Combatting HIV Or Other STIs Early (CHOOSE)

Conditions

• HIV
• HIV Prevention
• STIs
• STIs Prevention

Eligibility Criteria

Sex

MALE

Age

13 Years - 24 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

May 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• Experimental: Standard of Care and PrEP Choice at Enrollment
  Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit.
• Active Comparator: Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9
  Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit.

Primary Outcome Measure

PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up [ Time Frame: first 9 months of follow up ]

Central Contacts

• Erin Healey
  301-610-8703
  [email protected]
• Nancy Liu
  718-980-3937
  [email protected]

Locations (6)

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