Key Points
- This guidance from an expert panel of the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA) updates the 2013 HIV primary care guidelines.
- These recommendations encompass the comprehensive care of persons with HIV, including comorbidity management.
Diagnosis
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.
- HIV care sites should make every effort to provide care in a way that is linguistically and culturally appropriate.
- HIV care sites should implement programs incorporating evidence-based and evidence-informed interventions shown to improve HIV care engagement and viral suppression.
- HIV care sites should utilize a multidisciplinary model but identify a primary clinician for each patient and support the development of trusting, long-term, patient-clinician relationships.
II. INITIAL EVALUATION AND IMMEDIATE FOLLOW-UP FOR PERSONS WITH HIV
- A comprehensive present and past medical history including HIV-related information, medication/social/family history (Tables 1 and 2), review of systems, and physical examination (Table 3) should be obtained for all patients upon initiation of care, ideally at the first visit but, if not feasible, then as soon as possible thereafter. In particular, in settings of rapid ART initiation, clinicians may initially truncate parts of the comprehensive history and physical, providing a more targeted exam but with close follow-up to complete the essential and more comprehensive assessment. Since many patients will not be able to recall details of prior treatments and labs, medical records should be requested and reviewed, and the current medical record updated accordingly. Baseline laboratory assessments should be obtained at the initial visit. (See Table 4)
HIV-Specific Tests for All Persons With HIV
HIV Screening
- 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.
CD4 Cell Counts and Percentages
- A CD4 cell count with percentage should be obtained upon initiation of care.
- Measurement of the CD8 cell count and the ratio of CD4 cells to CD8 cells is unnecessary since the results are not used in clinical decision-making.
Plasma HIV RNA Levels
- A quantitative HIV RNA (viral load) level should be obtained upon initiation of care.
HIV Resistance Testing
- Patients should be assessed for transmitted drug resistance with a genotype assay for protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and nucleoside reverse transcriptase inhibitor (NRTI) mutations upon initiation of care.
- Resistance testing should be obtained for patients re-engaging in care who are currently not on ART or who have not had consistent ART access, recognizing that absence of resistance mutations does not guarantee absence of resistance when no selective pressure is present.
- To guide modification of ART, resistance testing, including for INSTIs if appropriate, is indicated for patients who are experiencing virologic failure and should be performed while on the failing ART regimen or within 4 weeks of discontinuing the ART regimen.
- If transmitted integrase strand transfer inhibitor (INSTI) resistance is suspected, genotypic testing for INSTI resistance should be obtained.
HIV-Related Tests in Selected Patients
Coreceptor Tropism Assay
- Tropism testing should be performed if the use of a CCR5 antagonist is being considered.
HLA B*5701
- HLA-B*5701 testing should be performed before initiating abacavir therapy.
- Patients who are positive for the HLA B*5701 haplotype are at high risk for abacavir hypersensitivity reaction and should never be treated with abacavir (and this should be noted appropriately in the medical record).
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) and glucose level, and urinalysis should be obtained upon initiation of care.
- 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.
Screening for Coinfections
Screening for Sexually Transmitted Infections (STIs) — 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.
- All persons having 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.
Syphilis
- All patients should be screened for syphilis upon initiation of care.
- 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.
- A lumbar puncture should be performed in patients who experience serologic treatment failure (i.e., whose nontreponemal titers fail to decline 4-fold after stage-appropriate therapy, or whose titers increase 4-fold if reinfection is ruled out).
Latent Tuberculosis (TB)
- Upon initiation of care, persons with HIV without a history of tuberculosis or a prior positive tuberculosis screening test should be screened for M. tuberculosis infection by either a tuberculin skin test (TST) or by 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.
- 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.
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.
- Persons with HIV should be screened for evidence of immunity to hepatitis A virus (HAV) with HAV IgG.
- 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.
- Infants born to persons with HBV- and/or HCV should be tested for HBV and HCV transmission, respectively.
- Persons who are not immune to HAV and HBV should be immunized according to Advisory Committee on Immunization Practices (ACIP) guidelines. (See Section III for further discussion)
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.
- 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.
Varicella Zoster Virus
- Serologic screening for varicella zoster virus (VZV) may be considered for persons who have not had chickenpox or shingles and who have not been previously vaccinated. (See Section III)
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 to rule out active tuberculosis. It may also be useful in other patients who are likely to have preexisting lung abnormalities.
Cervical Cancer Screening
- Persons with a uterus who are <30 years old should have a cervical Papanicolaou (Pap) test performed within one year of the onset of sexual activity but not later than 21 years of age. Persons with HIV between 21–29 years 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 <30 years of age, unless Pap test is abnormal.
- Persons with a uterus who are >30 years old should have a cervical Pap test performed at diagnosis. A Pap test alone or in combination with HPV testing can be performed.
- Persons with atypical squamous cells of unknown significance (ASC-US) on cytology or negative cytology with positive high-risk HPV (HRHPV) may have the Pap smear repeated in one 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.
- Following hysterectomy for benign disease, routine screening for vaginal cancer is NOT recommended for persons with HIV. Those with a history of high-grade CIN adenocarcinoma in situ or invasive cervical cancer should be followed with annual vaginal cuff Pap tests.
Anal Cancer Screening
- Persons with a history of receptive anal intercourse, 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.
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.
Pregnancy Testing
- All persons of childbearing potential should have a pregnancy test upon initiation of care or reengagement in care.
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.
- Obtaining testosterone levels in women at baseline in non-research settings is NOT recommended.
Tests NOT Recommended for General Screening Purposes
- Routine testing for HSV IgG, CMV IgG, Toxoplasma IgG, and biomarkers of inflammation is NOT recommended.
- Testing for serum cryptococcal antigen may be considered in persons with CD4 <100 cells/mm3 or in symptomatic patients.
III. ROUTINE HEALTHCARE MAINTENANCE CONSIDERATIONS FOR PEOPLE WITH HIV
HIV-Specific Monitoring Following the Initial Assessment
- 46. After initiation of ART, HIV RNA should be rechecked after 2–4 weeks but no later than 8 weeks, and then every 4–8 weeks until suppression is achieved. Afterwards, viral load should be monitored every 3–4 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 2–4 weeks, with repeat testing every 4–8 weeks until viral load becomes undetectable.
- CD4 cell count should be monitored to determine the need for prophylaxis against opportunistic infections. CD4 cell counts should generally be monitored every 3–6 months for the first 2 years, or if the virus is not suppressed. For patients on suppressive ART regimens with CD4 counts 300–500/µL, CD4 count can be monitored every 12 months unless there are changes in the patient’s clinical or virologic status. If the CD4 count rises above 500 cells/µL, CD4 monitoring is optional.
Screening for Mental Health and Substance Use Issues
- Screening for substance use should be done at all healthcare encounters.
- Screening for depression using validated screening tools should be conducted at least annually and as needed.
Screening and Vaccination for Infectious Diseases
Screening for Chlamydia, Gonorrhea, Trichomoniasis
- 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.
- All persons having vaginal sex should be screened for trichomoniasis annually.
- 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 exhibiting ongoing risk behavior should also be referred to programs capable of offering more extensive intervention programs.
Screening and Vaccination for Other Infectious Diseases
- Perform tuberculosis screening annually in persons at risk for infection. (See Section II)
- 54. 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.
- Vaccinations for pneumococcal infection, influenza, tetanus-diphtheria-whooping cough, and meningococcus should be offered according to CDC Opportunistic Infection and ACIP guidelines.
- Asymptomatic persons with CD4 >200 cells/mm3 who are traveling internationally should receive required vaccinations including live vaccines.
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 <10 IU/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 count.
- Vaccination should be recommended for nonimmune sexual partners of patients who are positive for HBsAg.
- Patients who are negative for HBsAg and HBsAb but positive for HBcAb should receive vaccination.
- Vaccination for HAV is recommended for all nonimmune individuals, especially those with indications for hepatitis A vaccine (e.g., persons who inject drugs, 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 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 for those who remain seronegative.
Human papillomavirus
- Persons between 9–26 years of age should be vaccinated against HPV, and persons with HIV 27–45 years who were not vaccinated or inadequately vaccinated should be offered the vaccination series if appropriate.
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.
- 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%.
- Recombinant zoster vaccine, two dose series, should be given to those >50 years on ART with CD4 >200 cells/µL to prevent herpes zoster.
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.
- Screening for prostate, breast, lung, and colon cancer should be conducted according to USPSTF and American Cancer Society guidelines for the general population.
- Biennial screening mammography is recommended for persons aged 50–74 years, as per USPSTF guidelines.
- Persons with HIV between 21–29 years of age 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.
- For persons >30 years of age, 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.
- Anal cancer screening: Periodic anal cytology by anal Pap test should be performed if access to referral and high-resolution anoscopy is available.
- Screening for hepatocellular carcinoma every 6 months by ultrasound with or without alpha-fetoprotein is recommended for those with cirrhosis from any cause.
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 (e.g., chronic kidney disease or hepatitis).
- Urinalysis should be monitored annually among those at risk for kidney disease.
- All persons with HIV should be asked about their reproductive desires. Persons capable of childbearing should be routinely asked about their plans and desires regarding pregnancy.
- 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.
- All persons with HIV should have semi-annual oral health examinations.
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.
- Random or fasting blood glucose (FBG) 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.
- 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.
- Testosterone replacement therapy for cisgender men should be prescribed with caution and only in those with symptomatic hypogonadism, given the long-term side consequences. (See Section VIII for discussion of hormone therapy for transgender men)
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.
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.
- Infants exposed to HIV in utero should be managed according to DHHS perinatal guidelines.
Breastfeeding
- In the US, persons with HIV should avoid breastfeeding.
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.
- All children with HIV should initiate ART, regardless of CD4 count/percentage, HIV RNA level, or symptoms.
- CD4 cell counts and HIV RNA should be monitored no less than every 3–4 months in infants and children.
- Childhood vaccinations should be administered according to ACIP schedules for infants and children with HIV.
- 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.
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.
- Adolescents with HIV should have a coordinated, deliberate transition to adult care.
- Vaccinations should be administered according to ACIP schedules children with HIV.
VIII. CONSIDERATIONS FOR TRANSGENDER AND GENDER DIVERSE POPULATIONS AT LEAST 18 YEARS OF AGE
- Transgender and gender diverse persons with HIV should have access to gender-affirming, non-discriminatory, non-stigmatizing, and culturally sensitive care.
- 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.
- 95. Transgender persons should be offered medical and/or surgical therapy in order to achieve their desired gender characteristics, in accordance with 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.
- Cancer screening should be conducted based on guidelines for the organs and tissues present in the individual.
Table 1. Initial Assessment: History of the Present Illness and HIV-specific History
| History of the Present Illness |
|---|
|
| HIV-specific History |
|
| People Who Currently Inject Drugs |
|
Table 2. Other Medical and Surgical History
| Comorbidities: Current or Past Chronic Medical Conditions That Might Affect the Choice of Therapy or Response to Therapy |
|---|
|
| Other Past Medical Conditions That May Have Implications for Persons With HIV |
|
| Gynecologic and Obstetric History |
|
| Mental Health History, Current and Past |
|
| Current or Past Use of Psychoactive Substances |
|
| Past Hospitalizations, Surgical Procedures, Transfusions or Blood Product Receipt |
|
| Immunization Status (Obtain from Past Medical Records if Possible) |
|
| Travel and Residential History |
|
| Pediatric |
|
| Family Medical History |
|
| Social History |
|
| Medications |
|
| Allergies and Intolerance |
|
| Healthcare Maintenance and Preventative Health Screenings (As Appropriate) |
Dates of last:
|
Table 3. Initial Assessment — Review of Systems and Physical Examination
| Review of Systems | Physical Examination |
|---|---|
A complete review of systems with special attention to the areas listed below:
| A complete physical examination should be performed, with special attention to the following areas:
|
Table 4. Recommended Initial Laboratory Screening and Other Studies in Persons with HIV
| Test | Comment(s) |
|---|---|
| HIV-specific Tests for All Persons with HIV | |
| HIV antigen/antibody testing | If written evidence of diagnosis not available or if viral load low or undetectable. |
| CD4 cell count and percentage | Assess need for opportunistic infection (OI) prophylaxis. |
| Plasma HIV RNA PCR (HIV viral load) | Establish baseline and monitor viral suppression. |
| HIV resistance testing | Baseline genotype for PI, NNRTI, NRTI mutations for persons who have never initiated therapy or who are reengaging in care and not on therapy or with inconsistent access to therapy. INSTI genotype is recommended only if suspicion for INSTI mutation transmission. |
| HIV-related Tests in Selected Patients | |
| Coreceptor tropism assay | If use of CCR5 antagonist is being considered. |
| HLA B*5701 | If use of abacavir is being considered. |
| Other Laboratory Tests | |
| Complete blood cell count with differential | Assess for anemia, neutropenia, thrombocytopenia. |
| Alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase | Assess for evidence of liver damage, hepatitis, or systemic infection (e.g., elevated alkaline phosphatase with some OIs). |
| Total protein and albumin | High total protein common with untreated HIV infection due to increased immunoglobulin fraction secondary to B-cell hyperplasia. Low albumin may indicate nutritional deficiency or nephrotic syndrome. |
| Electrolytes, blood urea nitrogen, creatinine | Assess kidney function: Use creatinine to calculate estimated GFR. |
| Lipid profile and blood glucose; hemoglobin A1c | Fasting not needed for initial lipid and glucose assessment. If abnormal, repeat fasting. Hemoglobin A1c should be measured prior to ART initiation but is not used for diagnosis of diabetes in those on ART. |
| Urinalysis | Assess for evidence of proteinuria, hematuria. |
| Screening for Coinfections | |
| Gonorrhea, chlamydia | NAAT testing with sites based on exposure history (e.g., urine, vaginal, rectal, oropharyngeal; 3 site testing preferred for all patients). |
| Trichomoniasis | In all persons who have vaginal sex. |
| Syphilis | Using local protocol (either RPR or treponemal-specific antibody tests). |
| Latent Mycobacterium tuberculosis | Tuberculin skin test or IGRA. IGRA preferred if history of BCG vaccination. |
| Varicella virus | Anti-varicella IgG if no known history of chickenpox or shingles. |
| Viral hepatitis A, B, and C | HBsAg, HBsAb, HBcAb, HCV antibody, HAV total or IgG antibody. If HBsAg+, or HBcAb positive, order HBV DNA level. If HCVAb+, order HCV RNA level and HCV genotype. Screen for hepatocellular carcinoma for all adult patients with cirrhosis and non-cirrhotic patients with chronic HBV for an extended period. |
| Measles titer | Adequate evidence of immunity includes being born in the US before 1957, written documentation of adequate vaccination, or serologic evidence of immunity. Persons born in the 1960’s may have been vaccinated with a vaccine other than MMR and may have waning immunity. Patients may opt to receive a booster MMR vaccine rather than check serology. |
| Tests That May Be Performed Under Certain Circumstances | |
| Chest radiography | For patients with evidence of latent M. tuberculosis infection. Consider in patients with underlying lung disease for use as comparison in evaluation of future respiratory illness. |
| Cytology: Cervical and/or anal Pap test | Cervical; anal if indicated. Abnormal results require follow-up with colposcopy or high-resolution anoscopy, respectively. |
| Glucose-6-phosphate dehydrogenase | Screen for deficiency in appropriate racial or ethnic groups to avoid use of oxidant drugs including dapsone, primaquine, sulfonamides. |
| Pregnancy test in persons of child-bearing potential | Pregnancy status is required to inform choice of ART and in discussions about conception in persons of child-bearing potential. |
| Serum testosterone level | In cisgender males with fatigue, weight loss, loss of libido, erectile dysfunction, or depression or who have evidence of reduced bone mineral density. Morning free testosterone preferred. See Section IV for management of hypogonadism. |
| Tests That Are NOT Recommended for General Screening Purposes | |
| HSV IgG, CMV IgG, Toxoplasma IgG, biomarkers of inflammation. | In asymptomatic persons, routine testing for all persons is NOT recommended for HSV, CMV, and Toxoplasma. Biomarkers of inflammation are NOT recommended. Toxoplasma IgG and cryptococcal antigen should be obtained in the context of suspicion for clinical disease. Toxoplasma IgG may be obtained in patients for whom prophylaxis is indicated. CMV IgG may be considered if blood transfusion is contemplated in a person at low risk for CMV exposure. A negative CMV IgG may support use of CMV-free blood products. |
| Serum cryptococcal antigen in persons with CD4 ≥100/mm3. | Serum cryptococcal antigen may be considered for persons with CD4 <100/mm3. |
Treatment
Table 5. Routine Healthcare Maintenance for People With HIV (After Initial Assessment)
| Intervention | Recommendation | Comments |
|---|---|---|
| HIV-specific Tests for All Persons with HIV | ||
| HIV RNA | Should be performed every 4–6 weeks after initiation of ART until <50 c/mL and then every 3–4 months. In patients with consistent viral suppression and stable CD4 for more than 2 years, can be measured every 6 months. | — |
| CD4 cell count | Every 3–6 months for the first 2 years after starting ART, or if viremia develops, or if CD4 <300/mm3. If CD4 300–500/mm3 and HIV RNA suppressed for 2 years, can be measured every 12 months. If CD4 >500/mm3 and HIV RNA suppressed for 2 years, measurement is optional. | — |
| Screening for Mental Health and Substance Use Issues | ||
| Depression screening | Perform at least annually and when clinically appropriate. | Use standard depression screening tool such as PHQ-9 GAD-2. |
| Substance use screening | General messages regarding risk reduction should be provided at all healthcare encounters, regardless of risk behaviors reported by the patient or perceived risk on the part of the healthcare provider. Such messages can be delivered by the provider, by others in the healthcare setting, or by educational materials (e.g., pamphlets, posters, and videos) in the healthcare setting. | — |
| Screening for and Monitoring of Metabolic Disorders (See also Section IV) | ||
| Blood pressure screening | Perform at every visit. | — |
| Weight measurement | Perform at every visit. | — |
| Screening for hyperlipidemia | Lipid profile: Perform every 5 years if normal; more frequently if abnormal or other cardiovascular risk factors present (every 6–12 months). If abnormal, repeat fasting. | Follow ASCVD Risk calculator. Consider testing 1–3 months after starting or changing ART. See Section IV for further discussion. |
| Screening for diabetes mellitus and glucose intolerance | Serum glucose: Perform annually. If abnormal, obtain fasting glucose. Hemoglobin A1C should be obtained prior to initiation of ART, if possible. In persons with diabetes, repeat at least every 6 months (more frequently if clinically indicated). Urine microalbumin or urine protein/creatinine ratio: In patients with diabetes, repeat at least every 6 months (more frequently if clinically indicated). | Consider testing 1–3 months after starting or changing antiretroviral medications. HbA1c is not used to diagnose diabetes in persons on ART. It may be used for screening and monitoring. Consider threshold cutoff of 5.8%. See Section IV for further discussion. |
| Screening for bone mineral density | Baseline bone densitometry by dual-energy X-ray absorptiometry (DXA) should be performed in all postmenopausal women and men aged ≥50 years. | See Section IV for further discussion. |
| Screening and Vaccination for Infectious Diseases | ||
| Syphilis screening | Perform at least annually in asymptomatic persons. Repeat every 3–6 months in asymptomatic persons if risk of acquisition is high. | Acquisition risk depends on sexual activities, use of barrier protection, and local prevalence. |
| Gonorrhea and chlamydia screening | Perform at least annually in asymptomatic persons. Can repeat every 3–6 months in asymptomatic persons if risk of acquisition is high. | Screening by NAAT at all sites of sexual contact (rectal, oropharyngeal, vaginal, urine/urethral) is recommended for all sexually active persons with HIV. Acquisition risk depends on sexual activities, use of barrier protection, and local prevalence. |
| Trichomoniasis screening | Perform annually for persons having vaginal sex. | Screen using NAAT testing. |
| Hepatitis A, B and C screening | Hepatitis C: In sexually active, HCV negative men having sex with men, transgender women, and PWID. Screen annually. | In those with new abnormal liver function test, check for acute HAV, HBV, and HCV. |
| Tuberculosis screening | Perform annually in patients at risk for tuberculosis. | Either TST or IGRA. |
| Vaccinations For most current vaccination recommendations, consult current vaccination schedules | Pneumococcus (PCV13 and PCV23): Repeat PCV23 once 5 years after first vaccination. All patients with HIV should receive one dose of PCV13. If not vaccinated previously, this should be the first dose. If never vaccinated, one dose PCV13 at least one year after PCV23. | — |
| Influenza: Administer annually. | Avoid live influenza vaccine if CD4 <200/µL. | |
| Tetanus-diphtheria-whooping cough: Administer Tdap once followed by Td or Tdap every 10 years and as indicated for wound management. | — | |
| Meningococcal Vaccine (MenACWY) × 2 doses; booster every 5 years depending on risk. | — | |
| Hepatitis A and B: Administer if not immune. | Check anti-HBs 1–2 months or next scheduled visit after completion of series. Administer hepatitis A and B boosters based on immune status. | |
| HPV vaccine: Administer if age ≤26 years. Consider administering if age 27–45 and unvaccinated or inadequately vaccinated. | HPV vaccine now recommended up to age 45. | |
| Varicella zoster: Shingrix® vaccine × 2 doses if over age 50 and CD4 200/µL. | The ACIP has not made a recommendation for CD4 ≤200/µL. | |
| Screening for and Prevention of Cancer | ||
| Smoking | Recommend cessation (if presently smoking) at every visit. | Provide resources per local guidelines, including classes/agents that facilitate smoking cessation. |
| Low dose chest CT scan | For smokers. | Between ages 55–80 who have 30 pack-years of smoking and are current smokers or have quit in the last 15 years should have an annual low-dose computed tomography scan of lung until smoking has been discontinued for 15 years. |
| Prostate cancer screening | Digital rectal exam: Considered primary evaluation before PSA screening. Consider for men aged 55–69. PSA screening:Age 50–69: Discuss risks and potential benefits with patient. Age ≥70: PSA screening is NOT recommended. | The impact of HIV on prostate cancer risk is not yet known. African-Americans and people with a relative with prostate cancer have a higher burden of prostate cancer. Clinicians should follow USPSTF or American Cancer Society guidelines, and consider patient wishes. |
| Colon cancer screening | Age 50–75: Screen using Perform starting at age 45–50 years at average risk. Age 76–85: Individualize screening based on overall health and prior screening. Consider screening earlier if first-degree relatives diagnosed with colon cancer prior to age 50. | Screening tests include: Stool-based screening (gFOBT, FIT, FIT-DNA) every year, or colonoscopy every 10 years if normal, or more frequently if polyps are identified. Begin screening in those patients who are high risk (first degree relatives of a patient with a diagnosis of colorectal cancer at age ≤50) 10 years prior to age at which the relative was diagnosed with cancer. |
| Breast cancer screening | Age 50–75: Mammography performed at least every 2 years. | Age 40–49: Inform of the potential risks and benefits of screening and offer screening every 2 years. See Section IV for further discussion. |
| Cervical cancer screening | Age <21: Pap within 1 year of sexual activity, no later than age 21. Age 21–29: Pap at diagnosis of HIV, repeat yearly × 3, then if all normal—Pap every 3 years. Age <30 years: No HPV testing unless abnormalities are found on Pap test. Age ≥30 years: Pap only, same as 21–29 years. OR Pap with HPV testing. If both neg THEN Pap with HPV every 3 years. Note: In general, continue screening past 65 years. | Abnormal Pap and/or HPV follow-up similar to general population. See Section II for further discussion. |
| Anal cancer screening | Digital anorectal exam: Perform at least annually if asymptomatic. Anal Pap: There are no national guidelines at this time. Some experts recommend anal cytology for persons with HIV who have receptive anal sex, but only if high-resolution anoscopy is available. | Abnormal anal Pap should prompt referral for high-resolution anoscopy. |
| Hepatocellular carcinoma screening | Alpha-fetoprotein (AFP) and liver ultrasound every 6 months. | For patients with cirrhosis for any cause or chronic hepatitis B. |
| Other Healthcare Maintenance | ||
| Complete blood count and chemistry panel | Perform as needed based upon underlying conditions and need for toxicity management for ART and other medications. | — |
| Contraceptive management | All persons with HIV should be asked about their reproductive desires. Persons capable of childbearing should be routinely asked about their plans and desires regarding pregnancy. | Plans for conception may influence the choice of ART. See Section IV for further discussion. |
| Oral health examination | All persons with HIV should have oral health examinations semiannually. | — |
| Patient education | Address regularly in all patients, particularly sexual risk reduction to prevent STIs (and HIV transmission if not virally suppressed) and importance of medication adherence for personal health and to eliminate HIV transmission to sexual partners. | General messages regarding sexual risk reduction should be provided at all HIV primary care encounters, including need for maximal viral control to improve personal health and eliminate HIV transmission to others (U=U). Those patients reporting high-risk behaviors, or those presenting with repeated STIs, should be offered brief counseling and tailored interventions to reduce their subsequent risk. Attempts should also be made to refer the patient to programs offering a more extensive intervention program. |
Table 6. Effect of Protease Inhibitors and Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs) on Statins
| Statin | Protease Inhibitors | NNRTI |
|---|---|---|
| Atorvastatin | Caution (moderately increase atorvastatin’s AUC). Use lowest starting atorvastatin dose. | Acceptable with appropriate dosing and monitoring. Efavirenz and etravirine decrease atorvastatin’s AUC. No data for nevirapine. May need higher atorvastatin starting dose. Doravirine does not affect levels of atorvastatin. |
| Fluvastatin | NOT recommended with nelfinavir. Use of other protease inhibitors is allowed with appropriate dosing and monitoring. | Acceptable with appropriate dosing and monitoring. Etravirine may increase fluvastatin’s AUC. May need lower fluvastatin starting dose with etravirine. No data on doravirine. |
| Lovastatin | Contraindicated (greatly increase lovastatin’s AUC) | Acceptable with appropriate dosing and monitoring. Decreases simvastatin’s AUC, so may need higher lovastatin starting dose. No data on doravirine. |
| Pitavastatin | Acceptable with appropriate dosing and monitoring. No significant change in pitavastatin’s AUC with lopinavir/ritonavir. Pitavastatin’s mean AUC decreased 26% with darunavir. | No data for NNRTIs. |
| Pravastatin | Acceptable with appropriate dosing and monitoring, except with darunavir. Decrease in pravastatin’s AUC, except with darunavir, which increases pravastatin’s AUC by 81%. | Acceptable with appropriate dosing and monitoring. Efavirenz decreases pravastatin’s AUC, but no change with etravirine. No data for nevirapine, rilpivirine, doravirine. May need higher pravastatin starting dose with efavirenz. |
| Rosuvastatin | Acceptable with appropriate dosing and monitoring. Lopinavir/ritonavir and tipranavir + ritonavir increase rosuvastatin’s AUC. May need to start rosuvastatin at lower dose with lopinavir/ritonavir. No dose adjustments with cobicistat. Cobicistat increases Cmax 89% and AUC by 38%. | Acceptable with appropriate dosing and monitoring. No data on doravirine. |
| Simvastatin | Contraindicated (greatly increase simvastatin’s AUC) | Acceptable with appropriate dosing and monitoring. Efavirenz and etravirine decrease simvastatin’s AUC. No data for nevirapine, doravirine. May need higher simvastatin starting dose. |
