HIV InfectionsSeroincidenceNCT05674682
Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study
A study testing HIV testing in people with HIV Infections and Risk Reduction, run by Evandro Chagas National Institute of Infectious Disease at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Risk Reduction, Risk Behavior
- What is being tested?
- HIV testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MSM and transgender women
- aged 18 years or older
- willingness and ability to sign an informed consent form.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)
Rio de Janeiro, Rio de Janeiro, 21040-360
Instituto Nacional de Infectologia Evandro Chagas/ FIOCRUZ
Rio de Janeiro, 21040-360
About this 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
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.
- Conditions
- HIV Infections, Risk Reduction, Risk Behavior, Risky Health Behavior, STD, HIV Seropositivity
- Being tested
- HIV testing
- Keywords
- MSM, TGW, Imprep, HIV
- Medical subject headings
- HIV Infections, Risk Reduction Behavior, Risk-Taking, Health Risk Behaviors, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV testingProcedure or surgery
venipuncture or digital puncture for HIV testing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: HIV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Oct 2019
- Primary completion31 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MSM and TGW, aged 18 yo or more
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evandro Chagas National Institute of Infectious Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Valdiléa Veloso dos Santos, Ph.D., Beatriz Grinzstejn, MD, PhD, Brenda Hoagland, MD, PhD, Celia Landmann Szwarcwald, PhD, Thiago Torres, PhD, Maria Cristina Pimenta, MD, PhD, Marcos Benedetti, MA, Marília Santini Oliveira, Ronaldo Ismério Moreira, PhD, Sandro Nazer Coutinho, Sylvia Lopes Maia Teixeira, PhD, Nilo Martínez Fernandes, PhD, Hamid Vega-Ramírez, MD, MSc, Sérgio Bautista-Arredondo, MD, PhD, René Leyva-Flores, PhD, Helleen Vermandere, Santiago Ávila-Ríos, PhD, Claudia García-Morales, PhD, Carlos Cáceres, MD, MPH, PhD, Kelika A. Konda, PhD, Juan Vicente Guanira, MD, PhD, Giovanni Ravasi, MD, MScPH
- Responsible party
- Principal investigator, Raquel Malaguthi de Souza, Evandro Chagas National Institute of Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674682
- Sponsor's protocol ID
- 20012619.9.1001.5262
- Acronym
- Seroincidence
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38076411
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05674682
- Acronym / sponsor ID
- Seroincidence / 20012619.9.1001.5262
- Conditions
- HIV Infections, Risk Reduction, Risk Behavior, Risky Health Behavior, STD, HIV Seropositivity
- Keywords
- MSM, TGW, Imprep, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Evandro Chagas National Institute of Infectious DiseaseUniversity, hospital or other
- Collaborators
- Valdiléa Veloso dos Santos, Ph.D., Beatriz Grinzstejn, MD, PhD, Brenda Hoagland, MD, PhD, Celia Landmann Szwarcwald, PhD, Thiago Torres, PhD, Maria Cristina Pimenta, MD, PhD, Marcos Benedetti, MA, Marília Santini Oliveira, Ronaldo Ismério Moreira, PhD, Sandro Nazer Coutinho, Sylvia Lopes Maia Teixeira, PhD, Nilo Martínez Fernandes, PhD, Hamid Vega-Ramírez, MD, MSc, Sérgio Bautista-Arredondo, MD, PhD, René Leyva-Flores, PhD, Helleen Vermandere, Santiago Ávila-Ríos, PhD, Claudia García-Morales, PhD, Carlos Cáceres, MD, MPH, PhD, Kelika A. Konda, PhD, Juan Vicente Guanira, MD, PhD, Giovanni Ravasi, MD, MScPH
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MSM and TGW, aged 18 yo or more
| Arm | Type | Receives |
|---|---|---|
| Venipuncture or digital puncture for HIV test | Other | Procedure: HIV testingMSM and transgender women aged 18 years or older, willing and able to sign informed consent to accept venipuncture or digital puncture for HIV testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MSM and transgender women
- aged 18 years or older
- willingness and ability to sign an informed consent form.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV testingvenipuncture or digital puncture for HIV testing | Procedure or surgery | Venipuncture or digital puncture for HIV test |
Primary outcome
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.
Time frame: 2 years
Blood collected for viral load from those with confirmed HIV infection will be used to distinguish recent HIV-1 infections of long-term infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 38076411Torres 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.
- 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 reviewLink provided by the sponsor.
- 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. LancetLink provided by the sponsor.
- Core Team, 2013. R: A language and environment for statistical computing \[Internet\]. Vienna: R Foundation for Statistical Computing; 2013.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Grinsztejn B, Jalil EM, Monteiro L, Velasque L, Moreira RI, Garcia ACF, et al. Unveiling of HIV dynamics among transgender womenLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV testing in people with HIV Infections and Risk Reduction, run by Evandro Chagas National Institute of Infectious Disease at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.