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
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.
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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]
References
Abdool Karim S. S., Naidoo K., Grobler A., et al. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med 2010;362(8):697-706. [PMID: 20181971]
Abdool Karim S. S., Naidoo K., Grobler A., et al. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med 2011;365(16):1492-501. [PMID: 22010915]
Amanyire G., Semitala F. C., Namusobya J., et al. Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. Lancet HIV 2016;3(11):e539-e548. [PMID: 27658873]
. Long-term benefits from early antiretroviral therapy initiation in HIV infection: findings from the extended follow-up of the START trial. Abstract LB2305. IDWeek; 2022 Oct 19-23. https://www.natap.org/2022/IDWeek/IDWeek_11.htm
Bacon O., Chin J., Cohen S. E., et al. Decreased time from human immunodeficiency virus diagnosis to care, antiretroviral therapy initiation, and virologic suppression during the citywide RAPID Initiative in San Francisco. Clin Infect Dis 2021;73(1):e122-e128. [PMID: 32449916]
Barth R. E., Aitken S. C., Tempelman H., et al. Accumulation of drug resistance and loss of therapeutic options precede commonly used criteria for treatment failure in HIV-1 subtype-C-infected patients. Antivir Ther 2012;17(2):377-86. [PMID: 22297391]
Bavinton B. R., Pinto A. N., Phanuphak N., et al. Viral suppression and HIV transmission in serodiscordant male couples: an international, prospective, observational, cohort study. Lancet HIV 2018;5(8):e438-e447. [PMID: 30025681]
Beach M. C., Duggan P. S., Moore R. D. Is patients' preferred involvement in health decisions related to outcomes for patients with HIV?. J Gen Intern Med 2007;22(8):1119-24. [PMID: 17514382]
Benson C., Emond B., Lefebvre P., et al. Rapid initiation of antiretroviral therapy following diagnosis of human immunodeficiency virus among patients with commercial insurance coverage. J Manag Care Spec Pharm 2020;26(2):129-141. [PMID: 31747358]
Bisson G. P., Molefi M., Bellamy S., et al. Early versus delayed antiretroviral therapy and cerebrospinal fluid fungal clearance in adults with HIV and cryptococcal meningitis. Clin Infect Dis 2013;56(8):1165-73. [PMID: 23362285]
Blanc F. X., Sok T., Laureillard D., et al. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med 2011;365(16):1471-81. [PMID: 22010913]
Boulware D. R., Meya D. B., Muzoora C., et al. Timing of antiretroviral therapy after diagnosis of cryptococcal meningitis. N Engl J Med 2014;370(26):2487-98. [PMID: 24963568]
Bourgi(a) K., Jenkins C. A., Rebeiro P. F., et al. Weight gain among treatment-naive persons with HIV starting integrase inhibitors compared to non-nucleoside reverse transcriptase inhibitors or protease inhibitors in a large observational cohort in the United States and Canada. J Int AIDS Soc 2020;23(4):e25484. [PMID: 32294337]
Bourgi(b) K., Rebeiro P. F., Turner M., et al. Greater weight gain in treatment-naive persons starting dolutegravir-based antiretroviral therapy. Clin Infect Dis 2020;70(7):1267-1274. [PMID: 31100116]
Braun H. M., Candelario J., Hanlon C. L., et al. Transgender women living with HIV frequently take antiretroviral therapy and/or feminizing hormone therapy differently than prescribed due to drug-drug interaction concerns. LGBT Health 2017;4(5):371-375. [PMID: 28876170]
Bruyand M., Thiebaut R., Lawson-Ayayi S., et al. Role of uncontrolled HIV RNA level and immunodeficiency in the occurrence of malignancy in HIV-infected patients during the combination antiretroviral therapy era: Agence Nationale de Recherche sur le Sida (ANRS) CO3 Aquitaine Cohort. Clin Infect Dis 2009;49(7):1109-16. [PMID: 19705973]
Cain L. E., Logan R., Robins J. M., et al. When to initiate combined antiretroviral therapy to reduce mortality and AIDS-defining illness in HIV-infected persons in developed countries: an observational study. Ann Intern Med 2011;154(8):509-15. [PMID: 21502648]
CASCADE Collaboration. Timing of HAART initiation and clinical outcomes in human immunodeficiency virus type 1 seroconverters. Arch Intern Med 2011;171(17):1560-9. [PMID: 21949165]
Castilla J., Del Romero J., Hernando V., et al. Effectiveness of highly active antiretroviral therapy in reducing heterosexual transmission of HIV. J Acquir Immune Defic Syndr 2005;40(1):96-101. [PMID: 16123689]
CDC(a). HIV surveillance report, 2020. 2022 Aug 26. https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html [accessed 2023 Feb 8]
CDC(b). Monitoring selected national HIV prevention and care objectives by using HIV surveillance data United States and 6 dependent areas, 2020. 2022 Aug. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-27-3.pdf [accessed 2023 Feb 8]
Coffey S., Bacchetti P., Sachdev D., et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. Aids 2019;33(5):825-832. [PMID: 30882490]
Cohen M. S., Chen Y. Q., McCauley M., et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med 2016;375(9):830-9. [PMID: 27424812]
Cohen M. S., Chen Y. Q., McCauley M., et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365(6):493-505. [PMID: 21767103]
Colasanti J., Sumitani J., Mehta C. C., et al. Implementation of a rapid entry program decreases time to viral suppression among vulnerable persons living with HIV in the southern United States. Open Forum Infect Dis 2018;5(6):ofy104. [PMID: 29992172]
Connor E. M., Sperling R. S., Gelber R., et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med 1994;331(18):1173-80. [PMID: 7935654]
Donnell D., Baeten J. M., Kiarie J., et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 2010;375(9731):2092-8. [PMID: 20537376]
El-Sadr W. M., Lundgren J., Neaton J. D., et al. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med 2006;355(22):2283-96. [PMID: 17135583]
Ellis R. J., Badiee J., Vaida F., et al. CD4 nadir is a predictor of HIV neurocognitive impairment in the era of combination antiretroviral therapy. Aids 2011;25(14):1747-51. [PMID: 21750419]
Ford N., Migone C., Calmy A., et al. Benefits and risks of rapid initiation of antiretroviral therapy. Aids 2018;32(1):17-23. [PMID: 29112073]
Friis-Moller N., Thiebaut R., Reiss P., et al. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study. Eur J Cardiovasc Prev Rehabil 2010;17(5):491-501. [PMID: 20543702]
Garvey L., Surendrakumar V., Winston A. Low rates of neurocognitive impairment are observed in neuro-asymptomatic HIV-infected subjects on effective antiretroviral therapy. HIV Clin Trials 2011;12(6):333-8. [PMID: 22189152]
Granich R. M., Gilks C. F., Dye C., et al. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet 2009;373(9657):48-57. [PMID: 19038438]
Guay L. A., Musoke P., Fleming T., et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999;354(9181):795-802. [PMID: 10485720]
Guiguet M., Boue F., Cadranel J., et al. Effect of immunodeficiency, HIV viral load, and antiretroviral therapy on the risk of individual malignancies (FHDH-ANRS CO4): a prospective cohort study. Lancet Oncol 2009;10(12):1152-9. [PMID: 19818686]
Havlir D. V., Kendall M. A., Ive P., et al. Timing of antiretroviral therapy for HIV-1 infection and tuberculosis. N Engl J Med 2011;365(16):1482-91. [PMID: 22010914]
Hileman C. O., Funderburg N. T. Inflammation, immune activation, and antiretroviral therapy in HIV. Curr HIV/AIDS Rep 2017;14(3):93-100. [PMID: 28434169]
Ho J. E., Deeks S. G., Hecht F. M., et al. Initiation of antiretroviral therapy at higher nadir CD4+ T-cell counts is associated with reduced arterial stiffness in HIV-infected individuals. Aids 2010;24(12):1897-905. [PMID: 20543654]
Ho J. E., Scherzer R., Hecht F. M., et al. The association of CD4+ T-cell counts and cardiovascular risk in treated HIV disease. Aids 2012;26(9):1115-20. [PMID: 22382147]
Hoy J. F., Grund B., Roediger M., et al. Immediate initiation of antiretroviral therapy for HIV infection accelerates bone loss relative to deferring therapy: Findings from the START Bone Mineral Density Substudy, a randomized trial. J Bone Miner Res 2017;32(9):1945-1955. [PMID: 28650589]
Huhn G. D., Crofoot G., Ramgopal M., et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid-initiation model of care for human immunodeficiency virus type 1 infection: Primary analysis of the DIAMOND study. Clin Infect Dis 2020;71(12):3110-3117. [PMID: 31879782]
Jain V., Hartogensis W., Bacchetti P., et al. Antiretroviral therapy initiated within 6 months of HIV infection is associated with lower T-cell activation and smaller HIV reservoir size. J Infect Dis 2013;208(8):1202-11. [PMID: 23852127]
Kagan R. M., Dunn K. J., Snell G. P., et al. Trends in HIV-1 drug resistance mutations from a U.S. reference laboratory from 2006 to 2017. AIDS Res Hum Retroviruses 2019;35(8):698-709. [PMID: 31169022]
Kitahata M. M., Gange S. J., Abraham A. G., et al. Effect of early versus deferred antiretroviral therapy for HIV on survival. N Engl J Med 2009;360(18):1815-26. [PMID: 19339714]
Koenig S. P., Dorvil N., Dévieux J. G., et al. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med 2017;14(7):e1002357. [PMID: 28742880]
Landovitz R. J., Li S., Eron J. J., et al. Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial. Lancet HIV 2020;7(7):e472-e481. [PMID: 32497491]
Lawn S. D., Torok M. E., Wood R. Optimum time to start antiretroviral therapy during HIV-associated opportunistic infections. Curr Opin Infect Dis 2011;24(1):34-42. [PMID: 21150593]
Lewden C., Bouteloup V., De Wit S., et al. All-cause mortality in treated HIV-infected adults with CD4 >/=500/mm3 compared with the general population: evidence from a large European observational cohort collaboration. Int J Epidemiol 2012;41(2):433-45. [PMID: 22493325]
Lewden C., Chene G., Morlat P., et al. HIV-infected adults with a CD4 cell count greater than 500 cells/mm3 on long-term combination antiretroviral therapy reach same mortality rates as the general population. J Acquir Immune Defic Syndr 2007;46(1):72-7. [PMID: 17621240]
Li X., Margolick J. B., Jamieson B. D., et al. CD4+ T-cell counts and plasma HIV-1 RNA levels beyond 5 years of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2011;57(5):421-8. [PMID: 21602699]
Li Z., Purcell D. W., Sansom S. L., et al. Vital signs: HIV transmission along the continuum of care - United States, 2016. MMWR Morb Mortal Wkly Rep 2019;68(11):267-272. [PMID: 30897075]
Lichtenstein K. A., Armon C., Buchacz K., et al. Low CD4+ T cell count is a risk factor for cardiovascular disease events in the HIV outpatient study. Clin Infect Dis 2010;51(4):435-47. [PMID: 20597691]
Long L. C., Maskew M., Brennan A. T., et al. Initiating antiretroviral therapy for HIV at a patient's first clinic visit: a cost-effectiveness analysis of the rapid initiation of treatment randomized controlled trial. Aids 2017;31(11):1611-1619. [PMID: 28463879]
Lundgren J. D., Babiker A. G., Gordin F., et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med 2015;373(9):795-807. [PMID: 26192873]
Manabe Y. C., Campbell J. D., Sydnor E., et al. Immune reconstitution inflammatory syndrome: risk factors and treatment implications. J Acquir Immune Defic Syndr 2007;46(4):456-62. [PMID: 18077835]
Marin B., Thiebaut R., Bucher H. C., et al. Non-AIDS-defining deaths and immunodeficiency in the era of combination antiretroviral therapy. Aids 2009;23(13):1743-53. [PMID: 19571723]
Marzinke M. A., Grinsztejn B., Fogel J. M., et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. J Infect Dis 2021;224(9):1581-1592. [PMID: 33740057]
Massanella M., Bender Ignacio R. A., Lama J. R., et al. Long-term effects of early antiretroviral initiation on HIV reservoir markers: a longitudinal analysis of the MERLIN clinical study. Lancet Microbe 2021;2(5):e198-e209. [PMID: 35544209]
Mateo-Urdiales A., Johnson S., Smith R., et al. Rapid initiation of antiretroviral therapy for people living with HIV. Cochrane Database Syst Rev 2019;6:CD012962. [PMID: 31206168]
Misra K., Huang J. S., Udeagu C. N. Ongoing disparities in prediagnosis preexposure prophylaxis use among persons recently diagnosed with HIV in New York City, 2015-2017. Am J Public Health 2019;109(9):1212-1215. [PMID: 31318600]
Mohammed D. Y., Martin E., Brewer R., et al. Same-day medical visit increases viral suppression, Peter Ho Memorial Clinic, 2014-2015 and 2016-2017. J Assoc Nurses AIDS Care 2019;30(3):292-300. [PMID: 30676360]
Monteiro N., Branco M., Peres S., et al. The impact of tenofovir disoproxil fumarate on kidney function: four-year data from the HIV-infected outpatient cohort. J Int AIDS Soc 2014;17(4 Suppl 3):19565. [PMID: 25394072]
NIAID. Bulletin: HIV treatment study in patients with cryptococcal meningitis ends enrollment early, higher mortality rate found with early antiretroviral therapy. 2012 May 30. https://www.thebodypro.com/article/hiv-treatment-study-in-patients-with-cryptococcal- [accessed 2023 Feb 8]
Novelli S., Lecuroux C., Avettand-Fenoel V., et al. Long-term therapeutic impact of the timing of antiretroviral therapy in patients diagnosed with primary human immunodeficiency virus type 1 infection. Clin Infect Dis 2018;66(10):1519-1527. [PMID: 29211834]
NYCDHMH. HIV surveillance annual report, 2020. 2021 Dec. https://www.nyc.gov/assets/doh/downloads/pdf/dires/hiv-surveillance-annualreport-2020.pdf [accessed 2023 Feb 8]
O'Connor J., Vjecha M. J., Phillips A. N., et al. Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per muL: secondary outcome results from a randomised controlled trial. Lancet HIV 2017;4(3):e105-e112. [PMID: 28063815]
Palella F. J., Hou Q., Li J., et al. Weight gain and metabolic effects in persons With HIV who switch to ART regimens containing integrase inhibitors or tenofovir alafenamide. J Acquir Immune Defic Syndr 2023;92(1):67-75. [PMID: 36150045]
Pathela P., Jamison K., Braunstein S. L., et al. Initiating antiretroviral treatment for newly diagnosed HIV patients in sexual health clinics greatly improves timeliness of viral suppression. Aids 2021;35(11):1805-1812. [PMID: 33973874]
Phillips A. N., Gazzard B., Gilson R., et al. Rate of AIDS diseases or death in HIV-infected antiretroviral therapy-naive individuals with high CD4 cell count. Aids 2007;21(13):1717-21. [PMID: 17690569]
Pilcher C. D., Ospina-Norvell C., Dasgupta A., et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a US public health setting. J Acquir Immune Defic Syndr 2017;74(1):44-51. [PMID: 27434707]
Politch J. A., Mayer K. H., Welles S. L., et al. Highly active antiretroviral therapy does not completely suppress HIV in semen of sexually active HIV-infected men who have sex with men. Aids 2012;26(12):1535-43. [PMID: 22441253]
Quinn T. C., Wawer M. J., Sewankambo N., et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med 2000;342(13):921-9. [PMID: 10738050]
Ray M., Logan R., Sterne J. A., et al. The effect of combined antiretroviral therapy on the overall mortality of HIV-infected individuals. Aids 2010;24(1):123-37. [PMID: 19770621]
Rodger A. J., Cambiano V., Bruun T., et al. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet 2019;393(10189):2428-2438. [PMID: 31056293]
Rodger A. J., Cambiano V., Bruun T., et al. Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner Is using suppressive antiretroviral therapy. Jama 2016;316(2):171-81. [PMID: 27404185]
Rolle C. P., Berhe M., Singh T., et al. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS 2021;35(12):1957-1965. [PMID: 34115650]
Rosen(a) S., Maskew M., Fox M. P., et al. Initiating antiretroviral therapy for HIV at a patient's first clinic visit: the RapIT Randomized Controlled Trial. PLoS Med 2016;13(5):e1002015. [PMID: 27163694]
Rosen(b) S., Maskew M., Fox M. P., et al. Correction: Initiating antiretroviral therapy for HIV at a patient's first clinic visit: the RapIT Randomized Controlled Trial. PLoS Med 2016;13(6):e1002050. [PMID: 27258028]
Sabin C. A., Smith C. J., d'Arminio Monforte A., et al. Response to combination antiretroviral therapy: variation by age. Aids 2008;22(12):1463-73. [PMID: 18614870]
Salzberg Global Seminar. Salzberg statement on shared decision making. BMJ 2011;342:d1745. [PMID: 21427038]
Scherrer A. U., von Wyl V., Yang W. L., et al. Emergence of acquired HIV-1 drug resistance almost stopped in Switzerland: A 15-year prospective cohort analysis. Clin Infect Dis 2016;62(10):1310-1317. [PMID: 26962075]
Severe P., Juste M. A., Ambroise A., et al. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med 2010;363(3):257-65. [PMID: 20647201]
Siddiqi A. E., Hall H. I., Hu X., et al. Population-based estimates of life expectancy after HIV diagnosis: United States 2008-2011. J Acquir Immune Defic Syndr 2016;72(2):230-6. [PMID: 26890283]
Sigel K., Wisnivesky J., Gordon K., et al. HIV as an independent risk factor for incident lung cancer. Aids 2012;26(8):1017-25. [PMID: 22382152]
Silverberg M. J., Chao C., Leyden W. A., et al. HIV infection, immunodeficiency, viral replication, and the risk of cancer. Cancer Epidemiol Biomarkers Prev 2011;20(12):2551-9. [PMID: 22109347]
Skarbinski J., Rosenberg E., Paz-Bailey G., et al. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med 2015;175(4):588-96. [PMID: 25706928]
Sterne J. A., May M., Costagliola D., et al. Timing of initiation of antiretroviral therapy in AIDS-free HIV-1-infected patients: a collaborative analysis of 18 HIV cohort studies. Lancet 2009;373(9672):1352-63. [PMID: 19361855]
Torok M. E., Yen N. T., Chau T. T., et al. Timing of initiation of antiretroviral therapy in human immunodeficiency virus (HIV)--associated tuberculous meningitis. Clin Infect Dis 2011;52(11):1374-83. [PMID: 21596680]
Tozzi V., Balestra P., Bellagamba R., et al. Persistence of neuropsychologic deficits despite long-term highly active antiretroviral therapy in patients with HIV-related neurocognitive impairment: prevalence and risk factors. J Acquir Immune Defic Syndr 2007;45(2):174-82. [PMID: 17356465]
Uy J., Armon C., Buchacz K., et al. Initiation of HAART at higher CD4 cell counts is associated with a lower frequency of antiretroviral drug resistance mutations at virologic failure. J Acquir Immune Defic Syndr 2009;51(4):450-3. [PMID: 19474757]
van Lelyveld S. F., Gras L., Kesselring A., et al. Long-term complications in patients with poor immunological recovery despite virological successful HAART in Dutch ATHENA cohort. Aids 2012;26(4):465-74. [PMID: 22112603]
Verburgh M. L., Wit Fwnm, Boyd A., et al. One in 10 virally suppressed persons with HIV in The Netherlands experiences >/=10% weight gain after switching to tenofovir alafenamide and/or integrase strand transfer inhibitor. Open Forum Infect Dis 2022;9(7):ofac291. [PMID: 35873291]
Volberding P. A., Deeks S. G. Antiretroviral therapy and management of HIV infection. Lancet 2010;376(9734):49-62. [PMID: 20609987]
Wallis C. L., Papathanasopolous M. A., Fox M., et al. Low rates of nucleoside reverse transcriptase inhibitor resistance in a well-monitored cohort in South Africa on antiretroviral therapy. Antivir Ther 2012;17(2):313-20. [PMID: 22293461]
WHO. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. 2021 16 Jul. https://www.who.int/publications/i/item/9789240031593 [accessed 2023 Feb 8]
Winston A., Puls R., Kerr S. J., et al. Dynamics of cognitive change in HIV-infected individuals commencing three different initial antiretroviral regimens: a randomized, controlled study. HIV Med 2012;13(4):245-51. [PMID: 22151608]
Wright S. T., Carr A., Woolley I., et al. CD4 cell responses to combination antiretroviral therapy in patients starting therapy at high CD4 cell counts. J Acquir Immune Defic Syndr 2011;58(1):72-9. [PMID: 21654498]
Wu Z., Zhao Y., Ge X., et al. Simplified HIV testing and treatment in China: Analysis of mortality rates before and after a structural intervention. PLoS Med 2015;12(9):e1001874. [PMID: 26348214]
Xia Q., Maduro G. A., Li W., et al. Life expectancy among people with HIV in New York City, 2009-2018. J Acquir Immune Defic Syndr 2022. [PMID: 36084201]
Young J., Psichogiou M., Meyer L., et al. CD4 cell count and the risk of AIDS or death in HIV-Infected adults on combination antiretroviral therapy with a suppressed viral load: a longitudinal cohort study from COHERE. PLoS Med 2012;9(3):e1001194. [PMID: 22448150]
Zolopa A., Andersen J., Powderly W., et al. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One 2009;4(5):e5575. [PMID: 19440326]
Zulliger R., Black S., Holtgrave D. R., et al. Cost-effectiveness of a package of interventions for expedited antiretroviral therapy initiation during pregnancy in Cape Town, South Africa. AIDS Behav 2014;18(4):697-705. [PMID: 24122044]
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 | |
| 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 |
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| Disclosure and management of conflicts of interest |
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| Evidence collection and review |
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| Recommendation development |
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| Review and approval process |
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| External reviews |
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| Update process |
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| 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 April 17, 2023