Evidence map›Paper›PMID 31229618›Full record

ArticleContemporary clinical trials2019

Rationale and design of an integrated bio-behavioral approach to improve adherence to pre-exposure prophylaxis and HIV risk reduction among opioid-dependent people who use drugs: The CHRP-BB study.

Roman Shrestha, Frederick L Altice, Brian Sibilio, Jude Ssenyonjo, Michael M Copenhaver

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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

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

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. 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

5 authors.

Roman ShresthaSection of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA. Electronic address: roman.shrestha@yale.edu.
Frederick L AlticeSection of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA; Division of Epidemiology of Microbial Diseases, Yale University School of Public Health, New Haven, CT, USA.
Brian SibilioDepartment of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.
Jude SsenyonjoDepartment of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.
Michael M CopenhaverDepartment of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.

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
Testing an integrated bio-behavioral primary HIV prevention intervention among high-risk people who use drugsR01DA044867 · NIDA · UNIVERSITY OF CONNECTICUT STORRS · PI COPENHAVER, MICHAEL · 2017 to 2021
$3.2M
Secondary HIV Prevention and Adherence Among HIV-infected Drug UsersR01DA032290 · NIDA · UNIVERSITY OF CONNECTICUT STORRS · PI COPENHAVER, MICHAEL · 2012 to 2016
$3.1M
Enhancing Health Outcomes Among HIV+ Substance AbusersK24DA017072 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2003 to 2012
$1.5M
Optimizing HIV Prevention Among Opioid-Dependent PersonsK24DA051344 · NIDA · UNIVERSITY OF CONNECTICUT STORRS · PI MICHAEL COPENHAVER · 2020 to 2026
$1.3M
HIV Prevention and Adherence Among Priority Drug Using PopulationsK02DA033139 · NIDA · UNIVERSITY OF CONNECTICUT STORRS · PI COPENHAVER, MICHAEL · 2013 to 2017
$697k
NCATS NIH HHS UL1 TR001863NIDA NIH HHS K02 DA033139NIDA NIH HHS K24 DA017072NIDA NIH HHS K24 DA051344NIDA NIH HHS R01 DA032290NIDA NIH HHS R01 DA044867
6 · The paper itself

Abstract

backgroundFew primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioid-dependent people who use drugs (PWUD). In response to this unmet need, we developed a brief, bio-behavioral intervention to simultaneously promote PrEP adherence and reduce HIV risk among opioid-dependent PWUD.

methodsUsing a Hybrid Type I implementation science design, we will examine the efficacy of the integrated bio-behavioral, Community-friendly Health Recovery Program (CHRP-BB) compared to a time-and-attention matched control condition among HIV-negative, opioid-dependent PWUD who are prescribed PrEP and enrolled in a methadone maintenance program (MMP) using a randomized controlled trial (RCT). Participants are assessed at baseline, immediately post-intervention (8 weeks) and follow-ups at weeks 20, 32, and 44 post-intervention. The primary outcome is biomedical (PrEP adherence), with secondary outcomes including behavioral (self-reported drug- and sex-related HIV risk behaviors), ongoing drug use (confirmed with urine drug testing), and related domains of the theoretical information-motivation-behavioral skills (IMB) model of behavior change related to PrEP adherence and HIV-transmission-risk reduction. Additionally, we will conduct a process evaluation of delivery/implementation of the intervention to collect valuable information to be used in future implementation.

conclusionsThis study will be among the first prospective trial to test an integrated bio-behavioral intervention to improve adherence to PrEP and HIV risk reduction among opioid-dependent PWUD.

Indexed as

Medication AdherencePre-Exposure ProphylaxisAdultAnti-HIV AgentsFemaleHIV InfectionsHumansMaleOpioid-Related DisordersPatient Education as TopicRandomized Controlled Trials as TopicResearch DesignRisk Reduction BehaviorSubstance Abuse, IntravenousAnti-HIV AgentsBiobehavioral interventionsCHRP-BBHIV preventionMethadone maintenance programPeople who use drugsPre-exposure prophylaxis (PrEP)

Identifiers

PMID31229618
PMCPMC6639056

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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.