Evidence map›Paper›PMID 30869203›Full record

ArticleJournal of the International AIDS Society2019

Going off antiretroviral treatment in a closely monitored HIV "cure" trial: longitudinal assessments of acutely diagnosed trial participants and decliners.

Gail E Henderson, Margaret Waltz, Karen Meagher, R Jean Cadigan, Thidarat Jupimai, Sinéad Isaacson, Nuchanart Q Ormsby, Donn J Colby, Eugène Kroon, Nittaya Phanuphak and 2 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of the International AIDS Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  14. Dysphagia and pill swallowing in HIV/AIDS in South Africa: Results of a scoping review.The South African journal of communication disorders = Die Suid-Afrikaanse tydskrif vir Kommunikasieafwykings · 2023
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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

12 authors at 6 institutions in 2 countries.

Gail E HendersonSocial Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Margaret WaltzSocial Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Karen MeagherBiomedical Ethics Research Program, Mayo Clinic, Rochester, MN, USA.
R Jean CadiganSocial Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Thidarat JupimaiCenter of Excellence in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Bangkok, Thailand.
Sinéad IsaacsonSocial Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Nuchanart Q OrmsbySocial Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Donn J ColbySEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Eugène KroonSEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Nittaya PhanuphakSEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Jintanat AnanworanichSEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Holly L PeayRTI International, Research Triangle Park, NC, USA.
University of North Carolina at Chapel Hill · USThai Red Cross Society · THChulalongkorn University · THMayo Clinic in Florida · USRTI International · USWalter Reed Army Institute of Research · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
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
NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI127024
6 · The paper itself

Abstract

introductionThe South East Asia Research Collaboration in HIV (SEARCH) RV411 clinical trial in Thailand was a systematic investigation of analytic treatment interruption (ATI) in individuals diagnosed and treated since Fiebig stage I acute HIV infection. Here, we explore decision-making processes and perceptions of trial participation in a phase I trial that raised important ethical considerations, to identify potential areas of improvement in this relatively new field of HIV research. Similar considerations apply to other HIV phase I trials, especially those involving ATI, making this trial a model to identify challenges and opportunities in promoting informed choice.

methodsUsing longitudinal semi-structured interviews and a validated questionnaire, we examined how decisions to join or decline the trial were made, whether there was evidence of decisional conflict, and reactions to the trial outcomes. We also explored contrasting views and experiences in this small trial cohort. We report analyses of data from these questionnaires and interviews, conducted from February through December of 2016 with the 14 SEARCH cohort participants who either joined (n = 8) or declined (n = 6) participation in RV411.

resultsThe eight participants and six decliners had low overall decisional conflict, which remained low over time. Decision making was more difficult for decliners than participants, at least initially. While all interviewees described being satisfied with their decisions, our study identified important negative consequences for a few individuals, including seroconversion, negative experiences with optional procedures and disappointment due to rapid viral rebound.

conclusionsAlthough our results reflect the experiences of a small group invited to join this trial, our overall finding of low decisional conflict even while some individuals reported negative experiences provides lessons for clinical trial investigators. We developed points-to-consider in helping participants make informed choices, to support participants during the trial and to support decliners in their decisions.

Indexed as

AdultAnti-HIV AgentsCohort StudiesDecision MakingFemaleHealth Services ResearchHIV InfectionsHumansLongitudinal StudiesMaleMiddle AgedPatient ParticipationSurveys and QuestionnairesThailandYoung AdultAnti-HIV Agentsanalytic treatment interruptionHIV clinical trialsinformed consentphase I clinical trialsqualitative researchresearch ethics

Identifiers

PMID30869203
PMCPMC6416664
OpenAlexW2922404688

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.