NCT07002866 · Washington University School of Medicine
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
HIV 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.
BEHAVIORAL
PrEP 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.
BEHAVIORAL
Matched 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.
Primary outcome measures
PrEP Initiation
Time frame: Baseline, 12, 24 and 36 months
Proportion of eligible participants who initiate PrEP
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- St Louis, Missouri
Collaborators
Makerere University, Columbia University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2025 · Source of record for eligibility and locations