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ARV Dose Adjustments for Hepatic or Renal Impairment (version 1)

Table 9: Recommended Dose Adjustments for Use of Selected Fixed-Dose Combination Antiretroviral Medications in Patients With Hepatic or Renal Impairment
Fixed-Dose Combination Hepatic Impairment Dose Adjustment [a] Renal Impairment Dose Adjustment
Recommended Dose Adjustment [a] Individual FDC Components and Recommended Dose Adjustment [a] Clinical Comments
Integrase Strand Transfer Inhibitors
Abacavir/
dolutegravir/
lamivudine
(ABC/DTG/3TC; Triumeq)

 Child-Pugh A,B,C: Do not use. CrCl <30 mL/min: Use of FDC is not recommended.
  • ABC: No renal dose adjustment is needed.
  • DTG: No renal dose adjustment is needed.
  • 3TC:
    • CrCl 30 to 49 mL/min: 150 mg once daily.
    • CrCl 15 to 29 mL/min: 150 mg first dose then 100 mg once daily.
    • CrCl 5 to 14 mL/min: 150 mg first dose then 50 mg once daily.
    • CrCl <5 mL/min: 50 mg first dose then 25 mg once daily.
  • CrCl >30 mL/min: Limited data to support use of FDC; 21 patients with CrCl >30 mL/min received full dose 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, without HD: Renal adjustment should be based on individual components; 13 patients with CrCl <30 mL/min not on HD received 100 to 150 mg of 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, with HD: Limited data to support use of FDC. Case series evaluating safety and efficacy of FDC in 9 patients with end-stage renal disease on HD reported viral suppression achieved in all 9 patients. No change in immune function. FDC generally well tolerated; one patient complained of nausea, which resolved without drug discontinuation [Michienzi, et al. 2019].
  • Note: DTG serum concentrations appear to be reduced in uninfected healthy controls with eGFR <30 mL/min/m2 compared to those with normal kidney function. This may increase the risk of therapeutic failure among patients with HIV drug resistance to INSTIs [Tivicay package insert].
Bictegravir/
emtricitabine/
tenofovir alafenamide [b]
(BIC/FTC/TAF; Biktarvy)

 Child-Pugh A,B: No dose adjustment is needed.

Child-Pugh C: Do not use.

 CrCl <30 mL/min: Use of FDC is not recommended.
  • BIC: No renal adjustment is needed.
  • FTC:
    • CrCl 30 to 49 mL/min: 200 mg every 48 hours.
    • CrCl 15 to 29 mL/min: 200 mg every 72 hours.
    • CrCl <15 mL/min: 200 mg every 96 hours.
  • TAF:
    • CrCl <15 mL/min, without HD: Use is not recommended.
    • CrCl <15 mL/min, with HD: No renal dose adjustment is needed.
  • CrCl <30 mL/min: No data to support use of FDC. Renal dose adjustment should be based on individual components.
  • CrCl 15 to 29 mL/min: No BIC dose adjustment is needed. In a study of 10 patients with CrCl 15 to 29 mL/min compared to 8 patients with normal renal function who received a single dose of BIC 75 mg, severe renal impairment did not produce clinically relevant changes in BIC exposure [Zhang, et al. 2017].

ARV Dose Adjustments for Hepatic or Renal Impairment (version 2)

Table 9: Recommended Dose Adjustments for Use of Selected Fixed-Dose Combination Antiretroviral Medications in Patients With Hepatic or Renal Impairment
Hepatic Impairment Dose Adjustment [a] Renal Impairment Dose Adjustment
Recommended Dose Adjustment [a] Individual FDC Components and Recommended Dose Adjustment [a] Clinical Comments
Integrase Strand Transfer Inhibitors
Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC; Triumeq) | See package insert
Child-Pugh A,B,C: Do not use. CrCl <30 mL/min: Use of FDC is not recommended.
  • ABC: No renal dose adjustment is needed.
  • DTG: No renal dose adjustment is needed.
  • 3TC:
    • CrCl 30 to 49 mL/min: 150 mg once daily.
    • CrCl 15 to 29 mL/min: 150 mg first dose then 100 mg once daily.
    • CrCl 5 to 14 mL/min: 150 mg first dose then 50mg once daily.
    • CrCl <5 mL/min: 50 mg first dose then 25 mg once daily.
  • CrCl >30 mL/min: Limited data to support use of FDC; 21 patients with CrCl >30 mL/min received full dose 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, without HD: Renal adjustment should be based on individual components; 13 patients with CrCl <30 mL/min not on HD received 100 to 150 mg of 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, with HD: Limited data to support use of FDC. Case series evaluating safety and efficacy of FDC in 9 patients with end-stage renal disease on HD reported viral suppression achieved in all 9 patients. No change in immune function. FDC generally well tolerated; one patient complained of nausea, which resolved without drug discontinuation [Michienzi, et al. 2019].
  • Note: DTG serum concentrations appear to be reduced in uninfected healthy controls with eGFR <30 mL/min/m2 compared to those with normal kidney function. This may increase the risk of therapeutic failure among patients with HIV drug resistance to INSTIs [Tivicay package insert].
Bictegravir/emtricitabine/tenofovir alafenamide [b] (BIC/FTC/TAF; Biktarvy) | See package insert
Child-Pugh A,B: No dose adjustment is needed.

Child-Pugh C: Do not use.

 CrCl <30 mL/min: Use of FDC is not recommended.
  • BIC: No renal adjustment is needed.
  • FTC:
    • CrCl 30 to 49 mL/min: 200 mg every 48 hours.
    • CrCl 15 to 29 mL/min: 200 mg every 72 hours.
    • CrCl <15 mL/min: 200 mg every 96 hours.
  • TAF:
    • CrCl <15 mL/min, without HD: Use is not recommended.
    • CrCl <15 mL/min, with HD: No renal dose adjustment is needed.
  • CrCl <30 mL/min: No data to support use of FDC. Renal dose adjustment should be based on individual components.
  • CrCl 15 to 29 mL/min: No BIC dose adjustment is needed. In a study of 10 patients with CrCl 15 to 29 mL/min compared to 8 patients with normal renal function who received a single dose of BIC 75 mg, severe renal impairment did not produce clinically relevant changes in BIC exposure [Zhang, et al. 2017].

ARV Dose Adjustments for Hepatic or Renal Impairment (version 3)

Table 9: Recommended Dose Adjustments for Use of Selected Fixed-Dose Combination Antiretroviral Medications in Patients With Hepatic or Renal Impairment
Fixed-Dose Combination Hepatic Impairment Dose Adjustment [a] Renal Impairment Dose Adjustment
Recommended Dose Adjustment [a] Individual FDC Components and Recommended Dose Adjustment [a]
Integrase Strand Transfer Inhibitors
Abacavir/
dolutegravir/
lamivudine
(ABC/DTG/3TC; Triumeq)

 Child-Pugh A,B,C: Do not use. CrCl <30 mL/min: Use of FDC is not recommended.
  • ABC: No renal dose adjustment is needed.
  • DTG: No renal dose adjustment is needed.
  • 3TC:
    • CrCl 30 to 49 mL/min: 150 mg once daily.
    • CrCl 15 to 29 mL/min: 150 mg first dose then 100 mg once daily.
    • CrCl 5 to 14 mL/min: 150 mg first dose then 50mg once daily.
    • CrCl <5 mL/min: 50 mg first dose then 25 mg once daily.
Clinical comments:
  • CrCl >30 mL/min: Limited data to support use of FDC; 21 patients with CrCl >30 mL/min received full dose 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, without HD: Renal adjustment should be based on individual components; 13 patients with CrCl <30 mL/min not on HD received 100 to 150 mg of 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, with HD: Limited data to support use of FDC. Case series evaluating safety and efficacy of FDC in 9 patients with end-stage renal disease on HD reported viral suppression achieved in all 9 patients. No change in immune function. FDC generally well tolerated; one patient complained of nausea, which resolved without drug discontinuation [Michienzi, et al. 2019].
  • Note: DTG serum concentrations appear to be reduced in uninfected healthy controls with eGFR <30 mL/min/m2 compared to those with normal kidney function. This may increase the risk of therapeutic failure among patients with HIV drug resistance to INSTIs [Tivicay package insert].
Bictegravir/
emtricitabine/
tenofovir alafenamide [b]
(BIC/FTC/TAF; Biktarvy)

 Child-Pugh A,B: No dose adjustment is needed.

Child-Pugh C: Do not use.

 CrCl <30 mL/min: Use of FDC is not recommended.
  • BIC: No renal adjustment is needed.
  • FTC:
    • CrCl 30 to 49 mL/min: 200 mg every 48 hours.
    • CrCl 15 to 29 mL/min: 200 mg every 72 hours.
    • CrCl <15 mL/min: 200 mg every 96 hours.
  • TAF:
    • CrCl <15 mL/min, without HD: Use is not recommended.
    • CrCl <15 mL/min, with HD: No renal dose adjustment is needed.
Clinical comments:
  • CrCl <30 mL/min: No data to support use of FDC. Renal dose adjustment should be based on individual components.
  • CrCl 15 to 29 mL/min: No BIC dose adjustment is needed. In a study of 10 patients with CrCl 15 to 29 mL/min compared to 8 patients with normal renal function who received a single dose of BIC 75 mg, severe renal impairment did not produce clinically relevant changes in BIC exposure [Zhang, et al. 2017].

ARV Dose Adjustments for Hepatic or Renal Impairment (version 4)

Table 9: Recommended Dose Adjustments for Use of Selected Fixed-Dose Combination Antiretroviral Medications in Patients With Hepatic or Renal Impairment
Hepatic Impairment Dose Adjustment [a] Renal Impairment Dose Adjustment
Recommended Dose Adjustment [a] Individual FDC Components and Recommended Dose Adjustment [a]
Integrase Strand Transfer Inhibitors
Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC; Triumeq) | See package insert
Child-Pugh A,B,C: Do not use. CrCl <30 mL/min: Use of FDC is not recommended.
  • ABC: No renal dose adjustment is needed.
  • DTG: No renal dose adjustment is needed.
  • 3TC:
    • CrCl 30 to 49 mL/min: 150 mg once daily.
    • CrCl 15 to 29 mL/min: 150 mg first dose then 100 mg once daily.
    • CrCl 5 to 14 mL/min: 150 mg first dose then 50mg once daily.
    • CrCl <5 mL/min: 50 mg first dose then 25 mg once daily.
Clinical comments:
  • CrCl >30 mL/min: Limited data to support use of FDC; 21 patients with CrCl >30 mL/min received full dose 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, without HD: Renal adjustment should be based on individual components; 13 patients with CrCl <30 mL/min not on HD received 100 to 150 mg of 3TC with minimal increases in AUC. No elevations in lactate or other ADRs reported [Fischetti, et al. 2018].
  • CrCl <30 mL/min, with HD: Limited data to support use of FDC. Case series evaluating safety and efficacy of FDC in 9 patients with end-stage renal disease on HD reported viral suppression achieved in all 9 patients. No change in immune function. FDC generally well tolerated; one patient complained of nausea, which resolved without drug discontinuation [Michienzi, et al. 2019].
  • Note: DTG serum concentrations appear to be reduced in uninfected healthy controls with eGFR <30 mL/min/m2 compared to those with normal kidney function. This may increase the risk of therapeutic failure among patients with HIV drug resistance to INSTIs [Tivicay package insert].
Bictegravir/emtricitabine/tenofovir alafenamide [b] (BIC/FTC/TAF; Biktarvy) | See package insert
Child-Pugh A,B: No dose adjustment is needed.

Child-Pugh C: Do not use.

 CrCl <30 mL/min: Use of FDC is not recommended.
  • BIC: No renal adjustment is needed.
  • FTC:
    • CrCl 30 to 49 mL/min: 200 mg every 48 hours.
    • CrCl 15 to 29 mL/min: 200 mg every 72 hours.
    • CrCl <15 mL/min: 200 mg every 96 hours.
  • TAF:
    • CrCl <15 mL/min, without HD: Use is not recommended.
    • CrCl <15 mL/min, with HD: No renal dose adjustment is needed.
Clinical comments:
  • CrCl <30 mL/min: No data to support use of FDC. Renal dose adjustment should be based on individual components.
  • CrCl 15 to 29 mL/min: No BIC dose adjustment is needed. In a study of 10 patients with CrCl 15 to 29 mL/min compared to 8 patients with normal renal function who received a single dose of BIC 75 mg, severe renal impairment did not produce clinically relevant changes in BIC exposure [Zhang, et al. 2017].

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

Rationale

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.

Benefits

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]

Approach

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.

SHARED DECISION-MAKING IN HIV CARE
  • 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.

RESOURCES
References

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. https://www.kingsfund.org.uk/sites/default/files/Making-shared-decision-making-a-reality-paper-Angela-Coulter-Alf-Collins-July-2011_0.pdf

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. https://www.ncbi.nlm.nih.gov/books/NBK222274/

KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. https://www.kff.org/racial-equity-and-health-policy/report/key-data-on-health-and-health-care-by-race-and-ethnicity/ [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]

Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication January
Intended users NYS clinicians
Author and writing group conflict of interest disclosures There are no author or writing group conflict of interest disclosures.
Committee

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.

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 September 15, 2023