Combatting HIV Or Other STIs Early (CHOOSE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age13-24
SponsorWestat
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Standard of care and PrEP Choice at Enrollment
Other interventionStandard 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
Other interventionStandard 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard of Care and PrEP Choice at EnrollmentExperimental treatment 1 intervention
Group B: Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
first 9 months of follow up2
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.
Time frame
first 9 months of follow-up3
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.
Time frame
18 months of follow up4
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.
Time frame
18 months of follow upSecondary outcomes
1
PrEP modality choice and switching
PrEP modality choice and switching, the proportion of participants who choose each PrEP regimen initially, the proportion of participants within each regimen who switch to another regimen, and the proportion of participants who choose each PrEP regimen with their second choice, among those who switch initial PrEP regimens through 18 months of study follow-up.
Time frame
18 months of follow up2
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
7\. 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 PrEP regimen and by the on-time CAB-LA and LEN injections for participants opting for injectable PrEP through the 18 months of study follow-up. PrEP adherence, 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, will be assessed every 3 months, and the rate at 18 months of study follow-up will be 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.
Time frame
18 months of follow up3
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
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 through 18 months of study follow-up. STIs will be assessed by STI testing at the site every 3 months through 18 months of study follow-up. Combined STI incidence is defined as having at least 1 STI at a study visit. Rates of STI will be compared between users of DoxyPEP and non-users through 18 months of study follow-up. Participants will be classified as a user or non-user at each study assessment based on their self-reported use since the last assessment.
Time frame
18 months of follow-up4
DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site
9\. DoxyPEP uptake, the rate at which participants receive DoxyPEP from the study site within 9 months of study follow-up. DoxyPEP uptake is binary, indicated 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 first 9 months of study follow-up, between treatment arms.
Time frame
First 9 months of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Westat
Lead sponsor
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
Source ClinicalTrials.gov