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

University of California (UC), Berkeley

Status: Enrolling

Conditions: Adherence, Medication; HIV Prevention

Treatments: Behavioral: Pharmacy-based PrEP refill and gift voucher; Behavioral: Control (Standard of care)

Study type: Interventional

Funder types: Other

Identifiers

NCT06348069

2022-11-15783

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pharmacy-based PrEP refills + gift cards

Experimental group

Description:

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.

Treatment:

Behavioral: Pharmacy-based PrEP refill and gift voucher

Control (Standard of Care)

Experimental group

Description:

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.

Treatment:

Behavioral: Control (Standard of care)