Clinical trial NCT05674682: Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Risk Reduction
Risk Behavior
Risky Health Behavior
STD
HIV Seropositivity
HIV Infection Primary
Keywords: MSM
TGW
Imprep
HIV
Lead sponsor: Evandro Chagas National Institute of Infectious Disease
Sponsor class: OTHER
Collaborators: name: Valdiléa Veloso dos Santos, Ph.D.
name: Beatriz Grinzstejn, MD, PhD
name: Brenda Hoagland, MD, PhD
name: Celia Landmann Szwarcwald, PhD
name: Thiago Torres, PhD
name: Maria Cristina Pimenta, MD, PhD
name: Marcos Benedetti, MA
name: Marília Santini Oliveira
name: Ronaldo Ismério Moreira, PhD
name: Sandro Nazer Coutinho
name: Sylvia Lopes Maia Teixeira, PhD
name: Nilo Martínez Fernandes, PhD
name: Hamid Vega-Ramírez, MD, MSc
name: Sérgio Bautista-Arredondo, MD, PhD
name: René Leyva-Flores, PhD
name: Helleen Vermandere
name: Santiago Ávila-Ríos, PhD
name: Claudia García-Morales, PhD
name: Carlos Cáceres, MD, MPH, PhD
name: Kelika A. Konda, PhD
name: Juan Vicente Guanira, MD, PhD
name: Giovanni Ravasi, MD, MScPH
First posted: 2023-01-06
Enrollment: 4000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MSM and TGW, aged 18 yo or more
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)
state: RJ
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ
Study officials:
References: