HIV InfectionPhase 3NCT07658976
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
A Phase 3 study testing HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP and 3P mHealth package in people with HIV Infection and Sexually Transmitted Infection, run by HIV Prevention Trials Network at 5 sites in 4 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Sexually Transmitted Infection
- What is being tested?
- HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP and 3P mHealth package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Phase 3
- 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 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men ages 18 - 29 years
- Men who are in communities most affected by the HIV epidemic
- Willing and able to provide informed consent
- Reports having anal sex with men in the last 6 months
- Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:
- Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed
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- Reporting 2 or more male partners, regardless of condom use
- Reporting gonorrhea, chlamydia, or syphilis diagnosis
- Any stimulant use (e.g., cocaine, amphetamines)
- Not on PrEP within the past 3 months due to participant choice
- Interested in learning more about PrEP or starting PrEP
- No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm
- Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages
- Must not share the mobile phone used for their participation in the study
- Able to read and write
Who cannot join
- Participated in HPTN 113-01
- Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
- Plans to move away from the study area within the next year
- Currently on doxycycline for STI PEP
- Has ever used CAB-LA or other long-acting PrEP agent
- Tetracycline allergy
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- Prior diagnosis of HIV infection
- Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
- Any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
United States2 sites
UCLA Vine Street Clinic
Los Angeles, California, 90095
Jesse Clark, MD, 323-461-3106, jlclark@mednet.ucla.edu
Bronx Prevention Research Center CRS
The Bronx, New York, 10451
Ellen Morrison, 212-305-6328, eam6@cumc.columbia.edu
Argentina1 site
Fundacion Huesped CRS
Buenos Aires, C1427CEA
Maria Figueroa, 54-11-49817777 ext. 1132, maria.figueroa@huesped.org.ar
Brazil1 site
Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, Rio de Janeiro, 221045-900
Peru1 site
San Miguel CRS
Lima, 32-15088
Javier Valencia, 51-1948081626, jvalencia@impactaperu.org
About this study
Official title: Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men
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
Read the detailed description
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).
- Conditions
- HIV Infection, Sexually Transmitted Infection
- Being tested
- HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package, Handout about HIV PrEP options available at the site, Standard-of-care HIV PrEP counseling from qualified study staff
- Keywords
- Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI), Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), Integrated Strategy, Young Men, Doxycycline for STI Post-Exposure Prophylaxis (Doxy-PEP), Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG), Hepatitis B (HBV), Mobile Health Tools (mHealth), MyPrEP + PrEPmate + PrEPsmart Tools (3P)
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV PrEP - choice of F/TDF, F/TAF, or CAB-LADrug
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
STI PEP - Doxycycline as Doxy-PEPDrug
Doxycycline as doxy-PEP for STI prevention
3P mHealth packageBehavioural
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 siteBehavioural
Handout about HIV PrEP options available at the site
Standard-of-care HIV PrEP counseling from qualified study staffBehavioural
Standard-of-care HIV PrEP counseling from qualified study staff
| Study group | Role | What they receive |
|---|---|---|
| 3P mHealth package | Experimental | 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 Receives: 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 |
| Standard-of-care services | Active comparator | HIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Weeks 20, 36, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be offered HIV PrEP and doxy-PEP. Participants will be randomized 1:1 to receive either the 3P mHealth package (3P: MyPrEP \+ PrEPmate + PrEPsmart tools) or standard-of-care services arm.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Gilead Sciences, ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Susan Buchbinder, MD, Study chair, San Francisco Department of Public Health and University of California San FranciscoJorge Gallardo-Cartagena, MD, Study chair, Centro de Investigaciones Tecnológicas Biomédicas y MedioambientalesThiago Torres, MD, Study chair, Instituto Nacional de Infectología Evandro Chagas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658976
- Sponsor's protocol ID
- HPTN 113
- Other IDs
- UM1AI068619
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men
- ClinicalTrials.gov ID
- NCT07658976
- Acronym / sponsor ID
- HPTN 113
- Conditions
- HIV Infection, Sexually Transmitted Infection
- Keywords
- Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI), Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), Integrated Strategy, Young Men, Doxycycline for STI Post-Exposure Prophylaxis (Doxy-PEP), Chlamydia Trachomatis (CT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Gilead Sciences, ViiV Healthcare
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 22 Jun 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.
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
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will be offered HIV PrEP and doxy-PEP. Participants will be randomized 1:1 to receive either the 3P mHealth package (3P: MyPrEP + PrEPmate + PrEPsmart tools) or standard-of-care services arm.
| Arm | Type | Receives |
|---|---|---|
| 3P mHealth package | Experimental | 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 staffHIV 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 |
| Standard-of-care services | Active comparator | 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 staffHIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Men ages 18 - 29 years
- Men who are in communities most affected by the HIV epidemic
- Willing and able to provide informed consent
- Reports having anal sex with men in the last 6 months
- Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:
Key exclusion criteria (9 listed)
- Participated in HPTN 113-01
- Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
- Plans to move away from the study area within the next year
- Currently on doxycycline for STI PEP
- Has ever used CAB-LA or other long-acting PrEP agent
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 |
|---|---|---|
| HIV PrEP - choice of F/TDF, F/TAF, or CAB-LAChoice of F/TDF, F/TAF, or CAB-LA for HIV prevention | Drug | 3P mHealth package, Standard-of-care services |
| STI PEP - Doxycycline as Doxy-PEPDoxycycline as doxy-PEP for STI prevention | Drug | 3P mHealth package, Standard-of-care services |
| 3P mHealth packageSuite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making | Behavioural | 3P mHealth package |
| Handout about HIV PrEP options available at the siteHandout about HIV PrEP options available at the site | Behavioural | 3P mHealth package, Standard-of-care services |
| Standard-of-care HIV PrEP counseling from qualified study staffStandard-of-care HIV PrEP counseling from qualified study staff | Behavioural | 3P mHealth package, Standard-of-care services |
Primary outcome
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
Time frame: 52 weeks
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.
To determine the efficacy of the 3P mHealth package on PrEP adherence among participants
Time frame: Weeks 20, 36, and 52
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.
To assess doxycycline PEP uptake and associated factors
Time frame: Week 52
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.
To assess doxycycline PEP use and associated factors
Time frame: Weeks 20, 36, and 52
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.
To assess doxycycline PEP acceptability and associated factors
Time frame: Week 52
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.
To assess the incidence of HIV infections among participants choosing to use CAB-LA
Time frame: Week 52
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.
4 secondary outcomes
To determine 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
Time frame: Week 52
To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen
Time frame: Week 52
To determine the efficacy of the 3P mHealth package on prevention-effective adherence
Time frame: Weeks 20, 36, and 52
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 22 Jun 2026.
- Individual participant dataSharing planned: 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).
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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, MD study chair
San Francisco Department of Public Health and University of California San Francisco
Jorge Gallardo-Cartagena, MD study chair
Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
Thiago Torres, MD study chair
Instituto Nacional de Infectología Evandro Chagas
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP and 3P mHealth package in people with HIV Infection and Sexually Transmitted Infection, run by HIV Prevention Trials Network at 5 sites in 4 countries.
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 15 inclusion and 9 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Argentina, Brazil, Peru. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kailazarid Gomez-Feliciano, MPM (919-321-3486, kgomez@fhi360.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants (time frame: 52 weeks). The study lists 6 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 22 Jun 2026.