Guideline Development and Committees

Guideline Development and Committees

Expert Committees

Composition: The Clinical Guidelines Program works directly with committees composed of experts in the field who represent multiple disciplines (medicine, nursing, psychology, pharmacy, public health, social work, mental health), clinical specialties (infectious diseases, family medicine, obstetrics and gynecology, hepatology, pediatrics, psychiatry, dentistry, prevention, etc.), and various geographic regions of New York State.

A Clinical Guidelines Program Steering Committee provides oversight and strategy to the following Clinical Guidelines Program committees, each of which is responsible for developing and updating clinical practice guidelines that fall under its area of expertise. Current committees (February 2020) include the following:

Financial disclosure and confidentiality agreement: All potential and active committee members are required to sign a confidentiality agreement and to disclose annually all financial relationships with commercial entities or gifts that may be actual, potential, or perceived as conflicts of interest. Committee members must report financial relationships with commercial entities that have existed in the 12 months prior to or are expected to exist in the 12 months after the date on which they sign their disclosure form.

Guideline development process: When the Clinical Guidelines Program identifies the need to develop or update a guideline, the committee under whose purview the guideline falls convenes to determine the goals of the guideline and its content, review the published literature, and weigh new evidence for recommendations. Text is then drafted by an author who has experience with the topic of the guideline. The guideline draft is edited by the team at JHU, and then reviewed and modified by the committee. This rigorous development process may entail multiple rounds of review, revision, rating, and editing. Decision-making occurs by consensus, and all guideline recommendations are reviewed by and receive the consensus approval of the full guideline committee. 

Evidence-based Recommendations: All recommendations are rated to reflect the strength of each recommendation and the quality of the supporting evidence. Ratings are reached through review of the evidence and consensus decision. If the published evidence in support of a particular recommendation is not sufficient, the group relies on collective best practices experience to develop a final statement. The rating scheme for recommendations appears below.

AIDS Institute Clinical Guidelines Program: Recommendations Ratings
(updated June 2019 [a])
Strength of Recommendation Ratings
A Strong recommendation
B Moderate recommendation
C Optional
Quality of Supporting Evidence Ratings
1 Evidence is derived from published results of at least one randomized trial with clinical outcomes or validated laboratory endpoints.
* Evidence is strong because it is based on a self-evident conclusion(s); conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.
2 Evidence is derived from published results of at least one well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes.
2† Evidence has been extrapolated from published results of well-designed studies (including non-randomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline.
3 Recommendation is based on the expert opinion of the committee members, with rationale provided in the guideline text.
  1. With the June 2019 update, the ratings for quality of supporting evidence were expanded to add the * rating and the 2† rating.

External review: All guidelines are reviewed by external experts in the field and by the AIDS Institute’s Consumer Advisory Committee. 

Final approval: The guideline is submitted to the AIDS Institute for review and final approval prior to publication. The AI may request additional review by other agencies and organizations when applicable.

Guideline Updates: Members of guideline committees monitor developments ongoing to maintain guideline currency, at regular intervals. Newly published data that provides support for existing recommendations will be cited in the text and the studies will be added to the reference list. If newly published data prompts a revision to recommendations or rationale, a planning committee proposes appropriate edits and determines whether any changes warrant full committee review and approval. 

Medical Care Criteria Committee (MCCC; Adult HIV Treatment and Prevention)

Updated July 2021 | Recent changes to the MCCC

Guidelines Writing Group

Chair: Joseph P. McGowan, MD, FACP, FIDSA
North Shore University Hospital, Manhasset, NY
No disclosures

Co-Vice-Chair (1/1/21): Steven M. Fine, MD, PhD
University of Rochester Medical Center, Rochester, NY
No disclosures

Co-Vice-Chair (1/1/21):  Rona M. Vail, MD
Callen-Lorde Community Health Center, New York, NY
No disclosures

Chair Emeritus: Samuel T. Merrick, MD
New York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY
No disclosures

Transgender Health Specialist: Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS
Callen-Lorde Community Health Center, New York, NY
No disclosures

Community Advisor:  Jessica Rodrigues
AVAC, New York, NY
No disclosures

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health, AIDS Institute, New York, NY
No disclosures

Clinical Advisor to the AIDS Institute: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Director, JHU-NYSDOH AI Guidelines Program: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

Contributing Members

Jessica M. Atrio, MD, MSc
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Oni J. Blackstock, MD, MHS
Health Justice, New York, NY
No disclosures

James C. M. Brust, MD
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Ethan A. Cowan, MD, MS
Icahn School of Medicine at Mount Sinai, New York, NY
No disclosures

Elliot DeHaan, MD
New York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY
No disclosures

Mary E. Dyer, MD
Sun River Health, Poughkeepsie, NY
No disclosures

John J. Faragon, PHARMD, BCPS, AAHIVP
Albany Medical Center, Albany, New York
No disclosures

Shauna H. Gunaratne, MD, MPH
Columbia University Medical Center, New York, NY
No disclosures

Bruce E. Hirsch, MD, FACP, FIDSA, AAHIVS
North Shore University Hospital, Manhasset, NY
No disclosures

Christine A. Kerr, MD
Galileo Health
No disclosures

Jeremy D. Kidd, MD, MPH
New York-Presbyterian Hospital, Columbia University, New York, NY
No disclosures

Hector I. Ojeda-Martinez, MD
Nuvance Health/Health Quest Medical Practice, Poughkeepsie, NY
No disclosures 

Sanjiv S. Shah, MD, MPH, AAHIVM, AAHIVS
NYC Health + Hospitals/Gotham Health, Gouverneur, New York, NY
No disclosures

Noga Shalev, MD
Columbia University Medical Center, New York, NY
No disclosures

Eugenia L. Siegler, MD
Weill Cornell Medical College, New York, NY
No disclosures

Maria Teresa (Tess) Timoney, MS, RN, CNM
Bronx Prevention Center, ICAP at Columbia, Bronx, NY
No disclosures

Benjamin W. Tsoi, MD, MPH
Bureau of HIV/AIDS Prevention and Control
New York City Department of Health and Mental Hygiene, New York, NY
No disclosures

Marguerite A. Urban, MD
University of Rochester School of Medicine and Dentistry, Rochester, NY
No disclosures

Antonio E. Urbina, MD 
The Mount Sinai Hospital, Comprehensive Health Program-Downtown, New York, NY
Scientific Advisor: Gilead, ViiV, Merck

Geoffrey A. Weinberg, MD
University of Rochester School of Medicine and Dentistry, Rochester, NY
No disclosures

Recent Changes to the MCCC

July 2021
  • Joined as a writing group member: Jessica Rodrigues, AVAC
March 2021
  • Joined as a contributing member:
    • John J. Faragon, PHARMD, BCPS, AAHIVP, Albany Medical Center
    • Shauna H. Gunaratne, MD, MPH, Columbia University Medical Center
    • Bruce E. Hirsch, MD, FACP, FIDSA, AAHIVS, North Shore University Hospital   
  • Stepped down: 
    • John M. Conry, PharmD, AAHIVP, FNAP, St. John’s University
    • Annette Gaudino, Treatment Action Group (TAG)
    • Jeremiah Johnson, Treatment Action Group (TAG)
    • Eugene D. Morse, PharmD, FCCP, BCPS, University at Buffalo School of Pharmacy & Pharmaceutical Sciences
February 2021
  • Joined as a contributing member: Benjamin W. Tsoi, MD, MPH,  Bureau of HIV/AIDS Prevention and Control, New York City Department of Health and Mental Hygiene
July 2020
  • Joined as a contributing member: Ethan A. Cowan, MD, MS, Icahn School of Medicine at Mount Sinai
  • Stepped down: Daniel J. Egan, MD, Columbia University Vagelos College of Physicians and Surgeons
January 2020
  • Joined as a contributing member:
    •  Jessica M. Atrio, MD, MSc, Albert Einstein College of Medicine/Montefiore Medical Center
    • Oni J. Blackstock, MD, MHS, New York City Department of Health and Mental Hygiene
  • Stepped down: Julie E. Myers, MD, MPH, New York City Department of Health and Mental Hygiene
December 2019
  • Stepped down:
    • Jack Fuhrer, MD, Stony Brook University School of Medicine
    • Luz Amarilis Lugo, MD, Mount Sinai Comprehensive Health Program-Downtown
    • Cynthia H. Miller, MD, Albany Medical Center
    • David C. Perlman, MD, Icahn School of Medicine at Mount Sinai

Hepatitis C Virus (HCV) Guideline Committee

Updated July 2021 | Recent changes to the HCV Guideline Committee

Guidelines Writing Group

Chair: Joshua S. Aron, MD
Elmhurst Hospital Center, Elmhurst, NY
No disclosures

Chair Emerita: Christine A. Kerr, MD
Galileo Health
No disclosures

Contributor: David E. Bernstein, MD, FAASLD, FACG, AGAF, FACP
Hofstra-Northwell School of Medicine, Manhasset, NY
Scientific Advisor: AbbVie, Gilead

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Clinical Advisor to the AIDS Institute: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Director, JHU-NYSDOH AI Guidelines Program: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

AIDS Institute Clinical Representative, Viral Hepatitis: Colleen Flanigan, RN, MS
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Contributing Members 

Mary Angerame, MS, APN-BC
Jordan Health, Rochester, NY
No disclosures

Ayse Aytaman, MD, AGAF, FACG
Veterans Affairs New York Harbor Healthcare System, Brooklyn, NY
No disclosures

Donald P. Kotler, MD
Albert Einstein College of Medicine/Jacobi Medical Center, Bronx, NY
No disclosures

Kristen Marks, MD
Weill Cornell Medical College, New York, NY
No disclosures

Brianna L. Norton, DO, MPH
Montefiore Medical Group, Bronx, NY
No disclosures

Andrew H. Talal, MD, MPH
SUNY Buffalo , Buffalo, NY
Scientific Advisor:  Abbott, Merck

Jeffrey J. Weiss, PhD, MS
Mount Sinai School of Medicine, New York, NY
No disclosures

Recent Changes to the HCV Guideline Committee

April 2021
  • Joined as a contributing member: Andrew H. Talal, MD, MPH, SUNY Buffalo 
March 2021
  • Joined as a contributing member: Donald P. Kotler, MD, Albert Einstein College of Medicine/Jacobi Medical Center
  • Stepped down: Annette Gaudino, Treatment Action Group (TAG)
September 2020
  • Stepped down: Ponni V. Perumalswami, MD, Icahn School of Medicine at Mount Sinai
February 2020
  • Appointed Vice-Chair: Ponni V. Perumalswami, MD, Icahn School of Medicine at Mount Sinai
  • Stepped down as Co-Chair; appointed Chair Emerita: Christine A. Kerr, MD, Galileo Health

Perinatal Transmission Prevention Guideline Committee

Updated February 2020

Leadership

Chair: Marc D. Foca, MD
Children’s Hospital at Montefiore Albert Einstein College of Medicine, Bronx, NY
No disclosures

Chair Emeritus: Rodney L. Wright, MD, MS
Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY
No disclosures

Chair Emeritus: Murli U. Purswani, MBChB, FAAP
Bronx-Lebanon Hospital Center, Bronx, NY
No disclosures

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Clinical Advisor to the AIDS Institute: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Director, JHU-NYSDOH AI Guidelines Program: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

AIDS Institute Clinical Representative, Perinatal HIV Prevention: Suzanne Kaufman, MPH, BSN, AACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Contributing Members

Helene Bernstein, MD, PhD
Upstate Medical University, Syracuse, NY
No disclosures

Aracelis D. Fernández, MD, FAAP
Harlem Hospital Center, New York, NY
No disclosures

Courtney Olson-Chen, MD
University of Rochester Medical School, Rochester, NY
No disclosures

Maria Teresa (Tess) Timoney, MS, RN, CNM
Bronx Prevention Center, ICAP at Columbia, Bronx, NY
No disclosures

Geoffrey A. Weinberg, MD
University of Rochester School of Medicine and Dentistry, Rochester, NY
No disclosures

Recent Changes to the Perinatal Transmission Prevention Guideline Committee

March 2021
  • Stepped down: Annette Gaudino, Treatment Action Group (TAG)

Substance Use Guidelines Committee

Updated June 2021 | Recent changes to the Substance Use Guidelines Committee

Leadership

Medical Director: Charles J. Gonzalez, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Clinical Advisor to the AIDS Institute: Lyn C. Stevens, MS, NP, ACRN
New York State Department of Health AIDS Institute, Albany, NY
No disclosures

Director, JHU-NYSDOH AI Guidelines Program: Christopher J. Hoffmann, MD, MPH
Johns Hopkins University School of Medicine, Division of Infectious Diseases, Baltimore, MD
No disclosures

AIDS Institute Clinical Representative, Harm Reduction in Healthcare: Sharon L. Stancliff, MD
New York State Department of Health AIDS Institute, New York, NY
No disclosures

AIDS Institute Clinical Representative, Drug User Health: Narelle Ellendon, RN
New York State Department of Health AIDS Institute, New York, NY
No disclosures

Contributing Members

Angela G. Giovanniello, PharmD, AAHIVP
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Giliane Joseph, MD
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

Shadi Nahvi, MD, MS
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
No disclosures

David C. Perlman, MD
Icahn School of Medicine at Mount Sinai, New York, NY
No disclosures

Susan D. Whitley, MD
New York City Health + Hospitals/Kings County, Brooklyn, NY
No disclosures

Timothy J. Wiegand, MD
University of Rochester Medical Center, Rochester, NY
Consultant: McKesson Corporation

Recent Changes to the Substance Use Guidelines Committee

June 2021

  • Stepped down: 
    • Chinazo O. Cunningham, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center (former Chair)
    • Hillary Kunins, MD, MPH, MS, New York City Department of Health and Mental Hygiene

March 2021

  • Stepped down: 
    • Annette Gaudino, Treatment Action Group (TAG)
    • Raymond Harvey, MD, Institute for Family Health

July 2020

  • Stepped down: 
    • Marcus Bachhuber, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center
    • Michael L. Christie, MD, University of Rochester Medical Center
  • Stepped down as Vice-Chair: Kelly S. Ramsey, MD, MPH, MA, FACP, New York State Office of Addiction Services and Support

Institutional, Agency, and Program Liaison Advisory Group

Updated April 2021

Sheldon T. Brown, MD
Infectious Diseases
Hudson Valley VA Healthcare System, Montrose, NY

Douglas Fish, MD
Office of Health Insurance Programs
New York State Department of Health, Albany, NY
No disclosures

Emma Kaplan-Lewis, MD
HIV Services, Office of Population Health
NYC Health and Hospitals, New York, NY

Ralph Liporace, MD
Coxsackie Correctional Facility
NYS Department of Corrections and Community Service, Albany NY

Monica Parker, PhD
Bloodborne Viruses Laboratory, Wadsworth Center
New York State Department of Health, Albany, NY
No disclosures

Thomas Smith, MD
Office of Mental Health
New York State Psychiatric Institute, New York, NY

William M. Valenti, MD, FIDSA, Trillium Health, Rochester, NY
Medical Society of the State of New York
Financial disclosure: Scientific Advisor, Gilead Sciences