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 groupsSponsors 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