Helping adolescent girls and young women in Uganda get and keep using PrEP

Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda

This project will test whether combining PrEP education, peer supporters, and a matched savings plus financial literacy program helps adolescent girls and young women (ages 15–24) in Ugandan HIV hotspots start and stay on PrEP.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 15 Years to 24 Years
• Sex: Female
• Sponsor: Washington University School of Medicine (Academic / other)
• Locations: 2 sites (St Louis, Missouri and 1 other locations)
• Trial ID: NCT07002866 on ClinicalTrials.gov

What this trial studies

This is a cluster-randomized intervention delivered at 30 health care sites in Uganda that will enroll 600 adolescent girls and young women aged 15–24 and assign sites to one of three arms: HIV risk reduction (HIVRR) only, HIVRR plus peer supporters (PS), or HIVRR plus PS plus an economic empowerment (EE) package including matched savings and financial literacy. The interventions run for about 20 months with repeated data collection on PrEP initiation and adherence and related psychosocial and economic outcomes. Peer supporters with lived PrEP experience will provide linkage and ongoing support while the EE component aims to reduce financial barriers to clinic access and adherence. Outcomes will compare PrEP uptake and sustained use across the three arms to see if adding peer support and economic supports yields better results.

Who should consider this trial

Good fit: Ideal participants are HIV-negative adolescent girls and young women aged 15–24 who live in the participating Ugandan hotspot communities and meet the study's high-risk behavioral criteria.

Not a fit: People who are HIV-positive, outside the 15–24 age range, not at substantial HIV risk per the criteria, unable to consent or unwilling/unable to commit to study procedures, or who do not live near participating sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combined approach could increase PrEP uptake and adherence among AGYW and reduce their risk of acquiring HIV.

How similar studies have performed: Peer support and economic empowerment approaches have separately shown promise in improving PrEP uptake and retention, but combining HIV risk reduction, peer supporters, and matched savings is a relatively novel, less extensively tested multilevel strategy.

Eligibility criteria

Inclusion Criteria:

1. Age 15-24 years
2. At a high risk of HIV. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool: 1) vaginal/anal sexual intercourse with more than one partner of unknown HIV status in the past six months, 2) vaginal/anal sex without a condom in the past six months, 3) sex in exchange for money, goods or a service in the last six months, 4) injecting drugs in the past six months, 5) diagnosis with an STI more than once in the past twelve months, 6) post-exposure prophylaxis (PEP) for sexual exposure to HIV in the past six months, and 7) having an HIV-infected sexual partner who was not on ART.

Exclusion Criteria:

1. HIV positive
2. Unable to understand the study procedures and/or participant rights during the informed consent process
3. Unwilling or unable to commit to completing the study

Where this trial is running

St Louis, Missouri and 1 other locations

• Washington University in St. Louis — St Louis, Missouri, United States (Active_not_recruiting)
• International Center for Child Health and Development (ICHAD) — Masaka, Uganda (Recruiting)

Study contacts

• Study coordinator: Fred M Ssewamala, PhD

Conditions HIV Prevention