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

Karine Dubé¹, Tia Morton², Lawrence Fox², Lynda Dee³, David Palm⁴, Thomas J Villa⁵, William Freshwater⁶, Jeff Taylor⁷, Gail Graham⁸, William B Carter⁹, John A Sauceda¹⁰, Michael J Peluso¹¹, Annette Rid¹²

Affiliations

¹ Division 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.
² Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
³ Delaney 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.
⁴ AIDS 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.
⁵ HIV 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.
⁶ Philadelphia, PA, USA.
⁷ Delaney 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.
⁸ Baltimore, MD, USA.
⁹ Baltimore, MD, USA; BEAT-HIV Collaboratory Delaney Community Advisory Board, Wistar Institute, Philadelphia, PA, USA.
¹⁰ Center for AIDS Prevention Studies, Division of Prevention Sciences, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
¹² Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.

PMID: 37295453
PMCID: PMC10543569
DOI: 10.1016/S1473-3099(23)00267-0

Review

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

Karine Dubé et al. Lancet Infect Dis. 2023 Oct.

. 2023 Oct;23(10):e418-e430.

doi: 10.1016/S1473-3099(23)00267-0. Epub 2023 Jun 6.

Authors

Affiliations

¹ Division 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.
² Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
³ Delaney 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.
⁴ AIDS 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.
⁵ HIV 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.
⁶ Philadelphia, PA, USA.
⁷ Delaney 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.
⁸ Baltimore, MD, USA.
⁹ Baltimore, MD, USA; BEAT-HIV Collaboratory Delaney Community Advisory Board, Wistar Institute, Philadelphia, PA, USA.
¹⁰ Center for AIDS Prevention Studies, Division of Prevention Sciences, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
¹² Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.

PMID: 37295453
PMCID: PMC10543569
DOI: 10.1016/S1473-3099(23)00267-0

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.

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Conflict of interest statement

Declaration of interests KD has received funding from Gilead Sciences and Merck & Co, that is not directly related to this manuscript; received support from ethics supplement to R21MH118120 from UM1AI126620, and UM1AI164570 from BEAT-HIV Collaboratory. KD, JAS, and MJP also received support from National Institute of Mental Health R01-MH126768. MJP is supported on K23AI157875 from US National Institute of Mental Health. AR was supported in part by the Clinical Center Department of Bioethics, which is in the Intramural Program of the US National Institutes of Health (NIH). All other authors declare no competing interests.

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical