A Phase 3 interventional study of HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA and STI PEP - Doxycycline as Doxy-PEP in HIV Infection and Sexually Transmitted Infection, sponsored by HIV Prevention Trials Network. Not yet recruiting at 5 sites in 4 countries. Open to male participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by HIV Prevention Trials Network · Phase 3, Interventional, and Prevention
Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men
This study will test a suite of mHealth tools to increase HIV pre-exposure prophylaxis (PrEP) uptake and adherence among young men in communities most affected by the HIV epidemic and evaluate the uptake, adherence, and acceptability of doxycycline for sexually transmitted infection (STI) post-exposure prophylaxis (doxy-PEP).
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 400 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →HIV Prevention Trials Network is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV PrEP, doxy-PEP, 3P mHealth package (3P: MyPrEP + PrEPmate + PrEPsmart tools) to assist with PrEP uptake and adherence decision making, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
Drug: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA · Drug: STI PEP - Doxycycline as Doxy-PEP · Behavioral: 3P mHealth package · Behavioral: Handout about HIV PrEP options available at the site · Behavioral: Standard-of-care HIV PrEP counseling from qualified study staff
HIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
Drug: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA · Drug: STI PEP - Doxycycline as Doxy-PEP · Behavioral: Handout about HIV PrEP options available at the site · Behavioral: Standard-of-care HIV PrEP counseling from qualified study staff
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
Doxycycline as doxy-PEP for STI prevention
Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
Handout about HIV PrEP options available at the site
Standard-of-care HIV PrEP counseling from qualified study staff
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
PrEP uptake is defined as the proportion of enrolled participants who elect to initiate PrEP (with a documented PrEP dispensation by the site) at any time during the 52 weeks of follow-up. Participants who did not initiate PrEP before loss to follow-up will be classified as non-initiators. PrEP uptake will be assessed at Week 52 for each study arm with 95% confidence limits computed using the binomial distribution. A logistic regression model will be used to compare PrEP uptake between the study arms.
Time frame: 52 weeks
To determine the efficacy of the 3P mHealth package on PrEP adherence among participants
PrEP adherence is assessed at Weeks 20, 36 and 52 through biomedical testing for oral PrEP regimens and documentation of CAB-LA injection for CAB-LA. Adherence measures are described in Section 8.7. Participants on oral PrEP missing an assessment visit and with no PrEP dispensed at their most recent visit will be considered non-adherent. Also, participants who have not yet initiated PrEP at a visit will be considered non-adherent at that visit. The average PrEP adherence at a visit will be computed as the proportion of participants who are determined to be adherent at that visit by study arm. The associated 95% confidence limits will be computed using the binomial distribution. Generalized estimating equations (GEE) with a logit link function will be used to examine differences in adherence proportions between the 3P and Control arms at Weeks 20, 36 and 52, while accounting for potential correlation between PrEP adherence measures over time for each participant.
Time frame: Weeks 20, 36, and 52
To assess doxycycline PEP uptake and associated factors
doxy-PEP uptake is defined as the proportion of participants dispensed doxy-PEP during the 52 weeks of study follow-up period. doxy-PEP uptake will be computed with 95% confidence limits at Week 52. Multivariable logistic regression models will be used to assess association between doxy-PEP uptake and factors including study group, demographic and behavioral characteristics.
Time frame: Week 52
To assess doxycycline PEP use and associated factors
doxy-PEP use will be assessed at Weeks 20, 36 and 52. Doxy-PEP use at an assessment visit will be computed as the proportion of participants reporting use following sex acts, reported at that visit. The corresponding 95% confidence limits will be computed based on the binomial distribution. Multivariable GEE models will be used to investigate possible associations between doxy-PEP use and factors including study group, demographic and behavioral characteristics.
Time frame: Weeks 20, 36, and 52
To assess doxycycline PEP acceptability and associated factors
Descriptive statistics will be used to summarize doxy-PEP acceptability. Multivariable generalized linear models (with a link function that is appropriate to the scale of the measure for doxy-PEP acceptability) will be used to investigate associations between doxy-PEP acceptability and factors including study group, sociodemographic, and behavioral characteristics.
Time frame: Week 52
To assess the incidence of HIV infections among participants choosing to use CAB-LA
Uptake of CAB-LA is defined as the proportion of participants choosing to initiate CAB-LA with a documented receipt of a CAB-LA injection during the study follow-up period. CAB-LA uptake will be computed with 95% confidence interval. Incidence of HIV infection between the date of CAB-LA initiation and the date of switch to oral PrEP (for participants switching from CAB-LA to oral PrEP) or end of follow-up (for participants staying on CAB-LA from initiation through the end of the follow-up period) will be computed with 95% confidence interval among participants choosing to use CAB-LA.
Time frame: Week 52
To determine the acceptability and use of the 3P mHealth package in the intervention arm by site
Descriptive statistics will be used to summarize the acceptability and use of the 3P mHealth package in the intervention arm by site.
Time frame: Week 52
To compare the frequency, directionality, and reasons for PrEP regimen choice and switching, between arms
Descriptive statistics will be used to summarize the frequency, directionality, and reasons for PrEP regimen choice and switching by arm. Generalized linear models will be used to assess differences in these descriptive summaries between the study arms. Reasons for PrEP regimen choice and switching obtained from qualitative interview data will be listed by arm.
Time frame: Week 52
To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen
Multivariable logistic regression models will be used to separately assess associations between each PrEP regimen choice and demographic, behavioral, and attitudinal factors.
Time frame: Week 52
To determine the efficacy of the 3P mHealth package on prevention-effective adherence
* The proportion of enrolled participants with incident STI infection will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm. * The proportion of enrolled participants with incident HIV infection will be computed at Weeks 20, 36 and 52 by study arm. * The proportion of enrolled participants reporting HIV risk based on self-reported sexual behavior and HIV status of sexual partner will be computed at Weeks 20, 36 and 52 by study arm. * The proportion of enrolled participants who are determined to be PrEP adherent and potentially at HIV risk (based on incident STI, self-reported sexual behavior and HIV status of partners) will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm. GEE models with a logit link function will be used to compare the proportions between the study arms
Time frame: Weeks 20, 36, and 52
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — For studies within two years of primary objective(s) publication, de-identified individual participant data that underlie results in a publication, will be provided upon request. For studies more than two years from the primary objective(s) publication, de-identified datasets will be available upon request (Public Use Datasets).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Investigators may request de-identified datasets in order to duplicate published results, as required by specific journals. Otherwise, de-identified datasets will be made available upon request, two years following publication of the primary results manuscript.
Access criteria: Researchers may submit a request for access to data that has informed published results, by sending an email to HPTN-Data-Access@scharp.org. To access available de-identified datasets, investigators must complete the request form on the Atlas website. Researchers of approved requests will need to sign an HIV Prevention Trials Network (HPTN) Data Use Agreement before receiving the data and agree to use the provided acknowledgement statement.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 44 non-industry phase 3 interventional studies under HIV Infections, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 63. This study's planned 36 months is below that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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