NCT06852508Active, not recruiting
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use Among Sexually Active Female University Students in Zambia: Study Protocol of a Hybrid Effectiveness-implementation Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is: • Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among high-risk female students in Zambia? Researchers will compare the mhealth peer navigator intervention to treatment as usual to see if there are effects on female student's use and continuation of PrEP for HIV prevention. Participants in the intervention will be paired with a trained peer navigator who will offer education, social support, and help navigating the health systems to access PrEP and other sexual and reproductive health services. All participants in both arms will complete surveys at baseline, 6 months, and 12 months to evaluate health behaviors.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 324 (estimated)
- First submitted
- 24 Feb 2025
- Start date
- 18 Feb 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- HIV
- NCT number
- NCT06852508
What you commit to
- Study type: Interventional
- Planned participants: 324
- From 18 Feb 2025 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed with HIV
- Less than 3 self-reported HIV risk behaviors
Age
- Less than 18 years of age
- Greater than 24 years of age
Other
- Male
- Not a university student
Who the study is looking for
- Female
- Aged 18 to 24 years
- Current university student
- Not diagnosed with HIV
- Self-report of 3 more HIV risk factors
Age in the registry: 18 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Zambia Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.