N/A
N=60
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04030520 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Initiation of PrEP — 18; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- POPPi (Behavioral); Comparison (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initiation of PrEP |
18; 21 | — |
| PRIMARY Adherence to PrEP |
19; 18 | — |
Summary
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.
Eligibility Criteria
Inclusion Criteria
- Female age 15- to 24-years old
- Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative
- Agree to participate in a minimum of four interviews over a 12-month period; including baseline
- Willing to receive services at Good Health for Women Project (GHWP)
- For those initiating PrEP (Truvada):
- Participants should have immunity to Hepatitis B infection and serum creatinine before
- Contra-indications for starting Truvada to be considered include Creatinine > 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.
Exclusion Criteria
- Inability to consent to participation in the study
- Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.
Data sourced from ClinicalTrials.gov (NCT04030520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.