Evidence map›Paper›PMID 39509356›Full record

Trial reportPloS one2024

Comparing the brief Holistic Health for HIV (3H+) to the Holistic Health Recovery Program (HHRP+) among people with HIV and opioid use disorder: Results from a randomized, controlled non-inferiority trial.

Alexei Zelenev, Tania B Huedo-Medina, Roman Shrestha, Colleen B Mistler, Frederick L Altice, Brian Sibilio, Michael M Copenhaver

Abstract readRandomized Controlled TrialComparative StudyEquivalence Trial
In one paragraph

Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

1 citing paper in PubMed.

  1. 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

7 authors.

Alexei ZelenevDepartment of Internal Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, CT, United States of America.ORCID 0000-0001-7092-037X
Tania B Huedo-MedinaIkerbasque Research Foundation, Bilbao, Spain.
Roman ShresthaDepartment of Internal Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, CT, United States of America.
Colleen B MistlerDepartment of Allied Health Sciences, University of Connecticut, Storrs, CT, United States of America.ORCID 0000-0002-8681-0252
Frederick L AlticeDepartment of Internal Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, CT, United States of America.
Brian SibilioInstitute for Collaboration on Health, Intervention and Policy, University of Connecticut, Storrs, CT, United States of America.
Michael M CopenhaverDepartment of Allied Health Sciences, University of Connecticut, Storrs, CT, United States of America.

Funding

Research Training Program in Substance Use PreventionT32DA019426 · NIDA · YALE UNIVERSITY · PI TAMI P SULLIVAN · 2005 to 2026
$7.5M
Training in Social Processes of HIV/AIDST32MH074387 · NIMH · UNIVERSITY OF CONNECTICUT STORRS · PI KALICHMAN, SETH C · 2006 to 2020
$3.9M
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
Training in MHealth Prevention with MSMK01DA051346 · NIDA · YALE UNIVERSITY · PI SHRESTHA, ROMAN · 2020 to 2024
$862k
NIDA NIH HHS K01 DA051346NIDA NIH HHS K24 DA017072NIDA NIH HHS K24 DA051344NIDA NIH HHS R01 DA032290NIDA NIH HHS T32 DA019426NIMH NIH HHS T32 MH074387
6 · The paper itself

Abstract

Few evidence-based interventions have been widely adopted in common clinical settings, particularly for opioid-dependent people with HIV (PWH) seeking drug treatment. We developed a brief evidence-based intervention, Holistic Health for HIV (3H+), specifically for ease of implementation and integration within drug treatment settings. In this study, we compared 3H+ to the gold standard, Holistic Health Recovery Program (HHRP+) using a non-inferiority trial. Between 2012 and 2017, 106 participants were randomly assigned to either the brief 3H+ intervention or the gold standard HHRP+. HIV treatment (ART adherence, viral suppression) and risk behaviors (sharing injection equipment, condom use) were compared between the two arms at baseline, end-of-intervention (EOI-12 weeks) and at follow-up (24 weeks). Average treatment effect was calculated based on the difference-in-difference (DID) estimator and a non-parametric bootstrap was used to assess non-inferiority. At the 12-week EOI point, 3H+ was found to be non-inferior to HHRP+ with respect to multiple outcomes: percent sharing syringes and needles (DID:1.4, 95%CI [-18.6,21.5], p<0.01) and attainment of high ART adherence (DID: 9.7, 95%CI: [-13.1, 32.2], p = 0.04). At the 24-week EOI point, 3H+ was found to be non-inferior to HHRP+ with respect to percent sharing syringes and needles (DID: 8.9, [-10.1, 28.30], p = 0.04) and attainment of viral suppression (DID: 18.9, 95% CI:[-7.1, 42.0], p = 0.01). For other indicators, such as consistent condom use, the hypothesis test for non-inferiority was inconclusive at the 12-week EOI (DID: -20.2, 95%CI [-48.9-10.7], p = 0.51). For HIV treatment as prevention to be effective, PWH need to achieve viral suppression. In the absence of this success, they must reduce HIV risk behaviors. The finding that 3H+ was non-inferior to HHRP+ suggests that brief behavioral interventions can be deployed in real world settings to help more efficiently achieve Ending the HIV Epidemic goals.

Indexed as

HIV InfectionsHolistic HealthOpioid-Related DisordersAdultFemaleHumansMaleMedication AdherenceMiddle AgedRisk-Taking

Identifiers

PMID39509356
PMCPMC11542883

What OpenQuestion holds

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LicenceCC BY
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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.