2013

1. Informed Consent in HIV vaccine trials Clinton Rautenbach, Graham Lindegger & Catherine Slack HAVEG, Discipline of Psychology School of Applied Human Sciences, UKZN, PMB 2013 http://www.saavi.org.za/haveg.htm

2. 1. Introduction to IC? • IC, as used in research, is the process by which potential research participants freely decide about research participation, and indicate their decision in some formal record • This is done in collaboration with researchers with possibility of including others important to the potential participant.

3. 1. Introduction to IC? • Widely recognized ethical requirement in international guidelines • Before participating in any research, clinical trial participants should freely agree to participate, on the basis of sound understanding • Expression of respect for the autonomy of persons and right to self-determination

4. 2. Origin and development of IC. • Initially started as a prevention of harm (non-maleficence) • Later becomes more focused on respect for autonomy or right to self-determination • Shift from information disclosed as basis of IC to understanding of information as basis

5. 3. Genuine, true, authentic consent • Recent talk of “genuine”, “true” or “authentic” IC. • Why are such concepts employed, and what are their implications? • Suggests formal IC be minimalistic rather than truly ethical • Seems to refer to underlying ethical process which determines genuine spirit of IC • What might this be?

6. 4. Legal vs. ethical notions cont. • Legal notion: indemnity against legal action • Legal notion is minimalistic • Ethical notion: “shared decision making as the embodiment of a higher level of moral commitment” 1 Ethical notion is aspirational • Ethical notion involves capacitation in order to decide – positive obligation(cf. B & C on positive and negative obligations) 1. Faden,R. Beauchamp. Informed consent.

7. 8. Three stages of CIHR/CHVI IC study. • Identifying indigenous mental models of vaccine and HVT to enhance information transmission for IC. • Comparison of understanding of HVT based on standard information delivery vs enhanced information delivery using indigenous models. • Relationship between social-psychological aspects of IC process and understanding.

8. Project 1:1 - Exploring mental models and lay/indigenous theories of HIV vaccine trial concepts in South Africa

9. Introduction • Understanding as one of the key components of IC • However, prospective trial participants often demonstrate a lack of understanding (Lindegger & Richter, 2000; Lindegger, Quayle, & Ndlovu, 2006; Watermeyer & Penn, 2008). • Short-term verbal memory rather than understanding (Lindegger et al., 1996; Richter, Lindegger, Karim, &Gasa, 1999). • Due to issues relating to language, literacy or cultural barriers (Lindegger & Richter, 2000; Richter et al., 1999; Watermeyer & Penn, 2008), and to the assessment process itself.

10. Introduction • Novel ways of describing and explaining HIVVT-related concepts and terminology are needed(Barrington, Moreno, & Kerrigan, 2007; Lindegger, Quayle, & Ndlovu, 2007). • Build upon preliminary studies of HIV vaccine mental models (Newman et al., 2009) and comprehension for informed consent (Lindegger et al., 2006; Lindegger, Quayle, & Ndlovu, 2007), by exploring these phenomena in the South African context.

11. Indigenous/lay theories • Beliefs about health and illness are constituted by a complex inherited folklore and lay theories (Helman, 1990, in Furnham, Akande, &Baguma, 1999) • “the epidemic of significance which has accompanied HIV and AIDS” (Treichler, 1999, in Dickinson, 2011, p. 338) • ‘Indigenous’ and ‘lay’ theories

12. Mental models/representations of HIV • “An internal representation having – in some abstract sense – the same structure as the aspect or portion of external reality that it represents” (Colman, 2003, p. 440). • Meaning representations such as feelings and emotions, attitudes, actions, symbols, personal values, goals, images, memories and representations of sensory experiences (Christensen & Olson, 2002). • Information relating to risk must incorporate pre-existing mental models (Morgan, Fischhoff, Bostrom, Lave, & Atman, 1992, in Newman et al., 2009) • Especially true of vaccine risk communication (Hershey, Asch, Thumasathit, & Meszaros, 1994, in Newman et al., 2009).

13. Mental models/representations of HIV • Health-related terminology and research interventions are understood in terms of pre-existing culturally determined health-related schemas (Farmer, 1990, in Landrine & Klonoff, 1992). • Thus, these schemas – or mental models – are crucial to any health-related intervention • Focus on indigenous, lay and metaphorical concepts, ideas and beliefs that may be useful • Similarly, are there mental models that act as barriers to the IC process?

14. Mental models/representations of HIV • However, mental models, in the constructivist sense, are not easily uncovered (Coll &Treagust, 2003). • Thus, our interest is in the ways in which these mental models are socially constructed (Burr, 1998) • Specifically, the point at which ‘expressed models’ become ‘consensus models’ – (Coll &Treagust, 2003).

15. Metaphor and understanding HIVVT-related concepts • Culture impacts upon constructions of experiences of health and illness. • Language - particularly metaphors – (Radley, 1983, in Furnham, Akande, & Baguma, 1999). • Metaphor plays a significant role when talking about abstract and complex ideas (Thibodeau & Boroditsky, 2011). • People tend to draw on metaphors from more experience-based domains and knowledge when talking about more abstract domains (Boroditsky & Ramscar, 2002). • This is important, given the nature of HIVVT-related concepts.

16. Metaphor and understanding HIVVT-related concepts • Ashforthand Nattrass (2005) found many ‘everyday metaphors’ that dominated understandings of HIV/AIDS. • E.g. the metaphor of dirt, or ‘dirty blood’, in which HIV infection is framed as a form of pollution. • Warfare: the body is besieged by destructive forces that kill its “amasojhaomzimba” (Ashforth & Nattrass, 2005, p. 286). • Could such metaphors enhance the comprehension of HIVVT concepts, and, therefore, the validity of the informed consent process?

17. Guiding questions : 1. What are lay or indigenous theories and conceptualisations of HIV vaccines, immunity and clinical trials? 2. How do participants construct their understandings of key concepts such as VISP, increased susceptibility to HIV infection, and preventative misconception? 3. Are there indigenous/lay explanatory systems, theories or metaphors which may be useful in the explanation of HIV vaccines and HIVVT? 4. Are there mental models of vaccines which may act as barriers to understanding and informed consent within the HIVVT process?

18. Methodology • Open, qualitative, process-oriented exploratory design (Strauss & Corbin, 1990; Babbie & Mouton, 2005). • Participants will be recruited from key constituencies with varying degrees of exposure to HIVVTs: • Community advisory board (CAB) members • Community vaccine educators and outreach workers • Key populations at higher risk of HIV exposure, including vaccine discussion group members and other potential and past trial participants • India: • Panthis • Kothis • MSM

19. Methodology • Key informant interviews (Kumar, 1989) will be conducted with community leaders/advocates with expertise on HIV and vulnerable populations. • Focus groups will be conducted at the site (Stewart & Shamdasani, 1998) • Social psychological brainstorming techniques (Paulus & Nijstad, 2003) will also be used. • Aim is to allow consensus models to emerge organically through dialogic collaboration and interaction.

20. Methodology • Thematic analysis (Boyatzis, 1998; Braun & Clarke, 2006) will be employed to identify mental models of HIVVT concepts • Framing and frame analysis (Kitzinger, 2007) may also be employed

21. Conclusions • Implications for information transmission and understanding • To enhance the IC process (ethical underpinnings)

22. Acknowledgements anthealesch, M.Sc, MPH stellenbosch university ashrafkagee, ph.d. stellenbosch university carmenlogie, ph.D. university of calgary catherine slack, M.A. university of kwazulu-natal Clinton Rautenbach, ph.d. (cand.) university of kwazulu-natal GRAHAM LINDEGGER, Ph.d. university of kwazulu-natal jamie weaver, mph university of toronto gregory D. zimet, ph.d. indiana university school of medicine KATE SNYDER, M.Sc university of cape town/DESMOND TUTU HIV FOUNDATION / FOGARTY FELLOW  Leslie swartz, ph.d. stellenbosch university linda-gailbekker, ph.d. University of cape town/DESMOND TUTU HIV FOUNDATION melissawallace, ph.d. university of cape town/DESMOND TUTU HIV FOUNDATION muralishanmugam, MSW Centre for Sexuality and Health Research and Policy (C-SHaRP) peter a. newman, ph.d. university of Toronto suchontepjan, B.A. university of toronto venksatesanchakrapani, m.d. the humsafar trust/c-sharp