Evidence map›Paper›PMID 33191774›Full record

Trial reportAIDS research and human retroviruses2021

Individualized Adherence Benchmarks for HIV Pre-Exposure Prophylaxis.

Mustafa E Ibrahim, Jose R Castillo-Mancilla, Jenna Yager, Kristina M Brooks, Lane Bushman, Laura Saba, Jennifer J Kiser, Samantha MaWhinney, Peter L Anderson

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in AIDS research and human retroviruses, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 26% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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  13. AIDS research and human retroviruses · 2021
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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

9 authors at 2 institutions in 1 country.

Mustafa E IbrahimDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
Jose R Castillo-MancillaDepartment of Medicine, Division of Infectious Diseases, School of Medicine, University of Colorado, Aurora, Colorado, USA.
Jenna YagerDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
Kristina M BrooksDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
Lane BushmanDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
Laura SabaDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
Jennifer J KiserDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
Samantha MaWhinneyDepartment of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, Aurora, Colorado, USA.
Peter L AndersonDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
University of Colorado Anschutz Medical Campus · USColorado School of Public Health · US

Funding

Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Novel approaches for quantitative assessment of adherenceR01AI122298 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2016 to 2020
$3.4M
PrEP and ART adherence monitoring using dried blood spotsU01AI106499 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2013 to 2016
$2.9M
Quantifying Drug Adherence and Drug Exposure to Antiretroviral TherapyK23AI104315 · NIAID · UNIVERSITY OF COLORADO DENVER · PI CASTILLO-MANCILLA, JOSE RAMON · 2013 to 2017
$910k
NCATS NIH HHS UL1 TR001082NIAID NIH HHS K23 AI104315NIAID NIH HHS R01 AI122298NIAID NIH HHS U01 AI106499
6 · The paper itself

Abstract

Tenofovir diphosphate (TFV-DP) concentrations measured with dried blood spots (DBS) can be used to classify adherence to emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP). A TFV-DP of 700 fmol/punch was previously associated with high PrEP efficacy, and was estimated to represent ≥4 doses/week on average. However, interindividual variability in TFV-DP concentrations may lead to adherence misclassification and decrease the precision of adherence-efficacy relationships. The purpose of this analysis was to evaluate sources of TFV-DP variability to improve the precision of TFV-DP for adherence assessments by incorporating individual characteristics. Data and samples from a 36-week study of TFV-DP in DBS, collected biweekly, among 48 HIV-negative volunteers (25 Females/26 Caucasian/10 African American/14 Hispanic) receiving F/TDF at 33%, 67%, and 100% of daily dosing under directly observed therapy were used for analysis. The simplest pharmacokinetic model to describe TFV-DP accumulation with acceptable performance was a one-compartment constant input model. Covariates, including laboratory values and demographics were ranked in importance of their association with

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisBenchmarkingEmtricitabineFemaleHumansMedication AdherenceAnti-HIV AgentsEmtricitabineadherenceHIVpharmacokineticspre-exposure prophylaxis

Identifiers

PMID33191774
PMCPMC8213008
OpenAlexW3105810161

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.