RecruitingNot ApplicableNCT07002866

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


Sponsor

Washington University School of Medicine

Enrollment

600 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 15 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study (Suubi4PrEP) is testing a program to help adolescent girls and young women in Uganda access and consistently take PrEP — a daily pill that prevents HIV infection — by addressing financial barriers and providing support. **You may be eligible if...** - You are a young woman between 15 and 24 years old in Uganda - You are at high risk of HIV based on your sexual behavior or other risk factors (such as multiple partners, unprotected sex, sex for money, or an HIV-positive partner not on treatment) - You are currently HIV-negative **You may NOT be eligible if...** - You are already HIV-positive - You are unable to understand the study procedures or your rights - You are not willing or able to complete the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHIV Risk Reduction (HIVRR)

This is an intervention comprised of 5 sessions of an evidence-based, HIV/STI risk reduction with PrEP to strengthen HIV prevention knowledge and behavioral skills intervention. Session content cover harm reduction, social support networks, HIV knowledge, transmission risks and testing procedures for HIV/STIs, build enthusiasm for condom use, alternatives to unsafe sex, importance of safer sex negotiations, strategies to negotiate safer sex, setting appropriate risk reduction goals, introduction to PrEP, PrEP screening and eligibility; monitoring and managing PrEP side effects and stigma, recognizing and understanding consequences of abusive behavior by any sexual partners or others; build safety plan skills; review and identify ways to increase social support; build skill in communication with health care professionals.

BEHAVIORALPrEP Peer Supporters (PS)

PrEP peer supporter are women currently on PrEP willing to share their lived experiences. Women will meet with peer supporters in a group at least 8 times during the intervention period (every 2-3 months). Sessions with peers will involve unstructured, in-depth discussions that integrate peers' own lived experiences and emerging PrEP-related issues as raised by participants. These may include, how to mitigate PrEP stigma and disclosure, creating PrEP adherence strategies, navigating family and intimate relationship issues, and navigating provider attitudes. At each stage of the facility visit (waiting space, consultation, and pharmacy), peer supporters will explain facility protocols, and strategies women can use to overcome facility-level barriers to care.

BEHAVIORALMatched Savings Accounts + Financial Literacy (FL)

A matched savings account (MSA) is a savings account held at a local bank whereby deposits made by the participants are matched by the intervention to encourage savings and investment in skills and asset development. The accounts introduce participants to financial management skills, introduce them to formal financial institutions, and by matching their deposits, incentivize women to save small amounts. Each participant will receive an account held in her own name, and will be allowed to save an equivalent of US$10 a month or US$200 for the 20-months intervention period. During the intervention period, participants will have direct access to both their personal savings deposited in the accounts and the match provided by the study. In addition, participants will also receive six 1-2-hour financial literacy (FL) workshop sessions that cover components on saving, and financial management.


Locations(2)

Washington University in St. Louis

St Louis, Missouri, United States

International Center for Child Health and Development (ICHAD)

Masaka, Uganda

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NCT07002866


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