Date of current publication: September 19, 2022
Committee: Perinatal Transmission Prevention Guideline Committee
Date of original publication: August 2020
The Perinatal Transmission Guideline Prevention Committee of the New York State Department of Health (NYSDOH) AIDS Institute (AI) Clinical Guidelines Program recommends that clinicians who provide medical care for infants exposed to HIV follow the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States > Management of Infants Born to People With HIV Infection published by the U.S. Department of Health and Human Services (DHHS). See the following key topics:
- Antiretroviral Management of Newborns With Perinatal HIV Exposure or HIV Infection
- Diagnosis of HIV Infection in Infants and Children
- Initial Postnatal Management of the Neonate Exposed to HIV
- Long-Term Follow-Up of Infants Exposed to Antiretroviral Drugs
NYS best practices: In addition to supporting the comprehensive DHHS recommendations, this Committee also encourages that care providers in NYS follow the good practices outlined below and in the September 2018 NYSDOH Dear Colleague Letter that addresses intrapartum antiretroviral therapy (ART)/prophylaxis, neonatal antiretroviral (ARV) prophylaxis, and HIV testing of infants and children younger than 24 months.
Note on “experienced” and “expert” HIV care providers: Throughout this guidance, when reference is made to “experienced HIV care provider” or “expert HIV care provider,” those terms are referring to the following 2017 NYSDOH AI definitions:
- Experienced HIV care provider: Practitioners who have been accorded HIV Experienced Provider status by the American Academy of HIV Medicine or have met the HIV Medicine Association’s definition of an experienced provider are eligible for designation as an HIV Experienced Provider in New York State. Nurse practitioners and licensed midwives who provide clinical care to individuals with HIV in collaboration with a physician may be considered HIV Experienced Providers as long as all other practice agreements are met (8 NYCRR 79-5:1; 10 NYCRR 85.36; 8 NYCRR 139-6900). Physician assistants who provide clinical care to individuals with HIV under the supervision of an HIV Specialist physician may also be considered HIV Experienced Providers (10 NYCRR 94.2)
- Expert HIV care provider: A provider with extensive experience in the management of complex patients with HIV.
Newborn HIV Testing in NYS
The NYSDOH strongly advises that all NYS birth facilities use the pediatric HIV testing services at the Wadsworth Center; the services are free of charge for those receiving testing and for NYS clinicians who provide care for HIV-exposed infants.
Early diagnosis of pediatric infection: A nucleic acid test (NAT) to detect HIV RNA or DNA will provide early diagnosis of pediatric HIV infection. Good practice in NYS is to perform an HIV NAT test in an infant at the following ages (see Figure 1, below):
- Within 48 hours of birth
- 2 weeks of age
- 4 to 6 weeks of age
- 8 to 12 weeks of age (see discussion of diagnostic testing within 2 to 6 weeks after completion of ARV prophylaxis, below)
- 4 to 6 months of age
Testing for all HIV-exposed infants within 48 hours of birth: The NYSDOH strongly advises performing an HIV NAT for all known HIV-exposed newborns within the first 48 hours of life. In NYS, from 2010 to 2018, there were 18 documented perinatal transmissions of HIV, and blood specimens were collected within 48 hours of birth among 2,696 exposed infants (72%). Nearly half of infants (44%; n=8) with perinatal transmission had a positive HIV NAT result from the specimen obtained at birth NYSDOH 2020.
Diagnostic testing within 2 to 6 weeks after completion of ARV medications: In 2022, a case of perinatal HIV transmission was identified through HIV NAT at 4 months of age following 3 prior negative NAT results (at birth, 2 weeks of age, and 4 weeks of age) NYSDOH 2022. The newborn was at high risk of perinatal HIV infection and received a 3-drug ARV regimen for presumptive HIV therapy, which was discontinued at 6 weeks of age. The infant was not exposed to HIV through breast milk, and there was no other postnatal HIV exposure risk. It is well documented that results of plasma HIV RNA NATs or plasma HIV RNA/DNA NATs can be affected by ARV drugs administered to newborns as prophylaxis or presumptive HIV therapy DHHS 2021; Patel, et al. 2020; Mazanderani, et al. 2018; Veldsman, et al. 2018; Uprety, et al. 2015.
Confirmatory HIV testing: When a positive HIV NAT result is received for an infant at any age, HIV testing repeated as soon as possible using a new sample is used to confirm a diagnosis of HIV. Two independent positive HIV NAT results provide a definitive diagnosis of HIV infection in exposed infants, and subsequent testing is not necessary.
Two negative HIV NAT results obtained at ≥4 weeks of age and then at ≥4 months of age will confirm that an exposed infant does not have HIV.
For clinical recommendations, see the DHHS guideline section Diagnosis of HIV Infection in Infants and Children.
HIV-2 exposure: Infant exposure to HIV-2 is rare. HIV-2 can be considered if the mother has a reactive HIV antibody screening test result but an unconfirmed diagnosis and HIV-2 has not yet been ruled out with results from an HIV-1/2 antibody differentiation test. If HIV-2 exposure is suspected in the infant, an HIV NAT that detects HIV-2 can be used to rule out or confirm the diagnosis.
For additional clinical recommendations, see the DHHS guideline section Diagnosis of HIV Infection in Infants and Children.
Consultation with an experienced HIV care provider is advised when newborns are exposed to HIV during the perinatal period and especially when there are factors that may increase the risk of transmission. Such factors include but may not be limited to the following: primary or acute HIV during pregnancy, inconsistent adherence to HIV medications, HIV RNA (viral load) ≥50 copies/mL, nonadherence to prenatal visits, undocumented HIV viral load within 4 weeks before delivery, undocumented HIV status at time of delivery, or a preliminary positive HIV test result during labor or shortly after delivery. Expert consultation is also advised if intrapartum ARV prophylaxis was not administered when indicated, when other ARV drugs in addition to zidovudine or early discontinuation of prophylaxis are being considered for the infant, or if the mother has acute or primary HIV while breastfeeding.
|RESOURCES FOR EXPERT CONSULTATION|
Newborn ART and Postnatal Management
ART for newborns: To reduce the risk of perinatal HIV transmission in exposed newborns, appropriate ARV medications, initiated as close to the time of birth as possible, are indicated. The benefit of ART for newborns decreases when initiation is delayed Fiscus, et al. 1999; Wade, et al. 1998. ART should be administered promptly after delivery, preferably within 6 to 12 hours of birth. ARV regimens may be administered to newborns as prophylaxis, presumptive treatment, or as ART when infection is confirmed.
For clinical recommendations, see the DHHS guideline Antiretroviral Management of Newborns With Perinatal HIV Exposure or Perinatal HIV, including Table 8. Newborn Antiretroviral Management According to Risk of HIV Infection in the Newborn and Table 9. Antiretroviral Dosing Recommendations for Newborns.
Initial postnatal management: Educating parents about feeding (i.e., avoidance of breastfeeding and premastication of food), diagnostic testing and medical follow-up, ARV administration, and availability of support services is an essential component of initial postnatal management for infants exposed to HIV. Also essential is emphasizing the need for serial HIV testing for the infant and providing information on the recommended testing schedule and interpretation of results.
The NYSDOH AI recommends that HIV-exposed infants be discharged from care with ARV medications in hand, not just a prescription. Good practice in NYS is to also include the tools needed to administer ARV medications, such as oral syringes. Ensuring that parents are able to administer medication to their newborns is another essential component of discharge planning, as is linkage to care and support services.
Infant feeding: For clinical recommendations, see the DHHS guideline section Infant Feeding for Individuals with HIV in the United States.
Opportunistic Infection Prophylaxis for Newborns
|NEW YORK STATE LAW||
Congenital syphilis: Concomitant sexually transmitted infections (STIs), including syphilis, in individuals with HIV are common. Comprehensive STI screening to identify disease is critical because coinfection increases the risk of adverse perinatal and neonatal outcomes, including likely higher rates of in utero transmission. Infants born to individuals with HIV and concurrent STIs require prompt evaluation to exclude the possibility of transmission of additional infectious agents Adachi(a), et al. 2018.
The NYSDOH recommends that clinicians obtain serologic screening for syphilis for pregnant patients with HIV at the first prenatal visit, during the third trimester (28 to 32 weeks of gestation), and at delivery. No data exist to suggest that infants with congenital syphilis born to individuals with HIV and syphilis require evaluation, therapy, or follow-up for syphilis different than what is recommended for all infants.
Pneumocystis jiroveci pneumonia (previously P. carinii pneumonia; PCP): Initiate PCP prophylaxis at 6 weeks of age for all HIV-exposed infants unless HIV diagnostic testing definitively or presumptively excludes HIV infection; if HIV diagnostic testing results are negative by 5 weeks of age, PCP prophylaxis is not necessary.
Congenital cytomegalovirus: cCMV is the most common intrauterine infection and the leading nongenetic cause of sensorineural hearing loss in children in the United States Grosse, et al. 2017. One in every 200 infants is born with cCMV infection, and approximately 20% of these infants will develop long-term health problems such as hearing or vision loss, intellectual disability, seizures, or developmental delay NYS Senate 2018.
HIV-exposed infants may be at higher risk for acquiring cCMV during pregnancy. Infants with HIV infection, particularly those who acquired HIV in utero, are at greatest risk for cCMV. Screening for cCMV is an important component of a comprehensive evaluation needed for HIV-exposed infants, particularly those born to women not on ART during pregnancy Adachi(b), et al. 2018.
Screening and early diagnosis of cCMV is the NYS standard of care to promote early intervention, monitoring, and medical care that optimizes hearing and developmental outcomes American Academy of Pediatrics 2018; Marsico and Kimberlin 2017; Rawlinson, et al. 2017.
Care providers should discuss with pregnant patients how to reduce the risk of cCMV. cCMV infection is common in children, and the virus can be found in especially high amounts in young children’s saliva and urine. Care providers should inform pregnant patients that they can reduce their risk of cCMV by washing hands after changing diapers and by avoiding sharing food, utensils, or cups with a child.
For clinical recommendations, see the DHHS guideline section Initial Postnatal Management of the Neonate Exposed to HIV.
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].
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|
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. 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]
Adachi(a) K., Xu J., Yeganeh N., et al. Combined evaluation of sexually transmitted infections in HIV-infected pregnant women and infant HIV transmission. PLoS One 2018;13(1):e0189851. [PMID: 29304083]
Adachi(b) K., Xu J., Ank B., et al. Congenital cytomegalovirus and HIV perinatal transmission. Pediatr Infect Dis J 2018;37(10):1016-21. [PMID: 30216294]
American Academy of Pediatrics. Summaries of infectious diseases: cytomegalovirus infection. Red book: report of the Committee on Infectious Diseases; 2018. https://doi.org/10.1542/9781610021470
DHHS. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. 2021 Dec 30. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/antiretroviral-management-newborns-perinatal-hiv-exposure-or-hiv-infection [accessed 2022 Sep 8]
Fiscus S. A., Schoenbach V. J., Wilfert C. Short courses of zidovudine and perinatal transmission of HIV. N Engl J Med 1999;340(13):1040-43. [PMID: 10189281]
Grosse S. D., Dollard S. C., Kimberlin D. W. Screening for congenital cytomegalovirus after newborn hearing screening: what comes next?. Pediatrics 2017;139(2):e20163837. [PMID: 28119427]
Marsico C., Kimberlin D. W. Congenital cytomegalovirus infection: advances and challenges in diagnosis, prevention and treatment. Ital J Pediatr 2017;43(1):1-8. [PMID: 28416012]
Mazanderani A. H., Moyo F., Kufa T., et al. Brief report: declining baseline viremia and escalating discordant HIV-1 confirmatory results within South Africa's early infant diagnosis program, 2010-2016. J Acquir Immune Defic Syndr 2018;77(2):212-16. [PMID: 29084045]
NYS Senate. Senate Bill S2816: requires urine polymerase chain reaction testing for cytomegalovirus of newborns with hearing impairments. 2018 Oct 2. https://www.nysenate.gov/legislation/bills/2017/s2816/amendment/original [accessed 2022 Sep 8]
NYSDOH. Unpublished data; 2020.
NYSDOH. Unpublished data; 2022.
Patel F., Thurman C., Liberty A., et al. Negative diagnostic PCR tests in school-aged, HIV-infected children on antiretroviral therapy since early life in Johannesburg, South Africa. J Acquir Immune Defic Syndr 2020;83(4):381-89. [PMID: 31913997]
Rawlinson W. D., Boppana S. B., Fowler K. B., et al. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis 2017;17(6):e177-88. [PMID: 28291720]
Uprety P., Chadwick E. G., Rainwater-Lovett K., et al. Cell-associated HIV-1 DNA and RNA decay dynamics during early combination antiretroviral therapy in HIV-1-infected infants. Clin Infect Dis 2015;61(12):1862-70. [PMID: 26270687]
Veldsman K. A., Maritz J., Isaacs S., et al. Rapid decline of HIV-1 DNA and RNA in infants starting very early antiretroviral therapy may pose a diagnostic challenge. AIDS 2018;32(5):629-34. [PMID: 29334551]
Wade N. A., Birkhead G. S., Warren B. L., et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339(20):1409-14. [PMID: 9811915]
Updates, Authorship, and Related Guidelines
|Updates, Authorship, and Related Guidelines|
|Date of original publication||August 2020|
|Intended users||NYS clinicians|
|Author and writing group conflict of interest disclosures||There are no author or writing group conflict of interest disclosures|
|Developer and funder|
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.|
|Disclosure and management of conflicts of interest||
|Evidence collection and review||
|Review and approval process||
|Recommendation Ratings Scheme|
|Strength||Quality of Evidence|
|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.|