New York State Department of Health
Full Text Guideline
Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for selected recommendations (see the "Major Recommendations" field).
Implementation of the Guideline
The AIDS Institute's Office of the Medical Director directly oversees the development, publication, dissemination and implementation of clinical practice guidelines, in collaboration with The Johns Hopkins University, Division of Infectious Diseases. These guidelines address the medical management of adults, adolescents and children with human immunodeficiency virus (HIV) infection; primary and secondary prevention in medical settings; and include informational brochures for care providers and the public.
Guidelines are disseminated to clinicians, support service providers and consumers through mass mailings and numerous AIDS Institute-sponsored educational programs. Distribution methods include the HIV Clinical Resource website, the Clinical Education Initiative (CEI), the AIDS Educational Training Centers (AETC) and the HIV/AIDS Materials Initiative. Printed copies of clinical guidelines are available for order from the New York State Department of Health (NYSDoH) Distribution Center for providers who lack internet access.
The HIV Clinical Guidelines Program works with other programs in the AIDS Institute to promote adoption of guidelines. Clinicians, for example, are targeted through the CEI and the AETC. The CEI provides tailored educational programming on site for health care providers on important topics in HIV care, including those addressed by the HIV Clinical Guidelines Program. The AETC provides conferences, grand rounds and other programs that cover topics contained in AIDS Institute guidelines.
Support service providers are targeted through the HIV Education and Training initiative which provides training on important HIV topics to non-physician health and human services providers. Education is carried out across the State as well as through video conferencing and audio conferencing.
The HIV Clinical Guidelines Program also works in a coordinated manner with the HIV Quality of Care Program to promote implementation of HIV guidelines in New York State. By developing quality indicators based on the guidelines, the AIDS Institute has created a mechanism for measurement of performance that allows providers and consumers to know to what extent specific guidelines have been implemented.
Finally, best practices booklets are developed through the HIV Clinical Guidelines Program. These contain practical solutions to common problems related to access, delivery or coordination of care, in an effort to ensure that HIV guidelines are implemented and that patients receive the highest level of HIV care possible.
Quick Reference Guides/Physician Guides
Benefits/Harms of Implementing the Guideline Recommendations
Appropriate evaluation and management of human immunodeficiency virus (HIV)-infected patients in primary care
Rating Scheme for the Strength of the Recommendations
Strength of Recommendation
- Strong recommendation for the statement
- Moderate recommendation for the statement
- Optional recommendation
When formulating guidelines for a disease as complex and fluid as human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), it is impossible to anticipate every scenario. It is expected that in specific situations, there will be valid exceptions to the approaches offered in these guidelines and sound reason to deviate from the recommendations provided within.
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Quality of Evidence for Recommendation
- One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
- One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
- Expert opinion
AIDS Institute clinical guidelines are developed by distinguished committees of clinicians and others with extensive experience providing care to people with HIV infection. Committees* meet regularly to assess current recommendations and to write and update guidelines in accordance with newly emerging clinical and research developments.
The Committees* rely on evidence to the extent possible in formulating recommendations. When data from randomized clinical trials are not available, Committees rely on developing guidelines based on consensus, balancing the use of new information with sound clinical judgment that results in recommendations that are in the best interest of patients.
*Current committees include:
- Medical Care Criteria Committee
- Committee for the Care of Children and Adolescents with HIV Infection
- Dental Standards of Care Committee
- Mental Health Guidelines Committee
- Committee for the Care of Women with HIV Infection
- Committee for the Care of Substance Users with HIV Infection
- Physicians' Prevention Advisory Committee
- Pharmacy Advisory Committee
A formal cost analysis was not performed and published cost analyses were not reviewed.
External Peer Review
All guidelines developed by the Committee are externally peer reviewed by at least two experts in that particular area of patient care, which ensures depth and quality of the guidelines.
Identifying Information and Availability
New York State Department of Health. Primary care approach to the HIV-infected patient. New York (NY): New York State Department of Health; 2011 Apr. 31 p. [7 references]
Not applicable: The guideline was not adapted from another source.
New York State Department of Health
Medical Care Criteria Committee
Committee Chair: Barry S Zingman, MD, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, New York
Committee Vice-chair: Judith A Aberg, MD, New York University School of Medicine, New York, New York
Committee Members: Bruce D Agins, MD, MPH, New York State Department of Health AIDS Institute, New York, New York; Barbara Chaffee, MD, MPH, United Health Services, Binghamton, New York; Steven M Fine, MD, PhD, University of Rochester Medical Center, Rochester, New York; Barbara E Johnston, MD, Mount Sinai Comprehensive Health Program, New York, New York; Jessica E Justman, MD, Mailman School of Public Health, Columbia University, New York, New York; Jason M Leider, MD, PhD, North Bronx Healthcare Network of Jacobi and North Central Bronx Hospitals, Bronx, New York; Joseph P McGowan, MD, FACP, Center for AIDS Research & Treatment, North Shore University Hospital, Manhasset, New York; Samuel T Merrick, MD, New York-Presbyterian Hospital, Weill Cornell Medical Center, New York, New York; Rona M Vail, MD, Callen-Lorde Community Health Center, New York, New York
Liaisons: Sheldon T Brown, MD, Liaison to the Department of Veterans Affairs Medical Center, James J Peters Veteran Affairs Medical Center, Bronx, New York; John M Conry, PharmD, BCPS, Liaison to Pharmacy Advisory Committee, for People with HIV Infection, Saint John's University, Queens, New York; Blayne Cutler, MD, PhD, Liaison to the New York City Department of Health and Mental Hygiene, Bureau of HIV/AIDS Prevention and Control, Long Island City, New York; Douglas G Fish, MD, Liaison to the New York State Department of Corrections, Albany Medical College, Albany, New York; Peter G Gordon, MD, Liaison to the HIV Quality of Care Advisory Committee, Columbia University College of Physicians and Surgeons, New York, New York; Carl J Koenigsmann, MD, Liaison to the New York State Department of Corrections, New York State Department of Correctional Services, Albany, New York; Joseph R Masci, MD, Liaison to New York City Health and Hospitals Corporation, Elmhurst Hospital Center, Elmhurst, New York; William Valenti, MD, FIDSA, Liaison to the Medical Society of the State of New York, AIDS Care — Center for Positive Living, University of Rochester School of Medicine, Rochester, New York
AIDS Institute Staff Physicians: Charles J Gonzalez, MD, New York State Department of Health AIDS Institute, New York, New York; Cheryl A Smith, MD, New York State Department of Health AIDS Institute, New York, New York
Principal Investigator: John G Bartlett, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland
This is the current release of the guideline.
This guideline updates a previous version: New York State Department of Health. Primary care approach to the HIV-infected patient. New York (NY): New York State Department of Health; 2007 Mar. 27 p.
Electronic copies: Available from the New York State Department of Health AIDS Institute Web site.
The following are available:
- Mental health screening: a quick reference guide for HIV primary care clinicians. New York (NY): New York State Department of Health; 2006 Feb. 8 p. Electronic copies: Available from the New York State Department of Health AIDS Institute Web site.
- Substance use screening: a quick reference guide for HIV primary care clinicians. New York (NY): New York State Department of Health; 2009 Feb. 8 p. Available from the New York State Department of Health AIDS Institute Web site.
This NGC summary was completed by ECRI on January 17, 2005. This NGC summary was updated by ECRI Institute on September 18, 2007. This NGC summary was updated by ECRI Institute on October 27, 2011.
- Human immunodeficiency virus (HIV) infection
- General physical, psychological, and reproductive health
Allergy and Immunology
Obstetrics and Gynecology
Advanced Practice Nurses
Health Care Providers
Public Health Departments
To develop guidelines for evaluation and management of human immunodeficiency virus (HIV)-infected patients in primary care
Human immunodeficiency virus (HIV)-infected patients in primary care
- General history including:
- Past hospitalizations, past and current illnesses
- Current prescription and non-prescription medicines
- Vaccination history
- Reproductive history
- Partner information for disclosure of human immunodeficiency virus (HIV) status
- Occupational history
- Allergies HIV treatment and staging including
- HIV exposure history
- Most recent viral load and CD4 count
- Current and previous antiretroviral (ARV) regimens
- Previous adverse ARV drug reactions
- Opportunistic infections
- Mental health and substance use history
- Sexual history
- Psychosocial history
- Review of systems
- Comprehensive physical examination including:
- Vital signs and pain assessment
- Ophthalmologic assessment and referral
- Head, ears, nose, and throat examination
- Oral examination
- Dermatologic examination
- Lymph node examination
- Endocrinologic examination
- Pulmonary and cardiac examination
- Abdominal examination
- Genital examination
- Rectal examination
- Musculoskeletal examination
- Neuropsychological examination
- Laboratory assessment and diagnostic testing including:
- Immunologic assessment
- Virologic assessment
- Tuberculosis evaluation
- Screening for sexually transmitted infections
- Cytologic screening
- Hematologic assessment
- Renal and hepatic assessment
- Metabolic assessment
- Behavioral health counseling and health promotion including:
- Safer sex education
- Substance use assessment and counseling
- Smoking cessation education
- Reproductive counseling
- Domestic violence screening
- Psychosocial assessment
- Diet and exercise counseling
- Coordination of care using case management
- Appropriate use of acute and chronic care services
- Standard health maintenance interventions, such as mammogram, prostate specific antigen (PSA), colorectal cancer screen
- Opportunistic infection prophylaxis (trimethoprim/sulfamethoxazole, azithromycin, clarithromycin)
The quality of evidence (I-III) and strength of recommendation (A-C) are defined at the end of the "Major Recommendations" field.
What's New — April 2011 Update
- Section II: Comprehensive Baseline History has been updated, including the table titled "Elements of a Comprehensive General History for HIV-Infected Patient" (see below and the original guideline document)
- Select terms in the table have been hyperlinked, allowing quick reference to related guidelines from the New York State Department of Health (NYSDoH) AIDS Institute (see the original guideline document for the links)
- A column in the table has been added to identify elements of the history that require ongoing assessment
Primary care clinicians should be capable of evaluating HIV-infected patients at all stages of HIV infection and should consult with a clinician who has experience with management of antiretroviral therapy (ART) according to current guidelines (see the National Guideline Clearinghouse [NGC] summary of the NYSDoH guideline Antiretroviral Therapy). (III)
Clinicians should involve patients in decisions regarding HIV treatment. (III)
Clinicians should schedule routine monitoring visits at least every 4 months for all HIV-infected patients who are clinically stable. (III)
Comprehensive Baseline History
- Obtain an HIV-related history at baseline (see table below titled "Elements of a Comprehensive General History for HIV-Infected Patient"). (AI)
- Use vocabulary that patients can understand, regardless of education level, when obtaining the history. (AIII)
- Use translator or sign language services when language barriers exist. (AIII)
Clinicians who treat HIV-infected patients should attempt to obtain previous medical records, including documentation of positive U.S. Food and Drug Administration (FDA)-approved diagnostic and confirmatory HIV tests (see the NGC summary of the NYSDoH guideline Diagnostic, Monitoring, and Resistance Laboratory Tests for HIV) (AIII).
Clinicians should educate patients with reportable illnesses in New York State about the potential for confidential follow-up from the New York State Department of Health.
Clinicians should address the importance of partner notification with HIV-infected patients and should stress the confidential nature of discussions regarding sexual history and substance use.
|Table: Elements of a Comprehensive General History for HIV-Infected Patients|
|General||Contact information—patient contact information, as well as contact person for emergencies or if unable to reach patient||At each visit|
|Review of sources of past medical care; obtain medical records whenever possible|
|Past hospitalizations, surgeries, past and current illnesses, and recent hospitalizations||At each visit, recent and current illnesses|
|Tuberculosis (TB) history ||At least annually|
|History of hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV), if known|
|History of chickenpox or shingles|
|Current prescription and nonprescription medications, including treatment for opioid dependence (methadone and buprenorphine); hormones; over-the-counter (OTC) agents (nonsteroidal anti-inflammatory drugs [NSAIDs], antihistamines, dietary supplements, vitamins); and other non-prescription medicines, including complementary and alternative medicines||Conduct thorough medication history at each visit|
|Reproductive history, including pregnancies, births, termination of pregnancy; current contraceptive use and contraceptive needs||At least annually|
|Partner information for disclosure of HIV status|
|Transfusion or blood product history, especially before 1985|
|Complete family medical history and chronic medical conditions, particularly those that might affect the choice of antiretroviral therapy (ART) or response to therapy: |
|History and results of neurocognitive screening|
|History and results of cancer screening||See Table 5 in the original guideline document|
|Allergies||At least annually|
|Travel history/place of birth|
|Occupational history and hobbies|
|Pets/animal exposures||At least annually|
|HIV Staging||HIV exposure history |
|Most recent viral load and CD4 count||See Table "Routine Laboratory Assessment and Diagnostic Screening" below|
|Nadir CD4 and peak viral load|
|HIV Treatment History||Drug-resistance, co-receptor tropism, and human leukocyte antigen testing||See Table "Routine Laboratory Assessment and Diagnostic Screening" below|
|Current and previous ART regimens ||At each routine monitoring visit: Response to current regimen and adherence|
|Opportunistic infections (OI) and malignancies|
|Previous adverse reactions to drugs used for OI prophylaxis|
|Providers who have been involved in the patient's HIV treatment|
|Patient's understanding of HIV disease and treatment||Ongoing assessment of health literacy|
|Mental Health||Mental health diagnoses, especially ||Routine mental health screening at least annually. See Mental Health Screening Card (see the "Availability of Companion Documents" field)|
|Psychotropic medications||At each visit, assess medication adherence, if applicable|
|Past psychiatric hospitalizations|
|Contact information for mental health providers if applicable|
|Substance Use||Types of drugs; past and current use ||Routine substance use screening at least annually. |
See Screening and Ongoing Assessment for Substance Use and Substance Use Screening Card (see the "Availability of Companion Documents" field)
|Frequency of use and usual route of administration|
|Risk behaviors—drug/needle sharing, exchanging sex for drugs, sexual risk-taking while under the influence of drugs or alcohol||At least annually|
|History of treatment and barriers to treatment, including adherence in the setting of mental health and substance use|
|Sexual||Current sexual activity||At least every 4 months|
|History of sexually transmitted infections—syphilis, herpes simplex, genital/rectal warts (human papilloma virus), chlamydia, gonorrhea, chancroid||See Table "Routine Laboratory Assessment and Diagnostic Screening" below for ongoing sexually transmitted infection (STI) assessment|
|Sexual practices—vaginal, anal, oral||At least every 4 months|
|Past and current partners||At least every 4 months|
|Risk behavior assessment, including knowledge about and use of latex or polyurethane barriers, number of partners||At least every 4 months|
|Sexual function (libido, erectile dysfunction, etc.)||At least annually|
|Use of sex-enhancing agents or testosterone replacement||At least annually|
|Psychosocial||Housing status||Psychosocial assessment should be performed at least annually*|
|Employment and insurance status|
|Social support |
|Stability of personal relationships, as well as history of mental or physical trauma (violence abuse); screen for: |
|Legal issues |
|How patients are coping with their HIV status|
|Obtain names and contact information for substance use, mental health, housing and case management providers|
|Home health care|
|Review of Systems||Constitutional—weight loss, malaise or fatigue, fevers, night sweats, changes in appetite, changes in sleep, adenopathy, frailty, use of ambulatory aides or wheelchair||Review of systems should be performed at least annually|
|Eyes—change in vision, including blurry vision, double vision, flashes of light, or loss of vision, glasses, legally blind or blind|
|Head, ears, nose, throat—headache, dysphagia, odynophagia, hearing loss, deafness, discharge, dental pain, periodontal disease, oral herpes simplex, denture fit, mastication|
|Pulmonary—cough, dyspnea at rest or on exertion, hemoptysis|
|Cardiac—chest pain, palpitations, heart murmur|
|Abdominal—nausea, vomiting, diarrhea, constipation, rectal bleeding, hemorrhoids|
|Extremities—muscle wasting, muscle weakness, muscle pain, joint swelling|
|Neurologic—cognitive changes, tingling, burning, pain, or numbness in the extremities, weakness, coordination, gait|
*Clinicians should work with the patient's case manager to provide necessary medical guidance related to psychosocial issues that are potential barriers to treatment adherence. When case managers are unavailable, clinicians should refer their patients to social workers who can provide psychosocial services and facilitate referrals to supportive services.
Comprehensive Physical Examination
Clinicians should perform a baseline and annual comprehensive physical examination, with particular attention to areas potentially affected by HIV (see the table below).
|Table: HIV-Related Physical Examination1|
|Vital signs, weight, and symptoms2||Assess at each visit|
|Pain assessment||Assess at each visit|
|Ophthalmologic||Perform or refer for a funduscopic examination3|
|Head, ears, nose, throat||Sinus infection, odynophagia, dysphagia, hearing loss|
|Oral||Oral candidiasis (thrush), hairy leukoplakia (examine lateral borders of tongue), Kaposi's sarcoma, gingival disease, aphthous ulcers|
|Dermatologic||Rash, pruritus, psoriasis, molluscum contagiosum, seborrheic dermatitis, maceration of the gluteal cleft, Kaposi's sarcoma, onychomycosis, diffuse folliculitis with pruritus, melanoma|
|Lymph nodes4||Particular attention to axillary, posterior cervical chain, supraclavicular, submental, epitrochlea, femoral|
|Endocrinologic||Abnormal subcutaneous fat redistribution|
|Pulmonary||Lung fields for wheezes, rhonchi, rales, or dullness|
|Cardiac examination||Heart rhythm, heart murmur, click or rub|
|Abdominal||Hepatosplenomegaly, multiple lipomata in the subcutaneous fat, increased visceral fat|
1Except where indicated, each element should be performed at baseline and at least annually
2Assessment of symptoms may require direct questioning because patients may not consider their symptoms important until after the symptoms have already caused significant morbidity.
3Patients with CD4 counts <50 cells/mm3 should be examined by an ophthalmologist at baseline and every 6 months.
4Significant abnormalities may present as clusters of large nodes, asymmetry, tenderness, or sudden increases in size or firmness of nodes.
Vital Signs, Symptoms, and General Appearance
Clinicians should assess vital signs and weight at each visit. (III)
Clinicians should inquire about new symptoms at each visit. (III)
Clinicians should note changes in general appearance, body habitus, and physical well-being. (III)
Clinicians should ask HIV-infected patients about pain at each visit, as well as document any complaints of pain, attempt to identify underlying causes, and respond with efforts to alleviate it. (III)
Clinicians should not deny treatment of pain because of a patient's history of addiction. (III)
Clinicians should assess patients with chronic pain for fatigue and mental health disorders and include referral to a pain-management specialist as a treatment option. (III)
Ophthalmologic Assessment and Referral
Patients with CD4 counts <50 cells/mm3 should be examined by an ophthalmologist at baseline and every 6 months. (III)
Patients with visual disturbances or unremitting ocular symptoms, regardless of CD4 cell count, should be evaluated by an ophthalmologist. (III)
Clinicians should ascertain whether their patients have a regular oral health provider and should refer all HIV-infected patients for annual hygiene and intraoral examinations, including dental caries and soft-tissue examinations. (III)
Genital and Rectal Examination
Clinicians should examine all HIV-infected patients for ulcerative lesions. (III)
Clinicians should perform a gynecologic examination in all HIV-infected women or refer them to a gynecologist at baseline and at least annually. (II)
At baseline and as part of the annual physical examination for all HIV-infected adults, regardless of age, clinicians should (III):
- Inquire about rectal symptoms, such as itching, bleeding, diarrhea, or pain
- Perform a visual inspection of the perianal region
- Perform a digital rectal examination
Clinicians should refer women with cervical high grade squamous intraepithelial lesion (HSIL) and any patient with abnormal anal physical findings, such as warts, hypopigmented or hyperpigmented plaques/lesions, lesions that bleed, or any other lesions of uncertain etiology, for high-resolution anoscopy and/or examination with biopsy of abnormal tissue.
Clinicians should examine for sensory and motor abnormalities, especially peripheral neuropathy, cerebellar function, and cognitive impairment.
Clinicians should refer patients with more complex suspected or proven peripheral neuropathy syndromes to a neurologist to assist with the diagnosis and management.
Mental Health and Substance Use Assessment
Clinicians should perform a mental health assessment at baseline and at least annually. The assessment should include the following components (I):
- Depression, anxiety, post-traumatic stress disorder, suicidal/violent ideation, and substance use
- Sleep habits and appetite assessment
- Psychiatric history, including psychotropic medications
- Psychosocial assessment, including domestic violence and housing status
Clinicians should refer patients to appropriate mental health and substance use treatment providers when indicated. (II)
Clinicians should incorporate selected brief screening instruments into the assessment process. The chosen screening instruments should be tailored for optimal use at initial, annual, and interim visits and adjusted for the patient's mental health or substance use history. (III)
Laboratory Assessment and Diagnostic Testing
Clinicians should order appropriate laboratory assessments and screening tests for management of HIV-infected patients (see the table below). (III)
|Table: Routine Laboratory Assessment and Diagnostic Screening|
|Immunologic assessment||CD4 lymphocyte count and percentage; to produce reliable results, the same testing laboratory should be used||Baseline and at least every 4 months|
|Virologic assessment|| ||Baseline and at least every 4 months |
|Tuberculosis evaluation|| ||Baseline and annually|
|Screening for sexually transmitted infections4||Rapid plasma reagin (RPR) or Venereal Disease Research Laboratory (VDRL) for syphilis with verification of positive test by confirmatory fluorescent treponemal antibody absorbance (FTA-Abs) or Treponema pallidum particle agglutination (TP-PA)||Baseline and at least annually; every 3 months for patients with continued high-risk behavior|
|Gonorrhea and chlamydia5 ||Baseline and at least annually|
|Cytologic Screening||Cervical Pap tests||Baseline, 6 months after baseline, then annually, as long as results are normal7|
|Anal Pap tests ||Baseline and annually|
|Hematologic assessment||Complete blood count, including differential||Baseline and at least every 4 months|
|Renal assessment||Urinalysis||Baseline and at least annually|
|Serum creatinine8, blood urea nitrogen (BUN), total protein, albumin||Baseline and at least every 4 months|
|Metabolic assessment|| || |
|Hepatic assessment|| ||Baseline|
|Hepatitis C serology9||Baseline; baseline and annually for patients at risk 10|
|Serum liver enzymes||Baseline and at least every 4 months for patients receiving ART|
|Additional tests11|| ||Baseline|
1The initial test performed in an ART-naive individual should be an assay that can document a potentially high viral load level. All patients with a viral load <400 copies/mL should be retested with an assay that can detect ≤50 copies/mL; the same testing laboratory and the same assay should be used thereafter.
2For additional information regarding genotypic and phenotypic testing, refer to HIV Resistance Assay in the NGC summary of the NYSDoH guideline Antiretroviral Therapy.
3Tuberculin skin test, commonly known as purified protein derivative (PPD).
4Patients who continue to engage in unsafe sexual practices are at increased risk for other STIs. Patients with any other STIs, whether ulcerative or not, are at higher risk for HIV transmission. Recent increases in STIs among men who have sex with men warrant screening of asymptomatic sexually active patients (see the NYSDoH guidelines for Management of STIs in HIV-Infected Patients).
5All sites of possible exposure are screened.
6Risk factors for women ≥25 years of age include one of the following: recent STI, having multiple sexual partners, having had a new sexual partner, or having a sexual partner with symptoms of an STI.
7Colposcopy should be performed for all HIV-infected women with abnormal Pap tests. Follow-up would then vary on a case-by-case basis. Abnormal Pap tests should be repeated every 3 to 6 months thereafter until there have been two successive normal cervical Pap tests. Women with cervical high-grade squamous intraepithelial lesion [HSIL] should be referred for high-resolution anoscopy and/or examination with biopsy of abnormal tissue.
8Routine calculation of estimated glomerular filtration rate is also recommended.
9A qualitative hepatitis C virus (HCV) RNA polymerase chain reaction (PCR) should be obtained when no hepatitis antibodies are detectable in a patient with elevated serum liver enzymes and risk factors for HCV.
10HIV-infected patients who are seronegative for HCV but have continued high-risk behaviors should be screened at least annually for HCV. Individuals at high risk include injection drug users, men who have sex with men without barrier protection, or anyone with multiple sexual partners (see the NYSDoH guideline Hepatitis C Virus).
11Depending on the patient's history, these additional baseline tests may be needed.
The CD4 lymphocyte profile should include both the absolute count and percentage. (I)
Clinicians should use an assay, with a high upper limit of detection (e.g., ≥750,000 copies/mL) for initial measurement of HIV viral load in ART-naive patients. All patients with a viral load of <400 copies/mL after the initial test should be monitored with an assay that can detect ≤50 copies/mL. (III)
Clinicians should obtain viral load before vaccinations and not during intercurrent illness because these situations may lead to a transient elevation in viral load. (III)
Clinicians should perform resistance testing under the following circumstances:
- At baseline, regardless of whether ART is being initiated (genotypic testing)
- In ART-naive patients before initiation of ART (genotypic testing)
- In patients experiencing treatment failure or incomplete viral suppression while receiving ART (genotypic and/or phenotypic testing)
Clinicians should seek expert consultation for interpretation of genotypes. (III)
Clinicians should obtain a TST (tuberculin skin test, commonly known as PPD) or other FDA-approved test for diagnosis of latent tuberculosis infection, unless the patient has previously tested positive or has had previously documented TB. (I)
After active tuberculosis has been excluded clinicians should prescribe TB prophylaxis when a TST results in induration of ≥5 mm or when another FDA-approved test indicates the presence of latent TB infection. (I)
Laboratory Screening for Sexually Transmitted Infections
Clinicians should screen HIV-infected patients for syphilis by obtaining a non-treponemal test (RPR or VDRL) with verification of reactive test by confirmatory fluorescent treponemal antibody absorbance (FTA-Abs) or Treponema pallidum particle agglutination (TP-PA) tests at baseline and at least annually. Patients with continued high-risk behavior should be screened for syphilis every 3 months.
Clinicians should screen sexually active HIV-infected women under the age of 25 for gonorrhea and chlamydia at baseline and at least annually. Clinicians should screen all sites of possible exposure, including the cervix, rectum, and pharynx. Culture or nucleic acid amplification tests (NAT) should be used to screen for gonorrhea. Immunofluorescence or deoxyribonucleic acid (DNA) amplification should be used for chlamydia.
Clinicians should screen women 25 years of age or older for gonorrhea and chlamydia at baseline and at least annually if they have or have had a recent sexually transmitted infection, have multiple sexual partners, have had a new sexual partner, or have a sexual partner with symptoms of an STI.
Clinicians should screen all HIV-infected men with ongoing high-risk sexual behaviors for gonorrhea and chlamydia at baseline and at least annually. Clinicians should screen all sites of possible exposure, including the urethra, rectum, and pharynx.
Cervical Pap Tests
Clinicians should obtain cervical Pap tests for all HIV-infected women at baseline, 6 months after baseline, and then repeat annually, as long as results are normal.
Colposcopy should be performed for women with abnormal Pap tests. Follow-up would then vary on a case-by-case basis.
Clinicians should repeat abnormal Pap tests every 3 to 6 months thereafter until there have been two successive normal cervical Pap tests. Women with cervical HSIL also should be referred for high-resolution anoscopy and/or examination with biopsy of abnormal tissue.
Clinicians should obtain at least an annual Pap test in HIV-infected women who have undergone either a supracervical or total hysterectomy.
Anal Pap Tests
Clinicians should obtain anal Pap tests at baseline and annually in the following HIV-infected populations:
- Men who have sex with men
- Any patient with a history of anogenital condylomas
- Women with abnormal cervical/vulvar histology
Clinicians should refer patients with abnormal anal cytology for high-resolution anoscopy and/or examination with biopsy of abnormal tissue. (III)
Health Promotion and Behavioral Health Counseling
Clinicians should provide routine HIV risk-reduction counseling and behavioral health counseling for HIV-infected patients. (I) (See Table 4 in the original guideline document.)
Safer Sex Education
Clinicians should discuss safer sexual practices with HIV-infected patients on a routine and ongoing basis. (I)
Clinicians should routinely discuss with patients the importance of disclosure to partners. Patients should be educated about the options for voluntary partner notification. These discussions should be clearly documented. Information about HIV reporting and partner notification in New York State is available at www.health.state.ny.us. (I)
Clinicians should emphasize that transmission of HIV may occur during unprotected sex, even when patients have undetectable HIV plasma viral loads. (I)
Clinicians should recommend the correct and consistent use of latex or, when latex allergies exist, polyurethane male condoms and should discuss the option of using polyurethane female condoms. (I)
Clinicians should instruct patients in the proper use of condoms, dental dams, and other barriers to reduce the risk of HIV transmission. (I)
Clinicians should educate their patients to avoid using condoms and creams containing nonoxynol-9. (I)
Substance Use Counseling
When current alcohol or other substance use is identified, clinicians should discuss the possible effects of such use on the patient's general health and HIV medications, as well as options for treatment if indicated. These discussions should be properly documented in the patient's chart. (I)
Clinicians should evaluate for possible interactions among illicit drugs and prescription drugs. (I)
Clinicians should issue prescriptions for new needles and syringes to patients who inject drugs.
Clinicians should discuss with patients other options for accessing new needles and syringes, including use of the Expanded Syringe Access Demonstration Program and Syringe Exchange Programs, New York State's two syringe access initiatives. (I)
Clinicians should collaborate with social work staff and other mental health providers, when available, to determine which treatment programs or substance use services best meet the patient's needs. (I)
Tobacco Use Assessment and Counseling
Clinicians should assess smoking status and should encourage those who smoke to stop. (I) Pharmacotherapy and referrals to smoking cessation programs should be provided if the patient is interested.
Clinicians should discuss family planning with patients, including risks to the mother and fetus during pregnancy.
Clinicians or a member of the healthcare team should screen all male and female HIV-infected patients for current and lifetime domestic violence at baseline and annually. (I)
Prior to screening patients for domestic violence, clinicians should discuss confidentiality and exceptions to confidentiality, including instances of suspected child abuse and maltreatment and intent to harm self or others.
Domestic violence screening should be performed only when the patient is alone.
The clinician or a member of the healthcare team should perform a psychosocial assessment of HIV-infected patients including housing status, at baseline and at least annually. (I) (Refer to Table 4 in the original guideline document.)
The clinician should work with the patient's case manager to provide necessary medical guidance related to psychosocial issues that are potential barriers to treatment adherence. (I)
Standard Health Maintenance
Clinicians should discuss general preventive health care and health maintenance with all HIV-infected patients routinely and, at a minimum, annually. (I)
Clinicians should perform standardized age– and sex–appropriate health-maintenance interventions, such as cancer screening, in HIV-infected patients according to the same guidelines used for non-HIV-infected patients. (I) (see Table 5 in the original guideline document.)
Clinicians should instruct patients on how to perform breast and testicular self-examinations. (III)
Opportunistic Infection Prophylaxis
Clinicians should initiate prophylaxis for specific opportunistic infections as indicated in Table 6 of the original guideline document and discontinue as indicated in Table 7 of the original guideline document. (I)
|Table: Recommended Immunizations for Non-Pregnant HIV-Infected Adults|
|Tetanus, diphtheria, and pertussis (Tdap), and tetanus-diphtheria (Td)||For patients who have not received the primary series or for whom vaccine status is unknown|| |
|For patients who have already received the primary series that did not include Tdap|| |
|Influenza||For all patients||Administer 1 annual dose. Do not use FluMist because it contains live virus.|
|Pneumococcal polysaccharide||For all patients||Administer 1 dose followed by one revaccination after 5 to 6 years (or more) have elapsed since initial vaccination|
|Hepatitis A||All HIV-infected patients who are negative for HAV immunoglobulin G (IgG)||Administer 2 doses (0 and 6 to 12 months)|
|Hepatitis B||For patients without serologic evidence of prior HBV infection or who have not previously received the complete series of HBV vaccination||Strongly encourage the vaccine series—3 doses (0, 1 to 2, and 6 months)|
|Measles, mumps, rubella (MMR)||For all asymptomatic HIV-infected patients who do not have evidence of severe immunosuppression and who are seronegative for antibody to MMR||Administer 1 dose|
|For patients with severe immunosuppression (<200 cells/mm3)||Do not administer vaccine|
|Human papillomavirus (HPV)||For women between the ages of 9 and 26 years||Administer 3 doses (at 0, 2, and 6 months)|
|Varicella||For persons who are susceptible||Consider administering 2 doses (at 0 and 4 to 8 weeks)|
Refer to the original guideline document for additional information on immunizations.
Coordination of Care
As part of the initial visit, the clinician or other member of the healthcare team should educate new patients on the following items (III):
- How to access emergency services (provide a phone number for 24-hour services)
- Whom to contact to schedule appointments
- How to obtain laboratory and radiology results, medical records, and other reports
After receiving patient consent, clinicians should share information with other agencies from which their patients are receiving services. (III)
Case management should be used to enhance coordination of care provided by agencies such as home care, nutrition services, and nursing services and to prevent duplication of services. (III)
Clinicians should regularly involve case managers in case conferences to discuss psychosocial issues that may affect a patient's ability to adhere to care. (III)
Appropriate Use of Acute Care Services
Outpatient clinicians who do not provide inpatient care should have a network of practitioners with whom they can communicate easily should their patients require hospitalization. (III)
Inpatient clinicians should ensure that the details of hospitalization, including the discharge medications and plans, are sent in a timely fashion to the outpatient clinicians. (III)
Appropriate Use of Chronic Care Services
Home Health Care
Home health nurses should be provided with a copy of the patient's medication list and information regarding current medical conditions and mental health or substance use disorders. (III)
Clinicians should encourage patients to prepare an advanced directive and designate a health care proxy and should review these arrangements at least annually.
As HIV disease progresses, clinicians should discuss patients' feelings about end-of-life care before they are unable to make decisions. Any medical decisions that are made should be in conjunction with the patient, or, if the patient is unable to decide for neurologic reasons, with the patient's health care proxy. (III)
Clinicians should be familiar with hospice services available in their area and should make referrals to them early enough for the patient to receive the full benefit of their support. (III) Clinicians should work in conjunction with hospice staff to establish which medical interventions may still be appropriate as quality of life evolves or changes. (III)
Quality of Evidence for Recommendation
- One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
- One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes
- Expert opinion
Strength of Recommendation
- Strong recommendation for the statement
- Moderate recommendation for the statement
- Optional recommendation
An algorithm is provided in the original guideline document for screening and managing suicidal or violent patients is available in the mental health screening quick reference guide (see the "Availability of Companion Documents" field).
Institute of Medicine (IOM) National Healthcare Quality Report Categories
End of Life Care
Living with Illness
The National Guideline Clearinghouseâ¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.
All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.
Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion-criteria.aspx.
NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.
Readers with questions regarding guideline content are directed to contact the guideline developer.