Evidence map›Paper›PMID 37368521›Full record

ArticleEthics & human research

The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials.

Stuart Rennie, Gail Henderson, Nittaya Phanuphak, Kristine Kuczynski, Donn Colby, Nuchanart Ormsby, Eugene Kroon, Denise Hsu, Udom Likhitwonnawut, Sandhya Vasan and 4 more

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In one paragraph

Article in Ethics & human research. 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
–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

3 citing papers in PubMed.

  1. Review
  2. Article
  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

14 authors.

Stuart RennieProfessor at the Center for Bioethics in the Department of Social Medicine at the University of North Carolina at Chapel Hill.
Gail HendersonProfessor in the Department of Social Medicine and the director of the Center for Genomics and Society at the University of North Carolina at Chapel Hill.
Nittaya PhanuphakExecutive director of the Institute of HIV Research and Innovation in Bangkok.
Kristine KuczynskiProgram manager at the Center for Genomics and Society and PPMH Precision Genomic Screening Program in the School of Medicine at the University of North Carolina at Chapel Hill.
Donn ColbySenior research physician at the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
Nuchanart OrmsbyResearch assistant and an administrative support associate in the Computational Medicine Program in the School of Medicine at the University of North Carolina at Chapel Hill.
Eugene KroonSenior research physician at the Institute of HIV Research and Innovation in Bangkok.
Denise HsuAssociate director of therapeutics at the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
Udom LikhitwonnawutMember of the National Community Advisory Board in Thailand.
Sandhya VasanVice president of Global Infectious Diseases Research and the director of the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
Carlo SacdalanResearch physician at the SEARCH Research Foundation in Bangkok.
Thidarat JupimaiClinical research assistant at the Center of Excellence in Pediatric Infectious Diseases and Vaccines Faculty of Medicine at the Chulalongkorn University in Bangkok.
Oratai ButterworthClinical project manager at the Henry M. Jackson Foundation for the Advancement of Military Medicine at the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research.
Holly PeaySenior research public health analyst at RTI International.

Funding

Integrating Decision Making Studies into HIV Cure Trials: A real-time longitudinal assessmentR01AI127024 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HENDERSON, GAIL E · 2016 to 2019
$2.2M
Decision Support for Early-Phase HIV Remission TrialsR34MH123328 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HENDERSON, GAIL E, PEAY, HOLLY LANDRUM · 2021 to 2022
$760k
NIAID NIH HHS R01 AI127024NIMH NIH HHS R34 MH123328
6 · The paper itself

Abstract

Analytic treatment interruption (ATI) is scientifically necessary in HIV-remission ("cure") studies to test the effects of new interventions. However, stopping antiretroviral treatment poses risks to research participants and their sexual partners. Ethical debate about whether and how to conduct such studies has largely centered on designing risk-mitigation strategies and identifying the responsibilities of research stakeholders. In this paper, we argue that because the possibility of HIV transmission from research participants to partners during ATI cannot practicably be eliminated-that is, it is ineliminable-the successful conduct of such trials ultimately depends on relationships of trust and trustworthiness. We describe our experiences with conducting and studying HIV-remission trials with ATI in Thailand to examine the strengths, complexities, and limitations of the risk-mitigation and responsibility approaches and to explore ways in which the building of trust-and trustworthiness-may help enhance the scientific, practical, and ethical dimensions of these trials.

Indexed as

HIV InfectionsAnti-Retroviral AgentsHumansSocial BehaviorTrustWithholding TreatmentAnti-Retroviral Agentsanalytic treatment interruptionHIV cure trialsHIV-remission trialsHIV-transmission riskresearch relationshipstrust

Identifiers

PMID37368521
PMCPMC11401446

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Registered trials

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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.