Last updated 5 days ago
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
400 patients around the world
Available in Peru, United States, Brazil, Argentina
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).
HIV Prevention Trials Network
3Research sites
400Patients around the world
This study is for people with
Hiv
Hiv prophylaxis
Requirements for the patient
To 29 Years
Male
Medical requirements
- 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.
- 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.
Sites
Fundación Huésped - Buenos Aires
Instituto Nacional de Infectologia Evandro Chagas
San Miguel CRS - Perú
SponsorHIV Prevention Trials Network
Study typeInterventional
Conditions
Hiv prophylaxis
Requirements
To 29 YearsMale
Unique study IDclinicaltrials.gov
NCT07658976
