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TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use

NCT ID: NCT06852508

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Hiv Contraception Behavior

Keywords

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HIV prevention Modern contraception Pre-exposure prophylaxis PrEP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TwySHE

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TwySHE

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

Intervention Type BEHAVIORAL

Other Intervention Names

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mhealth peer navigator intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zambia

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen M Hampanda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Zambia

Lusaka, , Zambia

Site Status RECRUITING

Countries

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Zambia

Central Contacts

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Karen M Hampanda, PhD

Role: CONTACT

Phone: 3037487805

Email: [email protected]

Facility Contacts

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Oliver Mweemba, PhD

Role: primary

Other Identifiers

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22-1151

Identifier Type: -

Identifier Source: org_study_id