Outpatient/Ambulatory Health Services

Service Standard

Outpatient/Ambulatory Health Services Service Standard print version

Subcategories Service Units

Outpatient/Ambulatory Health Services

Per visit

Dermatology

Per visit

Infectious Disease

Per visit

Neurology

Per visit

Ob/Gyn

Per visit

Oncology

Per visit

Ophthalmology

Per visit

Other Specialty

Per visit

Radiology

Per visit

Laboratory - Service (and test except CD4 and VRLD)

Per test

CD-4 T-Cell Count

Per test

Viral Load Test

Per test

 

Health Resources & Service Administration (HRSA) Description:

Outpatient/Ambulatory Health Services (OAHS) provide diagnostic and therapeutic-related activities directly to a client by a licensed healthcare provider in an outpatient medical setting. Outpatient medical settings may include: clinics, medical offices, mobile vans, using telehealth technology, and urgent care facilities for HIV-related visits.
 

Program Guidance:

Treatment adherence activities provided during an OAHS visit are considered OAHS services, whereas treatment adherence activities provided during a medical case management visit are considered medical case management services.

Language assistance must be provided to individuals who have limited English proficiency and/or other communication needs at no cost to them in order to facilitate timely access to all health care and services.

Subrecipients must provide easy-to-understand print and multimedia materials and signage in the languages commonly used by the populations in the service area to inform all individuals of the availability of language assistance services.

All AAs and subrecipients must establish culturally and linguistically appropriate goals, policies, and management accountability, and infuse them throughout the organizations’ planning and operations.
 

Limitations:

Non-HIV related visits to urgent care facilities are not allowable costs under OAHS per HRSA RWHAP PCN 16-02. Emergency room visits are not allowable costs within the OAHS category.
 

Services:

Allowable activities include:

  • Medical history taking
  • Physical examination
  • Diagnostic testing(including HIV confirmatory and viral load testing), as well as laboratory testing
  • Treatment and management of physical and behavioral health conditions
  • Behavioral risk assessment, subsequent counseling, and referral
  • Preventive care and screening
  • Pediatric developmental assessment
  • Prescription, and management of medication therapy
  • Treatment adherence
  • Education and counseling on health and prevention issues
  • Referral to and provision of specialty care related to HIV diagnosis, including audiology and ophthalmology

Care must include access to antiretroviral and other drug therapies, including prophylaxis and treatment of opportunistic infections and combination antiretroviral therapies (ART).

Diagnostic laboratory testing includes all indicated medical diagnostic testing, including all tests considered integral to treatment of HIV. Funded tests must meet the following conditions:

  • Tests must be consistent with medical and laboratory standards as established by scientific evidence and supported by professional panels, associations, or organizations;
  • Tests must be (1) approved by the U.S. Food and Drug Administration (FDA), when required under the FDA Medical Devices Act; and/or (2) performed in an approved Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified laboratory or State-exempt laboratory; and
  • Tests must be (1) ordered by a registered, certified, or licensed medical provider, and (2) necessary and appropriate based on established clinical practice standards and clinical judgment.

Telehealth and Telemedicine is an alternative modality to provide most Ryan White Part B and State Services funded services. For the Ryan White Part B/SS funded providers and Administrative Agencies, telehealth and telemedicine services are to be provided in real-time via audio and video communication technology which can include videoconferencing software.

DSHS HIV Care Services requires that for Ryan White Part B or SS funded services providers must use features to protect ePHI transmission between client and providers. RW Providers must use a telehealth vendor that provides assurances to protect ePHI that includes the vendor signing a business associate agreement (BAA). Ryan White Providers using telehealth must also follow DSHS HIV Care Services guidelines for telehealth and telemedicine outlined in DSHS Telemedicine Guidance.
 

Service Standard and Measure

The following Standards and Measures are guides to improving clinical care throughout the State of Texas within the Ryan White Part B and State Services Program. The most current U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Guide for HIV/AIDS Clinical Care – 2014 Edition are sources cited throughout the Standards for additional reference materials for direct care service providers.

Standard Measure

Comprehensive HIV-related history  
Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines. Providers should document a comprehensive HIV-related history that is inclusive of all components listed in the OAHS Standard as referenced in the HHS guidelines. This can be completed during the initial visit or divided over the course of two or three early visits.

History shall consist of, at a minimum, general medical history, a comprehensive HIV related history, and psychosocial history to include:

  • Documented past medical and surgical history with regard to chronic diseases such as diabetes, high blood pressure, heart disease, cholesterol, asthma or emphysema, sickle cell disease, etc. per HHS guidelines.
  • Psychosocial history to include socio-cultural assessment, occupational history, hobbies (as applicable), travel history, mental health, and housing status.
  • Lifestyle including tobacco use, alcohol use, illicit substance use, exercise, travel history.
  • Sexual Health including partners, practices, past sexually transmitted infections (STIs), contraception use (past and present).
  • HIV-related health history including most recent CD4 and Viral Load results, current ART (if applicable), previous adverse ART drug reactions, history of HIV-related illness and infections, HIV treatment history and staging.

Source: Page 61-70

Percentage of clients with a documented comprehensive HIV-related history that is inclusive of all components listed in the OAHS Standard as referenced in the HHS guidelines.

Physical examination  

Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines. Providers should perform a baseline and annual comprehensive physical examination, with attention to areas potentially affected by HIV.

Physical examination will include the documentation from the complete review of systems as indicated within the comprehensive medical history.    

Source: Page 73-77

Percentage of clients with a documented annual physical examination.

Percentage of clients with a diagnosis of HIV who received an oral cavity exam during the physical exam as documented in the client’s primary record.    

Laboratory tests, as clinically indicated by licensed provider
Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines. Tests will include as clinically indicated:

  • HIV Antibody, if not documented previously;
  • CD4 Count and/or CD4 Percentage
  • Quantitative Plasma HIV RNA (HIV Viral Load)
  • HIV Viral Load Suppression
  • Standard genotypic drug-resistance testing Refer to Table 3 in the “Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV” for guidance on other scenarios where genotype testing is recommended
  • Coreceptor Tropism Test (if considering use of CCR5 co-receptor antagonist or for clients who exhibit virologic failure on a CCR5 antagonist)
  • HLA-B*5701 testing (only before initiating abacavir-containing regimen per guidelines)
  • Complete Blood Count (CBC) with Differential and Platelets
  • Chemistry Profile: Electrolytes, Creatinine, Blood Urea Nitrogen (BUN)
  • Liver Transaminases, Bilirubin (Total and Direct)
  • Urinalysis with Urine Protein and Creatinine
  • Lipid Profile – random or non-fasting (Total Cholesterol, LDL, HDL, Triglycerides)
  • Glucose (random or non-fasting) or hemoglobin A1C
  • Hepatitis A antibody, Hepatitis B surface antigen, core Ab, and surface antibody & Hepatitis C antibody screens at initial intake (providers should screen all HIV diagnosed clients for anti-HCV antibodies at baseline)
    • Quantitative HCV RNA viral load testing (for Hepatitis C (HCV) positive clients who are candidates for treatment)
  • Toxoplasma gondii IgG
  • Pregnancy Test (for female clients of childbearing potential)
  • RPR or treponemal antibody (Syphilis Screening)
  • Gonorrhea (GC) and Chlamydia (CT) Testing
  • Trichomoniasis Testing 

Source: Page 79-89

Laboratory tests

Percentage of clients with documented laboratory tests completed according to the OAHS Standard and HHS treatment guidelines.

Percentage of clients with documented CD4 count (absolute).

Percentage of clients with documented HIV-RNA viral load.

Percentage of clients, regardless of age, HIV diagnosed with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year. (HRSA HAB Measure)

Percentage of clients, regardless of age, with a diagnosis of HIV who had an HIV drug resistance test performed before initiation of HIV ART if therapy started during the measurement year. (HRSA HAB Measure)

Percentage of clients, regardless of age, with a diagnosis of HIV who were prescribed HIV ART and who had a random or fasting lipid panel during the measurement year. (HRSA HAB Measure)

Percentage of clients with a diagnosis of HIV at risk for STIs who had a test for chlamydia within the measurement year. (HRSA HAB Measure)

Percentage of clients with a diagnosis of HIV at risk for STIs who had a test for gonorrhea within the measurement year. (HRSA HAB Measure)

Percentage of adult clients with a diagnosis of HIV who had a test for syphilis performed within the measurement year. (HRSA HAB Measure)

Hepatitis B screening was performed at least once since the diagnosis of HIV or for whom there is documented infection or immunity. (HRSA HAB Measure)

Percentage of clients for whom HCV screening was performed at least once since the diagnosis of HIV. (HRSA HAB Measure)

Percentage of clients with a Hepatitis C RNA viral load test, as applicable, completed within the measurement year.

Other diagnostic testing

Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines.

Chest x-ray will be completed if pulmonary symptoms are present; if positive LTBI test (either TST or Interferon Gamma Release Assay (IGRA)); or if prior evidence of LTBI or pulmonary TB (perform annually).

Source: Page 85

Percentage of clients with documented chest x-ray completed if pulmonary symptoms were present, after an initial positive (IGRA), after initial positive TST, or annually if prior evidence of LTBI or pulmonary TB. 

Screenings/Assessments  

Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines.

Clients should receive screening for opportunistic infections and assessment of psychosocial needs initially and annually according to the most current HHS guidelines.

Screening should include at a minimum:

  • Mental health assessment that includes screening for clinical depression (PHQ 2 at a minimum)
  • Psychosocial assessment, including domestic violence and housing status (housing status noted as: stable housing, unstable housing, or homeless)
  • Substance use
  • Tobacco use screening
  • Pediatric clients (14 years and younger) will be screened for child abuse as defined in Chapter 261 of the Texas Family Code and DSHS policy. Consider screening youth 14-17 for child abuse.
  • Oral health exam and assessment
  • Tuberculosis (TB) Screening
  • Cervical Cancer Screen (following the most current clinical recommendations)
    • Women Aged <30 Years with HIV:
      • If younger than age 21, known to have HIV or newly diagnosed with HIV, and sexually active, Pap test should be performed within one (1) year of onset of sexual activity regardless of mode of HIV transmission.
    • Women Aged >30 Years with HIV
      • Pap test should be done at baseline and every 12 months. If results of three (3) consecutive Pap tests are normal, follow-up Pap tests can be performed every three (3) years. 

Anal Cancer (Dysplasia) Screening
The Anal Cancer (Dysplasia) Screening Guidelines recommend, at a minimum, annual digital examination to detect masses on palpation that could be anal cancer. However, performing the digital exam alone as a screening procedure for anal dysplasia or cancer will miss many lesions. Anal cancer screening using a Pap test can improve sensitivity for detecting anal dysplasia or cancer. Cytology combined with high-resolution anoscope (HRA) is considered the best strategy for screening of precancerous lesions. If anal Pap is performed, clinicians should refer clients with abnormal anal cytology for HRA. In communities where HRA is not available, clinicians should consider referring clients with abnormal anal cytology to a surgeon for evaluation.

Source: Page 6-7, 83-89, 127

Recommended: Psychosocial Assessment Questions: page 65

Cervical Cancer Screen

Percentage of clients with documented medical screenings and assessments as indicated in the OAHS Standard and in accordance with HHS guidelines.

Percentage of female clients with a diagnosis of HIV who were screened for cervical cancer in the last three years. (HRSA HAB Measure)

Percentage of clients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool. (DSHS revised - HRSA HAB Measure)

Percentage of clients aged 12 years and older with positive clinical depression screen with follow-up plan documented on the date of the positive screen. (DSHS revised - HRSA HAB Measure)

Percentage of clients with documented psychosocial assessment to include domestic violence and housing status.

Percentage of clients with a diagnosis of HIV who have been screened for substance use (alcohol & drugs) in the measurement year. (HRSA HAB Measure)

Percentage of clients aged 18 years and older who were screened for tobacco use one or more times within 24 months. (DSHS Revised - HRSA HAB Measure)

Percentage of clients, if applicable, with completed child abuse assessment (completed if client aged 14 years and younger).

Percentage of clients aged three months and older with a diagnosis of HIV, for whom there was documentation that a tuberculosis (TB) screening test was performed and results interpreted (for TB skin tests) as least once since the diagnosis of HIV. (HRSA HAB Measure)

Immunizations

Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines.

Immunizations/vaccinations will be given according to the most current HHS guidelines and the CDC’s “ Table 2: Recommended Adult Immunization Schedule by Medical Condition and Other Indications, US 2020.” Providers will initiate prophylaxis for specific opportunistic infections.

Clients will be offered vaccinations for the following:

  • Tetanus, Diphtheria, and Pertussis (Tdap) per recommended treatment guidelines for immunizations 
  • Measles, Mumps, Rubella (MMR) per recommended treatment guidelines for immunizations. Adults and adolescents with a CD4 cell count <200 cells/uL should not receive MMR.
  • Influenza (inactivated vaccine)- annually during flu season October 1st - March 31st
  • Pneumococcal is recommended for all clients, two separate vaccines are recommended;
    • Receive a dose of PCV13, (Prevnar 13), followed by a dose of PPV23 (Pneumovax) at least eight (8) weeks later. 
  • Completion of Hepatitis B (HBV) vaccines series, unless otherwise documented as immune, vaccinated clients should be tested for HBsAb response 1–2 months after completed the series or at the next scheduled clinic visits after completing the series. 
  • Completion of Hepatitis A (HAV) vaccines series, unless otherwise documented as immune.
  • Varicella-Zoster (VZV): Please reference current treatment guidelines. *This vaccination is contraindicated in persons with HIV and CD4 count <200.

* HPV vaccine: The 2019 Advisory Committee on Immunization Practices (ACIP) recommends and DHHS states: “because of the potential benefit in preventing HPV-associated disease and cancer in this population, HPV vaccination is recommended for HIV-diagnosed males and females aged 11 through 26, but can be initiated as early as 9 years of age. For persons 27-45, ACIP recommends a conversation between provider and client regarding vaccine for this age group

Percentage of clients with Tetanus, Diphtheria, and Pertussis current within 10 years, Td booster doses every 10 years thereafter, or documentation of refusal.

Percentage of clients aged six months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization OR documentation of refusal. (DSHS Revised - HRSA HAB Measure)

Percentage of clients with a diagnosis of HIV who completed the vaccination series for Hepatitis B, or documentation of refusal. 

Percentage of clients with a diagnosis of HIV who ever received pneumococcal vaccine, or documentation of refusal. 

Percentage of clients with a diagnosis of HIV who completed the vaccination series for Hepatitis A, or documentation of refusal.

Percentage of clients with a diagnosis of HIV and are age >50 with a CD4>200 who ever received the Zoster vaccine, or documentation of refusal.

Percentage of clients with a diagnosis of HIV between the ages of 11 and 26 years (can be initiated as early as 9 years of age) who completed the series for HPV, or documentation of refusal.

Anti-retroviral Therapy (ART)  
Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines.

ART will be prescribed in accordance with the HHS established guidelines. 

Clients who meet current guidelines for ART are offered and/or prescribed ART.

Source: (ARV) Page 207-220

Percentage of clients, regardless of age, with a diagnosis of HIV are prescribed antiretroviral therapy (ART) for the treatment of HIV during the measurement year. (HRSA HAB Measure)

Health Education/Risk Reduction    
Health education will adhere to the most current HHS guidelines.

Providers will provide routine HIV risk-reduction counseling, sexual health promotion, and behavioral health counseling for HIV-diagnosed clients. 

Since clients’ behaviors change over time as the course of their disease changes and their social situations vary, health education providers will tailor routine risk-reduction counseling and behavioral health counseling not only to the individual client but also to the point in time in the client’s life. 

The following will be conducted initially and as needed:

  • Providers should discuss safer sexual practices so to decrease risk of transmitting HIV.
  • Providers should counsel HIV-diagnosed clients regarding all sites of possible transmission, such as anus, cervix, vagina, urethra, and oropharynx.
  • Providers should discuss family planning with clients
  • Contraception counseling/hormonal contraception
  • Drug interaction counseling
  • Providers should counsel clients on tobacco cessation annually for those clients that were screened and positive for smoking (or document decline of tobacco use)
  • When current alcohol or other substance use is identified, providers should discuss the possible effects of such use on the client’s general health and HIV medications, as well as options for treatment if indicated
  • Providers should routinely discuss with clients the importance of disclosure to partners. Clients should be educated about the options for voluntary partner notification.
  • When HIV-diagnosed clients are diagnosed with early syphilis (primary, secondary, or early latent), providers should intensify risk-reduction counseling, including discussions about the importance of condom use.
  • Nutritional Counseling regarding:
    • Quality and quantity of daily food and liquid intake
    • Exercise (as medically indicated)

Source: (Smoking Cessation) page 189-196

Source: (Patient Education) Page 57-59, 89, 102, 107, 111, 126, 143-154

Source: (Nutrition) page 197-202


Percentage of clients with a diagnosis of HIV who received HIV risk counseling in the measurement year. (HRSA HAB Measure)

Percentage of clients aged 18 years and older who received cessation counseling intervention if identified as a tobacco user. (DSHS Revised - HRSA HAB Measure)

Percentage of clients with documented counseling about family planning method appropriate to client’s status, as applicable, to include preconception counseling.

Percentage of clients with documented instruction regarding new medications, as appropriate.

Percentage of clients with documented counseling regarding the importance of disclosure to partners.

Treatment Adherence 
Assessment of treatment adherence and counseling will be provided that adheres to current HHS guidelines.

Clients are assessed for treatment adherence and counseling at a minimum of twice a year.

Those who are prescribed on-going ART regimen must receive adherence assessment and counseling on every HIV-related clinical encounter.

If adherence issue is identified by another member of the healthcare team (MCM, MA, LVN, RN), there is documented evidence of adherence counseling and follow-up action. This adherence counseling documentation must be evident in the client’s medical record and clearly indicated that the prescribing provider was made aware of the adherence issue.

Source: Page 273

Percentage of clients with documented assessment for treatment adherence two or more times within the measurement year if client is on ART.

Percentage of clients with documented adherence issues who received counseling for treatment adherence two or more times within the measurement year.

Percentage of clients, regardless of age, with a diagnosis of HIV who had at least one medical visit in each 6-month period of the 24-month measurement period with a minimum of 60 days between medical visits. (HRSA HAB Measure)

Percentage of clients, regardless of age, with a diagnosis of HIV who did not have a medical visit in the last 6 months of the measurement year. (HRSA HAB Measure)

Referrals  

Providers will refer to specialty care or other systems as appropriate in accordance with current HHS guidelines. At a minimum, clients should receive referrals to specialized health care/providers/services as needed or medically indicated to augment medical care:

  • AIDS Drug Assistance Program (ADAP)
  • Medication Assistance Programs
  • Medical care coordination
  • Medical specialties
  • Mental health and substance use services -Treatment education services
  • Partner counseling and referral
  • Annual oral hygiene and intraoral examinations, including dental caries and soft-tissue examinations.
  • Medical Nutrition Therapy (MNT)
  • Health maintenance, as medically indicated, such as:
    • Cervical Cancer Screening
    • Family Planning
    • Colorectal cancer screening
    • Breast cancer screening
  • Specialty medical care for any preexisting chronic diseases
  • Case Management Services or a Disease Investigation Specialist (DIS) for follow-up if missing appointments. 
  • Vision Care
  • Audiology

Providers/staff are expected to follow-up on each referral to assess attendance and outcomes. For specific details regarding screening modalities and timeframes see The United States Preventive Services Task Force

Source: Page 73
 

Percentage of clients, as medically indicated, who had documentation of referrals for:

  • Mental Health and/or Substance Use
  • Oral Health
  • Ophthalmological services
  • Child abuse if suspected abuse
  • Disease intervention specialist
  • Other specialty services.

Percentage of clients with a documented referral in the measurement year, has a progress note in the client’s chart regarding attendance, and outcomes of the referral.

Documentation in Clients' Medical Chart    

Primary medical care for the treatment of HIV includes the provision of care that is consistent with the most current HHS treatment guidelines. Clinicians (included but not limited to Providers with prescriptive authority, PharmD, PhD, LCSW, LCDC, RN, LVN, MA or MCM) will develop/ update plan of care at each visit.

If a client refuses a treatment, such as vaccinations, documentation of denial will be written in the client's medical chart. 

The provider developing the plan will sign each entry, an electronic signature is allowable.

Source:  See Section 2, Page 77

Percentage of client medical records with signed clinician entries.

Percentage of flow sheets present and updated in the client medical records.

Percentage of problem lists present and updated in the client medical records.

Percentage of medication lists present and updated in the client medical records.

Documentation of missed client appointments and efforts to bring the client into care.  
Provider and/or staff will conduct the following:

  • Contact clients who have missed appointments, using at least 3 different forms of contact (phone, mail, emergency contact, phone call, referral to DIS for home visit) prior to determining they are lost to follow-up;
  • Address any specific barriers to accessing services;
  • Document number of missed client appointments and efforts to bring the client into care.

Source: Page 1

Percentage of client medical records with documentation of any specific barriers and efforts made to address missed appointments.

Perinatally Exposed Infants Neonatal Zidovudine (ZDV) Prophylaxis
All newborns perinatally exposed to HIV should receive postpartum antiretroviral (ARV) drugs to reduce the risk of perinatal transmission of HIV.

Newborn ARV regimens—at gestational-age-appropriate doses—should be initiated as close to the time of birth as possible, preferably within 6 to 12 hours of delivery.

The selection of a newborn ARV regimen should be determined based on maternal and infant factors that influence risk of perinatal transmission of HIV. The uses of ARV Regiments in Newborns include:

  • ARV Prophylaxis: The administration of one or more ARV drugs to a newborn without documented HIV diagnosis to reduce the risk of perinatal acquisition of HIV.
  • Empiric HIV Therapy: The administration of a three-drug ARV regimen to newborns at highest risk of perinatal acquisition of HIV. Empiric HIV therapy is intended to be preliminary treatment for a newborn who is later documented to have HIV but also serves as prophylaxis against HIV acquisition for those newborns who are exposed to HIV in utero, during the birthing process, or during breastfeeding and who do not acquire HIV.
  • HIV Therapy: The administration of a three-drug ARV regimen at treatment dosages (antiretroviral therapy [ART]) to newborns with documented HIV diagnosis.

Providers with questions about ARV management of perinatal HIV exposure should consult the National Perinatal HIV Hotline (888-448-8765), which provides free clinical consultation on all aspects of perinatal HIV, including newborn care.

All newborns with perinatal exposure to HIV should receive antiretroviral (ARV) drugs in the neonatal period to reduce perinatal transmission of HIV, with selection of the appropriate ARV regimen guided by the level of transmission risk.

  • The most important factors that influence the risk of HIV transmission to a newborn exposed to HIV are whether the mother has received antepartum/intrapartum antiretroviral therapy (ART) and her viral load
  • The risk of transmission is increased in the absence of maternal ART or if maternal antepartum/intrapartum treatment was started after early pregnancy or was ineffective in producing virologic suppression; higher maternal viral load, especially in later pregnancy, correlates with higher risk of transmission.

There is a spectrum of transmission risk that depends on these and other maternal and infant factors, including mode of delivery, gestational age at delivery, and maternal health status. HIV transmission can occur in utero, intrapartum, or during breastfeeding.

Drug selection and dosing considerations are related to the age and gestational age of the newborn. Consultation is available through the National Perinatal HIV Hotline (888-448-8765).

Percentage of infants born to HIV + women who were prescribed ZDV prophylaxis for HIV within 12 hours of birth during the measurement year. (HRSA HAB Measure) 

Diagnostic Testing to Exclude HIV Diagnosis in Exposed Infants
Newborns Born to Mothers Who Received Antepartum/Intrapartum Antiretroviral Drugs with Effective Viral Suppression:
 According to US Department of Health and Human Services, (DHHS) the risk of HIV acquisition in newborns born to women who received ART regimens during pregnancy and labor and had undetectable viral loads at delivery is <1%.

DHHS recommends a 4-week neonatal zidovudine prophylaxis regimen for newborns if the mother has received ART during pregnancy with viral suppression (usually defined as confirmed HIV RNA level below the lower limits of detection of an ultrasensitive assay) at or after 36 weeks’ gestation, and there are no concerns related to maternal adherence.

Newborns Born to Mothers with Unknown HIV Status at Presentation in Labor

  • Expedited HIV testing is recommended during labor for women with unknown HIV status and, if not performed during labor, as soon as possible after birth for the mothers and/or their newborns (see Identification of Perinatal Exposure). Expedited test results should be available within 60 minutes.
  • If maternal or infant expedited testing is positive, the newborn should be immediately initiated on a multi-drug ARV prophylaxis regimen or empiric HIV therapy, without waiting for the results of supplemental tests
  • Expedited HIV testing should be available on a 24-hour basis at all facilities with a maternity service and/or neonatal intensive care unit or special care or newborn nursery
  • A nursing mother who is suspected of having HIV based on an initial positive antibody or antibody/antigen test result should stop breastfeeding until HIV is confirmed or ruled out
  • Breastfeeding is not recommended for women with confirmed HIV in the United States, including those receiving ART

Newborns Born to Mothers with Antiretroviral Drug-Resistant Virus

  • The optimal ARV regimen for newborns delivered by women with ARV drug-resistant virus is unknown. The ARV regimen for newborns born to mothers with known or suspected drug resistance should be determined in consultation with a pediatric HIV specialist before delivery or through consultation via the  National Perinatal HIV Hotline (888-448-8765)
  • Data exist to provide dosing recommendations appropriate for the treatment of HIV in neonates

For comprehensive guidance please see Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Percentage of infants born to HIV + women who received recommended virologic diagnostic testing for exclusion of HIV diagnosis in the measurement year. (HRSA HAB Measure)

 

References

American College of Obstetricians and Gynecologists (ACOG); 2011 Aug. 11 p. (ACOG practice bulletin; no. 122) Accessed October 15, 2020.

HIV Clinical Guidelines

U.S. Department of Health and Human Services, Health Resources and Services Administration, Guide for HIV/AIDS Clinical Care – 2014 Edition. Rockville, MD: U.S. Department of Health and Human Services, 2014

MMWR (January 31, 2014 / 63(04); 69-72) CDC Grand Rounds: Reducing the Burden of HPV- Associated Cancer and Disease

New York State Recommendations on Anal Pap Smears

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services

Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission. Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-infected Adults and Adolescents: Recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America

Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Department of Health and Human Services

Preexposure prophylaxis for the prevention of HIV infection in the United States-Update (2014). Department of Health and Human Services

Texas Administrative Code, Title 22, Part 9, Chapter 193, Rule §193.1

U.S. Department of Health and Human Services, Health Resources and Services. A Guide to the Clinical Care of Women with HIV – 2013 Edition. Rockville, Maryland: U.S. Department of Health and Human Services, 2013

U.S. Department of Health and Human Services, Health Resources and Services Administration, Guide for HIV/AIDS Clinical Care – 2014 Edition. Rockville, MD: U.S. Department of Health and Human Services, page 81, 85.

Primary Care Guidelines for Management of HIV. CID 2014:58 (1 January)

Recommended Immunization Schedule for Adults Aged 19 Years or Older. United States. 2020 Advisory Commission on Immunization Practices (ACIP), Table 1

Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. DHHS, 2020

HRSA/HAB Ryan White Program & Grants Management, Recipient Resources. Policy Notices and Program Letters, Ryan White HIV/AIDS Program Services: Eligible Individuals & Allowable Uses of Funds Policy Clarification Notice (PCN) #16-02 (Revised 10/22/2018)

Interim Guidance for the Use of Telemedicine and Telehealth for HIV Core and Support Services, March 2020

Interim Guidance for the Use of Telemedicine and Telehealth for HIV Core and Support Services – Users Guide and FAQs, March 2020