NCT07510048 · Westat
Combatting HIV Or Other STIs Early (CHOOSE)
(CHOOSE)
What this study is about
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the effectiveness 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.).
View original scientific description
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.
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.
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
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.
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
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.
DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site
Time frame: 18 months of follow up
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.
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
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.
DoxyPEP Acceptability; assessed by Likert scale every 3 months of study follow-up
Time frame: 18 months of 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- San Francisco, California
- Washington D.C., District of Columbia
- Tampa, Florida
- Chicago, Illinois
- New Orleans, Louisiana
- Memphis, Tennessee
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Florida State University, The Emmes Company, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations