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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Zambia
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.