Evidence map›Paper›PMID 22101218›Full record

Trial reportContemporary clinical trials2012

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

Ali Shabahang Saber-Tehrani, Sandra A Springer, Jingjun Qiu, Maua Herme, Jeffrey Wickersham, Frederick L Altice

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00786396 (Directly Observed Therapy for Community-Released HIV+ Prisoners), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 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.

NCT00786396 nacompletednot on this map

Directly Observed Therapy for Community-Released HIV+ Prisoners

TypeinterventionalSponsorYale UniversityRan2004 to 2010Enrolled151ConditionsHIV/AIDS, Substance AbuseArmsDirectly administered antiretroviral therapy
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  9. Article
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  11. Validation of a Brief Measure of Opioid Dependence: The Rapid Opioid Dependence Screen (RODS).Journal of correctional health care : the official journal of the National Commission on Correctional Health Care · 2015
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  12. Article
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  19. Frequent emergency department use among released prisoners with human immunodeficiency virus: characterization including a novel multimorbidity index.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2013
    Article
  20. 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

6 authors.

Ali Shabahang Saber-TehraniYale University School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, United States.
Sandra A Springer
Jingjun Qiu
Maua Herme
Jeffrey Wickersham
Frederick L Altice

Funding

Direct/Observed Therapy/Community-Released HIV+PrisonersR01DA017059 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2004 to 2008
$3.3M
Enhancing Health Outcomes Among HIV+ Substance AbusersK24DA017072 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2003 to 2012
$1.5M
Medication Assisted Therapy as a Conduit to Care for HIV+ CJS Populations TransitK02DA032322 · NIDA · YALE UNIVERSITY · PI SPRINGER, SANDRA ANN · 2011 to 2022
$1.3M
Improving Health Outcomes for Released HIV+ PrisonersR21DA019843 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2006 to 2007
$405k
NIDA NIH HHS K02 DA032322NIDA NIH HHS K24 DA017072NIDA NIH HHS R01 DA017059NIDA NIH HHS R21 DA019843
6 · The paper itself

Abstract

backgroundHIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners.

methodsSentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VL<400 copies/mL) at 6 months.

resultsBetween 2004 and 2009, 279 participants were screened, of which 202 met eligibility criteria and 154 were ultimately enrolled in the study; 103 subjects were randomized to DAART and 51 to SAT. Subjects were mostly male (81.2%), people of color (87.0%), had an alcohol use disorder (39.7%), had underlying depression (54.2%), were virally suppressed (78.8%) and had a mean CD4=390.7 cells/mL.

conclusionsOutcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.

Indexed as

HIVPrisonersAdultAnti-HIV AgentsDirectly Observed TherapyFemaleFollow-Up StudiesHIV InfectionsHumansMaleMiddle AgedProspective StudiesTreatment OutcomeViral LoadAnti-HIV Agents

Identifiers

PMID22101218
PMCPMC3268833

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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.