Primary Care Guidance for Persons With Human Immunodeficiency Virus

Publication Date: November 6, 2020
Last Updated: March 14, 2022

Recommendations

I. OPTIMIZING CARE ENGAGEMENT, MEDICATION ADHERENCE, AND VIRAL SUPPRESSION

All persons with HIV should be provided timely access to routine and urgent primary medical care, including approaches to expand access such as extended/weekend hours or telehealth.
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HIV care sites should make every effort to provide care in a way that is linguistically and culturally appropriate.
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HIV care sites should implement programs that incorporate evidence-based and evidence-informed interventions shown to improve HIV care engagement and viral suppression.
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HIV care sites should use a multidisciplinary model but identify a primary clinician for each patient and support the development of trusting long-term, patient–clinician relationships.
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II. INITIAL EVALUATION AND IMMEDIATE FOLLOW-UP FOR PERSONS WITH HIV

A comprehensive present and past medical history that includes HIV-related information, medication/social/family history, review of systems, and physical examination should be obtained for all patients upon initiation of care, ideally at the first visit or, if not feasible, as soon as possible thereafter. In particular, in settings of rapid ART initiation, clinicians may initially truncate parts of the comprehensive history and physical and provide a more targeted exam but with close follow-up to complete the essential and more comprehensive assessment. As many patients will not be able to recall details of prior treatments and laboratory results, medical records should be requested and reviewed, and the current medical record updated accordingly. Baseline laboratory assessments should be obtained at the initial visit.
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HIV-Specific Tests for All Persons With HIV and HIV Screening Recommendation

Patients who have no documentation of their HIV status or who were tested anonymously should have an HIV antigen/antibody screening test performed upon initiation of care.
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CD4 Cell Counts and Percentages

A CD4 cell count with percentage should be obtained upon initiation of care.
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Measurement of the CD8 cell count and the ratio of CD4 cells to CD8 cells are unnecessary, as the results are not used in clinical decision-making.
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Plasma HIV RNA Levels

A quantitative HIV RNA (viral load) level should be obtained upon initiation of care.
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HIV Resistance Testing

Patients should be assessed for transmitted drug resistance with a genotype assay for protease inhibitor (PI), nonnucleoside reverse transcriptase inhibitor (NNRTI), and nucleoside reverse transcriptase inhibitor (NRTI) mutations upon initiation of care.

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Resistance testing should be obtained for patients who reengage in care and who are currently not on ART or who have not had consistent ART access, recognizing that the absence of resistance mutations does not guarantee the absence of resistance when no selective pressure is present.
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Resistance testing, including for integrase strand transfer inhibitor (INSTIs), if appropriate, is indicated for patients who are experiencing virologic failure to guide modification of ART and should be performed while the patient is on the failing ART regimen or within 4 weeks of discontinuing the ART regimen.
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If transmitted INSTI resistance is suspected, genotypic testing for INSTI resistance should be obtained.
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HIV-related Tests in Select Patients and Coreceptor Tropism Assay

Tropism testing should be performed if the use of a C-C motif chemokine receptor 5 (CCR5) antagonist is being considered.
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HLA B5701

15. HLA B5701 testing should be performed before initiation of abacavir therapy.
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Patients who are positive for the HLA B5701 haplotype are at high risk for abacavir hypersensitivity reaction and should never be treated with abacavir (this should be noted appropriately in the medical record).
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Laboratory Tests to Assess Safety and General Health

A complete blood count with differential white blood cell count, chemistry panel with calculated creatinine clearance (or estimated glomerular filtration rate [eGFR]) and glucose level, and urinalysis should be obtained upon initiation of care.
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Because many antiretroviral drugs, HIV infection itself, and host factors are associated with increased cholesterol and triglyceride levels, a lipid profile should be obtained upon initiation of care and repeated fasting, if appropriate.
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Chlamydia, gonorrhea, trichomoniasis

Persons with HIV should be screened for gonorrhea and chlamydia infection at initial presentation. Screening should include all sites of contact (oral, anal, urethral [urine], and vaginal). Those found to have gonorrhea or chlamydia on initial screening should be treated and rescreened in 3 months because of high reinfection rates.
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All persons who have receptive vaginal sex should be screened for trichomoniasis at entry into care. Those found to have trichomoniasis on initial screening should be treated and rescreened in 3 months because of high reinfection rates.
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Syphilis

All patients should be screened for syphilis upon initiation of care.
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A lumbar puncture should always be performed for patients with a reactive syphilis serology who have neurologic or ocular symptoms or signs, irrespective of past syphilis treatment history.
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A lumbar puncture should be performed in patients who experience serologic treatment failure (ie, whose nontreponemal titers fail to decline 4-fold after stage-appropriate therapy or whose titers increase 4-fold if reinfection is ruled out).
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Latent Tuberculosis

Upon initiation of care, persons living with HIV without a history of tuberculosis or a prior positive tuberculosis screening test should be screened for Mycobacterium tuberculosis infection using either a PWID, people who inject drugs; tuberculin skin test (TST) or an interferon-γ release assay (IGRA). Those with positive test results should be treated for latent M. tuberculosis infection after active tuberculosis has been excluded.
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Persons with HIV who are close contacts of persons with infectious tuberculosis should be treated for latent M. tuberculosis infection regardless of their TST or IGRA results, age, or prior courses of tuberculosis treatment; active tuberculosis should be excluded first.
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Hepatitis A, B, and C

Persons with HIV should be screened for evidence of hepatitis B virus (HBV) infection upon initiation of care by detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and antibody to hepatitis B total core antigen (anti-HBc or HBcAb). If HBsAg is positive, HBV viral load should be ordered.
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Persons with HIV should be screened for evidence of immunity to hepatitis A virus (HAV) with HAV immunoglobulin G (IgG).
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Persons with HIV should be screened for HCV antibody upon initiation of care. If positive, HCV RNA should be ordered to assess for active HCV infection. Curative therapy should be offered to all who are diagnosed with HCV.
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Infants born to persons with HBV and/or HCV should be tested for HBV and HCV transmission.
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Persons who are not immune to HAV and HBV should be immunized according to Advisory Committee on Immunization Practices (ACIP) guidelines. Please see Section III for further discussion.
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Measles, Mumps, and Rubella

All persons with HIV born in 1957 or after should be tested for immunity to measles, mumps, and rubella (MMR) by measuring antibodies.
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MMR vaccine should be given to protect against measles, mumps, and rubella if persons were born in 1957 or after and have not received this vaccine or do not have immunity to these infections.
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Varicella Zoster Virus

Serologic screening for varicella zoster virus (VZV) may be considered for persons who have not had chicken pox or shingles and who have not been previously vaccinated (see Section III).
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Tests That May Be Performed Under Certain Circumstances: Chest Radiography

A baseline chest radiograph should be obtained in all persons with HIV who have a positive tuberculosis screening test result in order to rule out active tuberculosis. It may also be useful in other patients who are likely to have preexisting lung abnormalities.
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Cervical Cancer Screening

Persons with a uterus and who are aged <30 years should have a cervical Pap test performed within 1 year of the onset of sexual activity but not later than age 21 years. Persons with HIV aged between 21 and 29 years and who have a uterus should have a cervical Pap test at diagnosis, if not performed within the last year. Routine human papillomavirus (HPV) testing is not recommended for women with HIV aged < 30 years, unless the Pap test is abnormal.
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Persons with a uterus and who are aged >30 years should have a cervical Pap test performed at diagnosis. A Pap test alone or in combination with HPV testing can be performed.
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Persons with atypical squamous cells of unknown significance on cytology or negative cytology with positive high-risk HPV (HRHPV) may have the Pap smear repeated in 1 year or should undergo colposcopy. If the Pap test shows negative cytology but HRHPV 16 or 18, atypical squamous cells and cannot rule out high-grade squamous intraepithelial lesion (ASC-H), atypical glandular cells, low-grade or high-grade squamous intraepithelial lesion, or squamous carcinoma noted by Pap testing, the patient should undergo colposcopy and directed biopsy, with further treatment as indicated by results of evaluation.</
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Following hysterectomy for benign disease, routine screening for vaginal cancer is not recommended for persons with HIV. Those with a history of high-grade Cervical intraepithelial neoplasia (CIN) adenocarcinoma in situ or invasive cervical cancer should be followed with annual vaginal cuff Pap tests.
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Anal Cancer Screening

Persons with a history of receptive anal intercourse or abnormal cervical Pap test results and all persons with genital warts should have an anal Pap test if access to appropriate referral for follow-up, including high-resolution anoscopy, is available.
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Glucose-6-Phosphate Dehydrogenase

Screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency is recommended before starting therapy with oxidant drugs such as dapsone, primaquine, or sulfonamides in patients with a predisposing racial or ethnic background.
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Pregnancy Testing

All persons of childbearing potential should have a pregnancy test upon initiation of care or reengagement in care.
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Serum Testosterone Level

Morning serum testosterone levels are recommended in adult cisgender men with decreased libido, erectile dysfunction, reduced bone mass or low trauma fractures, hot flashes, or sweats.
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Obtaining testosterone levels in women at baseline in nonresearch settings is not recommended.
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Tests Not Recommended for General Screening Purposes

Routine testing for herpes simplex virus (HSV) IgG, cytomegalovirus (CMV) IgG, toxoplasma IgG, and biomarkers of inflammation is not recommended.
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Testing for serum cryptococcal antigen may be considered in persons with CD4 cell count <100 cells/mm3 or in symptomatic patients.
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III. ROUTINE HEALTHCARE MAINTENANCE CONSIDERATIONS FOR PEOPLE WITH HIV

HIV-specific Monitoring Following the Initial Assessment

After initiation of ART, HIV RNA should be rechecked after 2 to 4 weeks but no later than 8 weeks and then every 4 to 8 weeks until suppression is achieved. Afterward, viral load should be monitored every 3 to 4 months to confirm maintenance of suppression below the limit of assay detection. This interval may be prolonged to every 6 months for adherent patients whose viral load has been suppressed for more than 2 years and whose clinical and immunologic status is stable. Viral load should be monitored more frequently after initiation or change in ART, preferably within 2 to 4 weeks, with repeat testing every 4 to 8 weeks until viral load becomes undetectable.
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CD4 cell count should be monitored to determine the need for prophylaxis against opportunistic infections. CD4 cell counts should generally be monitored every 3 to 6 months for the first 2 years or if the virus is not suppressed. For patients on suppressive ART regimens with CD4 cell counts 300–500/µL, CD4 cell count can be monitored every 12 months unless there are changes in the patient’s clinical or virologic status. If the CD4 cell count rises above 500 cells/µL, CD4 monitoring is optional.
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Screening for Mental Health and Substance Use Issues

Screening for substance use should be done at all healthcare encounters.
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Screening for depression using validated screening tools should be conducted at least annually and as needed.
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Screening and Vaccination for Infectious Diseases: Screening for Chlamydia, Gonorrhea, Trichomonas and Syphilis

Screening for syphilis, chlamydia, and gonorrhea in asymptomatic persons should be repeated at least annually after initial screening or every 3–6 months depending on sexual activities, presence of other STIs in the patient or their partner, and local community STI prevalence.
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All persons who have vaginal sex should be screened for trichomonas annually.
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Tailored messages are critical for patients who report persistent high-risk behavior or who have symptoms or signs of STIs. In nearly all situations, the provider should offer brief counseling. In general, persons who exhibit ongoing risk behaviors should be referred to programs capable of offering more extensive interventional treatment.
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Screening and Vaccination for Other Infectious Diseases

Tuberculosis screening should be performed annually for persons at risk for infection (see Section II).
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Repeat testing is recommended in patients with advanced HIV disease who initially had negative TST or IGRA results but subsequently experienced an increase in the CD4 cell count to >200 cells/µL on ART and who may thus have developed sufficient immunocompetence to mount a positive reaction.
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Vaccinations for pneumococcal infection, influenza, tetanus-diphtheria-whooping cough, and meningococcus should be offered according to CDC Opportunistic Infection and ACIP guidelines.
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Asymptomatic persons with CD4 cell count >200 cells/mm3 who travel internationally should receive required vaccinations, including live vaccines.
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Hepatitis A and B (HAV, HBV)

Those who are susceptible to infection should be vaccinated against HBV. For those whose HBsAb levels are negative or <100 mIU/mL after a primary vaccine series, a second series is recommended using higher doses or an additional dose. Ideally, revaccination should be attempted after suppression of HIV viral load and improvement in CD4 cell count.
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Vaccination should be recommended for nonimmune sexual partners of patients who are positive for HBsAg.
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Patients who are negative for HBsAg and HBsAb but positive for HBcAb should receive vaccination.
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Vaccination for HAV is recommended for all nonimmune individuals especially those with indications for hepatitis A vaccine (eg, PWID, those unstably housed, those with current or prior incarceration, gay and bisexual men or transgender persons with chronic liver disease, travelers to countries with high endemicity, or persons who are infected with hepatitis B and/or C). HAV IgG antibody testing should be repeated 1–2 months or at the next scheduled visit after the second vaccine to assess for immunogenicity. A repeat vaccine series is recommended in those who remain seronegative.
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Human papillomavirus

Persons aged between 9 and 26 years should be vaccinated against HPV and persons with HIV aged 27–45 years who were not vaccinated or inadequately vaccinated should be offered the vaccination series if appropriate.
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Varicella zoster virus

Patients who are susceptible to VZV (those who have not been vaccinated, have no history of varicella or herpes zoster, or are seronegative for VZV) should receive postexposure prophylaxis with varicella zoster immune globulin (VariZIG) as soon as possible (but within 10 days) after exposure to a person with varicella or shingles.
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Varicella primary vaccination may be considered in VZV-seronegative persons aged >8 years with CD4 cell counts >200 cells/µL and in children with HIV aged 1–8 years with CD4 cell percentages >15%.
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Recombinant zoster vaccine, 2-dose series, should be given to those aged >50 years on ART with CD4 cell count >200 cells/µL to prevent herpes zoster.
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Screening for and Prevention of Cancer

All patients who smoke should be strongly encouraged to stop smoking and offered smoking cessation assistance. Screening for smoking should be done at every healthcare encounter.
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Screening for prostate, breast, lung, and colon cancer should be conducted according to the US Preventative Services Task Force (USPSTF) and American Cancer Society guidelines for the general population.
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Biennial screening mammography is recommended for persons aged 50–74 years, as per USPSTF guidelines.
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Persons with HIV aged between 21 and 29 years should have a cervical Pap test annually. If the results of 3 consecutive cervical Pap tests are normal, follow-up Pap screening should be in 3 years.
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For persons aged 30 years or greater, cervical Pap tests should be done annually. If the results of 3 consecutive Pap tests without an HPV test are normal, a follow-up Pap should be performed in 3 years. If the Pap test is done with HPV testing and both the cytology and HPV testing are negative, follow-up cervical cancer screening can be done in 3 years after a single Pap smear.
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Anal cancer screening: periodic anal cytology by anal Pap test should be performed if access to referral and high-resolution anoscopy is available.
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Screening for hepatocellular carcinoma every 6 months by ultrasound with or without alpha-fetoprotein is recommended for those with cirrhosis from any cause.
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Other Healthcare Maintenance

Complete blood count and chemistry panels should be monitored on a regular basis as needed to assess medication toxicity and to monitor potential or existing comorbid conditions (eg, chronic kidney disease, hepatitis).
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Urinalysis should be monitored annually among those at risk for kidney disease.
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All persons with HIV should be asked about their reproductive desires. Persons capable of bearing children should be routinely asked about their plans and desires regarding pregnancy.
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Patient education should be provided at every visit, tailored to the patient’s current needs. In particular, the clinician should evaluate the need for education on optimizing sexual health and the importance of medication adherence to maximize personal health and to eliminate HIV transmission to sexual partners.
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All persons with HIV should have semiannual oral health examinations.
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IV. METABOLIC AND OTHER NONCOMMUNICABLE COMORBIDITIES ASSOCIATED WITH HIV, ANTIRETROVIRAL THERAPY, AND AGING

Lipid levels should be obtained prior to and within 1–3 months after starting ART. Patients with abnormal lipid levels should be managed according to the National Lipid Association Part 2 and 2018 Multispecialty Blood Cholesterol Guidelines.
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Random or fasting blood glucose and hemoglobin A1c (HbA1c) should be obtained prior to starting ART. If random glucose is abnormal, fasting glucose should be obtained. After initiation of ART, only plasma glucose criteria should be used to diagnose diabetes. Patients with diabetes mellitus should have an HbA1c level monitored every 6 months with an HbA1c goal of <7%, in accordance with the American Diabetes Association Guidelines.
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Baseline bone densitometry (DXA) screening for osteoporosis should be performed in postmenopausal women and men aged ≥50 years. There is insufficient evidence to guide recommendations for bone density testing in transgender or nonbinary individuals. Screening for transgender people should follow national recommendations based upon their sex at birth and individualized based on risk for osteoporosis.
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Testosterone replacement therapy for cisgender men should be prescribed with caution and only in those with symptomatic hypogonadism given the long-term side effects. See Section VIII for discussion of hormone therapy for transgender men.
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V. SPECIAL CONSIDERATIONS FOR CISGENDER WOMEN AND TRANSGENDER MEN OF CHILDBEARING POTENTIAL AND FOR PREVENTION OF PERINATAL HIV TRANSMISSION

Contraception and Preconception Care

All persons with HIV who are of childbearing potential should be asked about their plans and desires regarding pregnancy upon initiation of care and routinely thereafter. Clinicians should ensure that informed decisions are made about contraception to prevent unintended pregnancy and offer counseling if pregnancy is desired.
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Prevention of Perinatal Transmission

To prevent perinatal transmission, all pregnant persons with HIV should be treated with ART, regardless of their immunologic or virologic status. Therapy should be initiated as early as possible, preferably prior to conception.
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Infants exposed to HIV in utero should be managed according to DHHS perinatal guidelines.
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Breastfeeding

In the United States, persons with HIV should avoid breastfeeding.
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VI. SPECIAL CONSIDERATIONS FOR CHILDREN

Infants diagnosed with HIV should undergo HIV resistance testing prior to administering ART and, because of the rapid progression of disease, ART should be initiated as early as possible regardless of CD4 cell count, HIV RNA level, or clinical status.
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All children with HIV should initiate ART, regardless of CD4 cell count/percentage, HIV RNA level, or symptoms.
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CD4 cell counts and HIV RNA should be monitored no less than every 3–4 months in infants and children.
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Childhood vaccinations should be administered according to ACIP schedules for infants and children with HIV.
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Infants and children with HIV should be managed by a specialist with knowledge of the unique therapeutic, pharmacologic, behavioral, psychosocial, and developmental issues associated with HIV.
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VII. SPECIAL CONSIDERATIONS FOR ADOLESCENTS

Adolescents with HIV require an individual and developmental approach to therapy and care, ideally through an HIV specialist with expertise in this population.
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Adolescents with HIV should have a coordinated, deliberate transition to adult care.
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Vaccinations should be administered according to ACIP schedules for children with HIV.
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VIII. CONSIDERATIONS FOR TRANSGENDER AND GENDER DIVERSE POPULATIONS AGED AT LEAST 18 YEARS

Transgender and gender-diverse persons with HIV should have access to gender-affirming, nondiscriminatory, nonstigmatizing, and culturally sensitive care.
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Intake forms, medical records, and other documentation should integrate gender-neutral language and include gender identity options rather than be limited to sex at birth.
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Transgender persons should be offered medical and/or surgical therapy in order to achieve their desired gender characteristics, in accordance with the World Professional Association for Transgender Health (WPATH) standards of care. HIV care providers should be familiar with initial laboratory monitoring and gender-affirming hormone treatment or provide referral to a clinician or endocrinologist experienced in transgender care.
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Cancer screening should be conducted based on guidelines for the organs and tissues present in the individual.
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Recommendation Grading

Overview

Title

Primary Care Guidance for Persons With Human Immunodeficiency Virus

Authoring Organizations

Publication Month/Year

November 6, 2020

Last Updated Month/Year

March 13, 2024

Supplemental Implementation Tools

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Inclusion Criteria

Female, Male, Adolescent, Adult, Child, Infant, Older adult

Health Care Settings

Ambulatory, Childcare center, Long term care, Outpatient

Intended Users

Social worker, physician, epidemiology infection prevention, nurse, nurse practitioner, physician assistant

Scope

Management, Treatment

Diseases/Conditions (MeSH)

D006678 - HIV

Keywords

human immunodeficiency virus (HIV), HIV monitoring, HIV care engagement, HIV comorbidities, sexually transmitted infections, antiretroviral theraphy