Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study

Summary

PrEP (pre-exposure prophylaxis) is an effective prevention strategy in which HIV-negative individuals take antiretroviral drugs (tenofovir disoproxil fumarate and emtricitabine - TDF/FTC) to reduce HIV acquisition. Clinical studies have shown that the TDF/FTC combination protects MSM and transgender women against HIV infection. According to the PROUD study, PrEP can decrease the risk of HIV infection among MSM by 86% (90% CI 64-96). The international community recognizes that PrEP can be an additional tool in the framework of a combination prevention package for those most at risk of contracting HIV. Data on HIV incidence among MSM and trans women are largely unknown. In Brazil, Mexico and Peru, data on the incidence of HIV among MSM and trans women are very scarce, limited to small cross-sectional studies.Current methods used to determine HIV-1 incidence have many limitations. These methods include mathematical modeling, retrospective calculations of AIDS case reports, age-based prevalence determinations, and prevalence determinations with multiple rounds of longitudinal surveys to estimate HIV incidence, which require numerous assumptions and inputs and can pose additional challenges in the era of expansion of antiretroviral therapy (ART) and increased survival of HIV-1 infected individuals. On the other hand, prospective longitudinal cohort studies of high-risk individuals can be used to estimate incidence; however, they are often labor-intensive, complex, very expensive, difficult to implement in most countries, and have recruitment biases. Laboratory methods can be unbiased and do not require complicated assumptions and case-by-case weighting. The cross-sectional use of Recent HIV Infection Tests (TRIs) based on biomarkers offers, in principle, accessible, reliable and low risk of bias options for estimating incidence.

Conditions

• HIV Infections
• Risk Reduction
• Risk Behavior
• Risky Health Behavior
• STD
• HIV Seropositivity
• HIV Infection Primary

Interventions

PROCEDURE

HIV testing

venipuncture or digital puncture for HIV testing

Sponsors & Collaborators

• Valdiléa Veloso dos Santos, Ph.D.

  collaborator UNKNOWN

• Beatriz Grinzstejn, MD, PhD

  collaborator UNKNOWN

• Brenda Hoagland, MD, PhD

  collaborator UNKNOWN

• Celia Landmann Szwarcwald, PhD

  collaborator UNKNOWN

• Thiago Torres, PhD

  collaborator UNKNOWN

• Maria Cristina Pimenta, MD, PhD

  collaborator UNKNOWN

• Marcos Benedetti, MA

  collaborator UNKNOWN

• Marília Santini Oliveira

  collaborator UNKNOWN

• Ronaldo Ismério Moreira, PhD

  collaborator UNKNOWN

• Sandro Nazer Coutinho

  collaborator UNKNOWN

• Sylvia Lopes Maia Teixeira, PhD

  collaborator UNKNOWN

• Nilo Martínez Fernandes, PhD

  collaborator UNKNOWN

• Hamid Vega-Ramírez, MD, MSc

  collaborator UNKNOWN

• Sérgio Bautista-Arredondo, MD, PhD

  collaborator UNKNOWN

• René Leyva-Flores, PhD

  collaborator UNKNOWN

• Helleen Vermandere

  collaborator UNKNOWN

• Santiago Ávila-Ríos, PhD

  collaborator UNKNOWN

• Claudia García-Morales, PhD

  collaborator UNKNOWN

• Carlos Cáceres, MD, MPH, PhD

  collaborator UNKNOWN

• Kelika A. Konda, PhD

  collaborator UNKNOWN

• Juan Vicente Guanira, MD, PhD

  collaborator UNKNOWN

• Giovanni Ravasi, MD, MScPH

  collaborator UNKNOWN

• Evandro Chagas National Institute of Infectious Disease

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2020-05-31

Completion

2020-06-30

Countries

• Brazil

Study Locations