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

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

Conditions

• HIV Infection
• Sexually Transmitted Infection

Interventions

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

DRUG

STI PEP - Doxycycline as Doxy-PEP

Doxycycline as doxy-PEP for STI prevention

DRUG

HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA

Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Gilead Sciences

  collaborator INDUSTRY

• ViiV Healthcare

  collaborator INDUSTRY

• HIV Prevention Trials Network

  lead NETWORK

Principal Investigators

• Susan Buchbinder, MD · San Francisco Department of Public Health and University of California San Francisco

• Jorge Gallardo-Cartagena, MD · Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales

• Thiago Torres, MD · Instituto Nacional de Infectología Evandro Chagas

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

29 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-09-01

Completion

2029-09-01

FDA Drug

Yes

Countries

• United States
• Argentina
• Brazil
• Peru

Study Locations