Clinical trial NCT06852508: TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Contraception Behavior
Keywords: HIV prevention
Modern contraception
Pre-exposure prophylaxis
PrEP
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Zambia
First posted: 2025-02-28
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: We are conducting a 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial to determine the effectiveness the TwySHE intervention in Lusaka, Zambia. We will follow all participants for 12 months with regular data collection. All intervention activities will end at 6 months (primary endpoint window), but we will continue to follow and survey participants in both study arms at 12 months to determine long-term post-intervention effectiveness. PrEP and contraception uptake and persistence will be objectively verified using a study medical visit card filled out and signed by health providers. We will also collect and assess behavioral mechanisms hypothesized to be on the casual pathway, including participant knowledge regarding HIV and unintended pregnancy prevention, health beliefs (perceived risk of HIV or unintended pregnancy), perceived social support to access and adhere to HIV/unintended pregnancy prevention methods, stigma, behavioral intention to use PrEP and contraception, and self-efficacy to use PrEP and contraception. Lastly, we will conduct exit interviews with peer-navigators and a sub-sample of participants to explore the implementation outcomes of the trial.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 to 24 years
* Current university student
* Not diagnosed with HIV
* Self-report of 3 more HIV risk factors

Exclusion Criteria:

* Male
* Less than 18 years of age
* Greater than 24 years of age
* Diagnosed with HIV
* Less than 3 self-reported HIV risk behaviors
* Not a university student

Primary outcomes:
measure: PrEP uptake
timeFrame: 6 months
Secondary outcomes:
measure: Contraception uptake
timeFrame: 6 months
Other outcomes:
measure: PrEP persistence
timeFrame: 12 months
measure: Contraception persistence
timeFrame: 12 months
Locations:
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
affiliation: University of Colorado, Denver
name: Karen M Hampanda, PhD
role: PRINCIPAL_INVESTIGATOR
References: