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

RecruitingNAAges 15 Years - 24 YearsFemaleWashington University School of Medicine
NCT07002866 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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+

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📋 Eligibility rules (as published)
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
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What it tests

  • HIV Risk Reduction (HIVRR)
  • PrEP Peer Supporters (PS)
  • Matched Savings Accounts + Financial Literacy (FL)
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Where

2 sites
Washington University in St. Louis
St Louis, United States
International Center for Child Health and Development (ICHAD)
Masaka, Uganda
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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