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

NCT06348069 | Recruiting

• 1 other identifier: 2022-11-15783
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication; HIV Prevention

Keywords

HIV; PrEP; People who engage in sex work

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PrEP retention at 6 months among FSW who are 18-24 years of age

  6 months

• : PrEP retention at 6 months among participants who have remained active in sex work

  6 months

• FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies

  9 months

Study Arms (2)

Pharmacy-based PrEP refills + gift cards

EXPERIMENTAL

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

Control (Standard of Care)

EXPERIMENTAL

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)

Interventions

Pharmacy-based PrEP refill and gift voucher BEHAVIORAL

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.

Pharmacy-based PrEP refills + gift cards

Control (Standard of care) BEHAVIORAL

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.

Control (Standard of Care)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

CESHHAR Zimbabwe

Harare, 0000, Zimbabwe

RECRUITING

Related Publications (1)

• Kuguyo O, Archer H, Azizi L, Watadzaushe C, Munhenzva S, Chidhanguro K, Takaruza A, Musemburi S, Packel L, Liu J, Matambanadzo P, Cowan FM, McCoy S, Sibanda EL. Establishing a Pharmacy-Based Pre-Exposure Prophylaxis Program for Young Women Who Sell Sex: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Dec 3;14:e74141. doi: 10.2196/74141.

  PMID: 41337741 DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Oppah Kuguyo, PhD

CONTACT

263775282460; oppah.kuguyo@ceshhar.co.zw

Lance A Azizi

CONTACT

lanceaazizi@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Groups (sites/clusters) are randomized to either the intervention (pharmacy-based PrEP refills plus gift card incentives) or the control (standard of care) and are followed and compared over time.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: March 25, 2024
• Primary Completion: March 11, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

ZI (1)