Evidence map›Paper›PMID 26990823›Full record

Observational studyJournal of acquired immune deficiency syndromes (1999)2016

PrEP Adherence Patterns Strongly Affect Individual HIV Risk and Observed Efficacy in Randomized Clinical Trials.

Dobromir T Dimitrov, Benoît R Mâsse, Deborah Donnell

Abstract readObservational Study
In one paragraph

Observational study in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 10% 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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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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

3 authors at 2 institutions in 2 countries.

Dobromir T Dimitrov*Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and Department of Applied Mathematics, University of Washington, Seattle, WA; †CHU Sainte-Justine Research Centre, University of Montreal, Montreal, Quebec, Canada; and ‡Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and Department of Global Health, University of Washington, Seattle, WA.
Benoît R Mâsse
Deborah Donnell
Fred Hutch Cancer Center · USUniversité de Montréal · CA

Funding

SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Prevention Trials NetworkU01AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DONNELL, DEBORAH J · 2006 to 2010
$28.8M
NIAID NIH HHS U01 AI068617NIAID NIH HHS UM1 AI068617
6 · The paper itself

Abstract

backgroundRandomized controlled trials (RCTs) suggest that the efficacy of tenofovir-based preexposure prophylaxis (PrEP) strongly depends on the consistency of PrEP use. We explore how the patterns of pill taking and waning of PrEP protection may affect PrEP efficacy for HIV prevention.

methodsA 2-arm RCT was simulated by mathematical models assuming that the prescribed daily doses were skipped periodically, randomly, or in large blocks. Risk-driven adherence, in which PrEP was taken when sex was expected, was also investigated. Three temporal PrEP protection profiles were explored: long (5 days), intermediate (3 days), and short (24 hours). Modeling results were compared to the efficacy observed in completed RCTs.

resultsThe expected PrEP efficacy was 60% with periodic, 50% with random, and 34% with block adherence when PrEP had a long protection profile and pills were taken only 50% of the days. Risk-driven pill taking resulted in 29% and 37% daily pills taken and efficacy of 43% and 51%, respectively, for long protection. High PrEP efficacy comparable with that observed in Partners PrEP and Centers for Disease Control and Prevention Botswana trials was simulated under long protection, high overall adherence, and limited block pill taking; the moderate efficacy observed in iPrEx and Bangkok trials was comparable with the 50% adherence scenarios under random pill taking and long protection.

conclusionsPill-taking patterns may have a substantial impact on the protection provided by PrEP even when the same numbers of pills are taken. When PrEP retains protection for longer than a day, pill-taking patterns can explain a broad range of efficacies observed in PrEP RCTs.

Indexed as

Drug MonitoringPre-Exposure ProphylaxisRandomized Controlled Trials as TopicFemaleHIV InfectionsHumansMaleModels, BiologicalSexual PartnersTenofovirTreatment OutcomeTenofovir

Identifiers

PMID26990823
PMCPMC4925182
OpenAlexW2298072787

What OpenQuestion holds

Textmetadata
LicenceTDM
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.