1. 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

2. 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)

4. 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.

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

6. 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%

7. 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

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

9. 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%

10. 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%

11. 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)

12. 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)

13. 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

14. 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

15. 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”

16. 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

17. 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

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