Understanding of Informed Consent

1. Understanding of Informed Consent and Motivators for Participation Among MSM HIV Vaccine Trial Participants Lisa Chin, JD, EdD, MPH, MA HIV Center Grand Rounds June 30, 2011

2. Why do people participate in HIV vaccine trials (HVT) and do they know what they are getting into?

3. Background HIV Vaccine Development • HIV vaccines are critical for comprehensive prevention strategy against HIV/AIDS • Human subject testing is essential aspect of HIV vaccine development

4. Recruitment Issues in HVTs • Many participants are needed to ensure power to assess a vaccine’s safety and efficacy • Willingness to participate in a HVT varied from 22% to 79% • In practice only 20% of participants actually enrolled (Buchbinder et al., 2004) • Understanding motivations to participate can help to improve recruitment

5. Participants’ Understanding of HVT • Informed Consent Information • Ethical implications for informed consent • Concerns about therapeutic misconception • Most studies among non-HVT study populations • Vaccine preparedness • Vaccine feasibility • Longitudinal epidemiological • Few studies with actual HVT participants • South African HVT • US IDU HVT participants • North American HVT – vaccine efficacy

6. Pilot Study • Qualitative Study with high- and low-risk participants in HVT • Formative Research for Quantitative Instrument Development • Quantitative Assessment with HVT Participants

7. Qualitative Part of Pilot Study • Domains of interest: • Understanding of HVT informed consent information • Perceptions of HVT informed consent process • Potential therapeutic misconception • Motivators for participating • Study participants: • High-risk individuals HVT participants (20 MSMs) • Low-risk individuals HVT participants (20 women & men)

8. Parent HVT for Pilot Study • Phase II Trial -- Double Blind Vaccine vs. Placebo • Study aims are to assess: • Vaccine safety and immunogenicity • Reduction of viral load upon HIV acquisition • Vaccines not made from HIV virus • Recruited from 2 research sites in NYC

9. Participants’ Demographics • Age range: 23-48 yrs (mean = 35.8) • Ethnicity • 7 White • 10 African-American • 1 Hispanic • 1 Asian • 1 Mixed • Education (Highest Level) • 1 <HS • 11 HS degrees • 6 BA degrees • 2 MA degrees

10. Qualitative Probes Motivators for participation • Decision to get involved • Other factors involved • Family or friends who are healthcare professionals • Role of payment • Role of HIV concerns Understanding of informed consent • Study goals • What study involves • Possible risks and benefits • Inputs/pressure to participate

11. Study Analysis Qualitative interviews • 1-2 hour interviews • Transcribed and Coded • 2 Coders Coding themes • Understanding/misunderstanding-misconception of HVT • Study purpose/goals • Study design • Vaccine and placebo • Perspectives on risks and benefits of participation • Understanding of voluntariness of participation • Motivators for participation • Sources for motivations • Role of compensation as a motivator

12. Motivators for Enrolling into • and Staying in Study Altruism Compensation

13. Altruistic Motives from Various Sources • Familial: Values taught that helping others is important • Cultural/Community: Emphasis on giving back to the community or the desire to help • Religious: Personal religious values/beliefs opposing observed hypocrisy • Experiential: Personal experiences with HIV/AIDS • Professional: Being a healthcare professional or having family members who are • Political: Activism in response to the HIV/AIDS epidemic • Moral: Making up for past wrongs • Existential: Provides a sense of meaning and purpose • Psychological: Obtaining gratification

14. Participants’ Altruistic Motives • Emphasis giving back to the community or the desire to help the community • I am helping my community, as far as gay men, black gay men…the community I live in. (AA, age 41) • Obtaining gratification • It’s very fulfilling for me. I’m very proud of being in this. (W, age 23)

15. Compensation as a Motivator • Sole motivator (n=1) • Important but not sole motivator (n=4) • Added bonus but not motivator (n=5) • Compensation not a motivator (n=10)

16. Compensation Important but not Sole Motivator • At the beginning, it was pretty much for extra cash. But I chose this particular study because my parents have had friends that had HIV. It’s pretty much a win-win. Win-win as in I would be doing something that I support and I would make a few extra bucks from it. (AA, age 23) • I’m unemployed. I need the money. I’m not going to lie about that. And the same thing is I know a lot of people with HIV. (AA, age 39)

17. Compensation as an Added Bonus • To maintain follow-up visits/adherence • I probably would have done it for free, but that definitely gets [you] to the appointment. (AA, age 28) • It motivates you to show up on time. If you feel like you’re not getting paid, you can start taking liberties with the responsibilities that you have. (W, age 43) • Acknowledgement of participant’s time • The amount of money that I end up getting from this study is not even really pocket change. It definitely does make me feel that my time is valuable at least. (W, age 23)

18. Compensation not a Factor • I’ve probably would’ve still participated even they weren’t paying me. (W, age 27) • I didn’t even know you got paid for it, so that wasn’t a factor…Just the fact I wanted to help. (W, age 28)

19. Understanding of Informed Consent (1) • Participants had basic understanding of HVT • Several misunderstandings/misconceptions about study elements and concepts • Study purpose • Many said “cure” or “prevent HIV acquisition”, not decrease viral load or examine vaccine safety • Process of randomization • What worked best for the participant I think the doctors after they look at my file, they found out what was best after they did all the blood work and all that. (AA, age 44) • Based on participant’s behavior I think it’s based on what you’re going in and telling them. It has to be based on some type of activity. (AA, age 39)

20. Understanding of Informed Consent (2) Some confusion about role of placebo It prevents people from changing behavior or lying about or overstating symptoms. [Participants] also lie about their symptoms. Like, are you really going to have nausea off a placebo? It’s to keep people honest. If I’m deciding not to be honest and say, “I’m feeling nauseous”, [the staff] will say, “Hold on, something’s up because you’re just taking a placebo.” So, it’s pretty much just to keep people honest. (AA, age 23)

21. Participants’ Interpretation of HVT Concepts Randomization • Interpreted literally as a “coin toss” (i.e., an actual coin was used Do y’all toss a coin and decide which shot you’re going to give me? (AA, age 42) What is in the vaccine • Synthetic HIV = “fake HIV” • “Crippling” actual HIV virus How the vaccine works • Taking a snapshot of virus or antibodies of virus…It’s kind of like a security guard having a picture of a wanted man. If that wanted man comes to the building, he knows. (AA, age 23)

22. Summary • Various motives for participation • Altruism is a multi-dimensional phenomena (instead of single dimension) • Compensation appears not to be the sole motivator for HVT participation • Overall basic understanding of HVT • Some difficulties in understanding more technical elements/components of HVT (e.g., randomization, placebo, vaccine)

23. Implications Use of altruism as a marketing strategy for HVT recruitment Strategies are needed to help participants better understand components of HVT • Simplify written patient education materials about HVT • Use of multi-media technology as an educational tool • Review informed consent information with participants at various points of HVT trial

24. Study Limitations • Study population limited to MSM: Motivations with other populations may differ • Participants interviewed after enrollment: Issue of recall bias • Participants interviewed only once: Views on motivation may change over time

25. Future Research Among different populations and with larger samples, future studies can examine: • Frequencies of types of altruism and possible associations with entrance and retention into study, and adherence to protocol • The role and importance of study compensation as a motivator (weighing of altruistic benefits against compensation) • Frequencies of types of misunderstandings and predictors (education, other socio-demographic variables, cultural factors and beliefs) • Effects of types of misunderstandings on entrance and retention into study, and adherence to protocol

26. Acknowledgments • Robert Klitzman, MD, Scientific Mentor • HIV Center Pilot Studies Program (Pat Warne, PhD) • HIV Center (PI: Anke Ehrhardt, PhD) • HIV Center Ethics and Policy Core, Development Core, IRMC, and HIV Center Administration • HIV Center T32 Postdoctoral Training Fellowship Program (PI: Theo Sandfort, PhD) • Scott Hammer, MD, and CUMC HIV Vaccine Trial Clinic and Beryl Koblin, PhD, and New York Blood Center Project Achieve • Jacqueline Berenson, MD (Clinical Forensic Psychiatry Program, NYSPI/CU)

27. Thank you

28. Participants’ Altruistic Motives • Familial – family values taught that helping others is important • It’s really important that everybody does something to give back to the community, which is something my mother instilled in me. (W, age 27) • Professional – Being a healthcare professional or having family members who are healthcare professional • I think [family members who are healthcare professionals] learn a lot from studies like this, a lot about diseases and how to prevent them, like how to find cures. (Asian, age 32)

29. Participants’ Altruistic Motives • Religious values/beliefs opposing observed hypocrisy • I was a closeted person. I was raised Italian Catholic. There was a lot shame around that. And I have a lot resentment toward the Catholic Church how they treat the LGBTQ community… So it’s very personal to me. It’s not about me or my future, but more about the future of the next generation to follow, if I can help out in any way. (W, age 45)

30. Participants’ Altruistic Motives • Existential, providing a sense of meaning and purpose • I wanted to be part of something that’s going to help. Be part of something that we need. Part of something that could help cure millions of people. (AA, age 44)

31. Participants’ Altruistic Motives • Moral – Making up for past wrongs • I did too much wrong, and if I could give back to the community, I did my part. (AA, age 44)

32. Participants’ Altruistic Motives • Personal experiences with HIV/AIDS • I chose that particular study because my parents have had friends that had HIV. I’ve been around it. (AA, age 23) • Political activism in response to the HIV/AIDS epidemic • I started working more formally in [HIV/AIDS outreach], trying to educate people, and just helping out people…participating in [the HIV vaccine trial] was like a next step… Somebody has to do it. (AA, age 28)