Peter A. Newman, 1 Carmen Logie, 1 Suzy Yim, 1 Roberta Halpenny, 2 Mona Loutfy 2,3
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1 Peter A. Newman, 1 Carmen Logie, 1 Suzy Yim, 1 Roberta Halpenny, 2 Mona Loutfy 2,3 1 University of Toronto, Faculty of Social Work, 2 Maple Leaf Medical Clinic, 3 University of Toronto, Faculty of Medicine
2 FUNDERS Ontario HIV Treatment Network Canada Research Chairs Program COMMUNITY COLLABORATORS Maple Leaf Medical Clinic AIDS Committee of Ottawa AIDS Committee of Toronto Streetlight Support Services Women s Health in Women s Hands PARTICIPANTS All participants for their contributions to advancing HIV vaccine research TRIAL SPONSOR Merck Dr. Michael Robertson
3 Important social and behavioral science research has focused on demographic, cognitive and social determinants of willingness to participate, and HIV risk behaviors Few investigations have focused on the social processes and outcomes of HIV vaccine trials (e.g., Buchbinder et al., 2004; Allen & Lau, 2007)
4 V A C C I N E S
5 Utilize the termination of an HIV vaccine trial as a case study Explore community reactions and narratives about the trial, and underlying beliefs and mental models regarding HIV vaccines and medical research Explore experiences and perspectives of trial participants, key informant service providers and clinical investigators
6 Mixed methods investigation Partnership: University of Toronto, Maple Leaf Medical Clinic, community-based organizations in Toronto and Ottawa Constructivist epistemology to explore social meanings and mental models in public discourse on HIV vaccine trials
7 9 community focus groups 6 HIV negative & 3 PLHA African & Caribbean black women (2) Men who have sex with men (2) Female sex workers (1) Injection drug/crack using men (1) & women (1) Aboriginal peoples - men (1) & women (1)
8 Brief self-administered baseline surveys among trial participants In-depth interviews with trial participants after study unblinding Key informant interviews with service providers and trialists
9 Focus groups and interviews digitally recorded and transcribed verbatim Thematic analysis and critical discourse analysis were conducted using NVivo software
10 Focus group participants (n=72) Mean age: 39 years 60% female 50% LGBT Ethnicity: 35% African/Caribbean 32% White 20% Aboriginal 7% Latino 5% Asian/mixed Mean monthly income: $1272
11 Trial participants (n=48) Mean age: 37 years 98% gay or bisexual male 73% white Mean monthly income: $1500 Key informants 4 service providers (prevention, outreach) 2 trialists
12 Individuals from populations at higher risk for HIV construct personal and social interpretations of HIV vaccines and clinical trials in striving for a coherent narrative to make sense of medical research
13 Disjunctures between public and biomedical interpretations reveal a coherent counter-narrative to biomedical discourse
14
15 Theme Number of Groups Public vs. Scientific Discourse Risk behavior 8 Therapeutic misconception vs. Ongoing risk behavior Eligibility to participate Dissemination of previous trial results 7 6 Social justice vs. Medical eligibility criteria Community knowledge translation vs. Biomedical knowledge dissemination Mistrust/conspiracy 6 Informed consent 5 Trial as social phenomenon vs. Trial as medical study Expertise as omniscience vs. Transparency Community engagement 4 Public discourse vs. Scientific discourse
16 They had the Superman syndrome; they acted like they conquered the disease; because they had the vaccine and they didn t realize it was still a trial. Aboriginal woman
17 You want the whole community, everyone should be involved upper class, white, working, professional male, to the street addicted individual every race, every class. so that all populations can say this is correct data. Female sex worker
18 This is why we had to stop the trial ; be very clear and very honest because while many people are suspicious, I wouldn t say our community is completely unwilling to engage in advances of medicine; but we d like to do it feeling that we ve come in with the best knowledge possible. African Caribbean woman
19 Trickery, what a piece of trickery! How are you going to tell me I have a vaccine and then tell me I m going to get HIV at the same time? A regular person would think, that doesn t add up. This is you guys messing around with people s lives again. African Caribbean women
20 It s going to be hard to find people to go to trials; I think it s going to be really hard. MSM
21 Make sure they really, really know what they re doing; it s not just sit down in a group and explain individually they need counseling. Female sex worker
22 My community wants to feel empowered, they want to feel engaged. Engage them in the actual setting up of the trial, in recruiting for the trial. Include them in every aspect. IDU
23 One thing about First Nations, when we educate, we educate the whole community. Aboriginal man
24
25 Stage Theme Description Pre-trial Motivations Altruism & protection In-trial Post-trial Informed consent Engagement in research Reactions upon study termination Termination & unblinding process Post-trial follow up & support Willingness to participate Retroactive doubt vs. trust Part of the team; pioneer Disappointment; anger; fear; sick; understanding;empathy Slow/inadequate communication Desire for greater support Ongoing commitment; ambivalence; highly unlikely
26 Ambivalence about the clarity and transparency of the consent process and the ethics of the trial They never actually said that anything like this could possibly happen (43 y.o. gay man)
27 Steadfast confidence in informed consent process and acceptance of the possibility that the trial results were unexpected They were very clear that they didn t know what was going to happen; but I think that that was a result maybe no one was expecting (n.a. gay man)
28 Relationship with the research team: I felt like an important part of the whole team...i wasn t just a guinea pig, you know (45 y.o. gay man) I felt a bit like a pioneer of sorts. It felt responsible I was quite proud to be part of something that could have some farreaching impact (48 y.o. gay man)
29 I felt sick. I'm sure it's not like finding out that you are HIV-positive but it was that similar kind of feeling. I didn't want to think about it it's like there's something foreign in your body that you wish wasn't there. I just wish I hadn't done it (40 y.o. bisexual man) And even though it didn t technically give anyone HIV, when you re in a high-risk category to begin with you feel like, oh great (n.a. gay man)
30 I was hopeful it was going to work. But I also felt confident that my health was not in peril because I'm healthy and I certainly didn't want to become unhealthy to save the world. I'm no martyr (48 y.o. gay man)
31 My negative reaction is based more on the handling of the dissemination than it is on the actual findings (n.a. gay man) When you want to find out if you're more susceptible to infection, you want to know like yesterday, not months in the future (37 y.o. gay man)
32 They went into defense mode and were protecting their interests; and that meant, no comment, which is not what you want to hear when you re like, I may have that vaccine in me (n.a. gay man)
33 I can t imagine, I mean, the people putting this test together always sound very professional and very interested and very goal-oriented, so I m sure that they felt just crushed the way the study must have ended. I mean, so I can t imagine anybody purposely putting me at risk. Research is research. It s not always easy; it s not always plain and simple (46 y.o. gay man)
34 Perspectives on the integrity and transparency of the informed consent process Feelings of connectedness with trial staff and investigators, sense of engagement in a shared mission Perceptions of the clarity and efficiency of communications by investigators and trial sponsors upon termination of the trial Post-trial follow-up information and psychosocial support
35 Therapeutic misconception Eligibility criteria Dissemination of previous trial results Mistrust/conspiracy Informed consent Community engagement
36 Public discourse on HIV vaccine trials reveals active construction of social meaning in interpretations of complex clinical trial processes and outcomes Social meanings & mental models of HIV vaccine trials emerge in the context of existing beliefs, conceptions & experiences viz. HIV vaccines, medical research & historical disenfranchisement
37 The entire web of knowledge that laypersons have about a particular subject (Fischhoff, Bostrom, & Quadrel, 1993)
38 Understanding public discourse on HIV vaccine trials, and trial participants constructions of meaning, can facilitate knowledge translation and community engagement in biomedical prevention research
39 Future HIV vaccine trials may benefit from intensified focus on: Improving the effectiveness of mechanisms for communication among participants, local communities, general public, media, investigators and trial sponsors Enhancing strategies for post-trial dissemination of information
40 Integrate social science research across the spectrum of HIV vaccine research and development Generate evidence-informed strategies for community engagement, trial recruitment, implementation, and dissemination
41 FUNDERS Ontario HIV Treatment Network Canada Research Chairs Program COMMUNITY COLLABORATORS Maple Leaf Medical Clinic AIDS Committee of Ottawa AIDS Committee of Toronto Streetlight Support Services Women s Health in Women s Hands PARTICIPANTS All participants for their contributions to advancing HIV vaccine research TRIAL SPONSOR Merck Dr. Michael Robertson
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