AVAC IAS Symposium July 23rd, 2017 Next Wave Of Prevention Options: Views From An HIV Prevention Researcher  Kenneth H. Mayer, MD AVAC IAS Symposium July 23rd, 2017

How to improve chemoprophylaxis effectiveness? Novel adherence strategies New oral PrEP drugs and dosing strategies Alternative delivery systems and formulations Injectables: ARVs and mAbs (Cabotegravir, VRC01) Vaginal & Rectal Microbicides (Tenofovir, other ARVs) Intravaginal rings (Dapivirine, Tenofovir) +/- Contraception)

Background Oral TDF/FTC is PrEP 1.0 Uptake has varied in diverse populations New modalities could limit need for daily dosing, but not much is known about community perceptions In March, 2016, an invitation to a link to a survey was sent from 2 sexual networking apps via a “push message” notification to the mobile phones of members who had used either app in the past 90 days. 16,466 members clicked the provided link to the survey, 4,638 of whom consented and were eligible.

Sociodemographic and Behavioral Characteristics of Online MSM Sample, 3/16 (N= 4,638)

Oral PrEP Knowledge and Experience (2016 MSM online survey, n=4,638) Heard of PrEP 78.2% Taken PrEP 14.9% Side effects among PrEP users 44.0% Ability to adhere to PrEP Very easy 80.0% Somewhat easy 11.4% Somewhat or very difficult 4.0%

PrEP-experienced MSM were more likely to: P value Be older >0.001 Identify as White Have Private Insurance Have a Graduate Degree Be Non-monogamous ↑ Condomless anal sex Used PEP Live on the West Coast Live in an Urban Area

Interest in new HIV prevention modalities (N=4,638 MSM, 3/16)

Interest and Preferences in Infusible Antibodies Reasons for interest: Liked idea of infrequent dosing 23.9% Liked idea of immune protection 71.4% Reasons not interested: Don’t like idea of IV infusions 62.7% Don’t think it would work 12.5% Already taking oral PrEP 6.3%

Compared to oral PrEP, injectable PrEP… would be less difficult to take as prescribed: 47.0% would be preferable, would not need to remember daily pill: 46.4% not sure yet, injectable medication not yet shown to work: 35.2% would be more difficult to take as prescribed: 21.9% would be undesirable, daily pill is safer and easier to stop when risk ends: 15.1%

Prefer Infusable Antibodies (vs. Prefer Daily Oral Pill) Factors associated with preference for antibody infusion, multivariable analysis   Prefer Infusable Antibodies (vs. Prefer Daily Oral Pill) aOR (95% CI) p Age 18-24 1.0 25-29 1.11 (0.08, 1.43) 0.432 30-39 1.03 (0.80, 1.31) 0.841 40+ 0.69 (0.55, 0.88) 0.002 Race/ethnicity White Black 1.16 (0.95, 1.42) 0.139 Hispanic 1.23 (0.96, 1.58) 0.106 Asian/PI 0.98 (0.72, 1.32) 0.870 Multiracial 1.38 (1.01, 1.90) 0.043 Other 1.07 (0.58, 1.97) 0.827 Insurance status No insurance Private 0.78 (0.61, 1.00) 0.050 Public 0.87 (0.66, 1.16) 0.354 0.81 (0.60, 1.09) 0.159 CAI past 3 months 1 1.18 (0.92, 1.51) 0.196 2+ 1.60 (1.37, 1.87) <0.001 Oral PrEP experienced Yes No 1.54 (1.25, 1.89)

Prefer Injectable PrEP (vs. Prefer Daily Oral Pill) Factors associated with preference for injectable PrEP, multivariable analysis   Prefer Injectable PrEP (vs. Prefer Daily Oral Pill) aOR (95% CI) p Age 18-24 1.0 25-29 1.12 (0.77, 1.63) 0.549 30-39 1.26 (0.88, 1.81) 0.212 40+ 0.68 (0.48, 0.96) 0.030 Race/ethnicity White Black 1.60 (1.18, 2.16) 0.003 Hispanic 1.58 (1.09, 2.29) 0.015 Asian/PI 1.14 (0.72, 1.80) 0.582 Multiracial 0.99 (0.65, 1.52) 0.978 Other 1.55 (0.57, 4.22) 0.390 Insurance status No insurance Private 1.05 (0.73, 1.50) 0.813 Public 0.98 (0.65, 1.50) 0.935 0.68 (0.44, 1.04) 0.077 CAI past 3 months 1 1.04 (0.73, 1.48) 0.832 2+ 1.47 (1.17, 1.86) 0.001 Oral PrEP experienced Yes No 1.79 (1.27, 2.52)

Limitations One time convenience sample Self-selection may → biases Norms are changing rapidly; done in 3/16 Acceptability does not necessarily = uptake Context matters, i.e. clinical trial efficacy data may alter perceptions Nonetheless, given large sample size and geographic diversity, findings reassuring

Bio-Prevention is always “Bio-Behavioral” (pills, rings, and injections require adherence) Depression, anxiety, other behavioral health issues, alcohol and other substance use Pleasure reduction Self efficacy Safer Sex Adherence Disease prevention Social Models Wulfert, Safren, et al., 1999; Journal of Applied Social Psychology

Where to provide new prevention modalities? Setting Barriers Facilitators STD Clinics Don’t provide 1° care High patient volume Limited counseling time See high risk populations Sexual health focus Partner notification services Community Health Centers Clinicians not trained in sexual health care Busy clinical practices Need to address 10 care issues Limited counseling staff Opportunity to integrate care Ongoing relationship Safety net insurance programs May be medical home for at risk, underserved patients Community-Based Organizations Lack of clinical support Often limited resources Need to link to clinicians, who may or may not be responsive Work with at-risk populations Able to do community outreach May have peer navigators Pharmacies Prescriber often not on site May not be able to address other health concerns Lack of private physical space for counseling Experience with medications and adherence counseling Collaborative drug therapy agreements Extended operating hours Potentially low service fees Primary Care Providers Generalist Busy schedule Discomfort discussing sexual behaviors Discomfort using new medications Able to integrate other primary care issues Long-term patient relationship common “One-stop shopping”

MSM in states with higher levels of structural stigma were more likely to report condomless anal sex, were less likely to have used PEP or PrEP, and less likely to disclose same sex behavior with their providers Oldenburg, C et al, AIDS, 2015

Conclusions In a national sample of MSM, most had heard of PrEP, but only 15% had used it in 2016 Interest in other modalities was high. Interest in infusable antibodies and in injectable antiretrovirals > than for topical rectal approaches. MSM who were more interested in parenteral approaches to HIV prevention were more likely to be: -from racial/ethnic minority communities -engaging in condomless anal sex with > 1 partner -oral PrEP inexperienced But behavioral and structural issues will also need to be addressed to optimize population-level impact

Thank you Katie Biello Connie Celum Mark Hatzenbuehler Doug Krakower Matthew Mimiaga David Novak Catie Oldenburg Participants Unrestricted research grant from ViiV Healthcare www.fenwayhealth.org www.thefenwayinstitute.org