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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05674682
Acronym
Seroincidence
Enrollment
4000
Registered
2023-01-06
Start date
2019-10-01
Completion date
2020-06-30
Last updated
2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

MSM, TGW, Imprep, HIV

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.

Interventions

PROCEDUREHIV testing

venipuncture or digital puncture for HIV testing

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

MSM and TGW, aged 18 yo or more

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
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.2 yearsBlood collected for viral load from those with confirmed HIV infection will be used to distinguish recent HIV-1 infections of long-term infections

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026