Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: JMIR Research Protocols

Date Submitted: Mar 19, 2025
Open Peer Review Period: Mar 21, 2025 - May 6, 2025
Date Accepted: Jun 18, 2025
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Establishing a Pharmacy-Based Pre-Exposure Prophylaxis Program for Young Women Who Sell Sex: Protocol for a Randomized Controlled Trial

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

JMIR Res Protoc 2025;14:e74141

DOI: 10.2196/74141

PMID: 41337741

PMCID: 12712568

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

JMIR Res Protoc 2025;14:e74141

DOI: 10.2196/74141

PMID: 41337741

PMCID: 12712568

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.