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Not yet recruiting NCT07510048

Combatting HIV Or Other STIs Early (CHOOSE)

Phase II Interventional HIV STIs STIs Prevention HIV Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9.
Who it may be relevant to
Registry conditions: HIV, STIs, STIs Prevention, HIV Prevention. Basic parameters: 13 years — 24 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed 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 about DoxyPEP. Participants in the intervention arm will receive the PrEP Choice package starting at enrollment. Participants in the control arm will receive the PrEP Choice package starting at 9 months after enrollment. Both intervention and control groups will be followed for a total of 18 months.

All PrEP drugs will be dispensed by the participating SCs. Participants can select from the following PrEP agents and regimens:

(1) daily oral tenofovir/emtricitabine (tenofovir disoproxil fumarate \[TDF\]/emtricitabine \[FTC\]; (2) daily oral tenofovir alafenamide (TAF)/FTC; (3) 2-1-1 event-driven oral TDF/FTC; (4) bimonthly long-acting injectable cabotegravir (CAB-LA); or (5) twice yearly long-acting injectable lenacapavir (LEN). Participants can opt to start PrEP or change regimens at any time in the 18 months of follow-up. At 9 months, participants originally randomized to the control condition will begin to receive the PrEP Choice package in a wait-list control design. This addresses ethical concerns about withholding a potentially effective intervention from the control arm for an extended period. This design also allows for comparison both between arms (intervention versus control), as well as within arms (before versus after the PrEP Choice package in control arm) and allows measurement of extended outcomes and switching patterns for those initially randomized to the PrEP Choice package over 18 months. In addition, DoxyPEP will be offered to both study arms throughout the study.

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 plat
  • 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 plat

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • PrEP modality choice and switching [Time frame: 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 [Time frame: 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 [Time frame: 18 months of follow-up]
  • DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site [Time frame: First 9 months of follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 6 centers
  • San Francisco Department of Public Health — San Francisco
  • Children's National Medical Center — Washington D.C.
  • University of South Florida — Tampa
  • University Illinois Chicago — Chicago
  • Tulane University — New Orleans
  • St. Jude Children's Research Hospital — Memphis

Identifiers

NCT: NCT07510048 · ATN166 Phase 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗