An interventional study of TwySHE in Hiv and Contraception Behavior, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in Zambia. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention
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:
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.
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.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 324 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Compared within Contraception Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants will receive a referral list for local HIV/SRH services and informed of the longitudinal data collection process through 12 months.
Interpersonal support from trained peers to access and use PrEP and contraception.
Also known as: mhealth peer navigator intervention
PrEP uptake
Self-reported use of PrEP products verified through health clinic documentation
Time frame: 6 months
Contraception uptake
Self-reported use of PrEP products verified through health clinic documentation
Time frame: 6 months
PrEP persistence
Self-reported continued use of PrEP if initiated verified through health clinic documentation
Time frame: 12 months
Contraception persistence
Self-reported continued use of PrEP if initiated verified through health clinic documentation
Time frame: 12 months
Plan to share: Yes — Individual participant data that underlie the results after deidentification
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After publication
Access criteria: Researchers who provide a methodologically sound proposal and sign a data use agreement
Ran from Feb 2025 to primary completion in Feb 2026, 12 months.
Of 64 non-industry interventional studies with no phase under Contraception Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 12 months is below that.
Counting every sponsor, half of 64 studies reached it within 20 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →