Combatting HIV Or Other STIs Early (CHOOSE)

Summary

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.

Conditions

• HIV
• STIs
• STIs Prevention
• HIV Prevention

Interventions

OTHER

Standard of care and PrEP Choice at Enrollment

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.

OTHER

Standard of care followed by PrEP Choice at Month 9

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Florida State University

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• Westat

  lead OTHER

Principal Investigators

• Susan Buchbinder · San Francisco Department of Public Health

• Albert Liu · San Francisco Department of Public Health

• Lisa Hightow-Weidman, MD, MPH · Florida State University

• Sybil Hosek, PhD · University of Illinois at Chicago

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

13 Years

Max Age

24 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2029-09-30

Completion

2029-09-30

Countries

• United States

Study Locations