or weight-for-height (WHZ) <3,</p>\n<p style=\"margin-left:18.0pt;\">\n (iv) any maternal or infant chronic illness,</p>\n<p style=\"margin-left:18.0pt;\">\n (v) administration of any vitamin or mineral supplements for the past 2 months, and</p>\n<p style=\"margin-left:18.0pt;\">\n (vi) any history of antibiotic treatment in the past 7 days.</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n  </p>\n<p>\n The primary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic <em>E. coli, C. difficile</em>, members of the <em>C. perfringens group, B. cereus, S. aureus</em>, sum of <em>Shigella</em> spp., and <em>Salmonella</em>) to beneficial (bifidobacteria and the group of La<em>ctobacillus/Leuconostoc/Pediococcus </em>spp.) bacterial genera at 1 month.</p>\n<p>\n  </p>\n<p>\n  </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_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifynutritional supplement efficacy trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n SITE CAPACITY</p>\n<p>\n Number of Staff: 17</p>\n<p>\n Study Manager: Mr. Francis Mwangome Katana</p>\n<p>\n Study coordinator: Suzane Nyilima (BSc. Environmental Health, MSc. Epidemiology Student). 3years working experience</p>\n<p>\n  </p>\n<p>\n Clinicians:</p>\n<p>\n Samuel Mwakai (Diploma in clinical Medicine and surgery) 7 Years working experience</p>\n<p>\n Monica Tallam (Diploma in clinical Medicine and surgery) 8 Years working experience</p>\n<p>\n Mwanaidi Waraka (Diploma in clinical Medicine and surgery) 6 Years working experience</p>\n<p>\n Hajjra Ruhinge (Diploma in clinical Medicine and surgery) 5 Years working experience</p>\n<p>\n  </p>\n<p>\n Study Team</p>\n<p>\n Team Leader: Hamadi Mambo: (BA Business Administration) 8 Years working experience.</p>\n<p>\n Team Leader: Ngome Mgaza (certificate in Project Management and leadership, Certificate in ICH good clinical Practice E6 (R2) 10 Years working experience.</p>\n<p>\n Naomi Koech (BSc. Community Health) 1 Year working experience.</p>\n<p>\n Munaa Lila (certificate in Research and Ethics, Certificate in ICH good clinical Practice E6 (R2)</p>\n<p>\n ) 12 Years working experience</p>\n<p>\n Anna Katana (Diploma in Community Health and Development) 4 Years working experience</p>\n<p>\n Yahya Said Makokha (BA Bachelor of Commerce) 1 Year working experience.</p>\n<p>\n Abdallah Rama Mwamkumba (Community Health Volunteer) 5 Years working experience</p>\n<p>\n Hemmed Hassan Ngere (Computer packages and driving Licence) 3 Years working experience</p>\n<p>\n Nasoro Salim (p1 certificate) 3 Years working experience</p>\n<p>\n Jumaa Mwapheku (community Health Volunteer) 10 Years working experience.</p>\n<p>\n  </p>\n<p>\n Study Team Designated Driver: Shee Salim Mkulu (Driving License) 25 Years working experience.</p>\n<p>\n SITE CAPACITY</p>\n<p>\n Number of Staff: 17</p>\n<p>\n Study Manager: Mr. Francis Mwangome Katana</p>\n<p>\n Study coordinator: Suzane Nyilima (BSc. Environmental Health, MSc. Epidemiology Student). 3years working experience</p>\n<p>\n  </p>\n<p>\n Clinicians:</p>\n<p>\n Samuel Mwakai (Diploma in clinical Medicine and surgery) 7 Years working experience</p>\n<p>\n Monica Tallam (Diploma in clinical Medicine and surgery) 8 Years working experience</p>\n<p>\n Mwanaidi Waraka (Diploma in clinical Medicine and surgery) 6 Years working experience</p>\n<p>\n Hajjra Ruhinge (Diploma in clinical Medicine and surgery) 5 Years working experience</p>\n<p>\n  </p>\n<p>\n Study Team</p>\n<p>\n Team Leader: Hamadi Mambo: (BA Business Administration) 8 Years working experience.</p>\n<p>\n Team Leader: Ngome Mgaza (certificate in Project Management and leadership, Certificate in ICH good clinical Practice E6 (R2) 10 Years working experience.</p>\n<p>\n Naomi Koech (BSc. Community Health) 1 Year working experience.</p>\n<p>\n Munaa Lila (certificate in Research and Ethics, Certificate in ICH good clinical Practice E6 (R2)</p>\n<p>\n ) 12 Years working experience</p>\n<p>\n Anna Katana (Diploma in Community Health and Development) 4 Years working experience</p>\n<p>\n Yahya Said Makokha (BA Bachelor of Commerce) 1 Year working experience.</p>\n<p>\n Abdallah Rama Mwamkumba (Community Health Volunteer) 5 Years working experience</p>\n<p>\n Hemmed Hassan Ngere (Computer packages and driving Licence) 3 Years working experience</p>\n<p>\n Nasoro Salim (p1 certificate) 3 Years working experience</p>\n<p>\n Jumaa Mwapheku (community Health Volunteer) 10 Years working experience.</p>\n<p>\n  </p>\n<p>\n Study Team Designated Driver: Shee Salim Mkulu (Driving License) 25 Years working experience.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The target population for the nutritional supplements we are using in this trial are anemic infants. The burden of anemia in infancy is high in Kenya. </p>\n<p>\n We have an extensive and successful collaboration with Jomo Kenyatta University for several years. </p>\n
      • other_details_regulatory_notapproved<p>\n none</p>\n
      • other_details_regulatory_approved<p>\n ETH Ethics Commmittee May 28th 2020</p>\n<p>\n IRB Columbia University Ethics Committee April 28th 2020</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_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorMNPs with no GOS and bLf
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMsambweni County Referral Hospital
      • single_site_physical_addressUkunda-Ramisi Road Ramisi Kwale Kenya
      • single_site_contact_personDr. Edith Mwasi
      • single_site_telephone+254721237653
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site288
      • total_participants_worldwide288
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSimon
      • investigator1_middle_name
      • investigator1_family_nameKaranja
      • investigator1_qualificationAssociate Professor JKUAT
      • investigator1_professional_addressSchool of Public Health Kenyatta University P. O. Box 43844 – 00100, Nairobi- Kenya
      • investigator1_telephone+254 726424669
      • investigator1_emailskaranja@jkuat.ac.ke
      • organisations_transferred_Yes
      • number_participants288
      • notification
      • approval_date21-02-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-10-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report(null)
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      • quantity_imported(null)
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      • balance_site(null)
      • final_date(null)
      • modified2022-08-05 14:09:32
      • created2020-07-01 10:29:03
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id568
        • application_id917
        • given_nameGary
        • middle_name
        • family_nameBrittenham
        • qualificationMedical Doctor
        • professional_addressNewYork-Presbyterian Morgan Stanley Children\'s Hospital 3959 Broadway New York, NY 10032
        • telephone(212) 305-7005
        • emailgmb31@cumc.columbia.edu
        • created2020-07-01 10:38:37
        • modified2020-10-08 15:03:06
    • SiteDetail(array)
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        • id797
        • application_id917
        • county_id(null)
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        • physical_address
        • contact_details
        • contact_person
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        • misc(null)
        • created2020-07-01 10:38:37
        • modified2020-10-08 15:03:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id442
        • application_id917
        • sponsorThe National Institute of Diabetes and Digestive and Kidney Diseases-NIH
        • sponsor_typeResearch Institution
        • contact_person
        • address9000 Rockville Pike, Bethesda, Maryland 20892
        • telephone_number1-866-569-1162
        • fax_number
        • cell_number1-800-860-8747
        • email_addresshealthinfo@niddk.nih.gov
        • created2020-07-01 10:38:37
        • modified2020-10-08 15:03:06
  • 1(array)
    • Application(array)
      • id477
      • user_id316
      • trial_status_id(null)
      • abstract_of_study<p>\n Acute respiratory infections (ARI) are a major cause of child morbidity and mortality globally. Pneumonia in particular is the leading cause of child mortality with developing countries accounting for majority of the deaths. In Kenya 17% of deaths among children below five years were caused by pneumonia. A total of 534,863 new cases of childhood pneumonia were registered in the year 2013 alone. The World Health Organization (WHO) recommends using respiratory rate cut-offs for diagnosis and classification of pneumonia in low-resource settings where chest radiology or blood tests are largely unavailable.  Accurate respiratory rate counting is thus critical in determining the subsequent management of childhood pneumonia. Therefore, it is crucial to improve ways of counting the respiratory rate. Having a better and more reliable device for accurate respiratory rate count is important for diagnosis and management of pneumonia in children. The Philips Research Group has developed an automated pneumonia diagnostic device named as “Children’s Automated Respiration Monitor (ChARM)”.The device automatically measures the respiratory rate and classifies according to the current WHO guidelines. This study aims at assessing the accuracy, usability and acceptability of the device as a step towards recommending it for large scale public use in the management of pneumonia in children.</p>\n
      • study_title<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>ASSESSING </strong><strong>THE ACCURACY, USABILITY AND ACCEPTABILITY OF CHILDREN’S AUTOMATED RESPIRATORY MONITOR AT SELECTED CLINICS IN  TURKANA COUNTY, KENYA ‘</strong></p>\n<p>\n <br />\n  </p>\n
      • laymans_summary(null)
      • short_titleASSESSING THE ACCURACY, USABILITY AND ACCEPTABILITY OF CHILDREN’S AUTOMATED RESPIRATORY MONITOR AT SELECTED CLINICS IN TURKANA COUNTY, KENYA ‘
      • protocol_noECCT/16/02/01
      • version_no7.0,
      • date_of_protocol10-12-2015
      • study_drugdevice for respiratory measurement
      • disease_conditionpneumonia
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_namenot applicable
      • product_type_medical_device_nameChild automated respiratory monitori
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressisaiahmwangi@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_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDR ISAIAH MWANGI
      • declaration_date102-02-2016
      • declaration_principal_investigatorDR RASHID SHAH
      • declaration_date202-02-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Child <5 years of age who will be attending Lodwar county hospital, Turkana county in Kenya will be eligible for the accuracy aspect of the study.</li>\n <li>\n Parents/caregivers of a recruited child  stated above will be eligible for the acceptability aspect of the study</li>\n <li>\n Health care provider in the participating health facilities will be eligible for usability and quality of care aspects of the study.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Child <5 years of age who will be attending Lodwar county hospital, Turkana county in Kenya will be eligible for the accuracy aspect of the study.</li>\n <li>\n Parents/caregivers of a recruited child  stated above will be eligible for the acceptability aspect of the study</li>\n <li>\n Health care provider in the participating health facilities will be eligible for usability and quality of care aspects of the study.</li>\n</ol>\n
      • primary_end_points<p>\n TOTAL RECRUITS REACH 120</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • 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_specifyMEICAL DEVICE
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyDEVICE
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n RESEARCH ASSISTANT</p>\n<p>\n STUDY CO ORDINATOR</p>\n<p>\n LIAISON PERSON</p>\n
      • other_details_explanation<p>\n This device is meeant for poor resource countries and Kenya is one of them</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n SAVE THE CHILDREN,S FUND USA</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration3 MONTHS
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites1
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site120
      • total_participants_worldwide120
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameRASHID
      • investigator1_middle_name
      • investigator1_family_nameSHAH
      • investigator1_qualificationPHD
      • investigator1_professional_addressKENYA MEDICAL RESEARCH INSTITE
      • investigator1_telephone+1 443 683 6236
      • investigator1_emailmshah@savethechildren.org
      • organisations_transferred_Yes
      • number_participants120
      • notification
      • approval_date21-03-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-02-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-03-21 19:32:37
      • created2016-02-02 10:02:11
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id319
        • application_id477
        • given_nameISAIAH
        • middle_name
        • family_nameMWANGI
        • qualificationMSC
        • professional_addressKENYA MEDICAL RESEARCH INSTITUTE
        • telephone+ 254 724 568 332
        • emailisaiahmwangi@gmail.com
        • created2016-02-02 10:04:36
        • modified2016-02-18 17:05:15
    • SiteDetail(array)
      • 0(array)
        • id380
        • application_id477
        • county_id23
        • site_namelodwar hospital
        • physical_address po box 20 lodwar
        • contact_detailsTel 0703677168
        • contact_personDave EKWAM
        • site_capacity(null)
        • misc(null)
        • created2016-02-02 10:04:36
        • modified2016-02-18 17:05:15
        • County(array)
          • id23
          • county_nameTurkana
          • created2012-06-15 10:24:43
          • modified2012-06-15 10:24:43
    • Sponsor(array)
      • 0(array)
        • id252
        • application_id477
        • sponsorPHILIPS MEDICAL
        • sponsor_type(null)
        • contact_personPavan Evan
        • addressPHILIPS MEDICAL NETHERLANDS
        • telephone_number+ 41 278 443 9877
        • fax_number
        • cell_number+ 41 278 5569265
        • email_addressinfo@philipsmedical.com
        • created2016-02-02 10:04:36
        • modified2016-02-18 17:05:15
  • 2(array)
    • Application(array)
      • id437
      • user_id301
      • trial_status_id5
      • abstract_of_study<p>\n  </p>\n<p align=\"center\">\n <strong>Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN): </strong><strong>A</strong> <strong>Prospective randomized, placebo-controlled, double-blinded clinical trial in western Kenya.</strong></p>\n<p align=\"center\">\n  </p>\n<p>\n <strong><u>Background:</u></strong>Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world.  Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.</p>\n<p>\n <strong><u>Hypothesis:</u></strong>First trimester administration of aspirin will reduce the risk of preterm birth.</p>\n<p>\n <strong><u>Study Design Type:</u></strong>Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial. Trial will be individually randomized with one-to-one ratio (intervention/control)</p>\n<p>\n <strong><u>Population:</u></strong>Nulliparous women between the ages of 18and 40,with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin. Minors who are ≥ 14 years of age may be enrolled if permitted by the country’s ethical guidelines. </p>\n<p>\n <strong><u>Intervention:</u></strong>Daily administration of low dose (81 mg) aspirin[also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo.Compliance and outcomes will be assessed biweekly.</p>\n<p>\n <strong><u>Outcomes:</u></strong></p>\n<p>\n <strong><em>Primary outcome</em>:</strong> To determine whether daily LDA initiated between 6 0/7 -13 6/7 weeksGA and continued to 36 0/7 weeks GA reduces the risk of PTB (birth prior to 37 0/7 weeksGA).</p>\n<p>\n  </p>\n<p>\n <strong><em>Secondary outcomes</em></strong> of interest are the rate of preeclampsia/eclampsia, small for gestational age (SGA), and perinatal mortality.</p>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p align=\"center\">\n <strong>Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN): </strong><strong>A</strong> <strong>Prospective randomized, placebo-controlled, double-blinded clinical trial in western Kenya.</strong></p>\n
      • laymans_summary(null)
      • short_title A Randomized Controlled Trial of ASPIRIN in Nulliparous Pregnant Women(ASPIRIN STUDY)
      • protocol_noECCT/15/12/01
      • version_noAspirin Protocol V1.0
      • date_of_protocol10-03-2015
      • study_drugLow Dose (81mg) Aspirin(Acetylsalicylic acid)(ASA)
      • disease_conditionPreterm Births
      • 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_nameAcetylsalicylic Acid (ASA)
      • product_type_medical_device_nameAcetylsalicylic Acid (ASA)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdrpaulnyongesa@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Paul Nyongesa
      • declaration_date123-10-2015
      • declaration_principal_investigatorProf Fabian Esamai
      • declaration_date223-10-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<h3>\n 1.1.1          Inclusion Criteria</h3>\n<p style=\"margin-left:.25in;\">\n §  Nulliparous women between 18 – 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country’s ethical guidelines. </p>\n<p style=\"margin-left:.25in;\">\n §  No more than two previous first trimester pregnancy losses</p>\n<p style=\"margin-left:.25in;\">\n §  No medical contraindications to aspirin;</p>\n<p style=\"margin-left:.25in;\">\n §  Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an earlydating ultrasound and with heart rate greater than >110 bpm.</p>\n
      • principal_exclusion_criteria<h3>\n 1.1.1          Exclusion Criteria</h3>\n<p style=\"margin-left:.25in;\">\n §  Women prescribed dailyaspirin for more than 7 days;</p>\n<p style=\"margin-left:.25in;\">\n §  Multiple gestations;</p>\n<p style=\"margin-left:.25in;\">\n §  Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.);</p>\n<p style=\"margin-left:.25in;\">\n §  Hemoglobin  <7.0 gm/dl at screening;</p>\n<p style=\"margin-left:.25in;\">\n §  Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, hypertension, or any other known significant disease)</p>\n
      • primary_end_points<p>\n <strong><em>Primary end point: </em></strong>Delivery at < 37 0/7 weeks gestation</p>\n<p>\n Secondary endpoints:  Preeclampsia and eclampsia,,</p>\n<p>\n                                  Small for gestational age(less than 10th percentile) and</p>\n<p>\n                                  Perinatal mortality(stillbirths and first week neonatal deaths)</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Capacity of The Global Network Kenya Site 12:</p>\n<p>\n TheGlobal Network  Kenya site12 is a research unit of the Global Network for Women's and Children's Health Research and part of the Academic Model Providing Access to Health Care(AMPATH) program in Western Kenya. AMPATH supports the Ministry of Health in 8 counties of Western Kenya Region with a catchment population of 21 million people .</p>\n<p>\n Kenya site 12 has 12 clusters for the Aspirin study located at: Amukura/421,Lukolis/411,Nasewa/425,Matayos/415,Madende/Khayo/414,Khunyangu/422,Bumala B/418, Bokoli/413,Chwele /417,Sirisia/426,Makunga/419,Mumias/423</p>\n<p>\n Number of Study Staff: 60-100 including Investigators, sonograghers,study,clinical and field coordinators, registry and data personnel, community health workers and support stall.</p>\n<p>\n Investigators and study coordinators: Principal Investigator: Prof Fabian Esamai, Consultant Paediatrician  and Professor of Child Health, Moi University, Senior Foreign Investigator with The Global Network for Women's and Children's Health with many years research experience (see CV). Dr. Paul Nyongesa, Consultant Obstetrician/Gynaecologist, Senior Lecturer, Moi University (see CV) and M/s Emma Achieng, Senior Tutor in Midewifery and Study Coordinator with Global Network for 5years.</p>\n<p>\n Site Facilities:</p>\n<p>\n Moi University, College of Health Sciences, Medical School, Moi Teaching and Referral Hospital and Western Kenya Region of Community Health Units,Dispensaries,Health Centres, sub-County and County Referral Hospitals. </p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n   1. Christiana Care Institutional Review Board, New Jersey, USA  approved on 27th April 2015</p>\n<p>\n   2. JNMC Insttutional Ethics Committee on Human Subjects, Belgaum, India.approved 28th March 2015 for one site  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration18months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalYes
      • 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_states6
      • number_of_sites12
      • multi_country_listDemocratic Republic of Congo, Zambia, Kenya,Nagpur India,Belgaum India, Pakistan and Guatemala
      • data_monitoring_committeeYes
      • total_enrolment_per_site150
      • total_participants_worldwide 11,920
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyParticipants incapable of giving consent personally,such as pregnant adolescent minors will assent and have informed consent given by husbands, if married, or guardians.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Paul Nyongesa
      • investigator1_middle_nameJohn
      • investigator1_family_nameObanda
      • investigator1_qualificationMbChB(U.O.N.), MMed(OB Gyn)(U.O.N.)
      • investigator1_professional_addressCollege of Health Sciences,Moi University,Dept of Reproductive Health Box 4606 30100 Eldoret ,Kenya
      • investigator1_telephone0733 788 063
      • investigator1_emaildrpaulnyongesa@yahoo.com
      • organisations_transferred_No
      • number_participants 1800
      • notification<p>\n Not applicable</p>\n
      • approval_date16-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-12-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-07-15 15:52:54
      • created2015-10-22 12:04:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id293
        • application_id437
        • given_nameProf Fabian Esamai
        • middle_nameOmoding
        • family_nameEsamai
        • qualificationMbChB, MMed(Paed),MPH,PhD
        • professional_addressCollege of Health Sciences,Moi University,Dept of Child Health and Paediatrics Box 4606 30100 Eldoret ,Kenya
        • telephone0733 836 410
        • emailfesamai2007@gmail.com
        • created2015-10-22 12:23:49
        • modified2015-12-07 13:28:38
    • SiteDetail(array)
      • 0(array)
        • id350
        • application_id437
        • county_id40
        • site_nameAmukura, Lukolis,Nasewa,Matayos,Khunyangu, Bumala B
        • physical_addressWestern Kenya
        • contact_details Box 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2015-10-22 12:23:49
        • modified2015-12-07 13:28:38
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
      • 1(array)
        • id354
        • application_id437
        • county_id39
        • site_nameSirisia, Chwele, Bokoli
        • physical_addressWestern Kenya
        • contact_details Box 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2015-10-29 10:38:39
        • modified2015-12-07 13:28:38
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 2(array)
        • id355
        • application_id437
        • county_id37
        • site_nameMakunga, Mumias
        • physical_addressWestern Kenya
        • contact_details Box 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2015-10-29 10:38:39
        • modified2015-12-07 13:28:38
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
    • Sponsor(array)
      • 0(array)
        • id228
        • application_id437
        • sponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
        • sponsor_type(null)
        • contact_personMenachem Miodovnik, MD
        • addressNational Institutes of Health 6100 Executive Blvd, Rm 4B03A Bethesda, MD 20892-7510
        • telephone_number): 301-451-5031
        • fax_number: 301-496-3790
        • cell_number): 301-451-5031
        • email_addressMenachem.Miodovnik@nih.gov
        • created2015-10-22 12:23:49
        • modified2015-12-07 13:28:38
  • 3(array)
    • Application(array)
      • id398
      • user_id77
      • trial_status_id5
      • abstract_of_study<p>\n  </p>\n<p>\n  </p>\n<p style=\"margin-left: 13.5pt\">\n  </p>\n<p>\n <strong>Project description and scope</strong></p>\n<p>\n <strong>Brief Description:</strong>     </p>\n<p>\n A5316 is a phase II, open-label, non-randomized, steady-state, parallel design trial to evaluate pharmacokinetic (PK) interactions between hormonal contraception (etonogestrel and ethinyl estradiol) delivered via a vaginal ring (NuvaRing) and efavirenz (EFV)- or atazanavir/ritonavir (ATV/r)-based regimens.  HIV-infected, non-pregnant women who are taking EFV- or ATV/r-based regimens or no antiretroviral therapy (ART) are eligible. Those subjects on ART will have intensive antiretroviral (ART) PK collected before and 3 weeks after placement of the NuvaRing.  All subjects will have weekly visits to collect blood for hormone analysis and cervicovaginal samples for immunological, microbiological and virological studies.</p>\n<p>\n  </p>\n<p>\n <strong>Objectives: </strong></p>\n<p>\n The primary objective of the study is to estimate the effect of ATV/r or EFV-based ART on the PK exposure of etonogestrel and ethinyl estradiol in HIV-infected participants using the NuvaRing.  The study will also estimate the effect of etonogestrel and ethinyl estradiol on the PK exposure of ATV, ritonavir (RTV), or EFV.  The safety of concomitant ART administered with the NuvaRing and the impact of the NuvaRing on virologic suppression, cervicovaginal immunology and microbiome will also be explored.</p>\n<p>\n  </p>\n<p>\n <strong>Requirements to Enter Study:  </strong></p>\n<p>\n <strong>     Inclusion Criteria</strong></p>\n<ul>\n <li>\n Premenopausal HIV-infected women age ³16 years</li>\n <li>\n Receiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART; stable for 30 days prior to entry with no plans to change therapy during study</li>\n <li>\n For participants on ART: HIV-1 RNA £400 copies/mL within 60 days prior to study entry</li>\n <li>\n For participants not on ART: CD4+ cell count ≥350 cells/mm³ within 60 days prior to study entry</li>\n <li>\n Laboratory values obtained within 60 days prior to study entry:</li>\n</ul>\n<ul>\n <li>\n Hemoglobin ³8.0 g/dL</li>\n <li>\n Platelet count ³50,000/mm³</li>\n <li>\n AST and ALT £ 5 ´ ULN</li>\n <li>\n Total bilirubin £2.0 x ULN</li>\n <li>\n Creatinine ≤1.5 x ULN</li>\n <li>\n Last menstrual period £6 months or verification of FSH £40 mIU/mL, unless there is a clinical reason for amenorrhea (such as pregnancy)</li>\n <li>\n Negative pregnancy test at screening and within 24 hours of entry </li>\n <li>\n Documentation of Pap smear within 1 year prior to study entry</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Exclusion criteria: </strong></p>\n<ul>\n <li>\n Received depot medroxyprogesterone acetate (DMPA) within 4 months, or other hormonal therapies within 30 days prior to study entry</li>\n <li>\n Contraindications to receiving hormonal contraception; Receiving medications known to interfere with either ART or hormone metabolism</li>\n <li>\n Use of systemic or inhaled corticosteroids</li>\n <li>\n Less than 6 weeks postpartum at study entry</li>\n <li>\n Clinically active cervical or vaginal infection at study entry. (Gonorrhea, chlamydia, trichomonas, bacterial vaginosis testing will be performed during screening using techniques available at the local sites.)</li>\n <li>\n History of invasive cancer of the reproductive tract, malignancy or increased risk of breast cancer; abnormal vaginal bleeding, liver tumors; or serious ocular disorders </li>\n</ul>\n<p>\n  </p>\n<p style=\"margin-left: 1.5in\">\n <strong>Treatment:  </strong></p>\n<p>\n Eligible study participants will be enrolled into one of the study treatment arms:</p>\n<p>\n  </p>\n<p>\n Arm A: NuvaRing for 3 weeks with NO ART</p>\n<p>\n Arm B: NuvaRing for 3 weeks with EFV 600 mg once daily plus ≥2 NRTIs</p>\n<p>\n Arm C: NuvaRing for 3 weeks with ATV/r 300/100 mg once daily plus</p>\n<p style=\"margin-left: 2.5in\">\n  Tenofovir (TDF) 300 mg and ≥1 NRTI</p>\n<p>\n  </p>\n<p>\n NuvaRing will be provided by the study. Participants will be offered an extra NuvaRing at the day 28 visit. ART medications are not provided.           </p>\n<p>\n  </p>\n<p>\n <strong>Duration:</strong> 28 days (weekly study visits).  Vaginal aspirates will be collected at each visit. Intensive ART PK sampling will be performed over 8 hours before and after vaginal ring placement (Days 0 and 21) for the EFV and ATV/r groups.  If participants choose to use an optional vaginal ring after day 28, they will receive a follow-up phone call day 56.</p>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p align=\"center\">\n <strong>A</strong><strong>5316</strong></p>\n<p align=\"center\">\n  </p>\n<p align=\"center\">\n  </p>\n<p align=\"center\">\n <strong>Evaluating Pharmacokinetic Interactions with Vaginal Ring Contraceptives and Antiretroviral Therapy</strong></p>\n
      • laymans_summary<p>\n This study will look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. We do not know whether the NuvaRing and ARVs interact when they are used together, so this study will look to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study will also include HIV-infected women who are not on ARVs but will use the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs.</p>\n<p>\n Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, we want to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the HIV virus, the bacterial make-up (microbiome) of the female genital track, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.</p>\n<p>\n The product under investigation in this study is the NuvaRing. The NuvaRing is a vaginal ring that has been approved by the US Food and Drug Administration as a safe and effective method of hormonal birth control. NuvaRing is a flexible ring that is inserted into the vagina once a month and releases a small dose of hormones that prevents pregnancy.</p>\n
      • short_titleA5316
      • protocol_noECCT/15/06/04
      • version_noFinal 1.0
      • date_of_protocol02-08-2013
      • study_drugReceiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART; stable for 30 days prior to entry with no plans to change therapy during study
      • disease_conditionHIV positive women
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameetorogestrel and ethinylestradiol
      • product_type_medical_device_nameNuvaring
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantElizabeth Ayuo
      • declaration_date114-05-2015
      • declaration_principal_investigatorDr. Esther Mumbi Makanga - National PI
      • declaration_date214-05-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<ul>\n <li>\n Premenopausal HIV-infected women age ³16 years</li>\n <li>\n Receiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART; stable for 30 days prior to entry with no plans to change therapy during study</li>\n <li>\n For participants on ART: HIV-1 RNA £400 copies/mL within 60 days prior to study entry</li>\n <li>\n For participants not on ART: CD4+ cell count ≥350 cells/mm³ within 60 days prior to study entry</li>\n <li>\n Laboratory values obtained within 60 days prior to study entry:</li>\n</ul>\n<ul>\n <li>\n Hemoglobin ³8.0 g/dL</li>\n <li>\n Platelet count ³50,000/mm³</li>\n <li>\n AST and ALT £ 5 ´ ULN</li>\n <li>\n Total bilirubin £2.0 x ULN</li>\n <li>\n Creatinine ≤1.5 x ULN</li>\n <li>\n Last menstrual period £6 months or verification of FSH £40 mIU/mL, unless there is a clinical reason for amenorrhea (such as pregnancy)</li>\n <li>\n Negative pregnancy test at screening and within 24 hours of entry </li>\n <li>\n Documentation of Pap smear within 1 year prior to study entry</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n  </p>\n<ul>\n <li>\n Received depot medroxyprogesterone acetate (DMPA) within 4 months, or other hormonal therapies within 30 days prior to study entry</li>\n <li>\n Contraindications to receiving hormonal contraception; Receiving medications known to interfere with either ART or hormone metabolism</li>\n <li>\n Use of systemic or inhaled corticosteroids</li>\n <li>\n Less than 6 weeks postpartum at study entry</li>\n <li>\n Clinically active cervical or vaginal infection at study entry. (Gonorrhea, chlamydia, trichomonas, bacterial vaginosis testing will be performed during screening using techniques available at the local sites.)</li>\n <li>\n History of invasive cancer of the reproductive tract, malignancy or increased risk of breast cancer; abnormal vaginal bleeding, liver tumors; or serious ocular disorders </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n To estimate the effect of ongoing ART containing either once daily ATV/r or EFV, in addition to two or more nucleosides/nucleotides, on the pharmacokinetic (PK) exposure of etonogestrel and ethinyl estradiol in HIV-infected participants at day 21 after placement of the etonogestrel/ethinyl estradiol vaginal ring (NuvaRing</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Dr. Mumbi Makanga</div>\n<div>\n MBChB, MPH</div>\n<div>\n Principal Investigator and Study Medical Officer,</div>\n<div>\n HIV Research Branch,</div>\n<div>\n KEMRI/CDC, (Kisumu)</div>\n<div>\n Will oversee daily study operations and implementation. Will supervise Kisumu-based study staff. Substantial input into site-specific study design, protocol development and assessment tools.</div>\n<div>\n Will provide patient management oversight, including clinical guidance on patient management, and medical care. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n<div>\n  </div>\n<div>\n <div>\n Clement Zeh</div>\n <div>\n PhD, MPH</div>\n <div>\n Co-Principal Investigator,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n CDC Kenya (Kisumu)</div>\n <div>\n Will provide input for data analysis and will write report. Will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools. Will assist with study implementation, data analysis and report writing.</div>\n <div>\n  </div>\n <div>\n <div>\n Dr. Victor Mudhune</div>\n <div>\n BPharm, MBA, MPH(c)</div>\n <div>\n Co-Principal Investigator and Study Pharmacist,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC, (Kisumu)</div>\n <div>\n Will provide input for data analysis and will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools. Will oversee all pharmaceutical aspects of the study and maintain oversight of study drugs. Will provide input for study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n <div>\n Taraz Samandari</div>\n <div>\n MD, PhD.</div>\n <div>\n Co-Investigator</div>\n <div>\n CDC ,Atlanta</div>\n <div>\n Will provide support for study from CDC Atlanta, including liaison with ACTG. Will provide substantial input into protocol development. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Robert T. Chen</div>\n <div>\n MD, MA</div>\n <div>\n Co-Investigator</div>\n <div>\n CDC, Atlanta</div>\n <div>\n Will provide support for study from CDC Atlanta, including liaison with ACTG. Will provide substantial input into site-specific study design, protocol development and assessment tools. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Allan Taylor</div>\n <div>\n MD, MPH</div>\n <div>\n Co-investigator</div>\n <div>\n CDC, Atlanta</div>\n <div>\n Will provide substantial input into site-specific study design, protocol development and assessment tools. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n <div>\n John Okanda</div>\n <div>\n BSc, MPH(c)</div>\n <div>\n Quality Assurance Officer</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC, (Kisumu)</div>\n <div>\n Will make sure all field components of the study, are done according to the protocol, study team and investigators, will provide input for study implementation, data analysis and report writing.</div>\n <div>\n  </div>\n <div>\n <div>\n Collin Odhiambo</div>\n <div>\n MSc, PhD(c)</div>\n <div>\n Laboratory Lead,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC, (Kisumu)</div>\n <div>\n Will oversee all laboratory aspects of the study and maintain oversight of laboratory procedures. Will provide input for study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Richard Ndivo</div>\n <div>\n MSc</div>\n <div>\n Lead Data Manager,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC (Kisumu)</div>\n <div>\n Will oversee all data aspects of this study and will be involved in all site-specific data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Elizabeth Ayuo</div>\n <div>\n BA</div>\n <div>\n Lead Regulatory officer</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC (Kisumu)</div>\n <div>\n Will provide guidance and oversight over all of the regulatory aspects of this study, including quality assurance and quality control, and ensure that all staff are GCP trained and compliant. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Ken Ondenge</div>\n <div>\n BA</div>\n <div>\n Lead Behavioral Scientist</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC (Kisumu)</div>\n <div>\n Will provide guidance and oversight over all of the qualitative aspects of this study and will be involved in site-specific study implementation with regard to liaising with all stakeholders/community. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n <div>\n Carren Amondi</div>\n <div>\n BBA</div>\n <div>\n Administrative Officer,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC Kenya (Kisumu)</div>\n <div>\n Will provide oversight of all administrative aspects of this study, including budget</div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<p style=\"margin: 0px 0px 10px\">\n  </p>\n<p style=\"margin: 0px 0px 10px\">\n  </p>\n
      • other_details_explanation<p>\n The trial is being done in the U.S and other places as indicated;</p>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11448\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Alabama CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10018\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Barranco CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10051\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Bhumibol Adulyadej Hospital</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10059\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> CAPRISA Umlazi Clinical Research Site (UKZN)</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10184\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Chapel Hill CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10278\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Columbia Physicians & Surgeons (P&S) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11530\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> David Geffen School of Medicine at UCLA NICHD CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10013\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Gaborone CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10000\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Instituto de Pesquisa Clinica Evandro Chagas CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10065\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Jacobi Medical Center Bronx</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11442\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11455\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> New Jersey Medical School Clinical Research Center CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10004\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Parirenyatwa CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10227\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Puerto Rico AIDS Clinical Trials Unit CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11328\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Rush University Cook County Hospital Chicago NICHD CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10098\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> San Juan City Hospital</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10019\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> San Miguel CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10046\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Shandukani Research CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10085\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> South Florida CDTC Ft Lauderdale NICHD CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11441\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Thai Red Cross AIDS Research Center Treatment (TRC-ARC Treatment) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10281\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> The Miriam Hospital (TMH) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10137\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> The University of Miami AIDS Clinical Research Unit (ACRU) CRS</a></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute Scientific Ethical Review Unit (SERU)</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration28 days for every participant from day of entry
      • design_controlled_randomisedNo
      • 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_comparatorArm A (n=25): NuvaRing fo
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI- CDC
      • single_site_physical_addressPO BOX 1578
      • single_site_contact_personDr Mumbi Makanga
      • single_site_telephone+254714063448
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide75
      • 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_healthyNo
      • subjects_patientsYes
      • 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_nameDr. Esther Mumbi
      • investigator1_middle_name
      • investigator1_family_nameMakanga
      • investigator1_qualificationMBchB, MPH
      • investigator1_professional_addressBOX 1578, KISUMU, 40100
      • investigator1_telephone+254714063448
      • investigator1_emailmmakanga@kemricdc.org
      • organisations_transferred_No
      • number_participants40
      • notification<p>\n None</p>\n
      • approval_date17-07-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-06-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs.</p>\n<p>\n Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.</p>\n
      • implication_results<p>\n We found that efavirenz–based ART significantly decreased the systemic exposure to both etonogestrel and ethinyl estradiol released from a IVR (79% and 59% lower, respectively) compared to women with HIV not receiving ART. Our findings raise concern for the effectiveness of the IVR contraceptive in women receiving efavirenz–based ART, and studies evaluating ovulation rates in the context of this DDI are necessary. In contrast, atazanavir–ritonavir containing ART resulted in variable influence on contraceptive hormone exposure compared to women not receiving ART (71% higher etonogestrel, 38% lower ethinyl estradiol). Hence, atazanavir/ritonavir–based ART is unlikely to influence the IVR contraceptive effectiveness, as progestin exposure was higher than controls. Despite these changes, no excess AEs were reported in the atazanavir/ritonavir group compared to controls. The influence of ART on etonogestrel is likely mediated via CYP3A4, the enzyme primarily responsible for etonogestrel metabolism, due to CYP3A4 induction by efavirenz and inhibition by atazanavir/ritonavir. The effect of ART on ethinyl estradiol is also likely related to induction of multiple pathways of ethinyl estradiol metabolism by both efavirenz and atazanavir/ritonavir. Although NRTIs were administered in both ART arms, studies have not observed significant DDIs between NRTIs and hormonal contraceptives.</p>\n
      • quantity_imported54
      • quantity_dispensed15
      • quantity_destroyed39
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2021-08-24 08:28:52
      • created2015-05-13 11:32:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id270
        • application_id398
        • given_nameDr. Esther Mumbi Makanga
        • middle_name
        • family_nameMakanga
        • qualificationMBchB, MPH
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+254714063448
        • emailmmakanga@kemricdc.org
        • created2015-05-13 12:04:50
        • modified2015-06-22 08:51:27
      • 1(array)
        • id271
        • application_id398
        • given_nameDr. Victor Akelo
        • middle_name
        • family_nameAkelo
        • qualificationMBchB, MPH
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+2540714063445
        • emailvakelo@kemricdc.org
        • created2015-05-13 12:04:58
        • modified2015-06-22 08:51:27
      • 2(array)
        • id272
        • application_id398
        • given_nameDr.Victor O. Mudhune
        • middle_name
        • family_nameMudhune
        • qualificationBpharm
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+254722687430
        • emailvotieno2@kemricdc.org
        • created2015-05-13 12:31:59
        • modified2015-06-22 08:51:27
      • 3(array)
        • id273
        • application_id398
        • given_nameDr. Kevin P. Cain
        • middle_name
        • family_nameCain
        • qualificationMD
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+254710602786
        • emailbvz1@cdc.gov
        • created2015-05-13 12:31:59
        • modified2015-06-22 08:51:27
    • SiteDetail(array)
      • 0(array)
        • id326
        • application_id398
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-05-13 12:04:50
        • modified2015-06-22 08:51:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id210
        • application_id398
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_person
        • address645 N. Michigan Avenue, Suite 900
        • telephone_number312-926-3693
        • fax_number
        • cell_number312-926-3693
        • email_addresssusan-cohn@northwestern.edu
        • created2015-05-13 12:04:50
        • modified2015-06-22 08:51:27
      • 1(array)
        • id211
        • application_id398
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_personSusan E. Cohn, MD, MPH
        • address645 N. Michigan Avenue, Suite 900
        • telephone_number312-926-3693
        • fax_number
        • cell_number312-926-3693
        • email_addresssusan-cohn@northwestern.edu
        • created2015-05-13 12:04:58
        • modified2015-06-22 08:51:27
  • 4(array)
    • Application(array)
      • id736
      • user_id467
      • trial_status_id7
      • abstract_of_study<p>\n  </p>\n<div class=\"page\" title=\"Page 7\">\n <div class=\"layoutArea\">\n <div class=\"column\">\n <p>\n <span style=\"font-size: 11pt; font-family: Arial;\">Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner’s HIV status, and have biologic changes or changes in their partner’s sexual partnerships that increase susceptibility. Oral pre-exposure antiretroviral prophylaxis (PrEP) may be an attractive strategy for HIV prevention in pregnancy/postpartum; however, it is important to ensure PrEP reaches women who are at risk for acquiring HIV during pregnancy while avoiding unnecessary PrEP use during pregnancy. Clinicians and women are using PrEP in pregnancy; in qualitative studies, women, health workers and policy-makers support use of PrEP in pregnancy but advocate for models of PrEP delivery that ensure women at risk receive PrEP while minimizing unnecessary PrEP use in women not at risk. Targeting PrEP to women at greatest risk of HIV may maximize benefits, minimize potential risks, and optimize cost-effectiveness. This cluster-randomized clinical trial (RCT) in 20 Maternal Child Health (MCH) clinics in western Kenya (10 clinics per arm, at least 200 women per clinic, 4000 women overall), will compare 2 models of PrEP delivery in pregnancy. Clinics will offer universal availability of PrEP (and women self-select whether to use) or targeted offer of PrEP (i.e., offer to women identified as high risk through a standardized risk assessment and partner self-testing, and then women identified as high-risk select whether to use). Leveraging the pre-existing MCH clinic visit schedule will enable programmatically relevant assessment of PrEP uptake, use, and HIV incidence. The outcome of the study will be a model of PrEP delivery in pregnancy that optimizes effectiveness, safety, and cost-effectiveness. </span></p>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<div class=\"page\" title=\"Page 1\">\n <div class=\"layoutArea\">\n <div class=\"column\">\n <p>\n <span style=\"font-size: 12pt; font-family: TimesNewRomanPS; font-weight: 700;\">PrEP Implementation for Mothers in Antenatal Care</span></p>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • laymans_summary<p>\n Pregnant and breastfeeding women living in areas that are highly affected by HIV are likely to be infected with HIV. Oral pre-exposure prophylaxis is a new method to help in prevention these women from being infected with HIV. It is important to ensure that this drug reaches women who have the most risk for infection and to ensure that the drug is not used among those with minimal risk. By targetting women who are most at risk, we may maximise benefits, minimise potential risks and ensure that the costs are minimal. This study seeks to look at the best way to deliver PrEP among pregnant and postpartum women.</p>\n
      • short_titlePrIMA
      • protocol_noECCT/18/11/01
      • version_noVersion 5.2
      • date_of_protocol31-07-2018
      • study_drugImplementation of Pre-exposure prophylaxis
      • disease_conditionImplementation of Pre-exposure prophylaxis
      • 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_nameTruvada
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressnancym390@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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • 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_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Nancy Ngumbau
      • declaration_date112-11-2018
      • declaration_principal_investigatorDr. John Kinuthia
      • declaration_date212-11-2018
      • placebo_presentNo
      • study_objectives<h2>\n <span style=\"font-size:12px;\">a)    BROAD OBJECTIVES</span></h2>\n<p>\n The broad objective of this study is to determine the best model for optimized PrEP delivery in pregnancy by using existing highly accessed MCH systems as a platform for efficiently delivering PrEP to pregnant women.</p>\n<h2>\n <span style=\"font-size:12px;\">b)   SPECIFIC OBJECTIVES</span></h2>\n<p>\n <strong>AIM 1a.</strong> In a cluster RCT among HIV-uninfected pregnant women, to compare universal PrEP (offered to all; women self-select PrEP) to targeted PrEP (offered to women with a high risk score incorporating available partner HIV self-test data) for outcomes reflecting the balance of PrEP effectiveness avoiding unnecessary PrEP exposure to women at low or no risk of HIV: HIV incidence at 9 months postpartum among all women (including those who did and did not receive PrEP) and proportion of women exposed to PrEP.</p>\n<p style=\"margin-left:36pt;\">\n ·       <em>Hypothesis: Because of better matching of PrEP and targeted, specific PrEP counseling, use to HIV risk, targeted PrEP will result in lower HIV incidence and optimized proportion of women on PrEP.</em></p>\n<p>\n <strong>AIM 1b</strong>. To compare universal versus targeted PrEP arms for proportion of all women on PrEP, proportion of women ‘appropriately’ on PrEP (based on risk factors), PrEP adherence (drug levels), PrEP duration, partners with HIV status, partners on ART, and infant birthweight, preterm birth, and growth curves; to compare infant outcomes in PrEP exposed infants vs. unexposed; and to determine cofactors of maternal HIV incidence overall and stratified by trial arm.</p>\n<p style=\"margin-left:36pt;\">\n ·       <em>Hypotheses: Targeted PrEP will result in more ‘appropriate’ PrEP use, better adherence, shorter PrEP duration (stop after partner viral suppression), more partners on ART, and similar infant outcomes.</em></p>\n<p>\n <strong>AIM 2.</strong> To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and in the postpartum period, per incident HIV infection and disability adjusted life year (DALY) averted.</p>\n<p style=\"margin-left:36pt;\">\n ·       <em>Hypothesis: Targeting PrEP to women at highest risk of HIV acquisition will be more cost-effective than universal PrEP provision.</em></p>\n<p>\n <strong>AIM 3.</strong> To qualitatively assess barriers and facilitators to adherence, acceptability, feasibility and potential adaptations in all 3 RCT arms at the organizational, provider, and individual woman level.</p>\n<p style=\"margin-left:36pt;\">\n ·       <em>Hypothesis: Both models will be acceptable to women and providers; organizations will prefer targeted PrEP.</em></p>\n
      • principal_inclusion_criteria<p>\n Eligibility for enrollment will include age ≥15 years, pregnancy, and tuberculosis negative, plans to reside in area for at least one year postpartum, plans to receive postnatal and infant care at the study facility, and are not currently enrolled in any other studies.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria is HIV positive, age <15 years, not pregnant.</p>\n
      • primary_end_points<p>\n The broad objective of this study is to determine the best model for optimized PrEP delivery in pregnancy by using existing highly accessed MCH systems as a platform for efficiently delivering PrEP to pregnant women.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • 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 of Pre-exposure prophylaxis according to NASCOP guidelines
      • 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 align=\"center\">\n <strong><u>SITE CAPACITY</u></strong></p>\n<p>\n PrIMA study is in 10 facilities in Homa Bay County and 10 facilities in Siaya County. It has 1 study coordinator, 2 assistant study coordinators, 2 data managers and each facility has one study nurse and 1 retention officer. Each county has 1 rotating nurse to assist. Each study staff has undertaken the NIH web-based training course on “Protecting Human Research Participants.” </p>\n<p>\n  </p>\n<p>\n The study coordinator is Dr. Nancy M. Ngumbau. She is a Registered Medical Officer by the Kenya Medical Practitioners and Dentist Board currently working at Kenyatta National Hospital. She is currently undertaking my Masters in Epidemiology in Jomo Kenyatta University of Agriculture and Technology.</p>\n<p>\n  </p>\n<p>\n The assistant study coordinators are:</p>\n<p>\n 1.    Ben Ochieng’ – A qualified and registered nurse who has a Bachelor of Science in Nursing degree from Moi University. He has prior research experience as a research assistant at Pacific Institute for Research and Evaluation. </p>\n<p>\n 2.    Felix Abuna – A qualified counsellor and laboratory technician who has extensive experience in research since 2009 and has been a study coordinator for several studies since 2014.</p>\n<p>\n Below is a list of the study facilities with the PrIMA staff. </p>\n<p>\n  </p>\n<p>\n <strong>1.    </strong><strong>Ober health centre: </strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Vivian Koros: A qualified and registered community health nurse with experience in working in the MCH clinic. </p>\n<p style=\"margin-left:72.0pt;\">\n b.    Lukio Agalo: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>2.    </strong> <strong>Rachuonyo South sub-county Hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Rhoda Oricho: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Alphonse Kungu: A qu alified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>3.    </strong><strong>Rachuonyo North sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Pauline Juma: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p>\n <strong>4.    </strong><strong>Kandiege Health center:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Sarah Achieng’: A qualified and registered community health nurse with experience in working in the MCH clinic.  </p>\n<p style=\"margin-left:72.0pt;\">\n b.    Joshua Onyango: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>5.    </strong><strong>Homabay county Referral hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Diana Oreje: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Wallace Juma: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>6.    </strong><strong>Rangwe sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Emma Opoko:  A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Richard Omondi: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>7.    </strong><strong>Marindi sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Geoffrey Gichana:  A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Sheila Marienga: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>8.    </strong><strong>Ndhiwa sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Eve Otumba: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Michael Odhiambo: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>9.    </strong><strong>Mbita sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Elizabeth Adongo: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>10.  </strong><strong>Suba sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Maureen Oketch: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Verena Okunya: </p>\n<p>\n <strong>11.  </strong><strong>Yala sub county hospital: </strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Gradus Okello: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Daisy Kemunto: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p>\n <strong>12.  </strong><strong>Malanga Health centre:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Stephanie Ojiambo: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Gift Akinyi: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>13.  </strong><strong>Ambira sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Violet Apondi: A qualified and registered community health nurse with experience in working in the MCH clinic. She has prior research experience.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Bernard Andiego: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>14.  </strong><strong>Siaya County teaching and referral hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    George Oketch: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Asterico Neema: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>15.  </strong><strong>Rwambwa sub county hospital: </strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    James Ingutia: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Deckins Agwanda: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>16.  </strong><strong>Bondo sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Sharon Achieng’: </p>\n<p style=\"margin-left:72.0pt;\">\n b.    Linda Merab Orwa: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>17.  </strong><strong>Usigu Health centre:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Judith Nyakina: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Fredrich Andere: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>18.  </strong><strong>Uyawi sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Jane Atieno: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Conceptor Anyango: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>19.  </strong><strong>Madiany sub county hospital:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Enock Sifuna: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p style=\"margin-left:72.0pt;\">\n b.    Sarah Ayuyo: A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p>\n <strong>20.  </strong><strong>Ong’ielo Health centre:</strong></p>\n<p style=\"margin-left:72.0pt;\">\n a.    Kennedy Oloo:  A qualified social worker who has undertaken the HIV testing and Counselling course and has prior research experience.</p>\n<p style=\"margin-left:72.0pt;\">\n b.     Maureen Akoth: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n<p>\n  </p>\n<p style=\"margin-left:18pt;\">\n Rotating nurse – Wilkista Awiti: A qualified and registered community health nurse with experience in working in the MCH clinic.</p>\n
      • other_details_explanation<p>\n There is a high HIV incidence among the pregnant and breastfeeding women in Kenya, more so in Homa BAy and Siaya Counties</p>\n
      • other_details_regulatory_notapproved<p>\n All Regulatory Authorities have approved the study</p>\n
      • other_details_regulatory_approved<p>\n Ethics Research Comittee. Approved on for 20 sites</p>\n<p>\n Institutional Review Board. Approved on for 20 sites in Kenya</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</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_comparatorComparing PrEP delivery b
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites20
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteAt least 200 participants per site
      • total_participants_worldwide5000
      • 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_bearingNo
      • 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_nameDr. John
      • investigator1_middle_name
      • investigator1_family_nameKinuthia
      • investigator1_qualificationMBCHB, Mmed, MPH
      • investigator1_professional_addressP.O. BOX 20723-00202
      • investigator1_telephone+254 722 799 052
      • investigator1_emailkinuthia@uw.edu
      • organisations_transferred_No
      • number_participants5000
      • notification<p>\n N/A</p>\n
      • approval_date16-05-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-05-24 16:35:30
      • created2018-10-26 12:57:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id460
        • application_id736
        • given_nameGrace John-Stewart
        • middle_name
        • family_nameJohn-Stewart
        • qualificationMD, PhD
        • professional_address325 Ninth Ave., Box 359909, Seattle, WA 98104
        • telephone+1-206-543-4278
        • emailgjohn@uw.edu
        • created2018-10-26 12:57:29
        • modified2020-05-12 17:12:19
      • 1(array)
        • id461
        • application_id736
        • given_nameJared
        • middle_name
        • family_nameBaeten
        • qualificationMD, PhD
        • professional_address325 Ninth Ave., Box 359927, Seattle, WA 98104
        • telephone+1-206-520-3808
        • emailjbaeten@uw.edu
        • created2018-10-29 15:19:07
        • modified2020-05-12 17:12:19
    • SiteDetail(array)
      • 0(array)
        • id581
        • application_id736
        • county_id43
        • site_nameHoma Bay County - 10 sites
        • physical_addressHoma Bay County
        • contact_detailsTel. No: 0714487874
        • contact_personBen Ochieng
        • site_capacity(null)
        • misc(null)
        • created2018-10-26 12:57:29
        • modified2020-05-12 17:12:19
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 1(array)
        • id583
        • application_id736
        • county_id41
        • site_nameSiaya County - 10 sites
        • physical_addressSiaya County
        • contact_detailsTel No: 0714487874
        • contact_personBen Ochieng
        • site_capacity(null)
        • misc(null)
        • created2018-11-15 12:40:43
        • modified2020-05-12 17:12:19
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id359
        • application_id736
        • sponsorNational Institute of Health
        • sponsor_typeResearch Institution
        • contact_personDr. Nancy Ngumbau
        • addressP.O. BOX 294-00515
        • telephone_number0713917226
        • fax_number
        • cell_number0713917226
        • email_addressnancym390@gmail.com
        • created2018-10-26 12:57:29
        • modified2020-05-12 17:12:19
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php