NCT06852508

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
4mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Feb 2025Aug 2026

Study Start

First participant enrolled

February 18, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 24, 2025

Last Update Submit

February 24, 2025

Conditions

HivContraception Behavior

Keywords

HIV preventionModern contraceptionPre-exposure prophylaxisPrEP

Outcome Measures

Primary Outcomes (1)

  • PrEP uptake

    Self-reported use of PrEP products verified through health clinic documentation

    6 months

Secondary Outcomes (1)

  • Contraception uptake

    6 months

Other Outcomes (2)

  • PrEP persistence

    12 months

  • Contraception persistence

    12 months

Study Arms (2)

TwySHE mhealth peer navigator intervention

EXPERIMENTAL

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.

Behavioral: TwySHE

Control

NO INTERVENTION

Participants will receive a referral list for local HIV/SRH services and informed of the longitudinal data collection process through 12 months.

Interventions

TwySHEBEHAVIORAL

Interpersonal support from trained peers to access and use PrEP and contraception.

Also known as: mhealth peer navigator intervention
TwySHE mhealth peer navigator intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zambia

Lusaka, Zambia

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeContraception Behavior

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesReproductive BehaviorBehavior

Study Officials

  • Karen M Hampanda, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen M Hampanda, PhD

CONTACT

3037487805KAREN.HAMPANDA@CUANSCHUTZ.EDU

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 28, 2025

Study Start

February 18, 2025

Primary Completion

February 28, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results after deidentification

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication
Access Criteria
Researchers who provide a methodologically sound proposal and sign a data use agreement

Locations

ZA(1)