Evidence map›Paper›PMID 23874575›Full record

Trial reportPloS one2013

Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial.

Gregory M Lucas, Bernadette Anna Mullen, Noya Galai, Richard D Moore, Katie Cook, Mary E McCaul, Sheldon Glass, Krisann K Oursler, Cynthia Rand

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

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00279110 (Directly Administered vs. Self-administered Antiretroviral Therapy in Methadone Clinics), which is not on this map. Cited by 7 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 4 pooled it
1.6field-weighted citation impact, top 18% 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.

NCT00279110 phase2 / phase3completednot on this map

Directly Administered vs. Self-administered Antiretroviral Therapy in Methadone Clinics

TypeinterventionalSponsorJohns Hopkins UniversityRan2006 to 2011Enrolled107ConditionsHIV Infections, Heroin DependenceArmsDirectly administered antiretroviral therapy (DAART)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 4 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
  7. Challenges in managing HIV in people who use drugs.Current opinion in infectious diseases · 2015
    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 3 institutions in 2 countries.

Gregory M LucasDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America. glucas@jhmi.edu
Bernadette Anna Mullen
Noya Galai
Richard D Moore
Katie Cook
Mary E McCaul
Sheldon Glass
Krisann K Oursler
Cynthia Rand
Johns Hopkins University · USJohns Hopkins Medicine · USUniversity of Maryland, Baltimore · US

Funding

HIV DISEASE OUTCOMES IN DRUG USERS IN CLINICAL PRACTICER01DA011602 · NIDA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 1998 to 2013
$10.8M
DIRECTLY ADMINISTERERD HIV THERAPY IN METHADONE CLINICSR01DA018577 · NIDA · JOHNS HOPKINS UNIVERSITY · PI LUCAS, GREGORY M · 2005 to 2009
$2.9M
MID CAREER INVESTIGATOR AWARDK24DA000432 · NIDA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 2000 to 2009
$1.5M
Alcohol and HIV Treatment and Clinical ProgressionR01AA016893 · NIAAA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 2008 to 2011
$1.3M
Directly observed antiretroviral therapy in drug abusersK23DA015616 · NIDA · JOHNS HOPKINS UNIVERSITY · PI LUCAS, GREGORY M · 2002 to 2006
$784k
NIAAA NIH HHS R01 AA016893NIAAA NIH HHS R01 AA16893NIDA NIH HHS K23 DA015616NIDA NIH HHS K23 DA15616NIDA NIH HHS K24 DA000432NIDA NIH HHS K24 DA00432NIDA NIH HHS R01 DA011602NIDA NIH HHS R01 DA018577NIDA NIH HHS R01 DA11602
6 · The paper itself

Abstract

backgroundData regarding the efficacy of directly administered antiretroviral therapy (DAART) are mixed. Opioid treatment programs (OTPs) provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT) among HIV-infected subjects attending five OTPs in Baltimore, MD.

methodsHIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART) or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA <50 copies/mL during the intervention phase (3-, 6-, and 12-month study visits), using a logistic regression model accounting for intra-person correlation due to repeated observations. Adherence was measured with electronic monitors in both arms.

resultsWe randomized 55 and 52 subjects from five Baltimore OTPs to DAART and SAT, respectively. The average proportions with HIV RNA <50 copies/mL during the intervention phase were 0.51 in DAART and 0.40 in SAT (difference 0.11, 95% CI: -0.020 to 0.24). There were no significant differences between arms in electronically-measured adherence, average CD4 cell increase from baseline, average change in log10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.

conclusionsIn this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.

trial registrationClinicalTrials.gov NCT00279110 NCT00279110&quest;term&hairsp;&equals;&hairsp;NCT00279110&rank&hairsp;&equals;&hairsp;1.

Indexed as

AdultAnalgesics, OpioidAnti-HIV AgentsFemaleHIV InfectionsHumansMaleMiddle AgedTreatment OutcomeViral LoadAnalgesics, OpioidAnti-HIV Agents

Identifiers

PMID23874575
PMCPMC3712961
OpenAlexW2042120180

What OpenQuestion holds

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LicenceCC BY
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.