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Establishing a pharmacy-based PrEP program for young women who sell sex in Zimbabwe: Protocol for a randomised control trial
Oppah Kuguyo;
Helena Archer;
Lance Azizi;
Constancia Watadzaushe;
Sharon Munhenzva;
Kudzai Chidhanguro;
Albert Takaruza;
Sithembile Musemburi;
Laura Packel;
Jenny Liu;
Primrose Matambanadzo;
Primrose Matambanadzo;
Frances Cowan;
Sandra McCoy;
Euphemia Sibanda
ABSTRACT
Background:
Sex workers (SW) are at risk of acquiring HIV infections. Despite this, SW have low uptake of relevant preventive measures such as HIV pre-exposure prophylaxis (PrEP). Community-based programs that make PrEP convenient and accessible have potential to drive PrEP continuation and reduce HIV risk.
Objective:
This paper describes the co-development and piloting of the TOPAZ study – which encompasses an intervention providing SW with the opportunity to access PrEP refills through pharmacies in Zimbabwe.
Methods:
Using a participatory process, the TOPAZ study will be collaboratively developed with pharmacy owners and SW. The TOPAZ study comprises provision of safe and convenient spaces for PrEP refill pick-ups bundled with a gift voucher incentive at pharmacies. Formative research will inform development of the preliminary model (Aim 1). A cluster randomised pilot trial of the PrEP in pharmacy intervention compared to clinic pick up in the Key Populations program (standard of care) will be done to evaluate the impact of the intervention on PrEP retention at 3, 6, 9, and 12 months after initiation (Aim 2). Finally, a mixed methods study will be conducted to understand the potential for scaling the PrEP in pharmacy program for SW, and based on the findings, translate lessons learned into the design of a future effectiveness trial (Aim 3).
Results:
The enrolment of study participants started in March 2024 and is expected to end in May 2025. The final comprehensive analysis of the results will be conducted in June 2025 after all the data has been collected and reviewed comprehensively.
Conclusions:
This study will report on feasibility, acceptability and effectiveness of having pharmacy-based PrEP refills to improve PrEP uptake among women who sell sex. If successful, this preliminary study will pave the way for a future effectiveness trial to evaluate this intervention more comprehensively. Clinical Trial: ClinicalTrials.gov NCT06348069
Citation
Please cite as:
Kuguyo O, Archer H, Azizi L, Watadzaushe C, Munhenzva S, Chidhanguro K, Takaruza A, Musemburi S, Packel L, Liu J, Matambanadzo P, Matambanadzo P, Cowan F, McCoy S, Sibanda E
Establishing a Pharmacy-Based Pre-Exposure Prophylaxis Program for Young Women Who Sell Sex: Protocol for a Randomized Controlled Trial