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

HIV Infections Clinical Trial

— Seroincidence  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674682
• Other study ID #: 20012619.9.1001.5262
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2023
• Source: Evandro Chagas National Institute of Infectious Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection Primary
• HIV Infections
• HIV Seropositivity
• Infections
• Risk Behavior
• Risk Reduction
• Risky Health Behavior
• STD

Intervention

Procedure:
• HIV testing
venipuncture or digital puncture for HIV testing

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)	Rio de Janeiro	RJ
Brazil	Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ	Rio De Janeiro

Sponsors (23)

Lead Sponsor

Collaborator

Evandro Chagas National Institute of Infectious Disease

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External 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.