Evidence map›Paper›PMID 28479216›Full record

Trial reportContemporary clinical trials2017

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

Alexander R Bazazi, Jeffrey A Wickersham, Martin P Wegman, Gabriel J Culbert, Veena Pillai, Roman Shrestha, Haider Al-Darraji, Michael M Copenhaver, Adeeba Kamarulzaman, Frederick L Altice

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Interventions for female drug-using offenders.The Cochrane database of systematic reviews · 2019
    Pooled it
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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

10 authors at 5 institutions in 2 countries.

Alexander R BazaziYale School of Public Health, Department of Epidemiology of Microbial Diseases, New Haven, CT, USA; Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA. Electronic address: alexander.bazazi@yale.edu.
Jeffrey A WickershamYale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia.
Martin P WegmanYale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University of Florida College of Medicine, Department of Health Outcomes and Policy, Gainesville, FL, USA.
Gabriel J CulbertYale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University of Illinois at Chicago College of Nursing, Department of Health Systems Science, Chicago, IL, USA.
Veena PillaiYale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia.
Roman ShresthaUniversity of Connecticut Health Center, Department of Community Medicine & Health Care, Farmington, CT, USA; University of Connecticut, Department of Allied Health Sciences, Storrs, CT, USA.
Haider Al-DarrajiUniversity Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia; Centre for International Health, Department of Preventive and Social Medicine, University of Otago, Dunedin 9016, New Zealand.
Michael M CopenhaverUniversity of Illinois at Chicago College of Nursing, Department of Health Systems Science, Chicago, IL, USA.
Adeeba KamarulzamanYale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia.
Frederick L AlticeYale School of Public Health, Department of Epidemiology of Microbial Diseases, New Haven, CT, USA; Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia.
Yale University · USUniversity of Illinois Chicago · USFlorida College · USUniversity of Connecticut · USUniversity of Otago · NZ

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
MEDICAL SCIENTIST TRAINING PROGRAMT32GM007205 · NIGMS · YALE UNIVERSITY · PI KAZMIERCZAK, BARBARA I · 1985 to 2019
$42.9M
Addiction, HIV and Tuberculosis in Malaysian Criminal Justice SettingsR01DA041271 · NIDA · YALE UNIVERSITY · PI SHENOI, SHEELA · 2016 to 2021
$3.3M
Intervention of HIV, Drug Use and the Criminal Justice System in MalaysiaR01DA025943 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2008 to 2012
$2.7M
Enhancing Health Outcomes Among HIV+ Substance AbusersK24DA017072 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2003 to 2012
$1.5M
Training in Drug Abuse & HIV Prevention for Female & Transgender Sex WorkersK01DA038529 · NIDA · YALE UNIVERSITY · PI WICKERSHAM, JEFFREY ALLEN · 2014 to 2018
$838k
Comparative effect of managed care on quality and costs of care for Medicaid adulF30MH105153 · NIMH · UNIVERSITY OF FLORIDA · PI WEGMAN, MARTIN P · 2014 to 2018
$145k
Improving HIV and substance use disorder treatment research by integrating randomized and nonrandomized studies: an evaluation of methadone for HIV-infected opioid-dependent Malaysian prisoners.F30DA039716 · NIDA · YALE UNIVERSITY · PI BAZAZI, ALEXANDER REZA · 2015 to 2017
$123k
NCATS NIH HHS UL1 TR001863NIDA NIH HHS F30 DA039716NIDA NIH HHS K01 DA038529NIDA NIH HHS K24 DA017072NIDA NIH HHS R01 DA025943NIDA NIH HHS R01 DA041271NIGMS NIH HHS T32 GM007205NIMH NIH HHS F30 MH105153
6 · The paper itself

Abstract

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed.

Indexed as

HIV InfectionsSubstance Abuse, IntravenousAdultBehavior TherapyEvidence-Based PracticeFemaleHumansMalaysiaMaleMethadoneNarcoticsOpiate Substitution TreatmentOutcome Assessment, Health CarePrisonersPrisonsResearch DesignMethadoneNarcoticsHIVMalaysiaMethadone maintenance therapyOpioid dependencePrisoner health

Identifiers

PMID28479216
PMCPMC5557499
OpenAlexW2611241234

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.