UNC Center For AIDS Research · UNC Center For AIDS Research . Organization The UNC CFAR is a consortium of three complementary ... •Increase capacity in South Carolina (collaboration

P30-AI050410

UNC Center For AIDS Research

www.unccfar.org

http://www.unccfar.org/

Organization

The UNC CFAR is a consortium of three complementary

institutions: The University of North Carolina at Chapel

Hill, Research Triangle Institute, and FHI 360, with each institution

adding significantly to the breadth of the research effort

Core A: Administrative Core

Core Director/PI – Ronald Swanstrom

Associate Director – Myron Cohen

Admini. Director – Prema Menezes

Admin. Assistant – Veronica CalvageSCEED Office

SCEED Office Faculty – Ronald Strauss

SCEED Office Director – Caressa White

Internal Advisory Board

(IAB)

Community Advisory Board

External Advisory Board

Core Directors Meeting

Users at UNC, FHI 360, RTI

Co

re E

va

luatio

ns

B: Developmental Core

Kate MacQueen

w/ IAB

C: Clinical Core

Joe Eron

w/ IAB

J: VIM Core

Julie Nelson

w/ IAB

E: Pharmacology Core

Angela Kashuba

w/ IAB

F: Biostatistics

Michael Hudgens

w/ IAB

G: Behavioral Core

Carol Golin

w/ IAB

I: International Core

Jeff Stringer

w/ IAB

Co

mm

unic

atio

ns

UNC CFAR Organizational Chart

8 cores

UNC CFAR Cores: Overview

o Cores are spread across the health affairs campus

engaging 8 different departments

o Core directors are senior faculty and a major strength

of our CFAR

• Three Core Directors hold leadership positions within their

departments

o Our working strategy has been to ask the cores to adapt to the needs of the membership rather than dropping and adding new cores

Specific Aims: Aim 1

o Provide administrative and scientific leadership by:• Catalyzing new strategic partnering (Biostatistics core

U24 largest NIH grant received by UNC in 2016)

• CARE Cure Collaboratory and the UNC/GSK HIV Cure Center (Two large funded applications UM1 AI)

• Managing and redistributing CFAR resources and pursuing additional resources (Dev core awards have directly increased HIV research capacity 1:16)


o Stimulate new innovative research in critically important areas and provide comprehensive mentoring to the next generation of HIV/AIDS researchers by:

• Funding innovative Developmental Awards (Lisa Hightow $3.8 mil iTech-HD)

• Leveraging CFAR funds (FHI/RTI; Medicine/Pub Health/SW/Nursing/ Pharmacy/Dentistry; NC TraCS/CTSA)

• Supporting new Scientific Working Groups (PrEP)

• Promoting innovative research: UNC Clinical Cohort/CNICS databases and specimens (R01-AI application: Genomics of adverse events of combined antiretroviral therapy in people living with HIV)


o Provide support to innovative multidisciplinary research through the CFAR Cores by:

• Providing access to state-of-the-art laboratory support in virology, immunology, microbiology, and pharmacology in CAP/CLIA-accredited space

• Managing a large clinical cohort linked with a specimen repository and patient-reported behavioral data for clinical and translational research (CSF collection for CNS reservoir research-MH)

• Providing biostatistical services and support for social and behavioral science research (Biostats boot camp; weekly pop-up clinic, networking events)


o Support major NIH-funded initiatives in HIV/AIDS research and CFAR-directed priorities by:

• Supporting members working in NIH networks including HPTN, ACTG, HVTN, MTN, IMPAACT, ATN

• Supporting members working with NIH HIV Cohorts: WIHS, CNICS, NAACORD, and IeDEA (Ann Dennis KO8 to RO1 submitted)

• Supporting members working in the Delaney CARE Cure Collaboratory (Faculty recruitment for Cure Ctr)

• Participating in and providing leadership for inter-CFAR collaborative working groups (Christopher Hurt PrEP)


o Strengthen the international research portfolio by:• Facilitating collaborations in 5 focus countries (Malawi,

S. Africa, Zambia, China, Vietnam)

• Matching dollars for Equipment Supplement application

• Developing new HIV/AIDS research talent among junior UNC and in-country investigators

• Faculty recruitment Nora Rosenberg/ non-faculty MagaChagomerana, head of the UNC Project, Malawi Analysis and Writing Unit

• Ensuring availability of high-quality laboratory services at supported sites

• Equipment

• Training: Laboratory skills/VIM core; Data analysis and manuscript writing/Admin Core


o Engage in outreach and education by:• Supporting an active Community Advisory Board

• Sponsoring an on-campus AIDS Course with distance-learning program, eg collaborating HBCUs

• Developing web-based outreach tools and publishing a CFAR electronic newsletter and event bulletin

• Holding networking events to engage targeted groups of local investigators for support and collaboration (David Price Congressman May 8th)

What is New Today?o Faculty recruitment: Cure Center and Biostats

o New PrEP SWG: interface with inter-CFAR WG and SE

Regional CFAR WG – Christopher Hurt)

o Core G (SBSRC) looking to roll out its survey instruments

library ($ support U Penn CFAR)

o Increased international research

capacity (Malawi new 1.2 million

Cancer Bldg)

o Biostat Core leads ATN network coordinating center

o VIM Core developing new drug resistance sequencing

platform

o Exploring rapid ART initiation and linkage to care with NC

DHHS (HIV Prevention SWG and Vicki Mobley HIV/STD

Medical Director)

P30-AI050410: UNC Center For AIDS Research

NIH Site Visit: May 11, 2017


Ron Swanstrom

Organization

Administrative Core

SCEED Office

Administrative Director

Prema Menezes

Associate Director

Myron Cohen

Core Director

Ron Swanstrom

Faculty Director

Ron Strauss

Website Manager

Dani Strauss

Director

Caressa White

Aim 1 (of 5): Leadership

o Communication: CFAR listserv, HIViews, Quarterly Newsletter

o CFAR website: Service Request System; Core-specific web pages; funding announcements; events

o Access to CFAR and Dissemination of Results

• Actively engage researchers working in or interested in HIV

• Disseminate research findings at weekly conference, CFAR membership network, institution media outlets

o Admin Support As Needed

• Communications support for CFAR events (networking, conferences, outreach, e.g. WAD)

• Personnel and dollar support for events

March 2017

Aim 2: Strategic Planning and Scientific Cores (1)

Infrastructure support and guidance to promote multidisciplinary research:

o Coordination and optimization of response to RFAs

• RTI and UNC response to NIDA/NIH RFA

• Phylodynamic Tracking of Transmission (Dennis AI-RO1)

o Support major NIH HIV/AIDS initiatives

• HIV Cure SWG

• HIV NC Prevention SWG (feeds directly into SE CFAR Consortium w/ NC State Health Dept.)

• HIV PrEP SWG (under development)

• Coordinate responses to CFAR Supplements

Aim 2: Strategic Planning and Scientific Cores (2)

o Meetings

• Monthly- Core Directors

• Yearly –EAB

• Yearly – Strategic Planning Meetings

o Surveys

• Biennial User Survey (How best to do?)

o Strategic Plan

• Yearly for each Core (Include IAB)

Aim 3: Support SCEED Office

Aim 4: Faculty and Facilities

o New Faculty Recruitment:

• Cure Ctr. (Medicine + Pharmacy); Biostatistics

• Capacity building (International Core, Malawi); Internship opportunities (Biostats, Solar, NCCU)

o Space allocations

• Collaboration with School of Medicine/LCCC (Space for new Administrative Director and SCEED office personnel-ID Division)

o Domestic Infrastructure Support

• NC Dept. of Health and Human Services

• Pharma

o International Infrastructure support

• Equipment cost sharing

Aim 5: CFAR Processes and Procedures (New Admin. Dir. and Admin. Assist.)

Promoting Collaborations and Interfacing With All Users:

o Decision Making

• Budgets and fiscal soundness

o Prioritization of Core Users

• Uniform policy for prioritization of core use

o Selection of CFAR leaders and advisors

• Review and selection of CFAR leadership (Added RTI/FHI 360)

o Selection of Developmental Awardees with Core B

• Review all applications and provide input

o NIH Reporting

• Responsible for non-competitive and competitive renewal and all other reports

Strategic Planning

o Reducing Incidence of HIV/AIDS:• Rapid ART initiation and linkage to care (NC State DHHS;

SE CFAR consortium potential inter CFAR WG)

• SWG (PrEP and NC HIV Prevention)

• Increase capacity in South Carolina (collaboration with SCHD and academia)

o Next Generation of HIV Therapies With Better Safety and Ease of Use:

• Foster interactions with Pharma/investigators/ACTU in the development of new therapies

o Research Toward A Cure:• Support the Cure Ctr. and Cure SWG• Provide opportunities for young investigators and all cure

investigators

o HIV-Associated Comorbidities, Co-Infections, and Complications

• Foster collaborations with RTI in studying the HCV co-epidemic. Consider a future SWG in Aging and Comorbidities.

o Research to Reduce Health Disparities in Incidence or Treatment Outcomes

• Support faculty interests in working in the NC correctional facilities and with primary care physicians

o Research Training of the Workforce to Conduct High Priority Research

• Support trainees (training grants, individual awards, internships) and training links with HBCUs.

• Explore a KRAFTS Club (with Dev Core) to mentor trainees in grant writing.

Strategic Planning

P30-AI050410-AI50410: UNC Center For AIDS Research



Strategic Community Engagement, Education, and Dissemination Office (SCEED)

Director:Caressa White

Faculty Director:Ron Strauss



Core A Specific Aim 3

Engage in outreach and education

o Connect the CFAR to the

community, media, people living

with HIV and their families,

research partners, and future

investigators

o Make HIV/AIDS research and findings accessible, viable,

and embedded in the lives of researched populations

o Maintains authentic, trusting, and reciprocal relationships

between CFAR scientists and communities

Key Contributions: Value Added

o Convene an active Community Advisory Board

o Teach AIDS Course enrolling 300-400 students

o Maintain web-based outreach, social media presence,

CFAR electronic newsletter and event bulletins

o Hold networking events to engage targeted groups of

researched populations and local investigators

o Outreach to HBCUs

o Participate in National CFAR CAB Coalition

o Sponsor events

• World AIDS Day

• Durham Knows HIV Testing Campaign

• Outreach to Seniors

• Health Fairs, Community Symposiums

• PiLLow Talk - Women and PrEP dissemination event

Promote Inter and Intra CFAR Synergy

o CFAR HIV in the South Workshop community

engagement panel

o Inter-CFAR Faith Working Group

o Social & Behavioral Sciences Meeting – community

panel on intersection of HIV and social justice in faith

communities

o National CFAR CAB Coalition strategic plan for

Community Outreach & Engagement

o Support CFAR Core G, Networking events and Projects

o Support HIV Cure Science Working Group with a focus

on CURE Research

Strategic Planning: Short and Long Term Goals

o Expand utilization of social media and promote the

wider use of community based settings as outlets to

disseminate research findings

o HBCU Initiative - build summer HIV research

internship opportunities

o Collaborate with Core G and School of Public Health to

better understand how to bridge community

engagement and Implementation Science

o Organize an NC HIV Leadership Council of

government and private stakeholders

o Implement a community engagement evaluation



Core B: Developmental Core

Kate MacQueen, PhD, MPH, Director

Cathy Emrick, MPH

Core Manager

Mentoring Advisory

Committee

Ada Adimora (Core B)

Tania Caravella (Cores C & I)

J. Victor Garcia-Martinez

(UNC Microbio & Imm)

Carol Golin (Core G)

La Verne Reid (NCCU)

David Wohl (UNC ID, NC

Prevention SWG member)

William Zule (RTI, Core G)

Ada Adimora, MD, MPH

Co-Director

Specific Aims

Aim 1. The Core will provide access to a Small Grants

Program

Aim 2. The Core will facilitate access to mentorship within

the CFAR community

Aim 3. The Core will build capacity domestically and

internationally

Aim 4. The Core will engage in evaluation and

strategic planning

1st place Return On Investment!

CFAR Tier Average amount of

pilot awards

% Pilots with

resulting award

Return on investment

% Pilots with NIH

grant as first award

% Pilots led to R01

Tier 1 $38,664 27.6% $8.41 21.8% 10.3%

Tier 2 $36,182 19.3% $7.28 14.8% 6.8%

UNC CFAR $20,351 27.6% $16.50 25.7% 14.3%

Tier 3 $54,312 32.4% $7.85 28.7% 13.4%

2017 Awardee/applicant survey respondents:

o “Fantastic support to propel research and set the

stage to apply for a bigger grant”

o “Great introduction to writing proposal and practice for

R01 application”

Developmental Award Priorities

Priority PI status Demographic Research focus

High

Low

New investigator

Newly recruited

junior faculty

Under-

represented

minority

Female

SWG related:

Cure/eradication

NC HIV Prevention

Independent

investigator new

to HIV

International

HBCU

NIH HIV Priorities

Independent HIV investigator

Other innovative HIV-related research

Developmental Award Types

o Traditional Developmental Awards ($30,000 + leveraged funds from institutional partners)

o SWG Awards ($40,000 + potential cofunding with Duke, Emory CFARs)

o Time-sensitive out-of-cycle opportunity ($30,000)

o Small secondary data analysis awards with Cores G and C (previously $5000, to be revised)

o NC TraCS (UNC CTSA) co-funded award ($25,000 CFAR + $25,000 TraCS)

o CFAR supplements, coordinated with Core A

2015 – 2017 Awards

Summary

Disciplinary focus

Basic Science 7

Clinical 1

Epidemiological 1

Social/Behavioral 3

Math Modeling 1

Total awards 13

Total funding $369,962

PI Demographic

International 3

Female PI 9

HBCU / minority 1

Research focus

Cure 4

PrEP 3

Core B Funding

Year Total Core Budget % from CFAR

2015-16 $46,857 100%

2016-17 $65,975 100%

Unique model relative to other Core budgets

NIH Programs and Grants Supported By Core B (2010-present)

o NIAID (9 R01, R56, R21, K01)

o NCI (R01, R21)

o NIMH (4 R01, 2 K99)

o NICHD (4 R01, K99, SC2)

o NIDA (R01)

o NINDS (R01)

o NIA (R24 pilot)

Average time to first NIH award: 1.8 years

Highlights: Former Core B Awardees

Lisa Hightow-Weidman (2006 award)

Post-doc to tenured Associate Professor

UNC School of Medicine

2016 NIDA/NICHD U19 UNC/Emory Center for

Innovative Technology (ITECH) across the prevention

and care continuum

Jennifer Tang (2013 award)

Post-doc to Assistant Professor

Global Women’s Health

2016 NICHD R01 Pharmacokinetic interactions

between efavirenz and the levonorgestrel

contraceptive implantTeaching emergency obstetric &

neonatal care in Malawi

Inter and Intra CFAR Synergy

o UCSF CFAR – Mentoring minisyposium (at UNC), Leadership Development seminar (at UCSF)

o Duke (PrEP SWG), Emory (Cure SWG) CFARs -joint Developmental Awards

o Core G /Social and Behavioral Science Research & Core C /Clinical - secondary data analysis RFA

o Core G /Social and Behavioral Science Research -mentoring webinar

o Fogarty Global Health Fellowship – travel funds for Fellows

Strategic Planning

Short Term Goals

o Strengthen mentoring – application requirements for

NIH readiness; forum presentations

o Increase in webinars – publishing, NIH grants,

professional development, international research

o Better publicize Core resources & opportunities

Long Term Goals

o Develop KRAFT-style mentoring process, i.e., K or

post-doc to R01

o Address barriers for HBCU applicants



Core C: Clinical Core

Director: Joseph J. Eron, MD

Associate Director: Sonia Napravnik, PhD

Facilitate and enhance clinical and translational research at UNC, FHI and RTI

Organization

Joseph Eron, MD

Director

Sonia

Napravnik, PhD

Associate

Director

Oksana

Zakharova, MS

Manager

Claire Farel, MD

MPH

Investigator

David Wohl, MD

Investigator

Kaitlyn Michalak, BSc

Data Manager

Tania Caravella,

MPH

Regulatory

Specialist

Cheryl

Hendrickson, BA

Regulatory

Assistant

Katherine Barley, BSc

RA, Screener

Ashley Boshe,

BSc, RA

Alexa Stout, BS

RA

Thibaut Davy, BS

Predoctoral

Student

Emma Liu, BSc

RA

Laurence

Brunet, PhD

Post-doctoral

Fellow

Amanda Antono,

BSc, RA

Heather Prince,

MPA

Study Coordinator

JoAnn Kuruc,

MSN

Program

Manager

Amy Heine, FNP

Project Manager

Jane Chen, BS

Predoctoral

Student

1. Provide essential patient-based services

2. Support CFAR initiatives & collaborative research

3. Foster synergy: intra- & inter-CFAR, Networks

4. Mentoring

5. Strategic planning

Core services across the translational and clinical research process

Specific Aims

Core C Funding

Year

Total Core

Budget

% Budget

from CFAR

2016-17 603,000 33%

NIH Programs and Grants Supported By Core C

o NIAID (3 UM1, 4 U01, 12 R01, 7 other R, 3 K, 4 T32)

o NCI (1 U01, 1 P01, 1 R01, 2 other)

o NIMH (5 R01, 2 other); NHLBI, NICHD, NIDA, FIC, NIGMS, NIDDK, NIAAA, NINDS & NIDCR (19 grants)

o Macrophage cells in latency: Garcia (R01 AI11899)

o IFN-TET-ISG pathway: Su (R01 AI127346)

o iENGAGE: Mugavero (R01 AI103661)

222

68 64

99 93110

97

29

06-10 11 12 13 14 15 16 17

Calendar Years

Publications


UCHCC

Ann Dennis, MD, MS

• Phylogenetics (Virus Evol

17)

• K08 AI112432

• R01 submitted

Lance Okeke, MD

• Hypertension (CID 16)

• R56 HL1298880 (CNICS)

• K23 submitted

UNC/DUKE CTSA

Collaborative Program


HIV CURE

o Participants (HIV-; HIV acute; HIV+)

o Protocols for blood, hair, genital tract, large volume CSF, bone marrow, GALT, lymph node biopsies

o Experienced research staff for

recruitment, enrollment, data &

specimen collection, regulatory

approvals

o Fetal thymus tissue from infants

undergoing cardiac surgery


Developmental

Targeted

RFAs (new)

Development

al award

reviews

Mentorship

IAB

Biostatistics

Grand Rounds

CNICS

Epi/Bios Core

Targeted RFA

(new)

Mentoring /

training

IAB

CPAC

Study

coordinator

Specimen /

tissue

collection

(new)

Administrative

Community

engagement

Advertising

Community

events &

symposia

Speakers

SBS

CSDBS and

PROs

UCHCC/Priso

n cohort

Targeted RFA

(new)

IAB

International

Mentoring

junior

investigators

(new)

Training

VIM

UCHCC /

repositories

Specimen

collection

SWG

Cure SWG

NC HIV

Prevention

SWG

Strategic Planning: Short Term Goals

oInfrastructure supporting multidisciplinary

translational, clinical & public health HIV

research

oTissue compartment sampling (GALT,

bone marrow, CSF), clinical biopsy

samples, blood and tissue repository

HIV/cancer

oHIV-uninfected cohort: access to

specimens and data; initial participants in

existing programs; future expansion to

cohort

oeResearch and mResearch: study

enrollment; online remote study

participation; PROs and CSDBS; participant

engagement

Strategic Planning: Long Term Goals

o HIV Cure and Eradication: enhance recruiting, assist with tissue

compartment collection (bone marrow, CSF, GALT)

o Research for combination prevention: Develop HIV-uninfected at

risk cohort in collaboration with SBS- using PrEP studies and

outreach effort and mobile and on-line follow-up

o HIV care continuum, transmission clusters, micro-epidemics,

entry and retention in HIV care: use granular data from UCHCC

and CNICS and linked sequence data to inform larger less

granular data set (NC DHHS data sets)

o HIV treatment, clinical and comorbidity outcomes: expand

UCHCC and CNICS to collect and adjudicate additional co-

morbid outcomes including hospitalization data

o HIV in women: facilitate cross-disciplinary research through

collection of genital secretions and cervical tissue in infected and

uninfected women.



Core E: Clinical Pharmacology and Analytical Chemistry Core

Director: Angela Kashuba

Assistant Director: Mackenzie Cottrell

Organization

Director (20%): Angela Kashuba

Assistant Director (20%): Mackenzie Cottrell

Lab Manager (15%): John Dohnal

QA Officer (15%): Hannah Bryan

Bioanalytical Chemistry Director (25%): Craig Sykes

3 analytical chemists supported on grants and recharge center

Kimberly Blake, Amanda Schauer, Nicole White

Imaging Mass Spectrometry (10%): Eli Rosen

Clinical Coordinator (10% Clin Core): Heather Prince

Pharmacometrician (20%): Jason Pirone

Specific Aims

1. Provide access to a diverse array of cost-effective services for pharmacology research

2. Stimulate, develop and disseminate new innovative technologies and services to enhance HIV/AIDS research

3. Support priority CFAR initiatives and goals and collaborative research

4. Develop and promote synergistic relationships between the Cores and Working Groups, and other CFARs

5. Provide clinical pharmacology, pharmacometric, and analytical chemistry training, mentoring, education, and outreach

6. Engage in evaluation and strategic planning

CLIA- (#34D1022136) and CAP- (LAP#7521077;AU-ID#1589458)

Core E Funding

YearTotal Core

Budget

% Budget

from CFAR

Grant

2015-16 $1,900,461 11%

2016-17 to date $1,197,591 17%

NIH Programs and Grants Supported By Core E: 2016-2017 to date

o Greenblatt (NIAID U01) – development of new methods to measure ARVs in hair

o Mitchell (NIAID P30) – CFAR supplement development and DBS analysis for PrEP at HBCUs

o J Tang (NICHD R01) – ARV interactions in plasma, cells and genital fluids with long acting hormonal contraceptives

o Samet (NIA U01) – ARV screening for Russia ARCH cohort

NIAID NICHD NIDDK NHLBI NIAAA

R01 12 3 1 1

R21 1

R56 2

U01 4 1

U19 1

Admin suppl 3

o Developed/validated vanguard bioanalytical methods

oHair ATV/RTG (DRV in development) for WIHS

oDBS 3TCtp, FTCtp, and TFVdp for ATN, RTI, CFARs (Duke, UCSF)

o Developing new technologies to provide innovative

pharmacology services:


Mass spectrometry imaging Hollow Fiber PK/PD Model System


o Provided proposal development

support for 15 applications in

2016/2017: 5 (33%) already have NOAs

o Assisted RTI on USAID proposal entitled

“Subcutaneous contraceptive and HIV implant

engineered for long-acting delivery (SCHIELD) in

multipurpose prevention technology (MPT): invited for

full review

o Training and Technology Transfer: Provided NIH

with training and assay for dolutegravir in plasma


o Inter-CFAR: Washington, Duke, Miami,

Rochester (Cape Town) California-San Diego

& San Francisco

o Intra-CFAR: Biostatistics, Clinical, VIM, Social and

Behavioral Cores

o Inter-network: IMPAACT, HPTN, WIHS, ATN, MTN, ACTG

and HVTN

o Intramural: Advisory Committee for the Office of

Research on Women’s Health, DAIDS Best Practices

Working Group for the Pharmacology of HIV Prevention

Strategies, DAIDS CPQA Program, Intracellular

Metabolite Assay Standardization, Validation criteria, etc.


o Mass Spec Imaging: Upgrade

MSI optics, prepare to offer service to CFAR investigators

o Clinical Pharmacology: Validate hollow fiber model

system for PK-PD analysis in HIV Cure; prepare to offer

service to CFAR investigators; onboard new

pharmacometrician

o Outreach: Increase social media presence; interact

annually with our CAB

o Infrastructure: Recalculate recharge center to ensure

charges are current and cost-effective


o Bioanalytical Chemistry: continue to follow trends for

most effective and innovative technologies and assays

to provide to users: should we be developing methods

for protein therapeutics?

o Clinical Pharmacology: build additional

pharmacometric services (PBPK, clinical trial

simulations)

o Training: develop a more formal training structure in

HIV clinical pharmacology for investigators

o Infrastructure: build a web-based interface for users to

track their samples/projects



UNC Center for AIDS Research (CFAR)

Core F: Biostatistics Core

Bios Core Personnel

Michael Hudgens, Ph.D.

Core Director

Professor of Biostatistics

Andrew Allmon, Ilana Trumble, Sarah

Reifeis

Graduate Research Assistants

Bios Ph.D. Students

Katie Mollan, M.S.

Core Manager

Senior Biostatistician

Camden Bay, Ph.D.

Biostatistician

June 2016

Stephen Cole, Ph.D.

Associate Core Director

Professor of Epidemiology

Bios Core Aims

1. Provide a broad spectrum of collaborative biostatistical services

2. Develop, implement, and disseminate innovative statistical methods for HIV/AIDS research

3. Support priority CFAR initiatives and goals

4. Promote CFAR research within UNC, foster inter-CFAR collaborations, and support HIV/AIDS research networks

5. Provide biostatistical training, mentoring, and education

6. Engage in evaluation and strategic planning (biennial user surveys, annual Internal Advisory Board meetings, biennial External Advisory Board meetings)

Core F Funding

Year

Total Core

Budget

% Budget

from CFAR

2015-16 250,600 60%

2016-17 350,528 48%

Programs and Grants Supported By Core F

o NIAID (K23, P01, P30, R21, R24, U01, 2 U19, 3 UM1, 10 R01),

o NIMH (D43, K23, K99, P01, R34, 3 R01)

o NICHD (R21, U24, 3 R01)

o NIDA (A14, K24, R01)

o FIC (K01), NINR (R01), NCI (R01), NIDCR (R01)

Bios Core

o ATN Coordinating Center (MPI: Carpenter, Hudgens). Partnered with UNC Bios Dept Collaborative Studies Coordinating Center. Including supplements, largest NIH award to UNC in 2016.

o CFAR-Network of Integrated Clinical Sciences, CNICS. Cole is Chair of CNICS Epid and Bios Core and supports multiple CNICS projects

o Project China (PI Tucker). Design, analysis, and interpretation of three large, online randomized trials. Mentoring visiting scholar from UNC Project China/Guangzhou Hospital. Grant application support.

Intra CFAR Synergy

• Core F involved in collaborative research with Clinical,

CPAC, Developmental, International, SBS, and VIM

Cores

• Administrative Core/SCEED office collaborating with

Core F to start a new Bios Core summer undergraduate

internship program with emphasis on diversity in

recruitment to STEM research

• Weekly pop-up clinic after Friday ID conference

• Presentation at FHI 360 Brown Bag Lunch (Oct 2016)

• Bios Core Research Group, quarterly presentations since 2013

Inter CFAR Synergy

• Co-Edited book “Quantitative Methods for HIV/AIDS

Research” with Duke CFAR Biostatistics and

Computational Biology Core w/ contributors from many

CFARs

• ENAR 2016 (Harvard, CWRU, Brown, UNC)

• Jointly hosted data/software carpentry workshop with

Duke CFAR BCB Core to improve statistical computing

skills CFAR researchers who would like (Sept 2016)

• Research collaboration with Tennessee CFAR (Mollan,

…, Haas. JID, In press)

Strategic Planning

Short Term

o Successful launch of ATN CC

o Foster involvement of Biostatistics faculty in CFAR

research

o Increase external funding support for new

biostatistician

o Increase involvement in SWGs

Long Term

o Achieve optimal size relative to UNC CFAR

o Add (jr) faculty member to Core

o Increase breadth of expertise, e.g., genomics,

bioinformatics, mHealth, Big Data, data science



Core G: Social and Behavioral

Sciences Core

Organization

Allison Pack, Bailey Herrington,

Camille McGirt, Margot Schein,

and Sruthi Scherkur

Core G RA Support

Steve Bradley-Bull, MA, MEd,

LPC and Catherine Grodensky,

MPH

MI Experts

Randall Teal, MA, and

Jessica Carda-Auten, MPH

Qualitative Experts

Carol E. Golin, MD, Core Director, William Zule,

DrPH, Core Co-Director, and Breana Castonguay,

MPH, Core Manager

Core G Leadership

David Rosen, MD, PhD, Epidemiologist, Prison

Database Designer, Criminal Justice Expert, Byron

Powell, PhD, Implementation Science, Seth Noar,

PhD, Health Communications Specialist, and Stuart

Rennie, PhD, Biomedical Ethics Expert

Core G Specialized Experts

Deshira Wallace and Venita

Embry

SABI Specialists

Specific Aims

1. Provide SBS Services: Facilitate investigation of social,

psychological, and structural factors of HIV epidemic.

2. Support SBS Interventions: Expand capacity of UNC

CFAR scientists to develop, implement and evaluate them.

3. Support and stimulate transdisciplinary HIV initiatives

that UNC CFAR has identified a priority areas.

4. Foster synergy: Supply leadership and resources among

Cores, SWGs, cross-CFAR, and NIH Networks.

5. Provide scientific leadership: by contributing mentoring,

training and networking opportunities.

6. Evaluation and strategic planning.

Year

Total Core

Budget

% Budget

from CFAR

2015-16 $267,925 89.3%

2016-17 $359,439 61.4%

Core G Funding

NIH Programs and Grants Supported

o NIAID: (8 R01, 1 R21, 1 K24, 2 UM1, 2 P30, 3 UO1)

o NIMH: (6 RO1, 2 R24, 1 R21, 1 K23, 2 K99)

o NIDA: ( 6 R01, 2 R34, 1 K01, 1 U01)

o FIC: (1 K01, 1 R25, 1 D43); NICHD: (2 R21, 1 K24, 1 U24)

o NIDDK: (1 K23); NINR: (1 R01, 1 R03); NIMHD: (1 R01)

Implementation Research to Optimize Treatment Response: A. Kashuba, R01 AI122319.

Strategies to Improve HIV Testing and Entry into Prevention Services: N. Rosenberg, K99 MH104154

Research to Reduce Disparities in HIV Incidence: Rosen, R01 AI116384


o Supported multiple junior investigators to obtain awards

for and/or carry out high priority HIV research.

o Networking activities provided numerous investigators

opportunities to brainstorm and meet collaborators.

o Community-based infrastructure provided a resource for

investigators of future implementation science studies.

o Collaboration with Clinical and Bios Cores provided a

DSMB to a large RTI HIV implementation trial.


o Programmed ACASI in multiple languages for “Expanding

HIV Testing and Prevention to Vulnerable Young Women.”

o Collected and analyzed vital qualitative data for several

HIV and HCV studies.

o Submission of an ATN grant proposal to more broadly

disseminate and further test a novel tablet-based eHealth

sexual communication program for adolescent girls.

o Provided multiple training opportunities for junior

investigators, particularly in qualitative research

methods.


o Transdisciplinary Networking Events with 50-75 Attendees

o Implementation Science support to NC Prevention SWG

o Mobile survey to expand clinical cohort SBS data collection

o RFA to support SBS research of large clinical cohorts

o Support NeuroAIDS Center grant application

o Update and launch Social and Behavioral Instrument (SABI) database (UPenn CFAR & SBSRN)

o Explore Cross-CFAR Implementation Science Group

o Facilitate participation of CJ Interest Group in Cross-CFAR CHIC

Spring 2016 “The Science of Community Engagement: Engaging Stakeholders”

Fall 2017 “The Science of Community Engagement: Disseminating Findings”

Spring 2017 “HIV Research that Reaches Policymakers” Rep. David Price- D-NC-04


o Complete sustainable SABI as a Cross-CFAR resource.

o Complete development of a mobile data collection tool.

o Launch more robust seed grant RFA in Fall 2017.

o Work with HIV Prevention SWG on implementation and

cohort studies of ART uptake and care retention.

o Provide motivational interviewing support to proposed

studies of young HIV-infected MSM.

o Conduct a systematic review of multi-level analysis

studies of geographic area level predictors of HIV risk.

o Expand manuscript formatting and submission service


o Continue to provide cornerstone services and resources

to studies of HIV testing, PrEP, TasP, & health disparities

o Increase use of large cohorts to answer questions about

gaps in implementation of HIV testing, Tx, and prevention

o Assist investigators to develop structural interventions to

ensure rapid ART initiation and retention in care.

o Support formative studies of HIV Cure research.

o Enhance capacity of Core Users in Implementation

Science and Community Engagement

o Facilitate publication and dissemination of HIV research



Core I: International Core

Jeff Stringer – Core co-Director

Myron Cohen – Core co-Director

Harmony Chi – Core Administrator

Organization

Specific Aims

1. Facilitate NIH-sponsored HIV research in focus

countries

2. Develop new HIV/AIDS research talent at UNC

and in our focus countries

3. Ensure CFAR’s international research is in line

with country priorities and includes local

investigators

4. Support high-quality laboratory services in focus

sites


Core I Funding

Year

Total Core

Budget

% Budget

from CFAR

2015-16 $197,696 57%

2016-17 $200,294 56%

NIH Programs and Grants Supported By Core I

o 46 NIH-funded projects supported from 11 FRB awards

o 60 non-FRB NIH-funded projects supported

o Highlighted awards:• Malawi – Progression of 3 awards to study HIV-related

malignancies (Gopal K01, R21, U54)

• Zambia – 2 related awards to study HIV and adverse birth outcomes in (R01 HD087119, R21 HD090987)

• Vietnam – Development of new HPTN site and launch of HPTN 074 and HPTN 083 studies

Malawi - Regional Cancer Center

Zambia - Containerized laboratory


1. Comprehensive regulatory support to international

sites, in-country training and monitoring

2. Increased engagement of in-country investigators on

manuscripts and grant applications

3. Increased laboratory capacity and coordinated

laboratory systems across focus countries

4. Improved communication between country sites with

longstanding HIV/AIDS research programs and UNC

collaborations


o Regulatory Unit provides support for both Clinical

(domestic) and International cores, leveraging same

systems and expertise

o International proposal design and development relies

significantly on expertise across cores

o Standardization of lab instrumentation, software, and

systems across sites (LIMS, LDMS, EQA)


o Ensure centralized regulatory submissions and

management

o Develop at least 1 new investigator NIH proposal from

in-country scientists each year

o Closer coordination with developmental core

o Increase manuscript output of past and current

international trainees

o Coordinate international mentorship activities with on-

campus T32s


o Pre-deployment curriculum for trainees headed abroad

o Coordination / standardization of clinical cohorts and

biorepositories with Core C

o Coordinate electronic data collection and management

systems between sites



Core J: Virology, Immunology & Microbiology (VIM) Core

Organization

Julie Nelson

Director

Virology

John Schmitz

Assoc Director

CAP

Kristina De Paris

Assoc Director

Immunology

Marcia Hobbs

Assoc Director

Microbiology

Nicole Maponga

Lab manager

Paul Alabanza

Processing

Training

Takesha McMillion

Processing

QA/QC

Dana Lapple

Assays

Kara Compliment

Assays

Maria Schanz

Processing

Login

Chuck West

Shipping

Repositories

CTRC tech

Specific Aims

1. Provide access to a diverse array of cost-effective services

2. Develop and evaluate new technologies applicable to research by CFAR investigators

3. Support of CFAR initiatives and collaborative research

4. Promote synergy between UNC CFAR Cores, SWGs, and other CFARs

5. Provide mentoring, training, education, and outreach in the areas of virology, immunology, and microbiology


Core J Funding

YearTotal Core

Budget

% Budget

from CFAR

2015-16 $1,034,000 23%

2016-17

(8 months)$788,000 18%

NIH Programs and Grants Supported By Core J

o NIAID (4 R01, 2 K23, 1 R21, 1 R24, 4 U01, 5 UM1, 1 P30 supplement)

o NCI (1 R21, 1 U54)

o NIDA (2 R01, 1 R34, 1 R43)

o NIMH (1 R01, 1 K23, 1 R21)

o NICHD (3 R01)

o 8 other institutes: 6 R01, 1 K01, 2 U01


o High impact clinical trial and cohort support• WIHS, ACTG, IMPAACT, HPTN, HVTN, Cure, Cancer• Rapid, local specimen processing, shipping, and

maintenance of local specimen repositories

o Progestin Contraception Study in Malawi (PI: Jennifer Tang, MD, UNC OB-GYN)

• Funding success story: CDC, Core B, K01, Gates/USAID, R01

• Role of inflammation, microbiome, and shedding in prevention of transmission (to and from women)

• Virology, immunology, and microbiology testing• PSA testing (biomarker for semen exposure)• Coordination of shipments to CPAC (Core E) and

outside labs


• Jericho Sciences (small business)• Developing alternate to QVOA for measuring the HIV

reservoir for Cure studies• Coordinated with Core C to facilitate specimen

processing; provided equipment, space, and technical assistance

• The company just relocated to RTP to work more closely with our CFAR


o HIV diagnostic testing on DBS for

enrollment into supplement-funded study at

Emory CFAR (Aaron Siegler)

o PK and VL testing on plasma from URBAN

ARCH Consortium study at

Providence/Boston CFAR (Jeffrey Samet,

Boston Univ.); coordination with CPAC Core

o Coordination with Clinical Core on UCHCC

Repository on storage and fulfilling CNICS

requests


o Increase efficiencies in processing

o Identify and develop new assays needed by users

o Assess and manage workload with existing staff

Long Term Goals

o Balance routine processing demands with scientific

innovation

o Increase visibility throughout the university to attract

work beyond specimen processing



North Carolina HIV Prevention Scientific

Working GroupHeidi Swygard, MD, MPH

Associate Professor of Medicine

Medical Epidemiologist NC DHHS

Organization of SWG Heidi Swygard, MD,

MPH

Jacquelyn Clymore

(State HIV/STD

program director

Representation

from Criminal

Justice Interest

Group, iTech, RTI

Arlene Sena-Soberano

Becky White

Lisa Hightow-Weidman

William Zule

Erika Samoff

Victoria Mobley

Represenation

from Field

Services,

Surveillance,

epidemiology,

CDC

Aaron Fleischauer

Specific Aims

1. Leverage relationship between the state and academic institutions to facilitate research performance and implementation

2. Use a combination of traditional surveillance data and molecular epidemiology to distinguish true incident HIV from undiagnosed prevalent HIV cases

3. Use the NC HIV care continuum as a framework for developing innovative, cross organizational collaborations

4. Foster early stage investigators using public health (state and county level) as our laboratory

NIH Programs and Grants Supported By NC HIV Prevention SWG

o NIAID: 3 RO1 (Dennis, Rosen, Gay, Powers)

o NIMH: R34 (Brinkley-Rubinstein)

o NIH: 1 RO1 (Rosen)

o NIH: 1 UG3/UH3 (Zule)

o Dennis, et al. “Timely monitoring and response to HIV transmission networks for intensified prevention” PAR-17-048

• Virology Core, Social Behavioral Core

• Duke CFAR

o Gay, et al. “Increased Knowledge and Innovative Strategies to Reduce HIV Incidence-iKnow Projects.”

• Social Behavioral Core, NC DHHS ADAP

• iTech collaboration (NIH U19)


o Development of HIV genotype database linked to

HIV/STD surveillance database in order to identify

expanding networks for targeted intervention to reduce

incidence

o Development of molecular methodology to differentiate

incident HIV infections from prevalent HIV infections

o Development of protocols to rapidly initiate HIV

treatment

o Add to understanding of co-occurring epidemics of HIV

and syndemic illnesses associated with injecting drug

use


o Duke CFAR (Georgia Tomaras, PhD)

o Administrative Core

o Social and Behavioral Core

o Developmental Core

o Virology, Immunology and Microbiology Core


o Establish pilot project with NC DPH to deliver 30-day

supply of ART at diagnosis via state DIS nurses

o Lead effort to write Implementation Science Proposal

• Venue-based HIV testing with focus on HIV negatives,

developing app to stay connected after testing

o Organize symposia

• Christopher Pilcher: RAPID HIV medication initiation

• Robin Dorman: pill aversion research

o Encourage developmental award submission targeted

towards NC HIV Prevention


o Establish first-ever cohort of newly

diagnosed HIV-infected persons in NC

• Conduct formative research workshop (DPH

leadership, State Bridge Counselors, and HIV

care providers)

• Provide mentorship for R21 and R01 proposals

o Establish cohort of high-risk HIV-negative

persons w/NCEDS database

o Evaluate DIS nurse & State Bridge

Counselor program

o Promote legal reporting requirements for

HIV genotypes

HIV Resistance Report



PrEP Scientific Working Group

Christopher B. Hurt, MD

Assistant Professor of Medicine

OrganizationLeadership

Membership

Christopher Hurt, MDUNC Infectious DiseasesYoung MSM of Color, HIV Testing

David Wohl, MDUNC Infectious DiseasesIncarcerated Populations

Sharon Parker, PhD, MSWNC A&T State UniversityWomen & Incarcerated Populations

Lauren Brinkley-Rubenstein, PhDUNC Center for Health Equity ResearchPWID & Incarcerated Populations

Arlene Seña, MD, MPHDurham County DPH & UNC IDSTI Prevention

Kathryn Lancaster, PhD, MPHUNC Institute for Global Health & IDFemale Sex Workers

Vivian Go, PhDUNC Health BehaviorPWID

Clare Barrington, PhDUNC Health BehaviorLatinx MSM & TGW, Female Sex Workers


NC HIV Prevention

SWG

Leverage partnerships

between academia &

public health

Traditional & molecular

epidemiology

Characterize &

measure HIV care

continuum in NC

Cure SWG

Leverage partnerships

between academia &

pharma

Basic & translational

science strategies

Identify barriers to cure

and delineate new

pathways in research

PrEP SWG

New interdisciplinary

partnerships &

community education

Behavioral, clinical &

implementation science

Examine barriers to

PrEP uptake & identify

sustainable strategies

to address them

Specific Aims

1. Create a centralized hub for PrEP-related research

endeavors across UNC’s health campuses

2. Promote multidisciplinary research to characterize

barriers to PrEP uptake among key populations in NC

3. Disseminate best practices and key advances

4. Encourage new investigators to study biomedical HIV

prevention and mentor early-career faculty


o Partner with Duke CFAR’s Biomedical Prevention

SWG (Amy Corneli, PhD & Mehri McKellar, MD)

o Joint / inter-CFAR developmental award being planned

o Co-sponsor local/regional summit on PrEP research

o Mock study section(s) for biomedical prevention grants


o Official SWG Launch fall 2017

o Coordinate with Cores and NC

AIDS Training & Education Center

to publicize new SWG

o With founding faculty, establish research and

collaboration priorities for first year

o Create directory of faculty interested in PrEP and

inventory of PrEP resources on campus

?



HIV Cure SWG

Directors

David Margolis & Brian Johns

Brian Johns has replaced Andrew Spaltenstein as

Co-Director with the retirement of AS from GSK

Organization of the HIV Cure SWG

Investigators

UNC

Margolis

Garcia

Swanstrom

Archin

Browne

Gay

Cotrell

Eron

Kashuba

Soriano

Su

Frye

James

Lee

Nelson

Strahl

Goonetilleke

McGinty

Joseph

Rennie

Tucker

Weeks

Willson

Zuercher

GSK Duke Emory

Johns

Favre

Dunham

Gordon

Chhabra

Tang

Brehm

Haynes

Ferrari

Moody

Tomaras

Bradley

Vandergrift

Bonsignori

Silvestri

Chahoudri

Pairdini

Mauvigner

Includes interactions with Macrogenics and Merck

further enriching the public/private partnership.

Specific Aims: HIV Cure SWG

1. Establish a broad-based SWG drawing from members

of the UNC HIV Cure Center, Qura/GSK and Merck and the

broader community

2. Explore roadblocks to reducing the latent reservoir

3. Foster inter-CFAR and cross-institutional research

4. Carry out strategic planning, mentor young investigators,

and evaluate milestones

Faculty Recruitments Impacted By SWG

CFAR investigator:

Nilu Goonetilleke Micro & Immuno

(CNIHR, AI U01 scored well)

Tenure Track faculty:

Rob McGinty Chem Biology

Lindsay James Chem Biol (CNIHR)

Nancie Archin Medicine

Ruian Ke NC State (Dev. Award)

Res Track faculty:

Ed Browne Medicine (Dev. Award)

McKenzie Cottrell Pharmacy (Dev. Award)

Sarah Joseph Micro and Imm

Natalia Soriano Medicine

Tenured faculty:

Aravind Asokan, Genetics (CNIHR)

New Faculty recruitment: collaboration with Dept. of Biochem and Bipohys

Key Contributions/Value Added

Interdisciplinary Collaborations

o Public/Private Partnership (GSK, Merck, Macrogenics)

o Ethics of HIV cure (Joe Tucker, Stuart Rennie,

Gail Henderson)

o Community outreach (Allison Mathews, SCEED Office)

o Cancer Center and cell-based therapies

o MHRP and acute infection to early treatment cohort

o Discussion of multiple latency models (human and cell

culture/Margolis; humanized mice/Garcia; SIV and

macaques/Silvestri)

Key Contributions/Value Added Mentoring

o Nancie Archin: R01 application for independent

funding with mentoring input from senior CFAR

members

o Natalia Soriano: promoted to faculty, awarded RO1 on

novel cellular reservoir of latent HIV infection

o Sarah Joseph & Nancie Archin: provided space in VIM

Core to set up VOA

o Julia Sung: received mentoring input on applications

for HXTCs, one of 2 UNC nominees for the Doris Duke

translational clinician scientist award

o Angela Wahl: received mentoring input, awarded R01

o Martina Kovarova: received mentoring input, awarded

R01

Key Contributions/Value Added Large Applications

o UM1 AI124436-01 (Hunter PI); 06/01/16-05/31/21; $134,082; B and

T Cell Biology of Protection from and Eradication of SIV/SHIV

Infection funded

o UM1AI126619 (Margolis PI); 07/14/16-06/30/21; $4,592,950;

Collaboratory of AIDS Researchers for Eradication (CARE) funded

o Swanstrom PPG application to “Novel NeuroAIDS Therapeutics:

Integrated Preclinical/Clinical Program (P01) PAR-13-267” (UNC

and Emory)

Intra-CFAR Synergy

Events

o 2016 UNC AIDS Day Symposium: “Reservoirs” session

with Elizabeth Connick, invited outside speaker, & local

junior investigators

o CFAR investigators on CARE working group calls, and

in new Cure center projects funded by Qura

o CFAR promotes all CARE/Cure Center-sponsored

monthly seminars

Core Support

o CPAC, Clinical, SBSR, Biostatistics, VIM and Admin.

Cores actively engaged in supporting HIV Cure SWG

investigators

Strategic Planning

o Expand engagement in HIV cure research across other

parts of the CFAR (UNC departments and schools, other

local institutions)

o Recruit additional faculty (effort has begun)

o Explore expanded efforts in cell and gene therapy

Documents

UNC Center For AIDS Research · UNC Center For AIDS Research . Organization The UNC CFAR is a consortium of three complementary ... •Increase capacity in South Carolina (collaboration