NCT05674682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 3, 2023

Last Update Submit

January 5, 2023

Conditions

HIV InfectionsRisk ReductionRisk BehaviorRisky Health BehaviorSTDHIV SeropositivityHIV Infection Primary

Keywords

MSMTGWImprepHIV

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Venipuncture or digital puncture for HIV test

OTHER

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

Interventions

HIV testingPROCEDURE

venipuncture or digital puncture for HIV testing

Venipuncture or digital puncture for HIV test

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen having Sex with other Men and Trans Gender Women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ

Rio de Janeiro, 21040-360, Brazil

Location

Related Publications (1)

  • Torres TS, Teixeira SLM, Hoagland B, Konda KA, Derrico M, Moreira RI, Guanira JV, Benedetti M, Nazer S, Calvo GM, Vargas S, Benites C, Bigolin A, Alonso Neto JB, Farias A, Guimaraes Lacerda MV, Raenck Silva DA, Paz LC, Madruga JV, Salvatierra Flores HJ, Boluarte GP, Osco Tamayo CV, Castro Antezana HT, Pimenta MC, Borquez A, Luz PM, Grinsztejn B, Szwarcwald CL, Caceres CF, Veloso VG; ImPrEP Seroincidence Study Group. Recent HIV infection and annualized HIV incidence rates among sexual and gender minorities in Brazil and Peru (ImPrEP seroincidence study): a cross-sectional, multicenter study. Lancet Reg Health Am. 2023 Dec 2;28:100642. doi: 10.1016/j.lana.2023.100642. eCollection 2023 Dec.

    PMID: 38076411DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsRisk Reduction BehaviorRisk-TakingHealth Risk BehaviorsHIV Seropositivity

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: MSM and TGW, aged 18 yo or more
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Regulatory Affairs Associate

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 6, 2023

Study Start

October 1, 2019

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)