NCT01989611|Unknown
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
PrEPBrasil
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PrEPBrasil
Sponsor study identifier
Secondary identifiers
REGISTRY · CAAE - Plataforma Brasil - IPEC / FIOCRUZ
interventional
400
1 country
3
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and transgender women . The demonstration project aims to include 400 participants over 12 months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2013
Actual (reported)November 21, 2013
Actual (reported)June 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Different compliance evaluations (the measure is a composite - please see description)
Acceptance and refusal rates Correlation of socio-demographic factors of acceptance and refusal Duration of PrEP Side effects and toxicities, including elevations of creatinine Adherence to PrEP: number of tablets per day, patterns of adherence Number of male sexual partners, by serostatus and condom use, and episodes of anal sex by partner serostatus, the interviewee practices and condom use.
two years
Number of patients infected and relation with medication compliance (the measure is a composite - please see description)
two years
Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year.
Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
emtricitabine / tenofovir 200/300 mg
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordInstituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ
Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil
Centro de Referência e Treinamento DST/AIDS
São Paulo, São Paulo, Brazil
University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Marins LMS, Torres TS, Leite IDC, Moreira RI, Luz PM, Hoagland B, Kallas EG, Madruga JV, Liu AY, Anderson PL, Grinsztejn B, Veloso VG. Performance of HIV pre-exposure prophylaxis indirect adherence measures among men who have sex with men and transgender women: Results from the PrEP Brasil Study. PLoS One. 2019 Aug 20;14(8):e0221281. doi: 10.1371/journal.pone.0221281. eCollection 2019.
Grinsztejn B, Hoagland B, Moreira RI, Kallas EG, Madruga JV, Goulart S, Leite IC, Freitas L, Martins LMS, Torres TS, Vasconcelos R, De Boni RB, Anderson PL, Liu A, Luz PM, Veloso VG; PrEP Brasil Study Team. Retention, engagement, and adherence to pre-exposure prophylaxis for men who have sex with men and transgender women in PrEP Brasil: 48 week results of a demonstration study. Lancet HIV. 2018 Mar;5(3):e136-e145. doi: 10.1016/S2352-3018(18)30008-0. Epub 2018 Feb 18.
Beatriz Grinsztejn, PhD
Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz
First Submitted
October 30, 2013
First Posted
November 21, 2013
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)SCOPE: Strategies to Combine PrEP With Prevention Efforts
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 12, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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