Michael Stiratt, PhD NIMH Division of AIDS Research CFAR Antiretrovirals for Prevention (AFP) Working Group October 2, 2017

1. New NIH Funded Research to
Advance Oral PrEP Use and Delivery
Michael Stirratt, PhD
NIMH Division of AIDS Research
CFAR Antiretrovirals for Prevention (AFP)
Working Group
October 2, 2017

2. Progress and Challenges in PrEP Use
2

3. NIH Request for Applications (RFA):
“Improving the PrEP Cascade”
•Sponsored by NIMH, NIAID, NIDA, NINR
• RFA-MH-17-360 & RFA-MH-17-361
• RFA = dedicated, set aside funds
• Supported R01 and R34 applications
• R01 = large projects
• R34 = developmental projects
Liu, IAPAC 2012

4. RFA Goals
•Called for research applications to
develop and test innovative approaches
to:
• Speed PrEP access and uptake
• Support PrEP adherence and
persistence
• Address key populations and age and
racial/ethnic disparities in PrEP use
Liu, IAPAC 2012

5. RFA Priority Populations
•Individuals in US or foreign settings who
may benefit from PrEP, including:
■ Men who have sex with men (MSM)
■ Transgender individuals
■ Cisgender women
■ Sex workers
■ Persons w/injection & non-injection
substance use disorders
■ Serodiscordant couples
•Interventions may also target:
■ Health care providers
■ Health care facilities Liu, IAPAC 2012

6. RFA Timeline and Outcomes
•Applications due Jan 6 2017
• 63 applications received
•Peer review April 2017
•Advisory council reviews May 2017
•Awards made summer 2017
• 13 awards made
Liu, IAPAC 2012

7. RFA Awarded Projects: Type and Funder
R34 pilot
projects,
6 awards
R01 large
projects,
7 awards
7
NIMH
6 awardsNIDA
5 awards*
NINR
2 awards
*Includes NIAID Co-funding

8. Early Stage Investigators (ESIs) in the RFA Awards
Early Stage
Investigator
32%
Other
Investigators
68%
• Phil Chan
• Kasey Claborn
• Andrew Medina-Marino*
• Amy Nunn*
• Parya Saberi*
• Aaron Siegler*
• Tyrel Starks*
* First NIH R01 award
8

9. Research location for awarded projects
Foreign
project, 2
US project,
11
South Africa
Mexico
9
National
1
Northeast, 3
Multisite, 3
(mostly South)
West, 3
Midwest
1

10. Themes Across Awarded Applications
• Understudied populations
▪ Latino MSM
▪ Male and female sex workers
▪ Cisgender women leaving prison
▪ Drug users
▪ Underserved US cities
• Novel approaches
▪ Innovations in care delivery
▪ Provider level interventions
▪ Social network interventions
▪ Behavioral economic incentives
▪ mHealth tools
10
• Preliminary data was valuable

11. Parya Saberi, 1 R01 NR017573-01
“Improving the HIV PrEP Cascade using an Intervention
for Healthcare Providers”
• Primary Aim: Evaluate efficacy of a clinic-level intervention
to increase PrEP prescriptions through a stepped-wedge
trial among 10 San Francisco primary care clinics
• Intervention: Web-based PrEP care management tool
(PrEP Rx) for screenings and flow + a centralized clinic PrEP
coordinator
• Secondary aim 1: Explore multilevel influences on PrEP
initiation, duration of use, and reasons for discontinuation
• Secondary aim 2: Explore intervention sustainability up to
8 mos after the trial phase
• Secondary aim 3: Investigate intervention experiences via
interviews with providers, PrEP Coordinators, and clinic
directors

12. Harold Green 1 R34 MH114696-01
“Improving PrEP Availability & Access for Populations at
High Risk for HIV: Social Network Tools that Improve
Uptake of Innovative Medical Best Practice”
• Concept: Use medical claims data to infer physician
networks and advance targeted network interventions
to encourage primary care providers to offer PrEP.
• Aim 1: Construct a PrEP-related physician-to-physician
network through claims data
• Aim 2: Test for determinants of PrEP prescribing
(including network characteristics, geographic factors,
and community-level social determinants)
• Aim 3: Use results to model and inform a strategic
campaign to promote PrEP prescribing

13. Jeffrey Kelly & Yuri Amirkanian 1 R01 NR017574-01
“Increasing PrEP Use in High-Risk Social Networks of African
American MSM in Underserved Low-Uptake Cities”
• Concept: Social network interventions can improve PrEP
use among Black MSM in Milwaukee and Cleveland
• Aim 1: Intervention mapping and refinement
• Aim 2: Recruit social networks of young Black MSM at
high risk for infection
• Aim 3: Randomize social networks to intervention or
control arms; network leaders in the intervention arm
receive a PrEP training program
• Aim 4: Compare outcomes (PrEP use) at 6 and 15 mos
and model impact on HIV incidence

14. Aaron Blashill & Kristen Wells 1 R34 MH114699
“Developing a Patient Navigation Intervention for
PrEP Continuum of Care among Young Latino MSM”
• Aim 1: Assess the needs/assets of young adult Latino
MSM (age 18-29) in San Diego regarding engagement
and retention in the PrEP cascade via qualitative data
• Aim 2: To develop and pretest a culturally relevant peer
PrEP patient navigation intervention in both Spanish and
English designed to facilitate engagement and retention
in the PrEP cascade among young adult Latino MSM
• Specific Aim 3: To conduct a pilot randomized controlled
trial of the patient navigation intervention by comparing
it to usual care to assess feasibility, acceptability, and
preliminary impact

15. Patrick Sullivan 1 R01 DA045612-01
“Theoretically Based Mobile App to Increase
PrEP Uptake Among MSM”
• Aim 1: Update the HealthMindr app to support PrEP
screening and linkage
• Aim 2. Test HealthMindr app use vs standard care on rate of
PrEP uptake among 657 MSM in 3 cities (Atlanta, Jackson,
and Washington DC) over 12-mos
• Aim 3. Quantify factors that mediate and moderate the
efficacy of the HealthMindr app on PrEP uptake, including
dose-response analysis.
• Aim 4. Conduct interviews with app-using men who did/did
not start PrEP to understand how it could be further
leveraged to promote PrEP uptake.

16. Susan Ramsey & Kasey Claborn 1 R34 DA045621
“Linkage to Community-Based HIV PrEP Care Among at Risk
Women upon Release from Incarceration”
• Aim 1: Conduct interviews with incarcerated women
at risk for HIV and other stakeholders to develop the
intervention
• Aim 2: Pilot the intervention (pre-release education +
motivational interviewing & post-release patient
navigation)
• Aim 3: Conduct a preliminary RCT comparing the
intervention to standard care among 80 at-risk
incarcerated women

17. Susan Sherman 1 R34 DA045619-01
“Developing a PrEP Adherence Intervention
Targeting At-Risk and Substance Using Women”
• Focus: street-based female sex workers (FSWs) in Baltimore
• Aim #1: Employ community forums, focus groups, provider
interviews to develop a small-group PrEP engagement and
mHealth enhanced intervention to promote PrEP uptake
and adherence among street-based FSWs
• Aim #2: Assess intervention acceptability, feasibility, and
preliminary impact on PrEP uptake and adherence in
intervention vs comparison arm (n=40 per arm) at 6-mos
Aim #3: Explore intervention mediators including empowerment (e.g. PrEP self-efficacy)
and structural vulnerability (e.g., access to care)
Aim #4: Explore patterns/predictors of PrEP adherence via drug concentrations among
intervention participants over 6-mos

18. Omar Galarraga 1 R34 MH114664-01
PrEP Seguro: Antiretroviral-based HIV prevention
among men at high risk in Mexico
• Hypothesis: PrEP adherence can be improved among male
sex workers (MSW) if PrEP is provided for free along with
highly-tailored conditional economic incentives (CEI).
• Aim 1: To refine user-centered CEI for PrEP adherence via
computer survey (n=200) and conjoint analysis.
• Aim 2: Conduct a randomized controlled pilot (n=100) of
CEI to promote PrEP adherence among MSW in Mexico City
• Aim 3: Estimate the preliminary cost-effectiveness of the
CEI intervention

19. Andrew Medina-Marino & Linda-Gail Bekker
1 R01 MH114648-01 “The Community PrEP Study”
• Aim 1: Assess adolescent girls and young women’s
(AGYW) uptake of PrEP when offered in the context
of community-based HIV counseling and testing
(CBCT) programs in urban and rural South Africa
• Aim 2: Randomize initiators to 3 community-based
interventions for prevention-effective PrEP
adherence (individual counseling, adherence clubs,
community-based prescription delivery)
• Aim 3: Evaluate cost per AGYW initiated on PrEP,
and the cost-effectiveness per incident HIV
infection averted

20. Joanne Stekler 1 R34 DA045620-01
“Interventions to Improve the HIV PrEP Cascade
among Methamphetamine Users”
• Aim #3: Evaluate acceptability
and impact of interactive text
messaging on meth use and
PrEP adherence
• Aim #1: Design interventions and finalize materials
through focus groups
• Aim #2: Conduct a pilot RCT to evaluate acceptability
and feasibility of a peer navigation intervention for
meth-using MSM/TG

21. Tyrel Starks, 1 R01 DA045613-01
“Intervention to reduce drug use and HIV incidence
among high PrEP priority partnered YMSM”
• PARTNER Intervention:
• MI-based counseling delivered to partnered YMSM on PrEP, drug use, and risk reduction
• Assertive communication skills training videos enhance general relationship functioning
and model PrEP-specific communication between partners
• AIM 1: Evaluate intervention efficacy on 1) PrEP uptake and adherence via dried
blood spots; 2) transmission risk behavior (condomless anal sex or bacterial STI
infection in the absence of adequate PrEP adherence); and 3) drug use
• AIM 2: Identify individual and relationship factors which moderate or mediate
intervention effects
• SECONDARY AIM 1: Gather ideographic data to inform a future effectiveness-
implementation study.
• SECONDARY AIM 2: Validate the use of fingernail assays as a biological marker
for PrEP adherence.

22. Philip Chan & Amy Nunn 1 R01 MH114657
“Characterizing the HIV PrEP Care Continuum for African
American and Hispanic/Latino Men Who Have Sex with Men”
Aim 1: Characterize the PrEP care continuum using an open, prospective cohort of 450 MSM in real-world
clinical settings in three cities (St. Louis MO, Jackson MI, and Providence RI).
- Assess patients who are: 1) retained and sub-optimally adherent (assessed by dried blood spots); 2)
retained and optimally adherent; 3) not retained in PrEP care; and 4) no longer clinically indicated for PrEP.
- Measure structural, social and individual-level factors associated with optimal and suboptimal adherence
and retention in PrEP care, with a focus on African American & Hispanic/Latino MSM.
- Assess entry and exit into the PrEP care continuum over time.
Aim 2: Measure the impact of suboptimal retention in care and adherence on population-level HIV incidence.
- Perform microsimulations using our real-world adherence and retention in care data to evaluate the impact
on HIV incidence in three US cities (Providence, St. Louis, and Jackson).

23. Aaron Siegler & Ken Mayer 1 R01 MH114692
“Making it last: A randomized, controlled trial of a home care system
to promote persistence in PrEP care”
• Persistence in PrEP care is suboptimal,
particularly among YMSM and YBMSM
• PrEP@Home is a home-based care
system for assessing HIV infection,
creatinine, syphilis, gonorrhea, and
drug levels + app based guidance
• Can address participant and
healthcare system burdens and reduce
annual in-person visits from 4 to 1

24. • Sites: Boston, Jackson, St.
Louis, Atlanta
• RCT with 396 participants
• 264 PrEP@Home
intervention
• 132 standard of care
referral control
• MSM sample to be 50%
Black, 50% young (<30)
• 12-month follow-up
• Outcome: effective
retention in care
• Determined by biomarker
at 6, 12 moSample app screens
• Aim 1. Levels of TFV-DP for
intervention relative to
control
• Hypothesis. Participants
randomized to PrEP@Home
will have higher levels of
TFV-DP than standard of
care controls.
• Aim 2. Adjusted,
exploratory analyses and
mathematical modeling for
population-level impact
estimates
• Aim 3. Cost-effectiveness
and cost-utility analyses of
the PrEP@Home
intervention.
Aaron Siegler & Ken Mayer 1 R01 MH114692
“Making it last: A randomized, controlled trial of a home care system
to promote persistence in PrEP care”

25. Themes Across Awarded Applications
• Understudied populations
▪ Latino MSM
▪ Male and female sex workers
▪ Cisgender women leaving prison
▪ Drug users
▪ Underserved US cities
• Novel approaches
▪ Innovations in care delivery
▪ Provider level interventions
▪ Social network interventions
▪ Behavioral economic incentives
▪ mHealth tools
25

26. NIMH Support for Behavioral/Social PrEP Research
Research Funding Opportunity Announcements
Year Title FOA number
2010 Behavioral Mechanisms in Biomedical Strategies
to Prevent HIV Infections
RFA-MH-11-090
2014 Strengthening Adherence to Antiretroviral-Based
HIV Prevention and Treatment
PA-MH-14-126
2016 HIV Pre-exposure Prophylaxis (PrEP)
Implementation Science in CDC-funded Public
Health Demonstration Projects (Admin Supp)
PA-MH-16-199
2016 Improving the HIV Pre-Exposure Prophylaxis
(PrEP) Cascade
RFA-MH-17-360
2017 Strengthening the HIV Pre-Exposure Prophylaxis
(PrEP) Care Continuum through Behavioral,
Social, and Implementation Science
PA-MH-17-104 &
PA-MH-17-105

27. • “Strengthening the HIV PrEP Care Continuum through Behavioral,
Social, and Implementation Science”
• PA-MH-17-104 & PA-MH-17-105
• This Funding Opportunity Announcement encourages research to:
■ identify gaps in the HIV PrEP care continuum and associated
determinants;
■ develop and test interventions to strengthen PrEP delivery, use,
and outcomes; and
■ reduce racial/ethnic and age-related disparities in PrEP uptake
and use
Calling for further research on PrEP use & care
27

28. Foundations for PrEP Success
• PrEP’s preventive impact builds on…PrEP
• Support for consumer adherence,
care engagement, and retention
Behavioral
support
• Access to care; culturally
competent care; provider and
clinic/organizational factors
Effective care and
service provision
• Addressing stigma;
community support;
structural factors
Supportive social, structural,
and policy environments

29. Putting the big picture together…
…the solution will involve each piece
Michael Stirratt, Ph.D.
Program Officer
NIMH Division of AIDS Research
stirrattm@mail.nih.gov
240-627-3875
THANKS!Biomedical prevention
Social Determinants
Behavioral approaches
Structural Interventions

30. Goals:
■ reduce HIV incidence worldwide
■ decrease the burden of living w/ HIV
■ advance HIV cure research
NIMH Division of AIDS Research (DAR)
Google “NIMH AIDS funding”
for current research funding
opportunities