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

Recruiting now · Not applicable

Conditions studied: HIV Prevention

In brief

The study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Specifically, the study will combine: 1) HIV risk reduction (HIVRR) that incorporates sessions on PrEP, 2) Peer Supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, share strategies to address misconceptions, manage disclosure and stigma, and model positive lifestyles while engaging in care services, and 3) an economic empowerment (EE) component that includes a matched savings account and financial literacy targeting poverty and financial barriers associated with PrEP access. Working within 30 health care systems, we will randomly assign 600 AGYW (at the community level) to one of three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. The interventions will be implemented for 20 months, and data collected at baseline, 12, 24, 36 months.

Key facts

Study ID: NCT07002866
Run by: Washington University School of Medicine
People needed: 600
Starts: 2025-10-20
Expected to finish: 2029-12-31
Last updated by the study team: 2025-11-05

Who can join

Age: 15 and older, up to 24. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Age 15-24 years
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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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