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

Not Applicable

Recruiting

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

• Registration Number: NCT06348069
• Lead Sponsor: University of California, Berkeley

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-25
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-03-11
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Standard of Care)	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.
Pharmacy-based PrEP refills + gift cards	Pharmacy-based PrEP refill and gift voucher	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.

Primary Outcome Measures

Name	Time	Method
PrEP retention at 6 months	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.

Trial Locations

Locations (1)

CESHHAR Zimbabwe; 🇿🇼 Harare, Zimbabwe