2016 HPTN & IMPAACT Network Annual Meetings

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Friday,

10 June

9:00 am – 11:00 am HPTN 052 Community Writing Team Jefferson 1:00 pm – 5:00 pm HPTN CWG Business Meeting Salon 1 & 2 5:30 pm – 7:30 pm HPTN 071 CWG Meeting Jefferson

Saturday,

11 June

8:00 am – 12:00 pm HPTN CWG Presentation Skills Salon 2

1:00 pm – 5:00 pm HPTN CWG Research Results Salon 2

8:00 am – 5:00 pm HPTN CWG How to Review a Protocol Training Salon 5

9:00 am – 5:00 pm HPTN 084 Meeting Salon 6

Sunday,

12 June

8:00 am – 5:00 pm HPTN CWG Plenary Salon 5 & 6 11:00 am – 3:00 pm HPTN Scholars Orientation Jefferson 12:00 pm – 6:00 pm HPTN Executive Committee and Committee Leadership

Meeting

Salon 4

5:00 pm – 7:00 pm IMPAACT ICAB Leadership Group Jefferson 6:30 pm – 9:00 pm HPTN Investigators Meeting Salon 3

Monday,

13 June

6:45 am – 8:15 am Breakfast Skyview & Foyers 8:00 am – 10:00 am HPTN 071 Protocol Team Meeting Salon 1 & 2 8:00 am – 12:00 pm IMPAACT 2014 Protocol Team Meeting Jefferson 8:00 am – 1:00 pm HVTN 704/ HPTN 085 & HVTN 703/ HPTN 081 Team Meeting Salon J

9:00 am – 5:00 pm DAIDS Training Resources Drop in Room(including Site Catalog

Demo) (Audience: IMPAACT & HPTN)

Salon G

9:00 am – 5:00 pm DAIDS Regulatory Support Center (RSC) Booth Arlington Foyer

9:00 am – 5:00 pm LDMS Demo Room(Audience: IMPAACT & HPTN) Salon D

9:00 am – 2:00 pm ICAB Business Meeting and Scientific Leaders Meeting Salon 5 & 6 10:00 am – 12:00 pm HPTN 071 Leadership Meeting Salon 1 & 2 10:00 am – 12:00 pm HPTN Women at Risk Scientific Committee Rosslyn

10:00 am – 12:30 pm IMPAACT P1093 Training Salon B

10:15 am – 10:45 am Break Foyers

11:30 am – 1:30 pm Lunch Skyview & Foyers 12:30 pm – 2:30 pm Expedited Adverse Event Reporting to DAIDS & DAERS

Refresher

Salon C

1:00 pm – 2:30 pm HPTN 077 Team Meeting Salon 1 & 2 1:00 pm – 2:30 pm HPTN Substance Use Scientific Committee Madison 1:00 pm – 3:00 pm HPTN 076 Protocol Team Meeting Salon H

1:00 pm – 4:00 pm IMPAACT TB Scientific Committee Meeting Salon 3

1:00 pm – 4:00 pm IMPAACT P1115 Training Salon 4

1:30 pm – 2:30 pm IMPAACT 2002 Team‐Site Meeting Salon K

1:30 pm – 2:45 pm IMPAACT P1093 Protocol Team Meeting Rosslyn

2:30 pm – 3:30 pm PPD Top Ten Monitoring Findings and How to Avoid Them

(Audience: IMPAACT & HPTN)

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2016 HPTN & IMPAACT Network Annual Meetings

Monday,

13 June

(continuation)

2:30 pm – 4:30 pm HPTN 083 Protocol Team Meeting Salon 5 & 6 2:30 pm – 6:30 pm HPTN 082 Protocol Team Meeting Salon J

2:45 pm – 3:15 pm Break Foyers

3:00 pm – 4:30 pm HPTN 075 Protocol Team Meeting Rosslyn

3:00 pm – 6:00 pm IMPAACT Complications and Co‐Morbidities Scientific

Committee Meeting

Salon A & B

3:30 pm – 5:30 pm DAIDS Process Evaluation Focus Group – Critical Events

(by invitation only)

Salon F

4:00 pm – 8:00 pm HPTN 071 Data Meeting Salon E

4:30 pm – 5:30 pm SCHARP Medidata Presentation (Audience: HPTN) Salon 5 & 6 4:30 pm – 5:30 pm IMPAACT 2008 Team‐Site Meeting: Protocol Update Salon 4

5:30 pm – 7:30 pm HPTN Joint Scholars Meeting Rosslyn

By appt IMPAACT JHU Budget Meetings with NIAID sites (by appt) McLean

Tuesday,

14 June

6:45 am – 8:15 am Breakfast Skyview & Foyers 8:00 am – 9:00 am HPTN Laboratory Plenary Salon 3 & 4 8:00 am – 11:00 am IMPAACT Treatment Scientific Committee Meeting Salon A‐B‐C 8:00 am – 12:00 pm IMPAACT 2001Training Salon F

8:30 am – 9:30 am IMPAACT 2004 Team‐Site Meeting Salon 1

9:00 am – 10:00 am IMPAACT Site Lab Interactive: Empowering Labs for Success Rosslyn

9:00 am – 10:15 am HPTN Scholars Plenary Salon 3 & 4 9:00 am – 5:00 pm DAIDS Training Resources Drop in Room (including Site

Catalog Demo)

Salon G

9:00 am – 5:00 pm DAIDS Regulatory Support Center (RSC) Booth Arlington Foyer 9:00 am – 5:00 pm LDMS Demo Room (IMPAACT & HPTN) Salon D

9:00 am – 5:30 pm IMPAACT CAB Utilization and Development Salon 5 & 6 10:00 am – 11:30 am SMILE New Frontiers in EQA Testing Rosslyn

10:00 am – 12:00 pm HPTN Ethics Working Group Meeting Lee

10:00 am – 1:00 pm HPTN Black Caucus Meeting Jefferson 10:00 am – 1:00 pm IMPAACT Cure Scientific Committee Meeting Salons H‐J‐K 10:15 am – 10:45 am Break Foyers

10:30 am – 11:30 am PPD Top Ten Monitoring Findings and How to Avoid Them

(Audience: IMPAACT & HPTN)

Salon 2

10:45 am – 11:30 am HPTN Modelling Plenary Salon 3 & 4 11:00 am – 12:30 pm IMPAACT P1026s Team‐ Site Meeting McLean

11:30 am – 12:30 pm HPTN Statistical Plenary Salon 3 & 4 11:30 am – 1:30 pm Lunch Skyview & Foyers 12:00 pm – 5:00 pm IMPAACT Data Management Center Demo Room (FSTRF) Salon E

1:00 pm – 2:30 pm IMPAACT P1078 Team‐Site Meeting Salon 1

1:00 pm – 4:00 pm IMPAACT Prevention Scientific Committee Meeting Salon A‐B‐C 1:15 pm – 6:00 pm HPTN Plenary Session Salon 3 & 4

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Tuesday,

14 June

(continuation)

1:30 pm – 3:30 pm DAIDS Process Evaluation Focus Group – Critical Events Salon F

3:00 pm – 4:00 pm IMPAACT P1104s Team‐Site Meeting McLean

4:00 pm – 5:00 pm IMPAACT P1097 Team‐Site Meeting Accrual Challenges and

Strategies

Salon H

4:00 pm – 5:00 pm Advances in HIV Diagnostics (IMPAACT Lab Center) Rosslyn

4:00 pm – 5:30 pm IMPAACT P1108 Team‐Site Meeting McLean

4:00 pm – 6:00 pm IMPAACT Adherence Working Group Meeting Salon 1 & 2 5:00 pm – 6:00 pm IMPAACT P1110 Training Draft LoA 3 Salon H

5:00 pm – 6:30 pm IMPAACT Laboratory Directors’ Meeting Rosslyn

6:30 pm – 9:30 pm HPTN & IMPAACT Joint Poster Session & Gathering Salon A‐B‐C‐H‐J‐K By appt IMPAACT JHU Budget Meetings with NIAID sites (by appt) Madison

Wednesday,

15 June

6:45 am – 8:15 am Breakfast Skyview & Foyers 8:00 am – 12:30 pm HPTN & IMPAACT Joint Plenary Session Salon 3‐4‐5‐6 8:00 am – 5:00 pm DAIDS Training Resources Drop in Room (including Site

Catalog Demo)

Salon G

9:00 am – 5:00 pm DAIDS Regulatory Support Center (RSC) Booth Arlington Foyer 10:00 am – 10:30 am Break Foyers

10:00 am – 2:00 pm SMILE Meet & Greet EQA – SMILE/VQA/IQA Rosslyn

11:30 am – 1:30 pm Lunch Skyview & Foyers 12:00 pm – 5:00 pm IMPAACT Data Management Center Demo Room (FSTRF) Salon E

12:15 pm – 3:00 pm HPTN 078 Protocol Team Meeting Salon C

12:30 pm – 2:00 pm HPTN 071 OGAC Meeting Salon D

1:00 pm – 2:30 pm IMPAACT Plenary Session Salon 3‐4‐5‐6 1:00 pm – 2:30 pm HPTN 073 Protocol Team Meeting Salon F

1:00 pm – 3:00 pm Youth Prevention Research Working Group Workshop

(HANC) – Open to all attendees

Salon A

1:30 pm – 5:00 pm HPTN 083 Community Educator Network Orientation

Meeting

Salon 1 & 2

2:00 pm – 6:00 pm HPTN Scientific Advisory Group Meeting Salon H

2:00 pm – 8:00 pm HPTN 074 Protocol Team Meeting Salon K

3:00 pm – 5:00 pm HPTN MSM Scientific Committee Salon F

3:00 pm – 5:30 pm IMPAACT Best Practices in the Community Salon 5 & 6 3:00 pm – 5:30 pm IMPAACT Study Coordinators Meeting Salon J

3:00 pm – 6:00 pm IMPAACT SLG and SC Chairs/Vice Chairs Salon B

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2016 HPTN & IMPAACT Network Annual Meetings

Thursday,

16 June

6:45 am – 8:15 am Breakfast Skyview & Foyers 8:00 am – 12:00 pm IMPAACT Plenary Session Salon 3‐4‐5‐6 8:00 am – 12:00 pm HPTN 073 Writing Protocol Team Call Salon F

8:00 am – 12:00 pm HPTN Scientific Advisory Group Meeting Salon H

8:00 am – 12:00 pm IMPAACT Data Management Center Demo Room (FSTRF) Salon E

8:00 am – 4:00 pm HPTN 083 Community Educator Protocol Orientation and

Capacity Building Training

Salon 1 & 2

9:00 am – 5:00 pm DAIDS Training Resources Drop in Room (including Site

Catalog Demo)

Salon G

10:00 am – 10:30 am Break Foyers

11:30 am – 1:30 pm Lunch Skyview & Foyers 12:00 pm – 1:00 pm NICHD P1091 Meeting Salon A

12:00 pm – 1:00 pm IMPAACT 2009 Team‐Site Meeting Salon B

12:00 pm – 1:00 pm IMPAACT P1101 Protocol Team Meeting Jackson

1:00 pm – 2:00 pm IMPAACT 2009 Protocol Team Meeting Salon B

1:30 pm – 2:30 pm IMPAACT 2010 Team‐Site Meeting Salon C

1:30 pm – 3:00 pm IMPAACT NICHD Investigator/Site Staff Breakout Salon 4‐5‐6 1:30 pm – 3:00 pm IMPAACT NIAID Investigator/Site Staff Breakout Salon 3

2:30 pm – 4:30 pm IMPAACT 2007 Training Salon A

3:00 pm – 4:30 pm PHOENIx Site Meeting Salon J

3:00 pm – 5:00 pm IMPAACT Scientific Leadership Group Meeting Salon H

Friday,

17 June

8:00 am – 12:00 pm HPTN 083 Community Educator Protocol Orientation and

Capacity Building Training

Salon 1 & 2

Crystal

Gateway

Marriott

1700

Jefferson

Davis

Highway

Arlington,

VA

22202

1 ‐

703 ‐

920 ‐

3230

Registration Desk Hours:

Friday June 10th _{12:00 pm – 5:00 pm} Saturday, June 11th _{7:00 am – 5:00 pm} Sunday, June 12th _{7:00 am – 5:00 pm} Monday, June 13th _{7:00 am – 5:00 pm} Tuesday, June 14th _{7:00 am – 6:00 pm} Wednesday, June 15th _{7:00 am – 5:00 pm} Thursday, June 16th _{7:00 am – 5:00 pm} Friday, June 17th _{7:00 am – 10:00 am}

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8:00 am HPTN LABORATORY PLENARY – Moderated by Susan Eshleman, MD, PhD  HIV Testing Update – Estelle Piwowar‐Manning, MT

 Population‐level Surveillance of Antiretroviral Drug Use – Jessica Fogel, PhD  Cross‐sectional HCV Incidence Testing – Oliver Laeyendecker, PhD, MBA  Questions & Answers

9:00 am HPTN SCHOLARS PLENARY – Moderated by Darrell Wheeler, PhD, MPH, ACSW or Sten

Vermund, MD, PhD

 Factors Associated with Recent and Repeat HIV Testing in Project Accept Sub populations (HPTN 043) – Brandon Brown, PhD, MPH

 Community‐Level Norms and Sexual Beliefs, Behaviors and STIs in HIV‐Infected

Men (HPTN 063) – Dustin Duncan, ScD

 Associations Between Gender and HIV Risk Among Injection Drug Users (HPTN

037) – Mandy Hill, DrPH

 Racial Disparities in HIV Prevalence and Composition of Risk Networks Among

People Who Inject Drugs (HPTN 037) – Florence Momplaisir, MD, MSHP  Sexual Risk Among Transgender Women Compared with Cisgender Women

and MSM Living with HIV (HPTN 063) – Tonia Poteat, PhD, MMSc (PA), MPH  Economic Resources and HIV Preventive Behaviors Among School‐enrolled

Young Women in Rural South Africa (HPTN 068) – Larissa Jennings, PhD, MHS  Questions & Answers

10:15 am MORNING BREAK

10:45 am MODELLING PLENARY – Moderated by Deborah Donnell, PhD

 Introducing the HPTN Modelling Centre – Marie‐Claude Boily, PhD  Modelling HIV Transmission and Treatment for US MSM to Estimate the

Impact of HPTN 078 on HIV Incidence – Kate Mitchell, PhD

 Predicting the Individual‐Level Effectiveness of Daily and Non‐Daily Prep Based on Study Results from HPTN 067 ADAPT – Dobromir Dimitrov, PhD

 Questions & Answers

11:30 am HPTN STATISTICAL PLENARY ‐ Moderated by Deborah Donnell, PhD  The Validity of Self‐Reported Behaviors: Methods for Estimating

Underreporting of Risk Behaviors – James Hughes, PhD

 Designing Non‐Inferiority Trials for CAB‐LA Compared to TDF/FTC when the

Non‐inferiority Margin Depends on Adherence – Brett Hanscom, PhD

 Combining Electronic Pill Records and Self‐Reported Data to Identify Adherers and Non‐Adherers: a Latent Class Model in HPTN 069 – Ying Qing Chen, PhD  Questions & Answers

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2016 HPTN Plenary Agenda

12:30 pm LUNCH

1:15 pm WELCOME AND SUMMARY OF THE MEETING – Moderated by Wafaa El‐Sadr, MD, MPH,

MPA and Myron Cohen, MD

1:30 pm SESSION 1: PREP – Moderated by Sinead Delany‐Moretlwe, MBBCh, PhD, DTMH and

Kenneth Mayer, MD

 How Do You Like Your PrEP? (HPTN 067/ADAPT) – Robert Grant, MD, MPH  Phase II Study of Maraviroc‐Containing Regimens for HIV PrEP in MSM (HPTN

069/ACTG 5305) – Roy Gulick, MD, MPH

 Uptake and Utilization of PrEP Among Black MSM: Why Race Matters (HPTN

073) – Darrell Wheeler, PhD, MPH, ACSW

 Dapivirine Ring: Current Progress and Future Plans (Ring Studies) – Zeda

Rosenberg, ScD

 Injectable Agents: Cabotegravir in MSM and Women (HPTN 083/HPTN 084) –

Raphael Landovitz, MD, MSc

 Monoclonal Antibodies for Prevention (HVTN 703/HPTN 081 and HVTN

704/HPTN 085) – Nyaradzo Mgodi, MBChB, Mmed  Questions & Answers

3:30 pm AFTERNOON BREAK

4:00 pm SESSION 2: WHERE DO WE GO FROM HERE? A Panel Discussion on Study Design, Ethical Implications, Optimization of Uptake and Adherence, and the Regulatory Environment – Moderated by Z. Mike Chirenje, MD, FRCOG and Quarraisha Abdool

Karim, PhD

Panelists:

 Jerome Singh, PhD, MHSc, LLM, LLB

 Linda‐Gail Bekker, MBChB, DCH, PhD, DTMH, FCP (SA)  Deborah Donnell, PhD

 LaRon Nelson, PhD, RN, NP

5:15 pm AWARD CEREMONY – Moderated by Quarraisha Abdool Karim, PhD

6:00 pm ADJOURN

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2016 Joint HPTN / IMPAACT Plenary Agenda

WEDNESDAY,

JUNE

15 –

JOINT

HPTN/IMPAACT

PLENARY

– Moderated by Myron Cohen, MD,

Wafaa El‐Sadr, MD, MPH, MPA, James McIntyre, MBCHB, FRCOG, and Sharon Nachman, MD

8:00 am WELCOME – Sharon Nachman, MD

8:10 am NIAID SCIENTIFIC PRIORITIES – Anthony S. Fauci, MD

8:30 am QUESTIONS & ANSWERS

8:40 am RECOGNITION OF WARD CATES – Myron Cohen, MD and Anthony S. Fauci, MD

8:50 am IMPAACT STATE OF THE NETWORK – Sharon Nachman, MD

9:15 am HPTN STATE OF THE NETWORK – Wafaa El‐Sadr, MD, MPH, MPA

9:40 am QUESTIONS & ANSWERS

10:30 am PEPFAR: UPDATE AND FOCUS ON ADOLESCENT GIRLS AND CHILDREN –

Ambassador Deborah Birx, MD

11:00 am OPTIMIZING TREATMENT FOR CHILDREN AND ADOLESCENTS: THE POWER OF NOW –

Martina Penazzato, MD, PhD, MSc, DTMH

11:15 am HIV‐POSITIVE ADOLESCENTS AND ISSUES OF DISCLOSURE OF HIV STATUS TO SEXUAL PARTNERS – Linda‐Gail Bekker, MBChB, DCH, PhD, DTMH, FCP (SA)

11:30 am HIV IN TRANSGENDER POPULATIONS: CHARTED AND UNCHARTED WATERS – Tonia

Poteat, PhD, MPH, PA‐C

11:45 am MALE INVOLVEMENT IN HIV PREVENTION STUDIES – Helen Ayles, MBBS, PhD, MSc,

DTMH, MRCP

12:00 pm QUESTIONS & ANSWERS

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WEDNESDAY,

JUNE

15 –

IMPAACT

PLENARY

1:00 pm UPDATE ON IMPAACT RESEARCH AGENDA: SCIENTIFIC COMMITTEES’ PRIORITIES & ACCOMPLISHMENTS – Sharon Nachman, MD

1:30 pm TARGETED LONG‐ACTING COMBINATION ANTIRETROVIRAL THERAPY – Rodney Ho,

PhD

2:00 pm ACTG 5300/IMPAACT 2003 ‐ PHOENIX FEASIBILITY STUDY: A MULTI‐COUNTRY STUDY OF MDR TB CASES AND THEIR HOUSEHOLD CONTACTS TO INFORM THE OPERATIONAL FEASIBILITY OF THE PHOENIX TRIAL – Amita Gupta, MD

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8:00 am WELCOME/INTRODUCTION – James McIntyre, MD

8:15 am DEBATE: CAN ADOLESCENTS BE SUCCESSFULLY INCLUDED IN HIV PREVENTION STUDIES? – Moderated by Pat Flynn, MD

 For inclusion: Mutsa Bwakura‐Dangarembizi, MBChB and Margaret Moon,

MD, MPH

 Against inclusion: Sybil Hosek, PhD and Jerome Singh, PhD, MHSc, LLM, LLB

9:00 am PANEL DISCUSSION: DESIGN OF THE NEXT GENERATION OF PEDIATRIC HIV

TREATMENT TRIALS: HOW TO GET DRUGS LICENSED MORE RAPIDLY FOR CHILDREN –

Moderated by Elaine Abrams, MD

Panelists:

 Yodit Belew, MD

 Martina Penazzato, MD, PhD, MSc, DTMH  Edmund Capparelli, PharmD

 Avy Violari, MD, FCPAED (SA)

10:30 am MOTHERS, MILK AND MICROBES: HOW TO MAKE HEALTHLY BABIES – Grace Aldrovandi, MD

11:15am STATISTICAL ISSUES IN IMPAACT STUDIES – David Shapiro, PhD

11:45am UPDATE ON ELECTRONIC DATA CAPTURE – Marlene Cooper, MS