Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-29
SponsorHIV Prevention Trials Network
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 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
Treatment groups
400 Participants
are divided into 2 treatment groupsLocations
5Argentina
Fundacion Huesped CRSC1427CEA, Buenos Aires Argentina
Brazil
Instituto de Pesquisa Clinicaq Evandro Chagas CRS221045-900, ManguinhosRio de Janeiro, Brazil
Peru
San Miguel CRS32-15088, Lima Peru
United States
UCLA Vine Street Clinic90095, Los AngelesCalifornia, United States
Sponsors and collaborators
HIV Prevention Trials Network
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Gilead Sciences
Collaborator
ViiV Healthcare
Collaborator
Source ClinicalTrials.gov