Evidence map›Paper›PMID 21324133›Full record

Trial reportBMC infectious diseases2011

Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs.

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

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2011. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. Trial
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.

Bernadette Anna MullenDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Katie Cook
Richard D Moore
Cynthia Rand
Noya Galai
Mary E McCaul
Sheldon Glass
Krisann K Oursler
Gregory M Lucas

Funding

DIRECTLY ADMINISTERERD HIV THERAPY IN METHADONE CLINICSR01DA018577 · NIDA · JOHNS HOPKINS UNIVERSITY · PI LUCAS, GREGORY M · 2005 to 2009
$2.9M
Directly observed antiretroviral therapy in drug abusersK23DA015616 · NIDA · JOHNS HOPKINS UNIVERSITY · PI LUCAS, GREGORY M · 2002 to 2006
$784k
NIDA NIH HHS K23-DA15616NIDA NIH HHS R01 DA018577
6 · The paper itself

Abstract

backgroundHIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than HIV-infected non-drug users. Prior work from our group and others suggests that directly administered antiretroviral therapy (DAART) delivered in opioid treatment programs (OTPs) may increase rates of viral suppression. METHODS/

designWe are conducting a randomized trial comparing DAART to self-administered therapy (SAT) in 5 OTPs in Baltimore, Maryland. Participants and investigators are aware of treatment assignments. The DAART intervention is 12 months. The primary outcome is HIV RNA < 50 copies/mL at 3, 6, and 12 months. To assess persistence of any study arm differences that emerge during the active intervention, we are conducting an 18-month visit (6 months after the intervention concludes). We are collecting electronic adherence data for 2 months in both study arms. Of 457 individuals screened, a total of 107 participants were enrolled, with 56 and 51 randomly assigned to DAART and SAT, respectively. Participants were predominantly African American, approximately half were women, and the median age was 47 years. Active use of cocaine and other drugs was common at baseline. HIV disease stage was advanced in most participants. The median CD4 count at enrollment was 207 cells/mm3, 66 (62%) had a history of an AIDS-defining opportunistic condition, and 21 (20%) were antiretroviral naïve.

conclusionsThis paper describes the rationale, methods, and baseline characteristics of subjects enrolled in a randomized clinical trial comparing DAART to SAT in opioid treatment programs.

trial registrationClinicalTrials.gov: NCT00279110.

Indexed as

Clinical Trials as TopicAdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBaltimoreBiomedical ResearchFemaleHIV InfectionsHumansMaleMiddle AgedRNA, ViralSelf AdministrationSubstance-Related DisordersTreatment OutcomeViral LoadAnti-HIV AgentsRNA, Viral

Identifiers

PMID21324133
PMCPMC3047295

What OpenQuestion holds

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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.