'Well, It's the Risk of the Unknown… Right?': A Qualitative Study of Perceived Risks and Benefits of HIV Cure Research in the United States

PLoS ONE - Tập 12 Số 1 - Trang e0170112
Karine Dubé1, Jeff Taylor2, Laurie Sylla3, David Evans4,5, Lynda Dee6, Burton Alasdair7, Loreen Willenberg8, Stuart Rennie9, Asheley Cockrell Skinner10,1, Joseph D. Tucker11,12, Bryan J. Weiner13,1, Sheila Greene1
1University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, United States of America
2Collaboratory of AIDS Researchers for Eradication (CARE) Community Advisory Board (CAB), Palm Springs, CA, United States of America
3defeatHIV CAB, Seattle, WA, United States of America
4Delaney AIDS Research Enterprise (DARE) CAB, Los Angeles, CA, United States of America
5Project Inform, Los Angeles, CA, United States of America
6AIDS Action Baltimore, Baltimore, MD, United States of America
7Multi-Decadal, Multi-CAB Member, Glendale, CA, United States of America
8Zephyr Long-Term Non-Progressors (LTNP) Foundation, Inc., Sacramento, CA, United States of America
9Department of Social Medicine, UNC Bioethics Center, Chapel Hill, NC, United States of America
10Duke Clinical Research Institute (DCRI), Durham, NC, United States of America
11UNC Institute of Global Health and Infectious Diseases (IGHID), Chapel Hill, NC, United States of America
12UNC Project China, Guangzhou, China
13Department of Global Health, University of Washington, Seattle, WA, United States of America

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K Dubé, 2014, Framing expectations in early HIV cure research, Trends in Microbiology, 22, 547, 10.1016/j.tim.2014.08.003

N Eyal, 2016, The benefit/risk ratio challenge in clinical research, and the case of HIV cure: an introduction, Journal of medical ethics, 1

K Dubé, 2017, Willingness to participate in HIV cure research: survey results from 400 people living with HIV in the United States, Journal of Virus Eradication, 3, 40, 10.1016/S2055-6640(20)30295-8

FDA (2013) Backgrounder for FDA’s HIV Patient-Focused Drug Development and HIV Cure Research Public Meeting. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM354549.pdf" xlink:type="simple">http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM354549.pdf</ext-link>.

NM Archin, 2014, Emerging strategies to deplete the HIV reservoir, Current Opinion in Infectious Diseases, 27, 29, 10.1097/QCO.0000000000000026

DM Margolis, 2013, Combined approaches for HIV cure, Current Opinion in HIV and AIDS, 8, 230, 10.1097/COH.0b013e32835ef089

TAG (2016) Research Toward a Cure Trials. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.treatmentactiongroup.org/cure/trials" xlink:type="simple">http://www.treatmentactiongroup.org/cure/trials</ext-link>.

Y Lo, 2015, Stakeholder engagement in HIV cure research: lessons learned from other HIV interventions and the way forward, AIDS Patient Care and STDs, 29, 1

UCLA Center for Health Policy Research (2016) Key Informant Interviews. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://healthpolicy.ucla.edu/programs/health-data/data-resources/Pages/Key-Informant-Interviews.aspx" xlink:type="simple">http://healthpolicy.ucla.edu/programs/health-data/data-resources/Pages/Key-Informant-Interviews.aspx</ext-link>.

J Cresswell, 2013, Research Design: Qualitative, Quantitative, and Mixed Methods Approaches, 142

J DeCuir-Gunby, 2003, Techniques to Identify Themes, Field Methods, 15, 85, 10.1177/1525822X02239569

R Krueger, 2009, Focus Groups: A Practical Guide for Applied Research

JM Prins, 1999, Immuno-activation with anti-CD3 and recombinant human IL-2 in HIV-1-infected patients on potent antiretroviral therapy, AIDS (London, England), 13, 2405, 10.1097/00002030-199912030-00012

CE Chu, 2015, Exploring the social meaning of curing HIV: a qualitative study of people who inject drugs in Guangzhou, China, AIDS Research and Human Retroviruses, 31, 78, 10.1089/aid.2014.0200

Ma Q, Wu F, Henderson G, Rennie S, Rich ZC, Cheng Y, et al. (2016) “I can coexist with HIV”: a qualitative study of perceptions of HIV cure among people living with HIV in Guangzhou, China: 170–174.

K Moodley, 2015, HIV cure research in South Africa: a preliminary exploration of stakeholder perspectives, AIDS Care, 0121, 1

R Dresser, 2016, First-in-human HIV-remission studies: reducing and justifying risk, Journal of medical ethics, 1

N King, 2005, Consent forms and the therapeutic misconception: the example of gene transfer research, IRB: Ethics and Human Research, 27, 1, 10.2307/3563865

GE Henderson, 2006, Therapeutic misconception in early phase gene transfer trials, Social Science & Medicine (1982), 62, 239, 10.1016/j.socscimed.2005.05.022

FDA (2014) The Voice of the Patient. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM389379.pdf" xlink:type="simple">http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM389379.pdf</ext-link>.

DHHS (n.d.) Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.hhs.gov/ohrp/newsroom/rfc/comstdofcare.html" xlink:type="simple">http://www.hhs.gov/ohrp/newsroom/rfc/comstdofcare.html</ext-link>.

A Rid, 2011, A framework for risk-benefit evaluations in biomedical research, Kennedy Institute of Ethics Journal, 21, 141, 10.1353/ken.2011.0007

Dubé K, Ramirez C, Handibode J, Taylor J, Skinner A, Greene SB, et al. (2015) Participation in HIV cure-related research: a scoping review of the proxy literature and implications for future research: 14–20.

NIH (2012) Organ Transplants Without Lifelong Drugs. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.nih.gov/news-events/nih-research-matters/organ-transplants-without-life-long-drugs" xlink:type="simple">https://www.nih.gov/news-events/nih-research-matters/organ-transplants-without-life-long-drugs</ext-link>.

J Hutchinson, 2015, Now or Never? The Case for Cell-Based Immunosuppression in Kidney Transplantation, Kidney International, 87, 1116, 10.1038/ki.2015.50

BDB Resnik, 2013, What is a “Reasonably Foreseeable Risk”? The SUPPORT Study Controversy, Journal of Clinical Research Best Practices, 9

CH Braddock, 2013, Supporting shared decision making when clinical evidence is low, Medical Care Research and Review, 70, 129S, 10.1177/1077558712460280

R Dressler, 2001, When science offers salvation. Patient advocacy and research ethics

JA Fisher, 2007, “Ready-to-recruit” or “ready-to-consent” populations? Informed consent and the limits of subject autonomy, Qualitative Inquiry, 13, 875, 10.1177/1077800407304460

GE Henderson, 2015, The ethics of HIV “cure” research: what can we learn from consent forms?, AIDS Research and Human Retroviruses, 31, 56, 10.1089/aid.2014.0219

J Różyńska, 2015, On the alleged right to participate in high-risk research, Bioethics, 29, 451, 10.1111/bioe.12146

CT Deakin, 2013, Gene therapy researchers’ assessments of risks and perceptions of risk acceptability in clinical trials, Molecular Therapy, 21, 806, 10.1038/mt.2012.230

N Eyal, 2013, Challenges in clinical trial design for HIV-1 cure research, Lancet, 382, 1464, 10.1016/S0140-6736(13)62040-1

Gilbertson A (2016) Unanticipated participant benefits in HIV cure clinical research: a qualitative analysis. Towards an HIV Cure Symposium. Available: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.iasociety.org/HIV-programmes/Towards-an-HIV-Cure/Events/2016-Symposium/Day-1" xlink:type="simple">https://www.iasociety.org/HIV-programmes/Towards-an-HIV-Cure/Events/2016-Symposium/Day-1</ext-link>.

T Godskesen, 2013, Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation, Supportive Care in Cancer, 21, 3137, 10.1007/s00520-013-1891-7

B Lo, 2013, Ethical considerations in HIV cure research: points to consider, Current Opinion in HIV and AIDS, 8, 243, 10.1097/COH.0b013e32835ea1c5

H Peay, 2015, What motivates participation in HIV cure trials? A call for real-time assessment to improve informed consent, Journal of Virus Eradication, 1, 51, 10.1016/S2055-6640(20)31143-2

E Largent, 2016, For love and money: the need to rethink benefits in HIV cure studies, Journal of medical ethics, 1

L Balfour, 2010, Altruism motivates participation in a therapeutic HIV vaccine trial (CTN 173), AIDS Care, 22, 1403, 10.1080/09540121003693522

L Buchak, 2016, Why high-risk, non-expected-utility-maximising gambles can be rational and beneficial: the case of HIV cure studies, Journal of medical ethics, 1

GE Henderson, 2007, Clinical trials and medical care: defining the therapeutic misconception, PLoS Medicine, 4, e324, 10.1371/journal.pmed.0040324

CI Grossman, 2016, Towards multidisciplinary HIV-cure research: integrating social science with biomedical research, Trends in Microbiology, 24, 5, 10.1016/j.tim.2015.10.011

JD Tucker, 2014, Social and ethical implications of HIV cure research, AIDS (London, England), 28, 1247, 10.1097/QAD.0000000000000210