Project PrEP Talk: An In-Depth Qualitative Analysis of PrEP Acceptability, Expectations and Risk Compensation Beliefs among United States MSM Kristen Underhill, D.Phil., J.D., Kathleen M. Morrow, Ph.D., Don Operario, Ph.D., Robert Ducharme, B.A., Caroline Kuo, D.Phil., Kenneth H. Mayer, M.D.

PrEP for MSM in the US New HIV diagnoses among MSM occur at >44 times the rate among other US men. 1 July 16, 2012: US FDA approved Truvada® for use by adults as daily oral PrEP. 2 Surveys of US MSM show willingness to use PrEP (44-79%), concerns about cost, risk compensation, side effects. 3-7 Project PrEP Talk: 8 two-hour focus groups Jan-June 2012 in Providence, RI. Each enrolled 4-6 HIV-negative MSM with recent non-seroconcordant UAI (n = 38) – Mean age = 38.5 (range = 21-61), 79% White, 37% gay, 45% unemployed, 39% no health insurance, 45% transactional sex in past 6m, 39% sex with men and women in past 6m. (WebMD)

Knowledge, Acceptability, and Risk Compensation Knowledge low for PrEP and all other biomedical strategies Majority willing to use PrEP, but motivations and expected benefits (for individuals and community) varied – "I would take that pill every day because I'm going to have unsafe sex if I take it or if I don't take it. So for someone like me, I think it's great." – "If there's a person… who has HIV that is afraid to have sex with me… it hurts me too that we can't enjoy that intimacy." Motivations for unwillingness to use PrEP also varied – "I think I would stick to what I'm doing … [my partner and I are] always safe." – "Rather than take pills because I'm doing risky behavior, I'd just stop the risky behavior first. Taking pills… that's whack to me." – "If my girlfriend found out I was taking something like that, you know, why do I need to be taking that?… Am I banging hoes? Our relationship's over period… I just wouldn't take it all.“ Many predicted increases in risk behavior among other PrEP users; fewer predicted personal increased risk-taking

Significance of FDA Approval for Acceptability Some saw FDA approval as irrelevant, for varying reasons: – "The street pharmacist doesn't wait for FDA approval." – "I would definitely do it even though it was not FDA approved… I don't mind being a guinea pig." – "The fact that it's been approved for a purpose and is being used for a related purpose – it would be fine by me." FDA approval was essential for others to use PrEP, also for varying reasons: – "I would wait till the FDA approved it just to be safe. It would make my mind more relieved." – "The FDA and the drug business is one of the most awful, bad, bad, bad, bad, like, industries in – in our country… It's constantly FDA approves medications that kill people… So of course, if they haven't approved it yet, God knows what could happen to you."

Conclusions Willingness to use PrEP is complex and draws on a variety of motivations, perceived barriers, and anticipated benefits or harms. Easily adaptable behavioral interventions are needed to support use. FDA approval will tip the balance in favor of PrEP acceptability among some potential users, but many will make acceptability decisions based on other factors – FDA approval will play a more indirect role. Impact of FDA approval on PrEP financing and insurance coverage may be more important; cost of pills and prescription was the primary barrier to use. Supportive interventions for PrEP users should account for perceptions of individual and community behavior, particularly in addressing risk compensation.

Acknowledgements Funding: 1 K01 MH (PI: Underhill) Yale Center for Interdisciplinary Research on AIDS/ Yale Law School Lifespan/Tufts/Brown Center for AIDS Research, especially Dr. Michelle Lally K01 grant mentors Project Weber All the men who generously shared their thoughts in our focus groups

References 1.CDC. CDC fact sheet: HIV and AIDS among gay and bisexual men 2011: 2.FDA. Truvada for PrEP fact sheet: Ensuring safe and proper use 2012: 3.Barash EA, Golden M. Awareness and use of HIV pre-exposure prophylaxis among attendees of a seattle gay pride event and sexually transmitted disease clinic. AIDS Patient Care STDs. 2010;24(11): Krakower DS, Mimiaga MJ, Rosenberger JG, et al. Limited awareness and low immediate uptake of pre-exposure prophylaxis among men who have sex with men using an internet social networking site. PLoS One. 2012;7(3):e Mimiaga MJ, Case P, Johnson CV, Safren SA, Mayer KH. Preexposure antiretroviral prophylaxis attitudes in high-risk Boston area men who report having sex with men: limited knowledge and experience but potential for increased utilization after education. J Acquir Immune Defic Syndr. 2009;50(1): Voetsch AC, Heffelfinger JD, Begley EB, Jafa-Bhushan K, Sullivan PS. Knowledge and use of preexposure and postexposure prophylaxis among attendees of minority gay pride events, 2005 through J Acquir Immune Defic Syndr. 2007;46(3): Golub SA, Kowalczyk W, Weinberger CL, Parsons JT. Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men. J Acquir Immune Defic Syndr. 2010;54(5):