Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy

ClinicalTrials.gov ID

NCT07658976

Lead Sponsor

HIV Prevention Trials NetworkNETWORK

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

400Estimated

Last Update Posted

Jun 22, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Sep 1, 2029Estimated

Completion Date

Sep 1, 2029Estimated

Official Title

Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men

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

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).

• HIV Infection
• Sexually Transmitted Infection

• 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

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

1. Men ages 18 - 29 years

2. Men who are in communities most affected by the HIV epidemic

3. Willing and able to provide informed consent

4. Reports having anal sex with men in the last 6 months

5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:

   1. 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
   2. Reporting 2 or more male partners, regardless of condom use
   3. Reporting gonorrhea, chlamydia, or syphilis diagnosis
   4. Any stimulant use (e.g., cocaine, amphetamines)

6. Not on PrEP within the past 3 months due to participant choice

7. Interested in learning more about PrEP or starting PrEP

8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm

9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages

10. Must not share the mobile phone used for their participation in the study

11. Able to read and write

Exclusion Criteria:

1. Participated in HPTN 113-01
2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
3. Plans to move away from the study area within the next year
4. Currently on doxycycline for STI PEP
5. Has ever used CAB-LA or other long-acting PrEP agent
6. Tetracycline allergy
7. Prior diagnosis of HIV infection
8. Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
9. 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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

HIV Prevention Trials NetworkNETWORK

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)NIH

Gilead SciencesINDUSTRY

ViiV HealthcareINDUSTRY

eam6@cumc.columbia.edu212-305-6328

maria.figueroa@huesped.org.ar54-11-49817777 ext. 1132

jvalencia@impactaperu.org51-1948081626

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