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.: PACTR202009710020465 Date of Registration: 01/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 'PrEP in Pharmacy - Pilot study
Official scientific title Pharmacy delivery to expand the reach of PrEP in Kenya: Pilot study
Brief summary describing the background and objectives of the trial Maximizing access, minimizing costs of delivery, and reaching at-risk populations are key priorities for 173 optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV prevention. In Africa, PrEP 174 is being added to an already-burdened public health infrastructure and the ability of the health systems 175 to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility evaluations of 176 PrEP in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, the costs of 177 staffing, and healthcare providers’ unfamiliarity with delivering prevention interventions. In Kenya, retail pharmacies fill an important gap in the health care system, providing access to treatment 179 of urgent conditions (e.g., evaluation and medication for STIs, upon presentation of a valid prescription), 180 monitoring of chronic conditions (e.g., blood pressure testing), and preventative care (e.g., 181 contraception). HIV testing is also now legally allowed at pharmacies through purchase of HIV self-tests 182 or pharmacy provider-assisted HIV self-testing. Pharmacy-delivered care has many attributes that may 183 be desirable for potential PrEP users, including convenience (as pharmacies outnumber clinics and have 184 shorter waiting times), anonymity (compared to seeking PrEP at an HIV care center), and engagement 185 (which may be greater for a preventative service at a pharmacy than at a clinic that prioritizes treating ill 186 individuals). Pharmacies can offer free, subsidized, or fully fee-for-service care, and paying for a service 187 could result in greater sustained consumer engagement.
Type of trial CCT
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 31/08/2020
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised 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
Experimental Group PrEP delivery in Retail pharmacies We have chosen single-arm trials for this study (i.e., no comparison pharmacies or CCCs) because this study is focused on testing the feasibility of pharmacy-based PrEP delivery and refining care pathways for this delivery model; ongoing PrEP delivery work in HIV care centers can serve as a general comparison in terms of demographics, retention, and adherence. 7 months We have chosen single-arm trials for this study (i.e., no comparison pharmacies or CCCs) because this study is focused on testing the feasibility of pharmacy-based PrEP delivery and refining care pathways for this delivery model; ongoing PrEP delivery work in HIV care centers can serve as a general comparison in terms of demographics, retention, and adherence. 300
Control Group PrEP delivery in Retail pharmacies We have chosen single-arm trials for this study (i.e., no comparison pharmacies or CCCs) because this study is focused on testing the feasibility of pharmacy-based PrEP delivery and refining care pathways for this delivery model; ongoing PrEP delivery work in HIV care centers can serve as a general comparison in terms of demographics, retention, and adherence. 7 months We have chosen single-arm trials for this study (i.e., no comparison pharmacies or CCCs) because this study is focused on testing the feasibility of pharmacy-based PrEP delivery and refining care pathways for this delivery model; ongoing PrEP delivery work in HIV care centers can serve as a general comparison in terms of demographics, retention, and adherence. 300 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We aim to enroll up to 100 clients in total across the four Aim 1a pharmacies and up to 200 clients in total initiating PrEP at the public HIV clinic participating in our pilot. • >18 years • Interested in initiating PrEP at a pilot pharmacy • Meets all criteria (e.g., tests HIV-negative) for PrEP initiation on the checklist • Able & willing to provide written informed consent • Initiated PrEP at a project-affiliated CCC • Meets all criteria (e.g., tests HIV-negative) for PrEP refill on the checklist • Able & willing to provide written informed consent Does not meet the inclusion criteria Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
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 17/08/2020 SCIENTIFIC ETHICS REVIEW UNIT
Ethics Committee Address
Street address City Postal code Country
MBAGATHI WAY Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PrEP initiation Aim 1a # of participants that initiated PrEP at pilot pharmacies • Quant survey • Pharm records M0 PrEP retention Aims 1a & 2 % of participants who return to the pilot pharmacies (or CCC) for PrEP refills • Quant survey • Pharm records M1*, M4*, M7 PrEP adherence Aims 1a & 2 % of participants that missed no pills in previous week % of participants that refill drugs at pharmacy % of DBS samples with drug concentrations indicating adherence Quant survey Pharm records DBS M1*, M4*, M7 0, M1, M4, M7
Secondary Outcome Selection of pharmacy-based PrEP Aim 2 % of participants who initiated PrEP at CCC and selected pharmacy-based PrEP refills Quant survey Pharm records M0 M0 - Enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KIAMBU COUNTY OAU ROAD THIKA 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
United States National Institute of Mental Health BETHESDA MD 20814 9692 Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington 4060 East Stevens Way Northeast Seattle Seattle United States of America University
COLLABORATORS
Name Street address City Postal code Country
Jomo Kenyatta University of Agriculture and Technology Juja Road JUJA Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kenneth Ngure kngure@pipsthika.org 0722362219 OAU ROAD
City Postal code Country Position/Affiliation
Thika Kenya Site Co Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Jared Baeten jbaeten@uw.edu 12065203808 105-Albert
City Postal code Country Position/Affiliation
seattle United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Peter Mogere patandi@pipsthika.org +254707177811 OAU Road
City Postal code Country Position/Affiliation
Thika 00202 Kenya Project Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study PIs are in agreement to include participant demographics and necessary granulation in articles to be published. Study Protocol The study PIs agree to share the study results at the end of the study and after the analysis is complete. The study outputs will be published in free access journals and the PIs are willing to always avail the publication on request.
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