Combatting HIV Or Other STIs Early (CHOOSE)

NCT07510048 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ATN166 Phase 2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up

  1\. PrEP uptake; the proportion of participants receiving PrEP from the study site within 9 months of study follow-up. PrEP uptake is binary, indicating whether the study participant has received PrEP from the study site. This endpoint compares the proportion of participants who receive PrEP from the study site within the first 9 months of study follow-up between the treatment arms.

  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

  1\. PrEP adherence, the rate at which participants who received PrEP on study adhere to the selected PrEP regimen as measured by dried blood spot for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants opting for injectable PrEP through the first 9 months of study follow-up. PrEP adherence, as measured by dried blood stop for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants option for injectable PrEP, will be assessed every 3 months, and the rate at 9 months of study follow-up will be compared between arms.

  first 9 months of follow-up

• DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site

  1\. DoxyPEP uptake, the rate at which participants receive DoxyPEP from the study site within 18 months of study follow-up. DoxyPEP uptake is binary, indicating whether the study participant has received DoxyPEP from the study site. This endpoint compares the rates of participants who receive DoxyPEP from the study site, assessed every 3 months through the 18 months of study follow-up, between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months.

  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

  1\. DoxyPEP adherence, the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report. DoxyPEP adherence is binary, indicated whether the study participant used DoxyPEP to cover their last condomless sexual exposure. This endpoint will be assessed every 3 months through 18 months of study follow-up and compared between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months.

  18 months of follow up

• DoxyPEP Acceptability; assessed by Likert scale every 3 months of study follow-up

  DoxyPEP acceptability, assessed by Likert scale every 3 months of study follow-up through 18 months of follow-up. DoxyPEP acceptability Likert scale results will be compared between the treatment conditions, assessed every 3 months through 18 months of study follow-up. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months. The Likert Scale is as follows: 1. Very acceptable 2. Somewhat acceptable 3. Neither acceptable nor unacceptable 4. Somewhat unacceptable 5. Very unacceptable

  18 months of follow up

Secondary Outcomes (4)

• PrEP modality choice and switching

  18 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

  18 months of follow up

• STI Incidence; individual and combined rates of gonorrhea, chlamydia, and/or early syphilis infection compared between DoxyPEP users and non-users, assessed every 3 months

  18 months of follow-up

• DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site

  First 9 months of follow-up

Study Arms (2)

Standard of Care and PrEP Choice at Enrollment

EXPERIMENTAL

Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit.

Other: Standard of care and PrEP Choice at Enrollment

Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9

ACTIVE COMPARATOR

Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit.

Other: Standard of care followed by PrEP Choice at Month 9

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 and PrEP Choice at Enrollment

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.

Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9

Eligibility Criteria

• Age: 13 Years - 24 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Westat: lead
• 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

Study Sites (6)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Children's National Medical Center

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

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

University Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38015, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susan Buchbinder

  San Francisco Department of Public Health

  STUDY CHAIR

• Albert Liu

  San Francisco Department of Public Health

  STUDY CHAIR

• Lisa Hightow-Weidman, MD, MPH

  Florida State University

  PRINCIPAL INVESTIGATOR

• Sybil Hosek, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Healey

CONTACT

301-610-8703; ErinHealey@westat.com

Nancy Liu

CONTACT

718-980-3937; NancyLiu@westat.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to the intervention arm will be onboarded at enrollment to PrEP Choice and continue to use the tools through the end of the 18-month follow up. Participants randomized to the control arm will be onboarded at 9 months post-enrollment to PrEP Choice in a waitlist control design and continue to use the tools through the end of the 18-months follow-up.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: April 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)