Evidence map›Paper›PMID 33757560›Full record

ArticleTrials2021

Per-protocol analysis of the ZINC trial for HIV disease among alcohol users.

Sara Lodi, Matthew Freiberg, Natalia Gnatienko, Elena Blokhina, Tatiana Yaroslavtseva, Evgeny Krupitsky, Eleanor Murray, Jeffrey H Samet, Debbie M Cheng

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01934803 (Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 48% 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.

NCT01934803 nacompletednot on this map

Zinc for HIV Disease Among Alcohol Users - an RCT in the Russia ARCH Cohort

TypeinterventionalSponsorBoston Medical CenterRan2013 to 2018Enrolled254ConditionsHIV Infection, Alcohol UseArmsZinc gluconate, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
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 4 institutions in 2 countries.

Sara LodiDepartment of Biostatistics, Boston University School of Public Health, 801 Massachusetts Avenue, Boston, MA, 02118, USA. slodi@bu.edu.ORCID 0000-0002-9419-7830
Matthew FreibergVanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Cardiovascular Division, Vanderbilt University Medical Center, Nashville, TN, USA.
Natalia GnatienkoDepartment of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, MA, USA.
Elena BlokhinaFirst Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation.
Tatiana YaroslavtsevaFirst Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation.
Evgeny KrupitskyFirst Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation.
Eleanor MurrayDepartment of Epidemiology, Boston University School of Public Health, Boston, MA, USA.
Jeffrey H SametDepartment of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston University School of Medicine, Boston, MA, USA.
Debbie M ChengDepartment of Biostatistics, Boston University School of Public Health, 801 Massachusetts Avenue, Boston, MA, 02118, USA.
Boston University · USFirst Pavlov State Medical University of St. Petersburg · RUBoston Medical Center · USVanderbilt University Medical Center · US

Funding

Tennessee CFAR: Implementation of Culturally Responsive Trauma-Informed Care with Youth with HIV in Memphis, TNP30AI110527 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI John Koethe · 2015 to 2026
$27.5M
URBAN ARCH 4/5 Russia Cohort-Targeting HIV-comorbidities with Pharmacotherapy to Reduce Alcohol and Tobacco Use in HIV-infected RussiansU01AA020780 · NIAAA · BOSTON MEDICAL CENTER · PI FREIBERG, MATTHEW S, SAMET, JEFFREY H. · 2011 to 2021
$4.4M
URBAN ARCH (2/5) Biostatistics and Data Management Core (BDM)U24AA020779 · NIAAA · BOSTON UNIVERSITY MEDICAL CAMPUS · PI CHENG, DEBBIE M. · 2011 to 2020
$3.6M
URBAN ARCH (1/5) Administrative Coordinating Core (Admin Core)U24AA020778 · NIAAA · BOSTON MEDICAL CENTER · PI SAMET, JEFFREY H. · 2011 to 2020
$3.5M
Zinc for HIV Disease among Alcohol Users -An RCT in the Russia ARCH CohortU01AA021989 · NIAAA · BOSTON MEDICAL CENTER · PI FREIBERG, MATTHEW S, SAMET, JEFFREY H. · 2012 to 2016
$3.3M
NIAAA NIH HHS U01 AA020780NIAAA NIH HHS U01AA020780NIAAA NIH HHS U01 AA021989NIAAA NIH HHS U01AA021989NIAAA NIH HHS U24 AA020778NIAAA NIH HHS U24AA020778NIAAA NIH HHS U24 AA020779NIAAA NIH HHS U24AA020779NIAID NIH HHS P30 AI110527
6 · The paper itself

Abstract

backgroundThe Zinc for INflammation and Chronic disease in HIV (ZINC) trial randomized person who live with HIV (PLWH) who engage in heavy drinking to either daily zinc supplementation or placebo. The primary outcome was change in the Veterans Aging Cohort Study (VACS) index, a predictor of mortality, between baseline and 18 months. Because adherence and follow-up were suboptimal, the intention-to-treat analysis, which was not statistically significant, may have underestimated the effect of the zinc supplementation.

objectiveWe estimated the per-protocol effect of zinc versus placebo in the ZINC trial (i.e., the effect that would have been observed if all participants had had high adherence and none was lost to follow-up).

methodsAdherence was measured as the self-reported percentage of pills taken in the previous 6 weeks and assessed at all post-baseline visits. We used inverse probability weighting to estimate and compare the change in the VACS index at 18 months in the zinc and placebo groups, had all the trial participants had high adherence (i.e., cumulative adherence ≥80% at 18 months). To examine trends by level of adherence, we rerun the analyses using thresholds for high adherence of 70% and 90% of average self-reported pill coverage.

resultsThe estimated (95% confidence interval) change in the VACS index was - 2.16 (- 8.07, 3.59) and 5.84 (0.73, 11.80) under high adherence and no loss to follow-up in the zinc and placebo groups, respectively. The per-protocol effect estimate of the mean difference in the change between the zinc and placebo groups was - 8.01 (- 16.42, 0.01), somewhat larger than the intention-to-treat effect difference in change (- 4.68 (- 9.62, 0.25)), but it was still not statistically significant. The mean difference in the change between individuals in the zinc and placebo groups was - 4.07 (- 11.5, 2.75) and -12.34 (- 20.14, -4.14) for high adherence defined as 70% and 90% of pill coverage, respectively.

conclusionsOverall, high adherence to zinc was associated with a lower VACS score, but confidence intervals were wide and crossed 0. Further studies with a larger sample size are needed to quantify the benefits of zinc supplementation in this population.

trial registrationClinicalTrials.gov NCT01934803 . Registered on August 30, 2013.

Indexed as

HIV InfectionsVeteransCohort StudiesHumansTreatment OutcomeZincZincAlcohol abuseHIVInverse probability weightingPer-protocolZinc

Identifiers

PMID33757560
PMCPMC7989012
OpenAlexW3136203151

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.