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New York State Department of Health AIDS Institute Clinical Guidelines

Baltimore (MD): Johns Hopkins University; -.

About the AIDS Institute Clinical Guidelines Program

Developer: New York State Department of Health AIDS Institute (NYSDOH AI) Clinical Guidelines Program

Funding Source: NYSDOH AI

Program Manager: Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff.

Mission: To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered.

Expert Committees: The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout NYS to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of NYS, all relevant clinical practice settings, key NYS agencies, and community service organizations.

Committee Structure:

  • Leadership: AI-appointed chair, vice chair(s), chair emeritus, clinical specialist(s), JHU Guidelines Program Director, AI Medical Director, AI Clinical Consultant, AVAC community advisor
  • Contributing members
  • Guideline writing groups: Lead author, coauthors if applicable, and all committee leaders

Disclosure and Management of Conflicts of Interest:

  • Annual disclosure of financial relationships with commercial entities for the 12 months prior and upcoming is required of all individuals who work with the guidelines program, and includes disclosure for partners or spouses and primary professional affiliation.
  • The NYSDOH AI assesses all reported financial relationships to determine the potential for undue influence on guideline recommendations and, when indicated, denies participation in the program or formulates a plan to manage potential conflicts. Disclosures are listed for each committee member.

Evidence Collection and Review:

  • Literature search and review strategy is defined by the guideline lead author based on the defined scope of a new guideline or update.
  • A comprehensive literature search and review is conducted for a new guideline or an extensive update using PubMed, other pertinent databases of peer-reviewed literature, and relevant conference abstracts to establish the evidence base for guideline recommendations.
  • A targeted search and review to identify recently published evidence is conducted for guidelines published within the previous 3 years. 
  • Title, abstract, and article reviews are performed by the lead author. The JHU editorial team collates evidence and creates and maintains an evidence table for each guideline.

Recommendation Development:

  • The lead author drafts recommendations to address the defined scope of the guideline based on available published data. 
  • Writing group members review the draft recommendations and evidence and deliberate to revise, refine, and reach consensus on all recommendations.
  • When published data are not available, support for a recommendation may be based on the committee’s expert opinion.
  • The writing group assigns a 2-part rating to each recommendation to indicate the strength of the recommendation and quality of the supporting evidence. The group reviews the evidence, deliberates, and may revise recommendations when required to reach consensus. 

Review and Approval Process:

  • Following writing group approval, draft guidelines are reviewed by all contributors, program liaisons, and a volunteer reviewer from the AI Community Advisory Committee.
  • Recommendations must be approved by two-thirds of the full committee. If necessary to achieve consensus, the full committee is invited to deliberate, review the evidence, and revise recommendations.
  • Final approval by the committee chair and the NYSDOH AI Medical Director is required for publication.

External Reviewers:

  • External review of each guideline is invited at the developer’s discretion.
  • External reviewers recognized for their experience and expertise review guidelines for accuracy, balance, clarity, and practicality and provide feedback.

Update Process:

  • JHU editorial staff ensure that each guideline is reviewed and determined to be current upon the 3-year anniversary of publication; guidelines that provide clinical recommendations in rapidly changing areas of practice may be reviewed annually. Published literature is surveilled to identify new evidence that may prompt changes to existing recommendations or development of new recommendations.
  • If changes in the standard of care, newly published studies, new drug approval, new drug-related warning, or a public health emergency indicate the need for immediate change to published guidelines, committee leadership will make recommendations and immediate updates and will invite full committee review as indicated.

Recommendation Ratings and Definitions: Each recommendation receives a 2-part rating for strength and quality of evidence (e.g., A1, B1, A2†, etc.).

Strength is rated as follows:

A—Strong

B—Moderate

C—Optional

Quality of evidence is rated as follows:

1—Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints.

*—Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.

2—Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes.

2†—Extrapolated from published results of well-designed studies (including nonrandomized 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—Based on committee expert opinion, with rationale provided in the guideline text.

Shared Decision-Making: Throughout its guidelines, the NYSDOH AI Clinical Guidelines Program recommends “shared decision-making,” an individualized process central to patient-centered care. With shared decision-making, clinicians and patients engage in meaningful dialogue to arrive at an informed, collaborative decision about a patient’s health, care, and treatment planning. See Clinical Guidelines Program Approach to Shared Decision-Making.

Contents

Current

  • Laboratory Monitoring for Adverse Effects of ART
    Lead Author: Shauna Gunaratne; Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Anne K. Monroe, Jessica Rodrigues, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; November 2024.
  • Perioperative Care in Adults With HIV
    Lead Author: Sangyoon Jason Shin; Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Jessica Rodrigues, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; November 2024.
  • Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections
    Lead Author(s): Daniela E. DiMarco and Marguerite A. Urban. Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Jessica Rodrigues, Brianna L. Norton, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; October 2024.
  • PEP to Prevent HIV Infection
    Lead Author: Ethan Cowan; Contributor(s): Christine A. Kerr, Aracelis Fernandez, Lisa-Gaye Robinson, and Ruby Fayorsey. Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Anne K. Monroe, Jessica Rodrigues, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; October 2024.
  • Prevention and Management of Hepatitis B Virus Infection in Adults With HIV
    Lead Author: Alok Gupta; Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Jessica Rodrigues, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; October 2024.
  • Second-Line ART After Treatment Failure or for Regimen Simplification
    Lead Author: Joseph P. McGowan; Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Samuel T. Merrick, Asa E. Radix, Jessica Rodriguez, Brianna L. Norton, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; August 2024.
  • Primary Care for Adults With HIV
    Lead Author(s): Christine Kerr and Mary Dyer. Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Anne K. Monroe, Jessica Rodriguez, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; July 2024.
  • Prevention and Treatment of Mpox
    Lead Author(s): Jacob R. McLean and Jason E. Zucker. Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Jessica Rodrigues, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; May 2024.
  • Substance Use Screening, Risk Assessment, and Use Disorder Diagnosis in Adults
    Lead Author(s): Jennifer McNeely, Leah K. Hamilton, and Susan D. Whitley. Writing Group: Timothy J. Wiegand, Sharon L. Stancliff, Brianna L. Norton, Charles J. Gonzalez, and Christopher J. Hoffman.
    Baltimore (MD): Johns Hopkins University; May 2024.
  • Immunizations for Adults With HIV
    Lead Author(s): Christine Kerr and Mary Dyer. Contributor: Marguerite A. Urban; Writing Group: Rona M. Vail, Sanjiv S. Shah, Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Jessica Rodrigues, Christopher J. Hoffmann, Brianna L. Norton, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; April 2024.
  • Management of IRIS
    Lead Author: James C. M. Brust; Writing Group: Joseph P. McGowan, Steven M. Fine, Samuel T. Merrick, Asa E. Radix, Rona M. Vail, Brianna Norton, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; March 2024.
  • Treatment of Opioid Use Disorder
    Lead Author: Tiffany Lu; Writing Group: Susan D. Whitley, Timothy J. Wiegand, Sharon L. Stancliff, Brianna L. Norton, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; February 2024.
  • Treatment of Alcohol Use Disorder
    Lead Author: Yonina Mar; Writing Group: Susan D. Whitley, Timothy J. Weigand, Sharon L. Stancliff, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; October 2023.
  • Substance Use Harm Reduction in Medical Care
    Lead Author: Judith Griffin; Writing Group: Susan D. Whitley, Timothy J. Wiegand, Sharon L. Stancliff, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; September 2023.
  • Diagnosis and Management of HIV-2 in Adults
    Lead Author: Sanjiv S. Shah; Writing Group: Steven M. Fine, Rona M. Vail, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; June 2023.
  • HIV Resistance Assays
    Lead Author: Steven M. Fine; Writing Group: Rona M. Vail, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Jessica Rodrigues, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; June 2023.
  • Use of Injectable CAB/RPV LA as Replacement ART in Virally Suppressed Adults
    Lead Author: Joseph P. McGowan; Writing Group: Steven M. Fine, Rona M. Vail, Samuel T. Merrick, Asa E. Radix, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; May 2023.
  • Management of Periodontal Disease
    Lead Author: Abhiram Maddi; Contributor: Stephen N. Abel; Writing Group: Steven M. Fine, Rona Vail, Joseph P. McGowan, Samuel T. Merrick, Asa Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; April 2023.
  • Treatment of Chronic Hepatitis C Virus Infection in Adults
    Lead Author: David E. Bernstein; Writing Group: Joshua S. Aron, Christine A. Kerr, Colleen Flanigan, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; April 2023.
  • Rapid ART Initiation
    Lead Author: Asa E. Radix; Writing Group: Steven M. Fine, Rona M. Vail, Joseph P. McGowan, Samuel T. Merrick, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; February 2023.
  • Hepatitis C Virus Screening, Testing, and Diagnosis in Adults
    Lead Author: Joshua S. Aron; Writing Group: Christine A. Kerr, David E. Bernstein, Colleen Flanigan, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; January 2023.
  • Prevention and Management of Human Papillomavirus Infection in Adults With HIV
    Lead Author: Meera Shah; Contributor(s): Maria Teresa Timoney and Jessica M. Atrio. Writing Group: Steven M. Fine, Rona M. Vail, Joseph P. McGowan, Samuel T. Merrick, Asa E. Radix, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; November 2022.
  • Pretreatment Assessment in Adults With Chronic Hepatitis C Virus Infection
    Lead Author: Christine A. Kerr; Writing Group: Joshua S. Aron, David E. Bernstein, Colleen Flanigan, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; October 2022.
  • HIV Testing During Pregnancy, at Delivery, and Postpartum
    Lead Author: Maria Teresa Timoney; Writing Group: Steven M. Fine, Rona Vail, Joseph P. McGowan, Samuel T. Merrick, Asa Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; September 2022.
  • Screening for Anal Dysplasia and Cancer in Adults With HIV
    Lead Author: Bruce Hirsch; Writing Group: Steven M. Fine, Rona Vail, Joseph P. McGowan, Samuel T. Merrick, Asa Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; August 2022.
  • Selecting an Initial ART Regimen
    Lead Author: Antonio E. Urbina; Contributor(s): Nicole Bradley, Yuman Lee, and John M. Conry. Writing Group: Steven M. Fine, Rona Vail, Joseph P. McGowan, Samuel T. Merrick, Asa Radix, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; August 2022.
  • Virologic and Immunologic Monitoring in HIV Care
    Lead Author: Samuel T. Merrick; Writing Group: Steven M. Fine, Rona Vail, Joseph P. McGowan, Asa Radix, Jessica Rodrigues, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; June 2022.
  • HIV Testing
    Lead Author: Benjamin W. Tsoi; Contributor: Monica Parker; Writing Group: Steven M. Fine, Joseph P. McGowan, Rona Vail, Samuel T. Merrick, Asa Radix, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; May 2022.
  • PrEP to Prevent HIV and Promote Sexual Health
    Lead Author: Rona M. Vail; Writing Group: Steven M. Fine, Joseph P. McGowan, Samuel T. Merrick, Asa Radix, Jessica Rodrigues, Christopher J. Hoffmann, Lyn C. Stevens, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; May 2022.
  • Mycoplasma genitalium Management in Adults
    Lead Author(s): Daniela E. DiMarco and Marguerite A. Urban. Writing Group: Joseph P. McGowan, Steven M. Fine, Rona Vail, Samuel T. Merrick, Asa E. Radix, Charles J. Gonzalez, and Christopher J. Hoffmann.
    Baltimore (MD): Johns Hopkins University; March 2022.
  • Screening for Cervical Dysplasia and Cancer in Adults With HIV
    Lead Author(s): Maria Teresa Timoney and Jessica M. Atrio. Writing Group: Joseph P. McGowan, Steven M. Fine, Rona Vail, Samuel T. Merrick, Asa Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; March 2022.
  • Therapeutic Use of Medical Cannabis in New York State
    Lead Author(s): Deepika Slawek and Julia H. Arnsten. Writing Group: Susan D. Whitley, Timothy J. Wiegand, Sharon Stancliff, Lyn C. Stevens, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; January 2022.
  • Diagnosis and Management of Acute HIV Infection
    Lead Author: Ethan A. Cowan; Writing Group: Joseph P. McGowan, Steven M. Fine, Rona Vail, Samuel T. Merrick, Asa Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; July 2021.
  • Substance Use Disorder Treatment in Pregnant Adults
    Lead Author: Kelly S. Ramsey; Writing Group: Sharon Stancliff, Lyn C. Stevens, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; July 2021.
  • Prevention and Management of Hepatitis A Virus Infection in Adults With HIV
    Lead Author: Hector I. Ojeda-Martinez; Writing Group: Joseph P. McGowan, Steven M. Fine, Rona Vail, Samuel T. Merrick, Asa Radix, Christopher J. Hoffmann, and Charles J. Gonzalez.
    Baltimore (MD): Johns Hopkins University; May 2021.
Copyright © Johns Hopkins University Clinical Guidelines Program. The Clinical Guidelines Program, a collaborative effort of the NYSDOH AI and the Johns Hopkins University School of Medicine, Division of Infectious Diseases, encourages the use, reproduction, and distribution of original documents and related graphics from this program website accompanied by a full citation of source that includes: Author(s). Committee. Title. Date of publication. Full URL. Date accessed. Links to pages on this Clinical Guidelines Program website are also encouraged and may be created without seeking permission. Requests to adapt material, i.e., to change or alter in any way material from this website for inclusion in another publication, should be sent to [email protected]. Please include detailed information about the intended use and desired adaptations.

This book is licensed under the terms of the Attribution-NonCommercial-NoDerivs 3.0 Unported (CC BY-NC-ND 3.0).

Bookshelf ID: NBK556473

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