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      The psychology of “cure” - unique challenges to consent processes in HIV cure research in South Africa

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          Abstract

          Background

          Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research.

          Methods

          In total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals - audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted.

          Results

          The majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants.

          Conclusion

          Unique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.

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          Most cited references 35

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          Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary?

          The purpose of this study was to assess informed consent to human immunodeficiency virus (HIV) testing in a perinatal HIV transmission study in a major referral hospital serving a largely Black population in South Africa. First-time antenatal clinic attenders who were randomly selected from those enrolled in the perinatal HIV study (n = 56) answered questionnaires before and after counseling. Knowledge of HIV transmission and prevention, high at the outset, was little improved after counseling. The acceptance rate for HIV testing was high. Despite assurances that participation was voluntary, 88% of the women said they felt compelled to participate in the study. Informed consent in this setting was truly informed but not truly voluntary.
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            Ethical considerations in HIV cure research: points to consider.

             Bernard Lo,  ,  Christine Grady (2013)
            Research directed toward an HIV cure presents ethical as well as scientific challenges. International guidelines, regulations, and the medical literature provide helpful guidance on protecting research participants. This review presents points to consider for researchers, sponsors, oversight committees, community advisory boards, and HIV advocates to help resolve ethical challenges that are particularly complex or difficult or that are not adequately addressed by current ethical guidelines. The points to consider are: collaborative partnership among international scientists from both the private and public sectors, as well as engagement of HIV-affected communities, social value, scientific validity, fair selection of participants and study sites, a favorable and acceptable risk-benefit balance, independent scientific and ethical review, informed and voluntary consent, and respect for enrolled patients and communities. To prevent therapeutic misconception, participants' comprehension of key features of the study may need to be assessed. Participants who suffer study-related adverse events should receive appropriate medical care and compensation. If interventions are shown capable of curing HIV, sponsors and international funding agencies should plan how to make them available and affordable in resource-poor countries.
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              Informed consent and participant perceptions of influenza vaccine trials in South Africa.

              There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa. Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration. A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication. Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.
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                Author and article information

                Contributors
                +27 21 9389600 , km@sun.ac.za
                c.staunton@mdx.ac.uk
                theresarossouw@icloud.com
                malcolmderoubaix@gmail.com
                zoeduby@gmail.com
                dskinner@sun.ac.za
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central (London )
                1472-6939
                24 January 2019
                24 January 2019
                2019
                : 20
                Affiliations
                [1 ]ISNI 0000 0001 2214 904X, GRID grid.11956.3a, Centre for Medical Ethics and Law, Department of Medicine, Faculty of Health Sciences, , Stellenbosch University, ; Stellenbosch, South Africa
                [2 ]ISNI 0000 0001 2107 2298, GRID grid.49697.35, Institute for Cellular and Molecular Medicine, Department of Immunology, , University of Pretoria, ; Pretoria, South Africa
                [3 ]ISNI 0000 0001 0071 1142, GRID grid.417715.1, HIV AIDS STDs and TB, Human Sciences Research Council, ; Cape Town, South Africa
                [4 ]ISNI 0000 0001 2214 904X, GRID grid.11956.3a, Dept. of Global Health, Faculty of Medicine and Health Sciences, , Stellenbosch University, ; Stellenbosch, South Africa
                Article
                348
                10.1186/s12910-019-0348-z
                6346569
                30678664
                © The Author(s). 2019

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: NIH
                Award ID: R01A108366-01
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Medicine

                hiv, cure, consent, south africa, stakeholders

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