Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210776132543 Date of Registration: 04/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AGYW Pharmacy PrEP Delivery
Official scientific title Enhancing PrEP outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform
Brief summary describing the background and objectives of the trial HIV incidence rates remain unacceptably high for adolescent girls and young women (AGYW). Pre-exposure prophylaxis (PrEP) HIV prevention tools are promising with tenofovir (TFV)-based daily oral PrEP and the dapivirine vaginal ring (DPV-VR) recommended by WHO for cisgender women at-risk for HIV. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP access with AGYW as a priority group. Our team pioneered integrated PrEP delivery in family planning (FP) clinics in Kenya; yet 40% of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by facility-based PrEP platforms. Retail pharmacies can increase options for reaching at-risk individuals with PrEP and efforts are underway to define pathways for pharmacy-delivered PrEP in Kenya. We adapted our FP clinic-based PrEP model and piloted PrEP delivery facilitated by nurse-navigators for AGYW seeking contraception at pharmacies. AGYW offered daily oral PrEP frequently initiated, planned to continue use, and were willing to pay for PrEP at pharmacies. Pill burden was a common reason for declining oral PrEP and could be addressed by offering DPV-VR. Through close collaboration with the Kenya Ministry of Health both, national- and county-level, we propose a Cluster Random Controlled Trial( cRCT() at 20 pharmacies in Kisumu, Kenya-a region with an HIV prevalence of up to 28% among women -to test the effectiveness of utilizing nurse-navigators at retail pharmacies to enhance AGYW PrEP use. We will expand on our successful pilot to offer both daily oral PrEP and the DPV-VR and prospectively ascertain PrEP outcomes (initiation, persistence, adherence) among AGYW. This effectiveness-implementation hybrid RCT is designed to expedite translation into practice by evaluating clinical effectiveness alongside implementation and cost outcomes. We hypothesize that combining nurse-navigators with pharmacy-based PrEP will provide a cost-effe
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 02/01/2023
Actual trial start date
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1900
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group AGYW PrEP initiation thorugh pharmacy provider only 3 years AGYW to get initiated and receive HIV PrEP from pharmacy providers only 950 Active-Treatment of Control Group
Experimental Group AGYW PrEP initiation thorugh pharmacy provider assited by a nurse navigator 3 years AGYW to initiate and receive PrEP from pharmacy provider assited by a nurse navigator 950
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Female gender • Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site • Age between ≥14 and <25 years old • Willingness to receive PrEP screening per national guidelines including HIV testing • Not currently taking PrEP • Able and willing to provide informed consent for participation • Male gender • Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site • Age between <14 or >24 years old • Not willing to receive PrEP screening per national guidelines or not willing to receive HIV testing • Currently taking PrEP • Not able or willing to provide informed consent for participation Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 14 Year(s) 25 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/08/2022 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Highway Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PrEP initiations, PrEP persistence and PrEP adherence within 10 months of first contact
Secondary Outcome PrEP method selection, predictors of non-adherence, STI incidence and cofactors within 10 months of first contact
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute Research Care and Training Programme Lumumba Subcounty Hospital Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 9000 Rockville Pike Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington 1410 NE Campus Parkway Seattle 98195 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Kenya Medical Research Institute Mbagathi Highway Nairobi 40100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Bukusi ebukusi@rctp.or.ke +254733617503 Mbagathi Highway
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Josephine Odoyo orajose@kemri-rctp.org +254733276275 Lumumba subcounty hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Project director
Role Name Email Phone Street address
Scientific Enquiries Jillian Pintye jpintye@uw.edu +12066850817 Seattle, WA 98195-7266
City Postal code Country Position/Affiliation
Seattle 98195 United States of America Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available.The Clinical study report will be available for researchers who provide a methodologically sound proposal immediately after study publication.This data shall only be used to achieve aims in the approved protocols Clinical Study Report 2 years Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information