Evidence map›Paper›PMID 21541021›Full record

Trial reportPloS one2011

Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana.

Deborah A Gust, Barudi Mosimaneotsile, Unami Mathebula, Balladiah Chingapane, Zaneta Gaul, Sherri L Pals, Taraz Samandari

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00164281 (A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana), which is not on this map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
1.8field-weighted citation impact, top 16% 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.

NCT00164281 phase4completednot on this map

A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2004 to 2011Enrolled1,995ConditionsTuberculosis, HIV InfectionsArmsIsoniazid
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 59 citations in OpenAlex.

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  7. Factors associated with non-completion of follow-up: 33-month latent tuberculous infection treatment trial.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2017
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  8. Factors Associated With Noncompletion of Latent Tuberculosis Infection Treatment: Experience From the PREVENT TB Trial in the United States and Canada.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
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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

7 authors at 5 institutions in 4 countries.

Deborah A GustDivision of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America. dgust@cdc.gov
Barudi Mosimaneotsile
Unami Mathebula
Balladiah Chingapane
Zaneta Gaul
Sherri L Pals
Taraz Samandari
Centers for Disease Control and Prevention · KECenters for Disease Control and Prevention · USBotswana Accountancy College · BWCDC Foundation · USCenters for Disease Control and Prevention · UG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParticipant non-adherence and loss to follow-up can compromise the validity of clinical trial results. An assessment of these issues was made in a 3-year tuberculosis prevention trial among HIV-infected adults in Botswana. METHODS AND

findingsBetween 11/2004-07/2006, 1995 participants were enrolled at eight public health clinics. They returned monthly to receive bottles of medication and were expected to take daily tablets of isoniazid or placebo for three years. Non-adherence was defined as refusing tablet ingestion but agreeing to quarterly physical examinations. Loss to follow-up was defined as not having returned for appointments in ≥60 days. Between 10/2008-04/2009, survey interviews were conducted with 83 participants identified as lost to follow-up and 127 identified as non-adherent. As a comparison, 252 randomly selected adherent participants were also surveyed. Multivariate logistic regression analysis was used to identify associations with selected risk factors. Men had higher odds of being non-adherent (adjusted odds ratio (AOR), 2.24; 95% confidence interval [95%CI] 1.24-4.04) and lost to follow-up (AOR 3.08; 95%CI 1.50-6.33). Non-adherent participants had higher odds of reporting difficulties taking the regimen or not knowing if they had difficulties (AOR 3.40; 95%CI 1.75-6.60) and lower odds associated with each year of age (AOR 0.95; 95%CI 0.91-0.98), but other variables such as employment, distance from clinic, alcohol use, and understanding study requirements were not significantly different than controls. Among participants who were non-adherent or lost to follow-up, 40/210 (19.0%) reported that they stopped the medication because of work commitments and 33/210 (15.7%) said they thought they had completed the study.

conclusionsMen had higher odds of non-adherence and loss to follow-up than women. Potential interventions that might improve adherence in trial participants may include:targeting health education for men, reducing barriers, clarifying study expectations, educating employers about HIV/AIDS to help reduce stigma in the workplace, and encouraging employers to support employee health.

trial registrationClinicalTrials.gov NCT00164281.

Indexed as

Lost to Follow-UpPatient ComplianceAdultBotswanaCase-Control StudiesFemaleHealth SurveysHumansInterviews as TopicIsoniazidMaleMultivariate AnalysisRegression AnalysisRisk FactorsSelf ReportIsoniazid

Identifiers

PMID21541021
PMCPMC3081815
OpenAlexW2040584701

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

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.