What Motivates Participation in HIV Cure Trials? A Call for Real-time Assessment to Improve Informed Consent

Overview

Journal J Virus Erad

Date 2015 Apr 14

PMID 25866844

Citations 32

Authors

Holly L Peay

Gail E Henderson

Affiliations

Soon will be listed here.

Abstract

HIV cure research, a diverse set of studies aimed at eradicating or greatly reducing HIV in latent reservoirs, has become a strategic priority for global AIDS research. However, in early-phase HIV cure research there are ethical challenges related to the uncertainty around potential risks and the risk-benefit balance. Similar to clinical trials in other disease areas, these concerns may impact clinical trial participants' comprehension and decision making. Here we suggest attention to the terminology used to describe HIV cure research that may promote therapeutic misconception, and exploration of the decision-making influences and processes of those who accept and decline participation in HIV cure trials. These data will facilitate efforts to improve protocols and informed consent based on an understanding of participant preferences and needs.

Citing Articles

Recall and Appraisal of the Risks, Benefits, and Objectives of Interrupting HIV Treatment in an HIV Cure-Related Study.

Korolkova A, Ndukwe S, Dee L, Deeks S, Peluso M, Hoh R AIDS Behav. 2024; 28(12):4136-4145.

PMID: 39287733 DOI: 10.1007/s10461-024-04485-x.

Participant experiences in a combination HIV cure-related trial with extended analytical treatment interruption in San Francisco, United States.

Dube K, Ndukwe S, Korolkova A, Dee L, Sugarman J, Sauceda J HIV Res Clin Pract. 2024; 25(1):2312318.

PMID: 38348830 PMC: 10951555.

Decision making for invasive and non-invasive optional procedures within an acute HIV research cohort in Bangkok.

Isaacson S, Kuczynski K, Ormsby N, Peay H, Rennie S, Cadigan R Contemp Clin Trials Commun. 2023; 31:101054.

PMID: 36636463 PMC: 9829688. DOI: 10.1016/j.conctc.2022.101054.

Perceptions of HIV cure and willingness to participate in HIV cure-related trials among people enrolled in the Netherlands cohort study on acute HIV infection.

van Paassen P, Dijkstra M, Peay H, Rokx C, Verbon A, Reiss P J Virus Erad. 2022; 8(2):100072.

PMID: 35769632 PMC: 9234345. DOI: 10.1016/j.jve.2022.100072.

Participant Perspectives and Experiences Following an Intensively Monitored Antiretroviral Pause in the United States: Results from the AIDS Clinical Trials Group A5345 Biomarker Study.

Dube K, Eskaf S, Barr L, Palm D, Hogg E, Simoni J AIDS Res Hum Retroviruses. 2022; 38(6):510-517.

PMID: 35323030 PMC: 9225827. DOI: 10.1089/AID.2021.0170.

References

Sugarman J . HIV cure research: expanding the ethical considerations. Ann Intern Med. 2013; 159(7):490-1. PMC: 3923855. DOI: 10.7326/0003-4819-159-7-201310010-00694. View

Sulmasy D, Astrow A, He M, Seils D, Meropol N, Micco E . The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer. 2010; 116(15):3702-11. PMC: 3644988. DOI: 10.1002/cncr.25201. View

Henderson G . The ethics of HIV "cure" research: what can we learn from consent forms?. AIDS Res Hum Retroviruses. 2014; 31(1):56-63. PMC: 4287120. DOI: 10.1089/AID.2014.0219. View

Jansen L . Mindsets, informed consent, and research. Hastings Cent Rep. 2013; 44(1):25-32. PMC: 3985429. DOI: 10.1002/hast.237. View

Peay H, Tibben A, Fisher T, Brenna E, Biesecker B . Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy. Clin Trials. 2013; 11(1):77-85. PMC: 3935382. DOI: 10.1177/1740774513512726. View

Eyal N, Kuritzkes D . Challenges in clinical trial design for HIV-1 cure research. Lancet. 2013; 382(9903):1464-5. DOI: 10.1016/S0140-6736(13)62040-1. View

Lidz C, Appelbaum P . Therapeutic misconception in clinical trials: fighting against it and living with it. Rev Clin Esp (Barc). 2014; 214(8):457-8. DOI: 10.1016/j.rce.2014.06.013. View

Lo B, Grady C . Ethical considerations in HIV cure research: points to consider. Curr Opin HIV AIDS. 2013; 8(3):243-9. PMC: 4825800. DOI: 10.1097/COH.0b013e32835ea1c5. View

Appelbaum P, Roth L, Lidz C . The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982; 5(3-4):319-29. DOI: 10.1016/0160-2527(82)90026-7. View

10.

Miller F, Rosenstein D . The therapeutic orientation to clinical trials. N Engl J Med. 2003; 348(14):1383-6. DOI: 10.1056/NEJMsb030228. View

11.

Horng S, Grady C . Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB. 2003; 25(1):11-6. View

12.

Henderson G, Churchill L, Davis A, Easter M, Grady C, Joffe S . Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007; 4(11):e324. PMC: 2082641. DOI: 10.1371/journal.pmed.0040324. View

13.

King N . Defining and describing benefit appropriately in clinical trials. J Law Med Ethics. 2001; 28(4):332-43. DOI: 10.1111/j.1748-720x.2000.tb00685.x. View

14.

Tucker J, Volberding P, Margolis D, Rennie S, Barre-Sinoussi F . Words matter: Discussing research towards an HIV cure in research and clinical contexts. J Acquir Immune Defic Syndr. 2014; 67(3):e110-1. PMC: 4199082. DOI: 10.1097/QAI.0000000000000305. View

15.

Tucker J, Rennie S . Social and ethical implications of HIV cure research. AIDS. 2014; 28(9):1247-50. PMC: 4071118. DOI: 10.1097/QAD.0000000000000210. View

16.

Joffe S, Weeks J . Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst. 2002; 94(24):1847-53. DOI: 10.1093/jnci/94.24.1847. View

17.

Dal-Re R, Morell F, Tejedor J, Gracia D . Therapeutic misconception in clinical trials: fighting against it and living with it. Rev Clin Esp (Barc). 2014; 214(8):470-4. DOI: 10.1016/j.rce.2014.03.013. View

18.

Janz N, BECKER M . The Health Belief Model: a decade later. Health Educ Q. 1984; 11(1):1-47. DOI: 10.1177/109019818401100101. View

19.

Leung K, Silvius J, Pimlott N, Dalziel W, Drummond N . Why health expectations and hopes are different: the development of a conceptual model. Health Expect. 2009; 12(4):347-60. PMC: 5060505. DOI: 10.1111/j.1369-7625.2009.00570.x. View

20.

Dube K, Henderson G, Margolis D . Framing expectations in early HIV cure research. Trends Microbiol. 2014; 22(10):547-9. PMC: 4201845. DOI: 10.1016/j.tim.2014.08.003. View