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

HIV Prevention Clinical Trial

— TOPAZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348069
• Other study ID #: 2022-11-15783
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of California, Berkeley
• Contact: Oppah Kuguyo, PhD
• Phone: 263775282460
• Email: oppah.kuguyo[@]ceshhar.co.zw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: March 11, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• HIV Prevention

Intervention

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.
• 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.

Locations

Country	Name	City	State
Zimbabwe	CESHHAR Zimbabwe	Harare

Sponsors (4)

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

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	: 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
Other	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
Other	HIV tests	The number and outcomes of HIV tests at the time of refill.	9 months
Other	HIV care referrals	This outcome will measure the number of referrals for HIV care.	9 months
Primary	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