Questions, Answers, and Best Practices for Expedited Partner Therapy (EPT)

April 15, 2022

Purpose of This Guidance

Date of current publication: April 15, 2022
Lead authors: Jason E. Zucker, MD, and Marguerite A. Urban, MD
Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: April 15, 2022

Sexually transmitted infections (STIs) are a significant cause of morbidity and mortality and may result in infertility, chronic abdominal pain, and an increased risk of acquiring HIV. In New York State, as of 2020, cases of chlamydia and gonorrhea, the most common bacterial STIs, had increased for the sixth consecutive year. Currently, New York State ranks 17th and 19th among all states for total number of cases of chlamydia and gonorrhea, respectively CDC 2023. People <24 years old, non-Hispanic Black individuals, and men who have sex with men have the highest rates of STIs in New York State; in 2019, rates also significantly increased among women NYSDOH 2021. It is imperative that all patients with STIs and their sex partners are treated to interrupt chains of transmission, help combat rising STI numbers, and move toward ending the STI epidemic. Expedited partner therapy (EPT) is an essential health service that can help combat the rising number of cases and is designed to be a low-barrier intervention. The New York State Department of Health (NYSDOH) encourages care providers to take steps to make EPT as available as possible NYSDOH 2022.

The answers to the frequently asked questions below offer guidance for clinicians in New York State who provide sexual health care, including testing and treatment for STIs. The goal is to inform clinicians about existing regulations that allow expedited treatment of sex partners of individuals diagnosed with gonorrhea, chlamydia, or trichomoniasis. EPT is not allowed for treatment of syphilis (see information regarding syphilis management in guidance section Definition, Legality, and Eligibility ).

More information is available through these resources:

Definition, Legality, and Eligibility

What is EPT?

Expedited partner therapy, or EPT, is the clinical practice of providing prescription medication for STI treatment without a healthcare visit for the sex partners of patients with a newly diagnosed STI. In New York State, EPT is permissible for chlamydia, gonorrhea, and trichomoniasis NYSDOH 2022CDC 2021. EPT is an opportunity to lower the threshold to an essential sexual health service and make treatment broadly available. EPT is not intended to replace clinic visits but to provide an alternative strategy for treating partners who are unable or unwilling to see a care provider for treatment. Clinic visits provide opportunities for STI screening in individuals who may require treatment for an STI other than the infection being treated with EPT. A visit with a care provider also offers the opportunity to provide additional services, such as risk-reduction counseling and HIV pre-exposure prophylaxis.

Is EPT legal?

Yes, in New York State, EPT is explicitly legal under NYS Public Health Law 2312 and can be provided for treatment of chlamydia, gonorrhea, and trichomoniasis, as recommended by the CDC: 2021 STI Treatment Guidelines.

EPT is permissible or potentially allowable in 50 states. State laws determine the STIs covered, who can receive EPT, and how it can be provided. Clinicians should review state-specific guidance before providing EPT.

Who is eligible for EPT?

Sex partners of patients with a clinical or laboratory diagnosis of gonorrhea, chlamydia, and trichomoniasis (referred to as index patients) are eligible for EPT, which can be prescribed regardless of the sexual or gender identity of the index patient or their sex partner.

There is no age threshold for EPT in New York State. According to NYS Public Health Law 2305, individuals <18 years old may give effective informed consent for services related to screening, treatment, and prevention of STIs. Therefore, EPT is applicable for patients of any age and their sex partner(s).


  1. Per New York State law, individuals <18 years old may give effective informed consent for services related to screening, treatment, and prevention of sexually transmitted infections.
Box: Eligibility for Expedited Partner Therapy (EPT) [a]
Eligible for EPT Not eligible for EPT
  • Patients with a clinical (without laboratory confirmation) or laboratory diagnosis of chlamydia, gonorrhea, and trichomoniasis (referred to as index patients) and their sex partners
  • All sex partners exposed within 60 days before the index patient’s symptom onset or diagnosis
  • The most recent sex partner, if the index patient has had no sex partners within 60 days of the diagnosis
  • Patients known to have syphilis in addition to gonorrhea, chlamydia, and trichomoniasis
  • Cases involving suspected or confirmed abuse (i.e., child abuse, sexual assault, or sexual abuse)

Why are patients known to have syphilis not eligible for EPT?

The recommended management of partners of individuals diagnosed with syphilis varies significantly depending on the stage of syphilis in the index patient. No data support use of EPT to treat partners of patients with syphilis. Partner services offered through state or local health departments are available to assist with partner treatment for syphilis throughout New York State. Of note, a clinician may prescribe EPT for gonorrhea, chlamydia, and trichomonas to a patient while syphilis test results are pending or if they are unable to be tested (e.g., a symptomatic telehealth visit). If the diagnosis of syphilis was unknown at the time EPT was prescribed, there is no liability.

Treatment, Medications, and Follow-Up

Which medications should be used for EPT?

Table 1, below, summarizes preferred and alternative regimens for EPT, which are aligned with the CDC: 2021 STI Treatment GuidelinesEPT treatment for an index patient and their sex partner(s) may not be the same.

Table 1: Preferred and Alternative Regimens for Expedited Partner Therapy (EPT)
CDC: 2021 Sexually Transmitted Infections Treatment Guidelines
STI Preferred
EPT Regimen
EPT Regimen
Chlamydia Doxycycline 100 mg by mouth twice daily for 7 days


Azithromycin 1 g by mouth in a single dose

Levofloxacin 500 mg by mouth daily for 7 days
  • Doxycycline and levofloxacin are contraindicated in pregnancy
  • Azithromycin is recommended for treatment of chlamydia in patients with unknown pregnancy status
Gonorrhea Cefixime 800 mg by mouth in a single dose Treat for chlamydia if it has not been excluded
Trichomoniasis Metronidazole 2 g by mouth in a single dose


Tinidazole 2 g by mouth in a single dose

Metronidazole 500 mg by mouth twice daily for 7 days Counsel symptomatic pregnant patients with trichomoniasis regarding the potential risks and benefits of treatment

Is the treatment for an index patient and a sex partner always the same?

The index patient’s and sex partner’s EPT regimens may differ based on individual patient factors. For guidance on the treatment of the index patient, see CDC: 2021 STI Treatment Guidelines.

How do I provide EPT medications?

Clinicians may dispense EPT medications in person at the point of care or may provide a prescription for the medications.

Partner packs, dispensed in person, are preferred. Partner packs include medication for the index patient and the sex partner along with informational materials.

Per New York State law, when dispensed, partner packs must be labeled with the name and address of the dispenser, directions for use, date of delivery, the proprietary or brand name of the drug, and the strength of the contents.

However, not all clinical environments may be able to dispense EPT in this way. When partner packs are not available, clinicians can provide a prescription to the index patient for their partner, along with informational materials and clinic contact information.

Prescribed (“Prescription – EPT”): If providing a prescription for EPT, the prescription must have “EPT” in the comments below the care provider information and above the medication, the dosage, refills (0), and instructions for use. The prescription may be issued electronically or on an official New York State prescription form. No identifiable information is required; per NYS Public Health Law Section 2312, a pharmacist can fill a prescription with the designation of “EPT” even when a sex partner’s name, address, and date of birth are not listed on the prescription. See the NYSDOH document EPT FAQs for Health Care Providers and Pharmacists for answers to common questions from health care providers regarding EPT prescriptions. Information on electronic prescribing rules, regulations, and allowable exemptions (including EPT) in New York State can be found on the NYSDOH Electronic Prescribing webpage.

  • Medications must be labeled with the name and address of the dispenser, directions for use, date of delivery, the proprietary or brand name of the drug, and the strength of the contents NYS Senate 2014.

Who is responsible for paying for EPT medications?

Medication costs are the responsibility of the sex partner and may be paid for in cash or through health insurance coverage. The index patient’s insurance cannot be billed for medications for a partner. If an index patient’s partner is uninsured, then the best approach is to provide the EPT medications in person when available. When EPT medications cannot be provided in person, partners should be sent to a local health department to cover the cost of the prescription.

How should I follow up?

Contact the index patient and, with consent, their partner by phone to ensure they have or will pick up the medications and that symptoms resolve. Schedule follow-up visits for index patients if symptoms persist or at 3 months for repeat testing because of the risk of reinfection. Advise that sex partners follow up for comprehensive sexual health services as soon as they are able.

Patient Education

What points should be covered in EPT educational materials?

  • Advise index patients to inform their sex partner(s) that they may have been exposed to an STI (chlamydia, gonorrhea, and/or trichomoniasis) and should seek evaluation and treatment even if they do not have symptoms.
  • Emphasize that partners should read the educational information provided before they take the EPT medication.
  • Make clear that the partner should seek medical care before starting the EPT medication if they:
    • Are allergic to antibiotics
    • Have abdominal pain, pelvic pain, testicular pain, fever, nausea, vomiting, or other symptoms of serious illness that require evaluation and may require treatment beyond EPT
    • Are pregnant or could be pregnant
    • Have serious health problems
    • Are taking prescription or nonprescription drugs, because potentially dangerous drug-drug interactions could occur
  • Educate index patients and partners about:
    • The possibility that additional treatment may be needed if the patient or partner has an STI that is not covered by the delivered EPT
    • Abstaining from sexual activity for at least 7 days after treatment is ended to decrease the likelihood of reinfection
    • Prevention of STIs in the future, including the use of barrier protection and PrEP for prevention of HIV
    • The preferred approach to STI care for partners, which is to see a health care provider for a complete STI evaluation, including HIV testing, even if they take the EPT medications

Where can I find free educational materials?

New York State offers free educational materials for distribution to partners in English and Spanish. These materials may be distributed with a digital link or a QR code or ordered through the NYSDOH website.

Best Practice Reminders

  • The best practice for STI care is to see and evaluate the sex partner(s) of an index patient diagnosed with an STI. An index patient may, if asked, be able to bring their sex partner(s) with them when they come for treatment.
  • EPT is a legal alternative STI treatment strategy for sex partners of patients with a clinical or laboratory diagnosis of gonorrhea, chlamydia, or trichomonas (not syphilis) and who are not able or not willing to be seen for medical care.
  • When possible, EPT should be provided as a partner pack that includes medication, informational materials, and clinic contact options.
  • When a partner pack is not available, a clinician can provide the index patient with a prescription for their partner(s) along with informational materials and clinic contact options.
  • If a prescription for EPT is provided instead of a partner pack, the partner is responsible for the cost of the medications.
  • Azithromycin is the EPT option for treatment of chlamydia in a partner who is or could be pregnant.
  • Follow up by phone with the index patient to ensure that they have their medications or will be able to get them, and if appropriate, to ask if symptoms have resolved.
  • With consent, also follow up with the partner(s) who received EPT.

Shared Decision-Making

Download Printable PDF of Shared Decision-Making Statement

Date of current publication: August 8, 2023
Lead authors:
Jessica Rodrigues, MS; Jessica M. Atrio, MD, MSc; and Johanna L. Gribble, MA
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 8, 2023


Throughout its guidelines, the New York State Department of Health (NYSDOH) AIDS Institute (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. The approach to shared decision-making described here applies to recommendations included in all program guidelines. The included elements are drawn from a comprehensive review of multiple sources and similar  attempts to define shared decision-making, including the Institute of Medicine’s original description [Institute of Medicine 2001]. For more information, a variety of informative resources and suggested readings are included at the end of the discussion.


The benefits to patients that have been associated with a shared decision-making approach include:

  • Decreased anxiety [Niburski, et al. 2020; Stalnikowicz and Brezis 2020]
  • Increased trust in clinicians [Acree, et al. 2020; Groot, et al. 2020; Stalnikowicz and Brezis 2020]
  • Improved engagement in preventive care [McNulty, et al. 2022; Scalia, et al. 2022; Bertakis and Azari 2011]
  • Improved treatment adherence, clinical outcomes, and satisfaction with care [Crawford, et al. 2021; Bertakis and Azari 2011; Robinson, et al. 2008]
  • Increased knowledge, confidence, empowerment, and self-efficacy [Chen, et al. 2021; Coronado-Vázquez, et al. 2020; Niburski, et al. 2020]


Collaborative care: Shared decision-making is an approach to healthcare delivery that respects a patient’s autonomy in responding to a clinician’s recommendations and facilitates dynamic, personalized, and collaborative care. Through this process, a clinician engages a patient in an open and respectful dialogue to elicit the patient’s knowledge, experience, healthcare goals, daily routine, lifestyle, support system, cultural and personal identity, and attitudes toward behavior, treatment, and risk. With this information and the clinician’s clinical expertise, the patient and clinician can collaborate to identify, evaluate, and choose from among available healthcare options [Coulter and Collins 2011]. This process emphasizes the importance of a patient’s values, preferences, needs, social context, and lived experience in evaluating the known benefits, risks, and limitations of a clinician’s recommendations for screening, prevention, treatment, and follow-up. As a result, shared decision-making also respects a patient’s autonomy, agency, and capacity in defining and managing their healthcare goals. Building a clinician-patient relationship rooted in shared decision-making can help clinicians engage in productive discussions with patients whose decisions may not align with optimal health outcomes. Fostering open and honest dialogue to understand a patient’s motivations while suspending judgment to reduce harm and explore alternatives is particularly vital when a patient chooses to engage in practices that may exacerbate or complicate health conditions [Halperin, et al. 2007].

Options: Implicit in the shared decision-making process is the recognition that the “right” healthcare decisions are those made by informed patients and clinicians working toward patient-centered and defined healthcare goals. When multiple options are available, shared decision-making encourages thoughtful discussion of the potential benefits and potential harms of all options, which may include doing nothing or waiting. This approach also acknowledges that efficacy may not be the most important factor in a patient’s preferences and choices [Sewell, et al. 2021].

Clinician awareness: The collaborative process of shared decision-making is enhanced by a clinician’s ability to demonstrate empathic interest in the patient, avoid stigmatizing language, employ cultural humility, recognize systemic barriers to equitable outcomes, and practice strategies of self-awareness and mitigation against implicit personal biases [Parish, et al. 2019].

Caveats: It is important for clinicians to recognize and be sensitive to the inherent power and influence they maintain throughout their interactions with patients. A clinician’s identity and community affiliations may influence their ability to navigate the shared decision-making process and develop a therapeutic alliance with the patient and may affect the treatment plan [KFF 2023; Greenwood, et al. 2020]. Furthermore, institutional policy and regional legislation, such as requirements for parental consent for gender-affirming care for transgender people or insurance coverage for sexual health care, may infringe upon a patient’s ability to access preventive- or treatment-related care [Sewell, et al. 2021].

Figure 1: Elements of Shared Decision-Making

Figure 1: Elements of Shared Decision-Making

Download figure: Elements of Shared Decision-Making

Health equity: Adapting a shared decision-making approach that supports diverse populations is necessary to achieve more equitable and inclusive health outcomes [Castaneda-Guarderas, et al. 2016]. For instance, clinicians may need to incorporate cultural- and community-specific considerations into discussions with women, gender-diverse individuals, and young people concerning their sexual behaviors, fertility intentions, and pregnancy or lactation status. Shared decision-making offers an opportunity to build trust among marginalized and disenfranchised communities by validating their symptoms, values, and lived experience. Furthermore, it can allow for improved consistency in patient screening and assessment of prevention options and treatment plans, which can reduce the influence of social constructs and implicit bias [Castaneda-Guarderas, et al. 2016].

Clinician bias has been associated with health disparities and can have profoundly negative effects [FitzGerald and Hurst 2017; Hall, et al. 2015]. It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use [Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012]. With its emphasis on eliciting patient information, a shared decision-making approach encourages clinicians to inquire about patients’ lived experiences rather than making assumptions and to recognize the influence of that experience in healthcare decision-making.

Stigma: Stigma may prevent individuals from seeking or receiving treatment and harm reduction services [Tsai, et al. 2019]. Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes [Turan, et al. 2017; Chambers, et al. 2015], and stigma among clinicians against people who use substances has been well-documented [Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013]. Sexual and reproductive health, including strategies to prevent HIV transmission, acquisition, and progression, may be subject to stigma, bias, social influence, and violence.

  • As prevention and treatment modalities in HIV care expand (i.e., vaccines, barriers, injectables, implants, on-demand therapies), it is important for clinicians to ask patients about their goals for prevention and treatment rather than assume that efficacy is the primary factor in patient preference [Sewell, et al. 2021].
  • The shared decision-making approach to clinical care enhances patient knowledge and uptake of new technologies and behavioral practices that align with the patient’s unique preferences and identity [Sewell, et al. 2021], ensures that the selection of a care plan is mutually agreed upon, and considers the patient’s ability to effectively use and adhere to the selected course of prevention or treatment.

Resources and Suggested Reading

In addition to the references cited below, the following resources and suggested reading may be useful to clinicians.


Acree ME, McNulty M, Blocker O, et al. Shared decision-making around anal cancer screening among black bisexual and gay men in the USA. Cult Health Sex 2020;22(2):201-16. [PMID: 30931831]

Avery JD, Taylor KE, Kast KA, et al. Attitudes toward individuals with mental illness and substance use disorders among resident physicians. Prim Care Companion CNS Disord 2019;21(1):18m02382. [PMID: 30620451]

Bertakis KD, Azari R. Patient-centered care is associated with decreased health care utilization. J Am Board Fam Med 2011;24(3):229-39. [PMID: 21551394]

Castaneda-Guarderas A, Glassberg J, Grudzen CR, et al. Shared decision making with vulnerable populations in the emergency department. Acad Emerg Med 2016;23(12):1410-16. [PMID: 27860022]

Chambers LA, Rueda S, Baker DN, et al. Stigma, HIV and health: a qualitative synthesis. BMC Public Health 2015;15:848. [PMID: 26334626]

Chen CH, Kang YN, Chiu PY, et al. Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: a randomized controlled trial. Patient Educ Couns 2021;104(10):2498-2504. [PMID: 33741234]

Coronado-Vázquez V, Canet-Fajas C, Delgado-Marroquín MT, et al. Interventions to facilitate shared decision-making using decision aids with patients in primary health care: a systematic review. Medicine (Baltimore) 2020;99(32):e21389. [PMID: 32769870]

Coulter A, Collins A. Making shared decision-making a reality: no decision about me, without me. 2011.

Crawford J, Petrie K, Harvey SB. Shared decision-making and the implementation of treatment recommendations for depression. Patient Educ Couns 2021;104(8):2119-21. [PMID: 33563500]

FitzGerald C, Hurst S. Implicit bias in healthcare professionals: a systematic review. BMC Med Ethics 2017;18(1):19. [PMID: 28249596]

Greenwood BN, Hardeman RR, Huang L, et al. Physician-patient racial concordance and disparities in birthing mortality for newborns. Proc Natl Acad Sci U S A 2020;117(35):21194-21200. [PMID: 32817561]

Groot G, Waldron T, Barreno L, et al. Trust and world view in shared decision making with indigenous patients: a realist synthesis. J Eval Clin Pract 2020;26(2):503-14. [PMID: 31750600]

Hall WJ, Chapman MV, Lee KM, et al. Implicit racial/ethnic bias among health care professionals and its influence on health care outcomes: a systematic review. Am J Public Health 2015;105(12):e60-76. [PMID: 26469668]

Halperin B, Melnychuk R, Downie J, et al. When is it permissible to dismiss a family who refuses vaccines? Legal, ethical and public health perspectives. Paediatr Child Health 2007;12(10):843-45. [PMID: 19043497]

Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. 2001.

KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. [accessed 2023 May 19]

Livingston JD, Milne T, Fang ML, et al. The effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review. Addiction 2012;107(1):39-50. [PMID: 21815959]

McNulty MC, Acree ME, Kerman J, et al. Shared decision making for HIV pre-exposure prophylaxis (PrEP) with black transgender women. Cult Health Sex 2022;24(8):1033-46. [PMID: 33983866]

Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, et al. Shared decision making in surgery: a meta-analysis of existing literature. Patient 2020;13(6):667-81. [PMID: 32880820]

Parish SJ, Hahn SR, Goldstein SW, et al. The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women. Mayo Clin Proc 2019;94(5):842-56. [PMID: 30954288]

Robinson JH, Callister LC, Berry JA, et al. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract 2008;20(12):600-607. [PMID: 19120591]

Scalia P, Durand MA, Elwyn G. Shared decision-making interventions: an overview and a meta-analysis of their impact on vaccine uptake. J Intern Med 2022;291(4):408-25. [PMID: 34700363]

Sewell WC, Solleveld P, Seidman D, et al. Patient-led decision-making for HIV preexposure prophylaxis. Curr HIV/AIDS Rep 2021;18(1):48-56. [PMID: 33417201]

Stalnikowicz R, Brezis M. Meaningful shared decision-making: complex process demanding cognitive and emotional skills. J Eval Clin Pract 2020;26(2):431-38. [PMID: 31989727]

Stone EM, Kennedy-Hendricks A, Barry CL, et al. The role of stigma in U.S. primary care physicians’ treatment of opioid use disorder. Drug Alcohol Depend 2021;221:108627. [PMID: 33621805]

Tsai AC, Kiang MV, Barnett ML, et al. Stigma as a fundamental hindrance to the United States opioid overdose crisis response. PLoS Med 2019;16(11):e1002969. [PMID: 31770387]

Turan B, Budhwani H, Fazeli PL, et al. How does stigma affect people living with HIV? The mediating roles of internalized and anticipated HIV stigma in the effects of perceived community stigma on health and psychosocial outcomes. AIDS Behav 2017;21(1):283-91. [PMID: 27272742]

van Boekel LC, Brouwers EP, van Weeghel J, et al. Stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review. Drug Alcohol Depend 2013;131(1-2):23-35. [PMID: 23490450]


CDC. Expedited partner therapy. 2021 Apr 19. [accessed 2022 Feb 24]

CDC. Sexually transmitted disease surveillance 2020. 2023 Apr 10. [accessed 2022 Apr 14]

NYS Senate. New York State public health law article 137, section 6807: pharmacy: exempt persons; special provisions. 2014 Sep 22. [accessed 2022 Mar 3]

NYSDOH. Sexually transmitted infections surveillance report, New York State, 2019. 2021 May 5. [accessed 2022 Feb 25]

NYSDOH. Expedited partner therapy. 2022 Sep. [accessed 2022 Feb 24]

Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication April 15, 2022
Intended users NYS clinicians
Lead author(s)

Jason E. Zucker, MD; Marguerite A. Urban, MD

Writing group

Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD

Author and writing group conflict of interest disclosures There are no author or writing group conflict of interest disclosures.

Medical Care Criteria Committee

Developer and funder

New York State Department of Health AIDS Institute (NYSDOH AI)

Development process

See Guideline Development and Recommendation Ratings Scheme, below.

Related NYSDOH AI guidelines

Related NYSDOH AI Guidance

Guideline Development and Recommendation Ratings

Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program
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 New York State to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of New York State, all relevant clinical practice settings, key New York State 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 reviews
  • 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 Scheme
Strength Quality of Evidence
Rating Definition Rating Definition
A Strong 1 Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints.
B Moderate * 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.
C Optional 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.

Last updated on October 31, 2023