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Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Sponsor: HIV Prevention Trials Network
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
Official title: Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men
Key Details
Gender
MALE
Age Range
18 Years - 29 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-09-01
Completion Date
2029-09-01
Last Updated
2026-06-22
Healthy Volunteers
Yes
Interventions
HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
STI PEP - Doxycycline as Doxy-PEP
Doxycycline as doxy-PEP for STI prevention
3P mHealth package
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
Handout about HIV PrEP options available at the site
Standard-of-care HIV PrEP counseling from qualified study staff
Standard-of-care HIV PrEP counseling from qualified study staff
Locations (5)
UCLA Vine Street Clinic
Los Angeles, California, United States
Bronx Prevention Research Center CRS
The Bronx, New York, United States
Fundacion Huesped CRS
Buenos Aires, Argentina
Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, Rio de Janeiro, Brazil
San Miguel CRS
Lima, Peru