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NCT Number: NCT06852508

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Contraception Behavior Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Reproductive Behavior Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Zambia

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TwySHE

Behavioral

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

Other names: mhealth peer navigator intervention

Primary outcomes

  1. PrEP uptake

    Time frame: 6 months

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

Secondary outcomes

  1. Contraception uptake

    Time frame: 6 months

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

Other outcomes

  1. PrEP persistence

    Time frame: 12 months

    Self-reported continued use of PrEP if initiated verified through health clinic documentation

  2. Contraception persistence

    Time frame: 12 months

    Self-reported continued use of PrEP if initiated verified through health clinic documentation

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • University of Zambia

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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