Men who have sex with men (MSM) and transgender individuals (TG) who are at higher risk of acquiring HIV infection in Brazil, Mexico and Peru
Conditions
Interventions
All study participants will receive a fixed dose combination of FTC/TDF (emtricitabine 200 mg / TDF 300 mg) orally once daily, The study will include 7500 enrolled participants (3000 in Brazil, 3000 i
Drug
Sponsors
Instituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz
Ministério da Saúde
Clinica Especializada Condesa
Nnstituto Nacional de Salud Pública
University Cayetano Heredia
Ministerio de Salud
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male sex (at birth), except for transgender male; Willing and able to provide written informed consent; Age 18 years or older; HIV-1-uninfected defined as: Rapid HIV test negative at the enrollment visit; Evidence of risk for acquiring HIV-1 infection including any one of the following: a. Condomless anal sex with male or transgender sex partners during the last 6 months; or b. Anal sex with at least one HIV+ partner during the last 6 months; or c. Reported rectal or urethral gonorrhea or chlamydia or syphilis in the 6 months prior to enrollment or diagnosed at enrollment; or d. Reporting to exchange sex for money, gifts, shelter or drugs in the last 6 months; No previous history of renal disease.
Exclusion criteria
Exclusion criteria: Signs or symptoms of acute HIV infection; Creatinine clearance < 60 ml/min as estimated by the Modification of Diet in Renal Disease (MDRD) formula; Previously diagnosed active and serious infections, including tuberculosis or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STIs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia, congestive heart failure), or previously diagnosed malignancy expected to require further treatment; History of pathological bone fractures not related to trauma; Receiving ongoing therapy with any of the following: ART, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors (except for antiretrovirals used for PEP) or investigational anti-retroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents; Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PrEP uptake at the moment of study enrollment, verifyed by first drug dispensation during baseline visit ; PrEP use during 3 years, verified by drug plasma level positive at months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, e 30, 33 e 36. | — |
Secondary
| Measure | Time frame |
|---|---|
| No HIV seroconversions during PrEP use, verified by negative HIV test at months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, e 33 e 36. | — |
Countries
Brazil, Mexico, Peru
Contacts
Public ContactValdilea Veloso
Instituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz
Outcome results
None listed