HIVCHOOSENCT07510048
Combatting HIV Or Other STIs Early (CHOOSE)
A study of HIV and STIs, run by Westat at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, STIs, STIs Prevention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Sep 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University Illinois Chicago
Chicago, Illinois, 60612
Rachel Jackson, 312-996-6018, rjacks34@uic.edu
Kelly Bojan
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38015
Mary Dillard, 901-595-4083, Mary.dillard@stjude.org
Aditya Gaur
- Recruiting
Tulane University
New Orleans, Louisiana, 70112
Leslie Kozina, 504-988-5348, lkozina@tulane.edu
Tina Simpson
- Recruiting
San Francisco Department of Public Health
San Francisco, California, 94102
Emily Schaeffer, 628-217-7456, emily.schaeffer@sfdph.org
Albert Liu
- Recruiting
University of South Florida
Tampa, Florida, 33612
Elizabeth Enriquez-Bruce, 813-250-2574, enriquezbruce@usf.edu
Patricia Emmanuel
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Justin Unternaher, 202-476-1030, junternahe@childrensnational.org
Natella Rakhmanina
About this study
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)
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.
Read the 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.
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Being tested
- Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9
- Keywords
- HIV, STIs, sexually transmitted infection, PrEP, DoxyPEP, mobile health, mHealth
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care and PrEP Choice at EnrollmentOther
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:
- MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method;
- 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 9Other
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:
- MyPrEP, a decision support website to help PrEP users choose their optimal PrEP method;
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care and PrEP Choice at Enrollment | Experimental | Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit. Receives: 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. Receives: Other: Standard of care followed by PrEP Choice at Month 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up
- 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.
Measured: 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
- 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.
Measured: first 9 months of follow-up
DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site
- 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.
Measured: 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
- 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.
Measured: 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:
- Very acceptable
- Somewhat acceptable
- Neither acceptable nor unacceptable
- Somewhat unacceptable
- Very unacceptable
Measured: 18 months of follow up
Secondary outcomes (4)
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.
Measured: 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
- 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.
Measured: 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
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.
Measured: 18 months of follow-up
DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site
- 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.
Measured: First 9 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start16 Sep 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Susan Buchbinder, Study chair, San Francisco Department of Public HealthAlbert Liu, Study chair, San Francisco Department of Public HealthLisa Hightow-Weidman, MD, MPH, Principal investigator, Florida State UniversitySybil Hosek, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510048
- Sponsor's protocol ID
- ATN166 Phase 2
- Acronym
- CHOOSE
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07510048
- Acronym / sponsor ID
- CHOOSE / ATN166 Phase 2
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Keywords
- HIV, STIs, sexually transmitted infection, PrEP, DoxyPEP, mobile health, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- WestatUniversity, hospital or other
- 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
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care and PrEP Choice at Enrollment | Experimental | Other: Standard of care and PrEP Choice at EnrollmentParticipants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit. |
| Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9 | Active comparator | Other: Standard of care followed by PrEP Choice at Month 9Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care and PrEP Choice at EnrollmentStandard 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 and PrEP Choice at Enrollment |
| Standard of care followed by PrEP Choice at Month 9Standard 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 for the first 9 months followed by initiation of PrEP Choice at Month 9 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Buchbinder study chair
San Francisco Department of Public Health
Albert Liu study chair
San Francisco Department of Public Health
Lisa Hightow-Weidman, MD, MPH principal investigator
Florida State University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of HIV and STIs, run by Westat at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Healey (301-610-8703, ErinHealey@westat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.