Evidence map›Paper›PMID 34825103›Full record

ArticleContemporary clinical trials communications2021

Design and implementation of a cohort study of persons living with HIV infection who are initiating medication treatment for opioid use disorder to evaluate HIV-1 persistence.

Alysse Schultheis, Mark Sanchez, Savannah Pedersen, Tassos Kyriakides, Ya-Chi Ho, Yuval Kluger, Sandra A Springer

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 42% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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 at 2 institutions in 1 country.

Alysse SchultheisDepartment of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, New Haven, CT, USA.
Mark SanchezDepartment of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, New Haven, CT, USA.
Savannah PedersenDepartment of Microbial Pathogenesis, Yale School of Medicine, New Haven, CT, USA.
Tassos KyriakidesVA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, USA.
Ya-Chi HoDepartment of Microbial Pathogenesis, Yale School of Medicine, New Haven, CT, USA.
Yuval KlugerDepartment of Pathology, Yale University School of Medicine, New Haven, CT, 06520, USA.
Sandra A SpringerDepartment of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, New Haven, CT, USA.
Yale University · USVA Connecticut Healthcare System · US

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
Evaluating the role of opioid medication assisted therapies in HIV-1 Persistence for persons living with HIV and opioid use disordersR61DA047037 · NIDA · YALE UNIVERSITY · PI HO, YA-CHI, KLUGER, YUVAL · 2018 to 2020
$2.3M
Evaluating the role of opioid medication assisted therapies in HIV-1 Persistence for persons living with HIV and opioid use disordersR33DA047037 · NIDA · YALE UNIVERSITY · PI HO, YA-CHI, KLUGER, YUVAL · 2021 to 2022
$1.7M
Medication Assisted Therapy as a Conduit to Care for HIV+ CJS Populations TransitK02DA032322 · NIDA · YALE UNIVERSITY · PI SPRINGER, SANDRA ANN · 2011 to 2022
$1.3M
NCATS NIH HHS UL1 TR001863NIDA NIH HHS K02 DA032322NIDA NIH HHS R33 DA047037NIDA NIH HHS R61 DA047037
6 · The paper itself

Abstract

backgroundOpioid use disorder (OUD) negatively impacts the HIV continuum of care for persons living with HIV (PLH). Medication treatment for OUD (MOUD) may have differential biological effects in individuals with HIV and OUD. To understand the role of MOUD - opioid agonist methadone, partial agonist buprenorphine and antagonist naltrexone - in HIV-1 persistence and reactivation, we will use molecular virology approaches to carry out the first prospective, longitudinal studies of adults living with HIV with OUD initiating MOUD. One of the major challenges to studying the impact of MOUD on HIV persistence is the low retention rate of study participants and the requirement of large-volume blood sampling to study the HIV proviral landscape and expression profiles.

methodsA prospective cohort study is underway to study the HIV-1 expression, proviral landscape, and clonal expansion dynamics using limited blood sampling from persons with DSM-5 diagnosed OUD who are living with HIV infection and initiating treatment with methadone, buprenorphine, or extended-release naltrexone.

resultsWe describe the recruitment, laboratory, and statistical methods of this study as well as the protocol details of this on-going study. Out of the 510 screened for enrollment into the study, 35 (7%) were eligible and 27 were enrolled thus far. Retention through month 3 has been high at 95%.

conclusionsThis on-going study is evaluating the impact of MOUD on HIV persistence at the molecular virology level using limited blood sampling via a prospective, longitudinal study of people living with HIV DSM-5 OUD initiating treatment with MOUD.

Indexed as

BuprenorphineExtended-release naltrexoneHIVHIV-1 latencyHIV-1 persistenceMedication treatment for opioid use disorderMethadoneOpioid use disorder

Identifiers

PMID34825103
PMCPMC8605182
OpenAlexW3212181388

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.