Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-24.
Status change: Not Yet Recruiting → Recruiting 2025-11-03
Trial Details
NCT Number NCT07002866
Lead Sponsor Washington University School of Medicine
Collaborators: Makerere University, Columbia University
Conditions HIV Prevention
Enrollment 600 participants
Start Date 2025-10-20
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-05