Evidence map›Paper›PMID 37295453›Full record

ReviewThe Lancet. Infectious diseases2023

A partner protection package for HIV cure-related trials involving analytical treatment interruptions.

Karine Dubé, Tia Morton, Lawrence Fox, Lynda Dee, David Palm, Thomas J Villa, William Freshwater, Jeff Taylor, Gail Graham, William B Carter and 3 more

Open access · greenAbstract readReview
In one paragraph

Review in The Lancet. Infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.7field-weighted citation impact, top 6% 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

22 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. The HIV Reservoir and Immune Landscape Across the Life Course of Women: Implications for Cure Strategies.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

13 authors at 10 institutions in 1 country.

Karine DubéDivision of Infectious Diseases and Global Public Health, University of California San Diego School of Medicine, La Jolla, CA, USA; University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA. Electronic address: kdube@health.ucsd.edu.
Tia MortonDivision of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
Lawrence FoxDivision of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
Lynda DeeDelaney AIDS Research Enterprise Community Engagement and Community Advisory Board University of California San Francisco, Department of Medicine, HIV, ID and Global Medicine, San Francisco, CA, USA; AIDS Action Baltimore, Baltimore, MD, USA.
David PalmAIDS Clinical Trials Group Global Community Advisory Board, Chapel Hill, NC, USA; Institute of Global Health and Infectious Diseases Clinical Trials Unit, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Thomas J VillaHIV Obstruction by Programmed Epigenetics Delaney Collaboratory Community Advisory Board, Gladstone Institutes, San Francisco, CA, USA; National HIV & Aging Advocacy Network, National Minority AIDS Council, Washington, DC, USA; Reversing Immune Dysfunction HIV Delaney Collaboratory Community Advisory Board, Scripps Research, La Jolla, CA, USA; Rockville, MD, USA.
William FreshwaterPhiladelphia, PA, USA.
Jeff TaylorDelaney AIDS Research Enterprise Community Engagement and Community Advisory Board University of California San Francisco, Department of Medicine, HIV, ID and Global Medicine, San Francisco, CA, USA; Reversing Immune Dysfunction HIV Delaney Collaboratory Community Advisory Board, Scripps Research, La Jolla, CA, USA; Palm Springs, CA, USA; HIV + Aging Research Project, Palm Springs, CA, USA.
Gail GrahamBaltimore, MD, USA.
William B CarterBaltimore, MD, USA; BEAT-HIV Collaboratory Delaney Community Advisory Board, Wistar Institute, Philadelphia, PA, USA.
John A SaucedaCenter for AIDS Prevention Studies, Division of Prevention Sciences, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Michael J PelusoDepartment of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Annette RidDepartment of Bioethics, NIH Clinical Center, Bethesda, MD, USA.
Advisory Board Company (United States) · USNational Institute of Allergy and Infectious Diseases · USUniversity of Baltimore · USDesert AIDS Project · USNational Institutes of Health Clinical Center · USPhiladelphia University · USSan Francisco General Hospital · USUniversity of California, San Diego · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · US

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Sheri Ann Lippman · 2001 to 2026
$57.4M
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination ImmunotherapyUM1AI164570 · NIAID · WISTAR INSTITUTE · PI Luis J Montaner, James L. Riley · 2021 to 2026
$34.7M
Delaney AIDS Research Enterprise to Cure HIVUM1AI164560 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS, Sharon Ruth Lewin · 2021 to 2026
$32.0M
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
Investigating Psychosocial Experiences of HIV Cure Trial Participants Undergoing Extended HIV Treatment Interruptions: Implications for Ethical ConductR01MH126768 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DUBE, KARINE, SAUCEDA, JOHN ANDREW · 2021 to 2025
$3.6M
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
NIAID NIH HHS K23 AI157875NIAID NIH HHS L30 AI147159NIAID NIH HHS UM1 AI126620NIAID NIH HHS UM1 AI164560NIAID NIH HHS UM1 AI164570NIMH NIH HHS P30 MH062246NIMH NIH HHS R01 MH126768NIMH NIH HHS R21 MH118120
6 · The paper itself

Abstract

Analytical treatment interruptions (ATIs) have become a key methodological approach to evaluate the effects of experimental HIV cure-related research interventions. During ATIs, sex partners of trial participants might be at risk of acquiring HIV. This risk raises both ethical and feasibility concerns about ATI trials. We propose a partner protection package (P3) approach to address these concerns. A P3 approach would provide guidance to investigators, sponsors, and those who are designing and implementing context-specific partner protections in HIV cure-related trials involving ATIs. The approach would also help assure institutional review boards, trial participants, and communities that ATI trials with a P3 would provide appropriate partner protections. We offer a prototype P3 framework that delineates three basic considerations for protecting participants' sex partners during ATI trials: (1) ensuring the scientific and social value of the ATI and the trial, (2) reducing the likelihood of unintended HIV transmission, and (3) ensuring prompt management of any acquired HIV infection. We outline possible ways of implementing these basic considerations.

Indexed as

HIV InfectionsClinical Trials as TopicHumans

Identifiers

PMID37295453
PMCPMC10543569
OpenAlexW4379797773

What OpenQuestion holds

Textmetadata
LicenceTDM
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.