Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe (TOPAZ)

Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention; Adherence, Medication
• Intervention / Treatment: Behavioral: Pharmacy-based PrEP refill and gift voucher; Behavioral: Control (Standard of care)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oppah Kuguyo, PhD; Phone Number: 263775282460; Email: oppah.kuguyo@ceshhar.co.zw
• Study Contact Backup: Name: Lance A Azizi; Email: lanceaazizi@berkeley.edu

Study Locations

• Zimbabwe
  • Harare, Zimbabwe, 0000
    • Recruiting
    • CESHHAR Zimbabwe
    • Contact: Oppah Kuguyo; Email: oppah.kuguyo@ceshhar.co.zw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1) Exchanged sexual intercourse for money or gifts in past 6 months
• 2) Age 16 or older
• 3) HIV negative (via rapid test per national guidelines) at enrollment and no signs/symptoms of acute HIV infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacy-based PrEP refills + gift cards; Participants who have, in addition to the standard practice of refill pickups at CESHHAR clinics, the opportunity to retrieve PrEP refills at private pharmacies, and who receive gift card incentives at the designated refill time-points of 1, 3, and 6 months.	Behavioral: Pharmacy-based PrEP refill and gift voucher; The intervention arm of this study introduces the opportunity for a pharmacy-based PrEP refill system for sex workers, coupled with financial incentives to increase adherence. Participants receive PrEP medications from selected pharmacies, a strategy designed to improve PrEP access and enhance privacy/discretion. Additionally, participants in the intervention are awarded escalating gift card values for each successful refill collection at study pharmacies, aiming to incentivize continued PrEP use for effective HIV prevention. The intervention seeks to enhance convenience and motivate adherence through financial rewards.
Experimental: Control (Standard of Care); Participants who do not have the opportunity to retrieve PrEP refills at private pharmacies. PrEP refill pick-ups are available through CESHHAR Zimbabwe's existing network of clinical sites.	Behavioral: Control (Standard of care); For sex workers in the control group, PrEP refill pick-up will be available through CESHHAR's existing network of clinical sites. There is no gift card incentive and no pick-up at private pharmacies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP retention at 6 months	This will be measured as attendance within one week (before and after) of the scheduled refill visit at the 6-month visit. Outcome 1 will also be measured as follows: Proportion of visits completed as scheduled, by arm.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP retention at 6 months among FSW who are 18-24 years of age	: PrEP retention at 6 months among FSW who are 18-24 years of age, stratified by pickup location. This will be measured as attendance within one week (before and after) of the scheduled refill visit at the 6-month visit. Outcome 2 will also be measured as follows: Proportion of visits completed as scheduled, by arm.	6 months
: PrEP retention at 6 months among participants who have remained active in sex work	PrEP retention at 6 months among participants who have remained active in sex work (based on program, referral app and microplanner data). This will be measured as attendance within one week (before and after) of the scheduled refill visit at the 6-month visit. Outcome 3 will also be measured as follows: Proportion of visits completed as scheduled, by arm.	6 months
FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies	FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies, defined as the proportion of PrEP refill pick-ups in intervention suburbs occurring at pharmacies.	9 months
HIV tests	The number and outcomes of HIV tests at the time of refill.	9 months
HIV care referrals	This outcome will measure the number of referrals for HIV care.	9 months

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: University of California, San Francisco; Liverpool School of Tropical Medicine; Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 11, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HIV; PrEP; People who engage in sex work
• Other Study ID Numbers: 2022-11-15783

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No