Implementation of HIV Pre-exposure Prophylaxis (PrEP) for men who have sex with men and transgender individuals at high risk for HIV infection: A Demonstration Project in the context of Combination Prevention in Brazil, Mexico and Peru

Not Applicable

Recruiting

• Conditions: 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; SP5.001.012.033.024.020; M01.390

• Registration Number: RBR-4x3cnp
• Lead Sponsor: Instituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;PrEP uptake at the moment of study enrollment, verifyed by first drug dispensation during baseline visit<br>

Secondary Outcome Measures

Name	Time	Method
o 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.