Status and phase
Conditions
Treatments
About
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.
Full description
The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP from prior studies.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Willing and able to provide written informed consent;
Male gender at birth;
Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of signed informed consent;
Self reports evidence of high risk for acquiring HIV infection including at least one of the following:
Tests HIV antibody negative at time of screening;
Willing to provide locator information to study staff;
Willing to take pre-exposure prophylaxis (PrEP);
Willing to participate in behavioral intervention;
Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; and
Does not have a job or other obligations that would require long absences from the AMTU study area (greater than 4 weeks at a time).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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