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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05674682
Other study ID # 20012619.9.1001.5262
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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