RECRUITING Not applicable ClinicalTrials.gov

Combatting HIV Or Other STIs Early (CHOOSE)

Sponsor: Westat • ClinicalTrials.gov ID: NCT07510048

Registry updated: 2026-10-09

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Description

The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.

Interventions

Standard of care and PrEP Choice at Enrollment (Other)
Standard of care includes a handout describing the different PrEP regimens as well as a handout describing DoxyPEP. PrEP Choice is a package of three mHealth tools: 1. MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method; 2. PrEPsmart, a mobile app to support PrEP adherence for persons using on-demand PrEP (2-1-1 oral PrEP) by providing dosing reminders and feedback on levels of protection; and PrEPmate, a bidirectional short message service (SMS) texting platform with automated daily reminders for oral PrEP users and a triage function to help those experiencing difficulties.
Standard of care followed by PrEP Choice at Month 9 (Other)
Standard of care includes a handout describing the different PrEP regimens as well as a handout describing DoxyPEP. PrEP Choice is a package of three mHealth tools: 1. MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method; 2. PrEPsmart, a mobile app to support PrEP adherence for persons using on-demand PrEP (2-1-1 oral PrEP) by providing dosing reminders and feedback on levels of protection; and PrEPmate, a bidirectional short message service (SMS) texting platform with automated daily reminders for oral PrEP users and a triage function to help those experiencing difficulties.

Eligibility criteria

Inclusion Criteria * Age 13-24 years, inclusive; * Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime; * Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package; * Not currently on PrEP and interested in learning more about PrEP; * Is not living with HIV; * Weighs at least 35 kg; * Willing to receive PrEP care from a provider at a participating ATN SC; * Able to understand, read, and speak English; * Able to participate at the study site; and * Willing and able to provide written informed consent. * If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation. * If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation. Exclusion Criteria: * Female; * In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months; * Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir study); * Plan to move within 18 months to an area inaccessible to a participating ATN SC; * An employee of the participating SC; or * Any concurrent participation in other clinical trials or behavioral intervention studies without prior approval from the protocol team. * Any other medical, behavioral, or other conditions that in the opinion of the SC Project Lead could interfere with adherence to study procedures or the individual's ability to remain in the study for an 18-month period or compromise interpretation of study results.

Conditions

HIV STIs STIs Prevention HIV Prevention

Locations

San Francisco Department of Public Health — San Francisco, California, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
University of South Florida — Tampa, Florida, United States
University Illinois Chicago — Chicago, Illinois, United States
Tulane University — New Orleans, Louisiana, United States
St. Jude Children's Research Hospital — Memphis, Tennessee, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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