Brief Report: Representations and Willingness of People Living With HIV in Switzerland to Participate in HIV Cure Trials: The Case of Gene-Modified Cell Therapies.
Journal
Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005
Informations de publication
Date de publication:
15 08 2021
15 08 2021
Historique:
received:
11
12
2020
accepted:
17
03
2021
entrez:
6
7
2021
pubmed:
7
7
2021
medline:
9
11
2021
Statut:
ppublish
Résumé
Recent advances made in cell and gene therapies for cancer suggest that they represent plausible strategies to cure HIV. However, the health risks and constraints associated with these therapies require a deeper understanding of the expectations of such treatments among people living with HIV (PLWH). We conducted 15 semistructured in-depth interviews among patients from 2 HIV units in Switzerland. After a conversation about their perceptions of research on HIV therapies, participants were provided with a trial description using a gene-modified cell therapy as a potentially curative approach. They were invited to discuss how they might consider participation in the trial. Content analysis was performed to identify core themes. Participants perceived the trial as burdensome and uncertain. Most were aware that cure was not guaranteed, and 6 of the 15 considered that they would participate. Two main concerns were expressed about potential participation: (1) the impact on the professional life and fear to be stigmatized because of this and (2) the fact that stopping antiretroviral treatment would challenge the balance currently achieved in their lives. The decision to participate would depend on their understanding of the trial, the availability of sufficient information, and the relationship with health care professionals. Involving PLWH in early stages of research would be crucial to improve their understanding of gene-modified cell therapies. It could also help adapt trials to address key factors, including the anticipation of stigma, which may discourage PLWH from participating in treatment research.
Sections du résumé
BACKGROUND
Recent advances made in cell and gene therapies for cancer suggest that they represent plausible strategies to cure HIV. However, the health risks and constraints associated with these therapies require a deeper understanding of the expectations of such treatments among people living with HIV (PLWH).
METHODS
We conducted 15 semistructured in-depth interviews among patients from 2 HIV units in Switzerland. After a conversation about their perceptions of research on HIV therapies, participants were provided with a trial description using a gene-modified cell therapy as a potentially curative approach. They were invited to discuss how they might consider participation in the trial. Content analysis was performed to identify core themes.
RESULTS
Participants perceived the trial as burdensome and uncertain. Most were aware that cure was not guaranteed, and 6 of the 15 considered that they would participate. Two main concerns were expressed about potential participation: (1) the impact on the professional life and fear to be stigmatized because of this and (2) the fact that stopping antiretroviral treatment would challenge the balance currently achieved in their lives. The decision to participate would depend on their understanding of the trial, the availability of sufficient information, and the relationship with health care professionals.
CONCLUSION
Involving PLWH in early stages of research would be crucial to improve their understanding of gene-modified cell therapies. It could also help adapt trials to address key factors, including the anticipation of stigma, which may discourage PLWH from participating in treatment research.
Identifiants
pubmed: 34229328
doi: 10.1097/QAI.0000000000002693
pii: 00126334-202108150-00006
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1154-1160Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to disclose.
Références
Dubé K, Evans D, Sylla L, et al. Willingness to participate and take risks in HIV cure research: survey results from 400 people living with HIV in the US. J Virus Erad. 2017;3:40–50.
Prator CA, Donatelli J, Henrich TJ. From berlin to London: HIV-1 reservoir reduction following stem cell transplantation. Curr HIV/AIDS Rep. 2020;17:385–393.
Allers K, Hutter G, Hofmann J, et al. Evidence for the cure of HIV infection by CCR5D32/D32 stem cell transplantation. Blood. 2011;117:2791–2799.
Gupta RK, Abdul-Jawad S, McCoy L, et al. HIV-1 remission following CCR5 D-32/D-32 haematopoietic stem-cell transplantation. Nature. 2019;568:244–248.
Henderson GE, Peay HL, Kroon E, et al. Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment. J Med Ethics. 2018;44:270–276.
Eyal N, Holtzman LG, Deeks SG. Ethical issues in HIV remission trials. Curr Opin HIV AIDS. 2018;13:422–427.
Protière C, Spire B, Mora M, et al. Patterns of patient and healthcare provider viewpoints regarding participation in HIV cure-related clinical trials: findings from a multicentre French survey using Q methodology (ANRS-ASPECT). PLoS One. 2017;12:e0187489.
Dubé K, Ramirez C, Handibode J, et al. Participation in HIV cure-related research: a scoping review of the proxy literature and implications for future research. J Virus Erad. 2015;1:250–256.
Dubé K, Simoni J, Louella M, et al. Acceptability of cell and gene therapy for curing HIV infection among people living with HIV in the northwestern United States: a qualitative study. AIDS Res Hum Retroviruses. 2019;35:649–659.
Power J, Westle A, Dowsett GW, et al. Perceptions of HIV cure research among people living with HIV in Australia. PLoS One. 2018;13:e0202647.
Arnold M, Evans D, Vergel N. Recruitment and ethical considerations in HIV cure trials requiring treatment interruption. J Virus Erad. 2015;1:43–48.
Dubé K, Taylor J, Sylla L, et al. “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. 2017;12:e0170112.
Gilbertson A, Kelly EP, Rennie S, et al. Indirect benefits in HIV cure clinical research: a qualitative analysis. AIDS Res Hum Retroviruses. 2018;35:100–107.
Kratka A, Ubel PA, Scherr K, et al. HIV cure research: risks patients expressed willingness to accept. Ethics Hum Res. 2019;41:23–34.
Simmons R, Kall M, Collins S, et al. Collaborative HIV Eradication of viral Reservoirs (CHERUB) Survey collaboration. A global survey of HIV‐positive people's attitudes towards cure research. HIV Med. 2017;18:73–79.
Preau M, Doumergue M, Protiere C, et al. Acceptability of HIV cure-related trials: the challenges for physicians and people living with HIV (ANRS-APSEC). AIDS Care. 2018;30:914–920.
Murray BR, Kratka A, Scherr KA, et al. What risk of death would people take to be cured of HIV and why? A survey of people living with HIV. J Virus Erad. 2019;5:109–115.
Sculier D, Wandeler G, Yerly S, et al. Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial. PLoS Med. 2020;17:e1003421.
Protiere C, Fiorentino M, Sow A, et al. Who are the persons living with HIV who might refuse to participate in HIV cure-related clinical trials with treatment interruption? AIDS. 2020;34:1095–1099.
Wagner W, Kronberger N, Seifert F. Collective symbolic coping with new technology: knowledge, images and public discourse. Br J Soc Psychol. 2002;41:323–343.
Dubé K, Dee L. Willingness to risk death endpoint in HIV cure-related research with otherwise healthy volunteers is misleading. J Virus Erad. 2020;6:81–84.
Domecq JP, Prutsky G, Elraiyah T, et al. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014;14:89.
Greenhalgh T, Hinton L, Finlay T, et al. Frameworks for supporting patient and public involvement in research: systematic review and co-design pilot. Health Expect. 2019;22:785–801.
Maccarthy J, Guerin S, Wilson AG, et al. Facilitating public and patient involvement in basic and preclinical health research. PLoS One. 2019;14:e0216600.
UNAIDS. Policy Brief: The Greater Involvement of People Living With HIV (GIPA); 2007. Available at: https://www.unaids.org/en/resources/documents/2007/20070410_jc1299-policybrief-gipa_en.pdf . Accessed March 10, 2021.
UNAIDS/AIDS vaccine advocacy coalition, eds. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials. Geneva, Switzerland: UNAIDS; 2011.
PROUD. Patient and Public Involvement (PPI). College London, United Kingdom: University. Available at: http://www.proud.mrc.ac.uk/about/patient-and-public-involvement-ppi/ . Accessed March 10, 2021.
Lewis J. Learning about how public involvement strengthens HIV research as a medical student. Res Involv Engagem. 2020;6:20.
Gafos M, South A, Hanley B, et al. “PROUD to have been involved”: an evaluation of participant and community involvement in the PROUD HIV prevention trial. Res Involv Engagem. 2020;6:13.
Simoni J, Mason H, Marks G, et al. Women's self-disclosure of HIV infection: rates, reasons, and reactions. J Consult Clin Psychol. 1995;63:474–478.
Newman PA, Daley A, Halpenny R, et al. Community heroes or “high-risk” pariahs? Reasons for declining to enroll in an HIV vaccine trial. Vaccine. 2008;26:1091–1097.
Nyblade L, Singh S, Ashburn K, et al. “Once I begin to participate, people will run away from me”: understanding stigma as a barrier to HIV vaccine research participation in Kenya. Vaccine. 2011;29:8924–8928.
Mahajan AP, Sayles JN, Patel VA, et al. Stigma in the HIV/AIDS epidemic: a review of the literature and recommendations for the way forward. AIDS. 2008;22:S67–S79.
Moyer E, Hardon A. A disease unlike any other? Why HIV remains exceptional in the age of treatment. Med Anthropol. 2014;33:263–269.
Nyblade L, Stangl A, Weiss E, et al. Combating HIV stigma in health care settings: what works? J Int AIDS Soc. 2009;12:15.
Kall M, Simmons R, Collins S, et al.; for the CHERUB Collaboration. Altruism and medical advice are key factors in decision-making about participating in HIV cure research: results from a UK-wide survey of people living with HIV (BIVA abstract P159). HIV Med. 2015;16:62–63.
Dubé K, Perry KE, Mathur K, et al. Altruism: scoping review of the literature and future directions for HIV cure-related research. J Virus Erad. 2020;6:100008.
Jansen LA. The ethics of altruism in clinical research. Hastings Cent Rep. 2009;39:26–36.
Bidad N, MacDonald L, Winters ZE, et al. How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction). Trials. 2016;17:431.