Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
2 other identifiers
interventional
400
4 countries
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2026
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
Study Completion
Last participant's last visit for all outcomes
September 1, 2029
June 22, 2026
June 1, 2026
3 years
October 7, 2024
June 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
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.
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.
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.
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.
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.
Week 52
Secondary Outcomes (4)
To determine the acceptability and use of the 3P mHealth package in the intervention arm by site
Week 52
To compare the frequency, directionality, and reasons for PrEP regimen choice and switching, between arms
Week 52
To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen
Week 52
To determine the efficacy of the 3P mHealth package on prevention-effective adherence
Weeks 20, 36, and 52
Study Arms (2)
3P mHealth package
EXPERIMENTALHIV 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 COMPARATORHIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HIV Prevention Trials Networklead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Gilead Sciencescollaborator
- ViiV Healthcarecollaborator
Study Sites (5)
UCLA Vine Street Clinic
Los Angeles, California, 90095, United States
Bronx Prevention Research Center CRS
The Bronx, New York, 10451, United States
Fundacion Huesped CRS
Buenos Aires, C1427CEA, Argentina
Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, Rio de Janeiro, 221045-900, Brazil
San Miguel CRS
Lima, 32-15088, Peru
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susan Buchbinder, MD
San Francisco Department of Public Health and University of California San Francisco
- STUDY CHAIR
Jorge Gallardo-Cartagena, MD
Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
- STUDY CHAIR
Thiago Torres, MD
Instituto Nacional de Infectología Evandro Chagas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2024
First Posted
June 22, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
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).