Combatting HIV Or Other STIs Early (CHOOSE): An Integrated Strategy of Pre-Exposure Prophylaxis (PrEP) Mobile Health (mHealth) Support and Doxycycline Post-Exposure Prophylaxis (DoxyPEP)
Westat
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.
Description
This is an individual-level randomized trial with a wait-list control and provides PrEP and DoxyPEP for study participants at the Adolescent Medicine Trials Network for HIV Interventions (ATN) Site Consortiums (SCs). This study will be conducted to determine the efficacy and cost of the PrEP Choice package on initiation and long-term adherence (persistence) of PrEP use over 18 months among young people (n=200). All participants will receive brief, basic counseling about the different PrEP methods and a PrEP handout from the participating SC. They will also receive counseling and a handout abou…
Eligibility
- Age range
- 13–24 years
- Sex
- Male
- Healthy volunteers
- Yes
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 informe…
Interventions
- OtherStandard 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.
- OtherStandard 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.
Locations (6)
- San Francisco Department of Public HealthSan Francisco, California
- Children's National Medical CenterWashington D.C., District of Columbia
- University of South FloridaTampa, Florida
- University Illinois ChicagoChicago, Illinois
- Tulane UniversityNew Orleans, Louisiana
- St. Jude Children's Research HospitalMemphis, Tennessee