Menu
Not yet recruiting NCT07658976

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

Phase III Interventional HIV Infection Sexually Transmitted Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: HIV Infection, Sexually Transmitted Infection. Basic parameters: 18 years — 29 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Brazil, Peru
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
    Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
  • Drug STI PEP - Doxycycline as Doxy-PEP
    Doxycycline as doxy-PEP for STI prevention
  • Behavioral 3P mHealth package
    Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
  • Behavioral Handout about HIV PrEP options available at the site
    Handout about HIV PrEP options available at the site
  • Behavioral Standard-of-care HIV PrEP counseling from qualified study staff
    Standard-of-care HIV PrEP counseling from qualified study staff

Primary outcome measures

  • To determine the efficacy of the 3P mHealth package on PrEP uptake among participants [Time frame: 52 weeks]
  • To determine the efficacy of the 3P mHealth package on PrEP adherence among participants [Time frame: Weeks 20, 36, and 52]
  • To assess doxycycline PEP uptake and associated factors [Time frame: Week 52]
  • To assess doxycycline PEP use and associated factors [Time frame: Weeks 20, 36, and 52]
  • To assess doxycycline PEP acceptability and associated factors [Time frame: Week 52]
  • To assess the incidence of HIV infections among participants choosing to use CAB-LA [Time frame: Week 52]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • UCLA Vine Street Clinic — Los Angeles
  • Bronx Prevention Research Center CRS — The Bronx
Argentina · 1 center
  • Fundacion Huesped CRS — Buenos Aires
Brazil · 1 center
  • Instituto de Pesquisa Clinicaq Evandro Chagas CRS — Manguinhos
Peru · 1 center
  • San Miguel CRS — Lima

Identifiers

NCT: NCT07658976 · HPTN 113 · UM1AI068619

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗