Evidence map›Paper›PMID 31430318›Full record

Trial reportPloS one2019

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.

Luana M S Marins, Thiago S Torres, Iuri da C Leite, Ronaldo I Moreira, Paula M Luz, Brenda Hoagland, Esper G Kallas, José Valdez Madruga, Albert Y Liu, Peter L Anderson and 2 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01989611 (Implementation of the Pre-Exposure Prophylaxis), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01989611 naunknown statusnot on this map

Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.

TypeinterventionalSponsorOswaldo Cruz FoundationRan2014 to 2016Enrolled400ConditionsHIVArmsemtricitabine / tenofovir 200/300 mg
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  15. A Scoping Review of Biobehavioural Interventions to Improve PrEP Continuum of Care in Latin America.Acta colombiana de psicologia : revista de la Facultad de Psicologia, Universidad Catolica de Colombia · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Luana M S MarinsFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.ORCID 0000-0003-0045-6764
Thiago S TorresFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.
Iuri da C LeiteFundação Oswaldo Cruz, Escola Nacional de Saúde Pública (ENSP/Fiocruz), Rio de Janeiro, Brazil.
Ronaldo I MoreiraFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.
Paula M LuzFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.
Brenda HoaglandFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.
Esper G KallasUniversidade de São Paulo, Escola de Medicina, São Paulo, Brazil.ORCID 0000-0003-2026-6925
José Valdez MadrugaCentro de Referência e Treinamento em DST/AIDS, São Paulo, Brazil.
Albert Y LiuSan Francisco Department of Public Health, Bridge HIV, San Francisco, California, United States of America.
Peter L AndersonSkaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, United States of America.
Beatriz GrinsztejnFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.
Valdilea G VelosoFundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.

Funding

The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
NIAID NIH HHS UM1 AI069476
6 · The paper itself

Abstract

introductionEfficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for PrEP is strongly dependent on the adherence. We examined the concordance between indirect adherence measures and protective drug levels among participants retained through 48 weeks in the PrEP Brasil Study.

methodsPrEP Brasil was a prospective, multicenter, open-label demonstration project evaluating PrEP provision for men who have sex with men (MSM) and transgender women (TGW) at higher risk for HIV infection within the setting of Brazilian Public Health System. Three indirect adherence measures were obtained at week 48: medication possession ratio (MPR), pill count and self-report (30-days recall). Tenofovir diphosphate (TFV-DP) concentration in Dried Blood Spot (DBS) was measured at week 48. Areas under (AUC) the receiver operating characteristics (ROC) curve were used to evaluate the concordance between achieving protective drug levels (TFV-DP≥700fmol/punch) and the indirect adherence measures. Youden's index and distance to corner were used to determine the optimal cutoff points for each indirect adherence measure. We calculated sensitivity, specificity, negative (NPV) and positive (PPV) predictive values for the found cutoff points. Finally, Delong test was used to compare AUCs. RESULTS AND DISCUSSION: From April, 2014 to July, 2016, 450 participants initiated PrEP, 375(83.3%) were retained through 48 weeks. Of these, 74% (277/375) had TFV-DP ≥700fmol/punch. All adherence measures discriminated between participants with and without protective drug levels (AUC>0.5). High indirect adherence measure was predictive of protective drug levels (PPV>0.8) while low indirect adherence measure was not predictive of lack of protective drug levels (NPV<0.5). No significant differences were found between the adherence methods (p = 0.44).

conclusionsLow-burden measurements such as MPR and self-report can be used to predict PrEP adherence in a public health context in Brazil for MSM and TGW retained through 48 weeks. Clinical Trial Number: NCT01989611.

Indexed as

Drug MonitoringAdolescentAdultAnti-HIV AgentsBrazilDried Blood Spot TestingEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFeasibility StudiesFemaleHIV InfectionsHumansMalePre-Exposure ProphylaxisProspective StudiesSelf ReportSexual and Gender MinoritiesAnti-HIV AgentsEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Identifiers

PMID31430318
PMCPMC6701758

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.