Evidence map›Paper›PMID 34663375›Full record

ArticleAIDS research and therapy2021

Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States.

Karine Dubé, John Kanazawa, Lynda Dee, Jeff Taylor, John A Sauceda, Sara Gianella, Davey Smith, Steven G Deeks, Michael J Peluso

Open access · goldAbstract read
In one paragraph

Article in AIDS research and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Searching for a HIV-1 Cure.Theranostics · 2026
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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

9 authors at 6 institutions in 1 country.

Karine DubéUniversity of North Carolina Chapel Hill, Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599, USA. karine_dube@med.unc.edu.ORCID 0000-0003-3458-1539
John KanazawaUniversity of North Carolina Chapel Hill, Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599, USA.
Lynda DeeAIDS Action Baltimore, 14 East Eager Street, Baltimore, MD, 21202, USA.
Jeff TaylorDelaney AIDS Research Enterprise (DARE) Community Advisory Board (CAB), 995 Potrero Avenue, San Francisco, CA, 94110, USA.
John A SaucedaDepartment of Medicine, Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), University of California, San Francisco (UCSF), 550 16th Street, 3rd Floor, San Francisco, CA, 94158, USA.
Sara GianellaDepartment of Medicine, Division of Infectious Diseases and Global Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.
Davey SmithDepartment of Medicine, Division of Infectious Diseases and Global Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.
Steven G DeeksDepartment of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, San Francisco General Hospital, University of California, San Francisco (UCSF), Ward 84, Building 80, San Francisco, CA, 94110, USA.
Michael J PelusoDepartment of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, San Francisco General Hospital, University of California, San Francisco (UCSF), Ward 84, Building 80, San Francisco, CA, 94110, USA.
San Francisco General Hospital · USUniversity of California San Diego · USUniversity of North Carolina at Chapel Hill · USAdvisory Board Company (United States) · USAIDS United · USUniversity of California, San Francisco · US

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
VirologyP30AI036214 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SUSAN JANET LITTLE · 1994 to 2026
$78.4M
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
STRUCTURAL NEUROIMAGING COREP30MH062512 · NIMH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Jessica Lynette Montoya · 2001 to 2026
$50.4M
First-in-human study of two anti-SARS CoV-2 antibodies in health volunteersUM1AI126620 · NIAID · WISTAR INSTITUTE · PI MONTANER, LUIS J, RILEY, JAMES L. · 2016 to 2021
$24.5M
Training in HIV Translational ResearchT32AI060530 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Diane V Havlir · 2005 to 2026
$6.4M
Training Program for Scientists Conducting Research to Reduce HIV Health DisparitR25MH067127 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Emily A Arnold, Torsten Brian Neilands · 2003 to 2026
$5.4M
Characterizing the virologic and immunologic signatures of HIV exceptional controlK23AI157875 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PELUSO, MICHAEL JOSEPH · 2021 to 2025
$927k
Pilot Integration of Participant-Centered Outcomes in HIV Cure Research in the United States: Implications for Ethical ConductR21MH118120 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DUBE, KARINE · 2019 to 2020
$566k
NCATS NIH HHS UL1 TR001442NIAID NIH HHS K23 AI157875NIAID NIH HHS L30 AI147159NIAID NIH HHS P30 AI036214NIAID NIH HHS T32 AI060530NIAID NIH HHS UM1 AI126620NIMH NIH HHS P30 MH062246NIMH NIH HHS P30 MH062512NIMH NIH HHS R21 MH118120NIMH NIH HHS R21MH118120NIMH NIH HHS R25 MH067127
6 · The paper itself

Abstract

backgroundAn increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.

methodsWe used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.

resultsWe interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.

conclusionThe increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

Indexed as

HIV InfectionsHumansQualitative ResearchResearch PersonnelUnited StatesCombination approachesEmpirical ethics researchHIVHIV cure researchPeople living with HIV

Identifiers

PMID34663375
PMCPMC8522863
OpenAlexW3206984543

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.