Recruiting

PrEP Choice

Sponsor:

Westat

Code:

NCT07510048

Conditions

HIV

STIs

STIs Prevention

HIV Prevention

Eligibility Criteria

Sex: Male

Age: 13 - 24

Healthy Volunteers: Accepted

Interventions

Standard of care and PrEP Choice at Enrollment

Standard of care followed by PrEP Choice at Month 9

Study Details

Brief 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

Study ID

NCT07510048

Start date

Sep 16, 2026

Status verified date

Oct, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 13 - 24

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 ]
  • PrEP Adherence; rate at which participants who received PrEP on study adhere to selected PrEP regimen as measured by dried blood spot for oral regimen and by the on-time CAB-LA and LEN injections for injectable PrEP [ Time Frame: first 9 months of follow-up ]
  • DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site [ Time Frame: 18 months of follow up ]
  • DoxyPEP Adherence; the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report [ Time Frame: 18 months of follow up ]
  • DoxyPEP Acceptability; assessed by Likert scale every 3 months of study follow-up [ Time Frame: 18 months of follow up ]

Central Contacts and Locations

Central contacts

Erin Healey

301-610-8703ErinHealey@westat.com

Nancy Liu

718-980-3937NancyLiu@westat.com

Locations

San Francisco Department of Public Health

Recruiting

San Francisco, California, United States, 94102

Contacts

Emily Schaeffer

628-217-7456emily.schaeffer@sfdph.org

Principal Investigator:

Albert Liu

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Justin Unternaher

202-476-1030junternahe@childrensnational.org

Principal Investigator:

Natella Rakhmanina

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Elizabeth Enriquez-Bruce

813-250-2574enriquezbruce@usf.edu

Principal Investigator:

Patricia Emmanuel

University Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Rachel Jackson

312-996-6018rjacks34@uic.edu

Principal Investigator:

Kelly Bojan

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Leslie Kozina

504-988-5348lkozina@tulane.edu

Principal Investigator:

Tina Simpson

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38015

Contacts

Mary Dillard

901-595-4083Mary.dillard@stjude.org

Principal Investigator:

Aditya Gaur

More Information

Sponsor

Westat

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • HIV
  • STIs
  • sexually transmitted infection
  • PrEP
  • DoxyPEP
  • mobile health
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Westat on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.