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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 24
Healthy Volunteers: t
View:

• Female

• Aged 18 to 24 years

• Current university student

• Not diagnosed with HIV

• Self-report of 3 more HIV risk factors

Locations
Other Locations
Zambia
University of Zambia
RECRUITING
Lusaka
Contact Information
Primary
Karen M Hampanda, PhD
KAREN.HAMPANDA@CUANSCHUTZ.EDU
3037487805
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 324
Treatments
Experimental: TwySHE mhealth peer navigator intervention
Trained peer navigators will promote PrEP and contraception uptake/persistence among participants by communicating with them in-person or over mobile devices twice per month for 6 months. The first visit (in-person) is focused on building rapport and a trusting relationship with the participant. During the second visit (in-person) and subsequent sessions (in-person or mobile communication), the peer navigators will focus on encouraging, supporting, and helping build the skills of their participants to address their HIV/SRH needs, provide referrals and linkage to available services, and follow up to ensure participants access those services. Subsequent visits will be conducted as needed, depending on the participant.
No_intervention: Control
Participants will receive a referral list for local HIV/SRH services and informed of the longitudinal data collection process through 12 months.
Related Therapeutic Areas
Sponsors
Collaborators: University of Zambia
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov