Combatting HIV Or Other STIs Early (CHOOSE)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age13-24
SponsorWestat
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Standard of care and PrEP Choice at Enrollment
- Standard of care followed by PrEP Choice at Month 9
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Westat
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
National Institutes of Health (NIH)
Collaborator
Florida State University
Collaborator
The Emmes Company, LLC
Collaborator
Source ClinicalTrials.gov