See if PrEP Choice helps young people start and stick with HIV prevention methods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an individual-level randomized trial with a wait-list control to evaluate the PrEP Choice integrated mHealth package and its cost in promoting PrEP initiation and adherence among young people. Participants receive counseling and a PrEP/DoxyPEP handout, with the intervention group starting PrEP Choice at enrollment and the control group at 9 months, followed for 18 months. PrEP options include daily TDF/FTC, TAF/FTC, event-driven TDF/FTC, CAB-LA injections, and LEN injections, with regimen changes allowed. The study is conducted through ATN site networks at multiple U.S. locations and aims to assess uptake, persistence, and acceptability of PrEP and DoxyPEP. Lead sponsor is Westat, with NICHD, NIDA, and NIMH as collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Lisa Hightow-Weidman, MD, MPH — Florida State University
• Study coordinator: Erin Healey
• Email: ErinHealey@westat.com
• Phone: 301-610-8703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.