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

Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study. A Sub-study of Implementation of HIV Pre-exposure Prophylaxis (PrEP) for Men Who Have Sex With Men and Transgender People: A Demonstration Project in the Context of Combined Prevention in Brazil, Mexico and Peru - the ImPrEP Study

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Risk Behavior; HIV Seropositivity; Risk Reduction; STD; HIV Infection Primary; Risky Health Behavior
• Intervention / Treatment: Procedure: HIV testing

• Study Type: Interventional
• Enrollment (Actual): 4000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 21040-360
    • Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21040-360
      • Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• MSM and transgender women
• aged 18 years or older
• willingness and ability to sign an informed consent form.

Exclusion Criteria:

• Individuals currently using PrEP, PEP or receiving antiretroviral therapy;
• Individuals unable to understand the study or who do not agree to sign the consent form;
• Individuals who are participating in a clinical trial of antiretroviral medication or any investigational product to prevent the acquisition of HIV infection (for example, monoclonal antibodies such as PEP or PrEP)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Venipuncture or digital puncture for HIV test; MSM and transgender women aged 18 years or older, willing and able to sign informed consent to accept venipuncture or digital puncture for HIV testing	Procedure: HIV testing; venipuncture or digital puncture for HIV testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of recent infections in a given high-risk population (MSM and TGW), including those in defined geographic areas for evaluate epidemics, calibrate models, design and evaluate interventions.	Blood collected for viral load from those with confirmed HIV infection will be used to distinguish recent HIV-1 infections of long-term infections	2 years

Collaborators and Investigators

• Sponsor: Evandro Chagas National Institute of Infectious Disease
• Collaborators: Valdiléa Veloso dos Santos, Ph.D.; Beatriz Grinzstejn, MD, PhD; Brenda Hoagland, MD, PhD; Celia Landmann Szwarcwald, PhD; Thiago Torres, PhD; Maria Cristina Pimenta, MD, PhD; Marcos Benedetti, MA; Marília Santini Oliveira; Ronaldo Ismério Moreira, PhD; Sandro Nazer Coutinho; Sylvia Lopes Maia Teixeira, PhD; Nilo Martínez Fernandes, PhD; Hamid Vega-Ramírez, MD, MSc; Sérgio Bautista-Arredondo, MD, PhD; René Leyva-Flores, PhD; Helleen Vermandere; Santiago Ávila-Ríos, PhD; Claudia García-Morales, PhD; Carlos Cáceres, MD, MPH, PhD; Kelika A. Konda, PhD; Juan Vicente Guanira, MD, PhD; Giovanni Ravasi, MD, MScPH

Publications and helpful links

Helpful Links

• Baral S, Sifakis F, Cleghorn F, Beyrer C. Elevated risk for HIV infection among men who have sex with men in low- and middle-income countries 2000-2006: a systematic review
• Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, et al. Series HIV in men who have sex with men 1 Global epidemiology of HIV infection in men who have sex with men. Lancet
• Core Team, 2013. R: A language and environment for statistical computing [Internet]. Vienna: R Foundation for Statistical Computing; 2013.
• Gomez GB, Borquez A, Caceres CF, Segura ER, Grant RM, Garnett GP, et al. The potential impact of pre-exposure prophylaxis for HIV prevention among men who have sex with men and transwomen in Lima, Peru: a mathematical modelling study. Salomon JA, editor.
• Grinsztejn B, Jalil EM, Monteiro L, Velasque L, Moreira RI, Garcia ACF, et al. Unveiling of HIV dynamics among transgender women
• Silva-Santisteban A, Eng S, de la Iglesia G, Falistocco C, Mazin R. HIV prevention among transgender women in Latin America: implementation, gaps and challenges. J Int AIDS Soc [Internet]. 2016 [cited 2018 Mar 14];19(3 Suppl 2):20799.
• UNAIDS. Miles to go - closing gaps. Global AIDS update 2018.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Estimate): January 6, 2023

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: HIV; MSM; TGW; Imprep
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; HIV Seropositivity
• Other Study ID Numbers: 20012619.9.1001.5262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No