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## Complete Summary

#### GUIDELINE TITLE

Revised recommendations for HIV testing of adults, adolescents, and
pregnant women in health-care settings.

#### BIBLIOGRAPHIC SOURCE(S)

Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB,
Clark JE, Centers for Disease Control and Prevention (CDC). Revised
recommendations for HIV testing of adults, adolescents, and pregnant
women in health-care settings. MMWR Recomm Rep 2006 Sep
22;55(RR-14):1-17; quiz CE1-4. \[119 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16988643)

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates two previous versions:

-   Centers for Disease Control and Prevention (CDC). Revised guidelines
    for HIV counseling, testing, and referral. MMWR Recomm Rep 2001 Nov
    9;50(RR-19):1-58. \[151 references\]

-   Revised recommendations for HIV screening of pregnant women. MMWR
    Recomm Rep 2001 Nov 9;50(RR-19):59-86. \[87 references\]

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Human immunodeficiency virus (HIV) infection

#### GUIDELINE CATEGORY

Diagnosis\
Prevention\
Screening

#### CLINICAL SPECIALTY

Critical Care\
Emergency Medicine\
Family Practice\
Infectious Diseases\
Internal Medicine\
Obstetrics and Gynecology\
Pediatrics\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Emergency Medical Technicians/Paramedics\
Health Care Providers\
Hospitals\
Nurses\
Physician Assistants\
Physicians\
Public Health Departments\
Substance Use Disorders Treatment Providers

#### GUIDELINE OBJECTIVE(S)

-   To update previous recommendations for human immunodeficiency virus
    (HIV) testing in health-care settings and for screening of pregnant
    women

-   To increase HIV screening of patients, including pregnant women, in
    health-care settings

-   To foster earlier detection of HIV infection

-   To identify and counsel persons with unrecognized HIV infection and
    link them to clinical and prevention services

-   To further reduce perinatal transmission of HIV in the United States

Note: The guidelines address HIV testing in health-care settings only;
they do not modify existing guidelines concerning HIV counseling,
testing, and referral for persons at high risk for HIV who seek or
receive HIV testing in nonclinical settings (e.g., community-based
organizations, outreach settings, or mobile vans).

#### TARGET POPULATION

-   All patients 13 to 65 years old seen in health-care settings
    (screening)

-   Patients with signs and symptoms consistent with human
    immunodeficiency virus (HIV) infection or an opportunistic illness
    characteristic of acquired immune deficiency syndrome (AIDS)
    (diagnostic testing)

-   All pregnant women in the United States

-   Infants born to women whose HIV status is unknown (testing)

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Screening**

1.  Routine screening for human immunodeficiency virus (HIV)

2.  Repeat screening as indicated

3.  Patient education

4.  Special considerations for pregnant women and adolescents

**Diagnosis**

1.  HIV antibody testing

2.  Plasma RNA testing as indicated

3.  Special considerations for pregnant women and newborns

4.  Additional considerations

    -   Test results (e.g., communicating and documenting results, rapid
        HIV tests, and HIV vaccine trials)

5.  Referral for treatment including:

    -   Partner counseling and referral

    -   Antibiotic prophylaxis for HIV-exposed infants (e.g.,
        trimethoprim-sulfamethoxazole)

**Prevention**

1.  Prevention services

2.  HIV/acquired immune deficiency syndrome (AIDS) surveillance

3.  Monitoring and evaluation

#### MAJOR OUTCOMES CONSIDERED

-   Rates of sexual and perinatal transmission of human immunodeficiency
    virus (HIV)

-   Number of patients tested and percentage of positive tests

-   Cost-effectiveness of screening

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

In April 2005, the Centers for Disease Control and Prevention (CDC)
initiated a comprehensive review of the literature regarding human
immunodeficiency virus (HIV) testing in health-care settings and, on the
basis of published evidence and lessons learned from CDC-sponsored
demonstration projects of HIV screening in health-care facilities, began
to prepare recommendations to implement these strategies.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review\
Review of Published Meta-Analyses

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

In March 2004, the Centers for Disease Control and Prevention (CDC)
convened a meeting of health-care providers, representatives from
professional associations, and local health officials to obtain advice
concerning how best to expand human immunodeficiency virus (HIV)
testing, especially in high-volume, high-prevalence acute-care settings.
Consultants recommended simplifying the HIV screening process to make it
more feasible and less costly and advocated more frequent diagnostic
testing of patients with symptoms. In April 2005, CDC initiated a
comprehensive review of the literature regarding HIV testing in
health-care settings and, on the basis of published evidence and lessons
learned from CDC-sponsored demonstration projects of HIV screening in
health-care facilities, began to prepare recommendations to implement
these strategies. In August 2005, CDC invited health-care providers,
representatives from public health agencies and community organizations,
and persons living with HIV to review an outline of proposed
recommendations. In November 2005, CDC convened a meeting of
researchers, representatives of professional health-care provider
organizations, clinicians, persons living with HIV, and representatives
from community organizations and agencies overseeing care of
HIV-infected persons to review CDC\'s proposed recommendations.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

**Cost-Effectiveness of Screening and Testing**

-   Recent studies demonstrate that voluntary human immunodeficiency
    virus (HIV) screening is cost-effective even in health-care settings
    in which HIV prevalence is low. In populations for which prevalence
    of undiagnosed HIV infection is [\>]{.underline}0.1%, HIV screening
    is as cost-effective as other established screening programs for
    chronic diseases (e.g., hypertension, colon cancer, and breast
    cancer). Because of the substantial survival advantage resulting
    from earlier diagnosis of HIV infection when therapy can be
    initiated before severe immunologic compromise occurs, screening
    reaches conventional benchmarks for cost-effectiveness even before
    including the important public health benefit from reduced
    transmission to sex partners.

-   Linking patients who have received a diagnosis of HIV infection to
    prevention and care is essential. HIV screening without such linkage
    confers little or no benefit to the patient. Although moving
    patients into care incurs substantial costs, it also triggers
    sufficient survival benefits that justify the additional costs. Even
    if only a limited fraction of patients who receive HIV-positive
    results are linked to care, the survival benefits per dollar spent
    on screening represent good comparative value.

-   A second HIV test during the third trimester for women in settings
    with elevated HIV incidence (\>17 cases per 100,000 person-years) is
    cost-effective and might result in substantial reductions in
    mother-to-child HIV transmission.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Before final revision of these recommendations, the Centers for Disease
Control and Prevention (CDC) described the proposals at national
meetings of researchers and healthcare providers and, in March 2006,
solicited peer review by health-care professionals, in compliance with
requirements of the Office of Management and Budget for influential
scientific assessments, and invited comment from multiple professional
and community organizations. The final recommendations were further
refined on the basis of comments from these constituents.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

***Note from the National Guideline Clearinghouse (NGC) and the Centers
from Disease Control and Prevention (CDC)**: These revised
recommendations update previous recommendations for human
immunodeficiency virus (HIV) testing in health-care settings and for
screening of pregnant women (see \"Guideline Status\" field). Major
revisions from previously published guidelines are as follows:*

*For patients in all health-care settings*

-   *HIV screening is recommended for patients in all health-care
    settings after the patient is notified that testing will be
    performed unless the patient declines (opt-out screening).*

-   *Persons at high risk for HIV infection should be screened for HIV
    at least annually.*

-   *Separate written consent for HIV testing should not be required;
    general consent for medical care should be considered sufficient to
    encompass consent for HIV testing.*

-   *Prevention counseling should not be required with HIV diagnostic
    testing or as part of HIV screening programs in health-care
    settings.*

*For pregnant women*

-   *HIV screening should be included in the routine panel of prenatal
    screening tests for all pregnant women.*

-   *HIV screening is recommended after the patient is notified that
    testing will be performed unless the patient declines (opt-out
    screening).*

-   *Separate written consent for HIV testing should not be required;
    general consent for medical care should be considered sufficient to
    encompass consent for HIV testing.*

-   *Repeat screening in the third trimester is recommended in certain
    jurisdictions with elevated rates of HIV infection among pregnant
    women.*

*See the original guideline document for a full discussion of the
similarities and differences between current and previous
recommendations.*

**[Recommendations for Adults and Adolescents]{.underline}**

The Centers for Disease Control and Prevention (CDC) recommends that
diagnostic human immunodeficiency (HIV) testing and opt-out HIV
screening be a part of routine clinical care in all health-care settings
while also preserving the patient\'s option to decline HIV testing and
ensuring a provider-patient relationship conducive to optimal clinical
and preventive care. The recommendations are intended for providers in
all health-care settings, including hospital emergency departments
(EDs), urgent-care clinics, inpatient services, sexually transmitted
disease (STD) clinics or other venues offering clinical STD services,
tuberculosis (TB) clinics, substance abuse treatment clinics, other
public health clinics, community clinics, correctional health-care
facilities, and primary care settings. The guidelines address HIV
testing in health-care settings only; they do not modify existing
guidelines concerning HIV counseling, testing, and referral for persons
at high risk for HIV who seek or receive HIV testing in nonclinical
settings (e.g., community-based organizations, outreach settings, or
mobile vans).

**Screening for HIV Infection**

-   In all health-care settings, screening for HIV infection should be
    performed routinely for all patients aged 13 to 64 years.
    Health-care providers should initiate screening unless prevalence of
    undiagnosed HIV infection in their patients has been documented to
    be \<0.1%. In the absence of existing data for HIV prevalence,
    health-care providers should initiate voluntary HIV screening until
    they establish that the diagnostic yield is \<1 per 1,000 patients
    screened, at which point such screening is no longer warranted.

-   All patients initiating treatment for TB should be screened
    routinely for HIV infection (Taylor, Nolan, & Blumberg, 2005). (Also
    see the National Guideline Clearinghouse \[NGC\] summary of the CDC
    guideline [Controlling Tuberculosis in the United
    States](http://www.guideline.gov/summary/summary.aspx?doc_id=8328&nbr=004660).)

-   All patients seeking treatment for STDs, including all patients
    attending STD clinics, should be screened routinely for HIV during
    each visit for a new complaint, regardless of whether the patient is
    known or suspected to have specific behavior risks for HIV
    infection.

**Repeat Screening**

-   Health-care providers should subsequently test all persons likely to
    be at high risk for HIV at least annually. Persons likely to be at
    high risk include injection-drug users and their sex partners,
    persons who exchange sex for money or drugs, sex partners of
    HIV-infected persons, and men who have sex with men (MSM) or
    heterosexual persons who themselves or whose sex partners have had
    more than one sex partner since their most recent HIV test.

-   Health-care providers should encourage patients and their
    prospective sex partners to be tested before initiating a new sexual
    relationship.

-   Repeat screening of persons not likely to be at high risk for HIV
    should be performed on the basis of clinical judgment.

-   Unless recent HIV test results are immediately available, any person
    whose blood or body fluid is the source of an occupational exposure
    for a health-care provider should be informed of the incident and
    tested for HIV infection at the time the exposure occurs.

**Consent and Pretest Information**

-   Screening should be voluntary and undertaken only with the
    patient\'s knowledge and understanding that HIV testing is planned.

-   Patients should be informed orally or in writing that HIV testing
    will be performed unless they decline (opt-out screening). Oral or
    written information should include an explanation of HIV infection
    and the meanings of positive and negative test results, and the
    patient should be offered an opportunity to ask questions and to
    decline testing. With such notification, consent for HIV screening
    should be incorporated into the patient\'s general informed consent
    for medical care on the same basis as are other screening or
    diagnostic tests; a separate consent form for HIV testing is not
    recommended.

-   Easily understood informational materials should be made available
    in the languages of the commonly encountered populations within the
    service area. The competence of interpreters and bilingual staff to
    provide language assistance to patients with limited English
    proficiency must be ensured.

-   If a patient declines an HIV test, this decision should be
    documented in the medical record.

**Diagnostic Testing for HIV Infection**

-   All patients with signs or symptoms consistent with HIV infection or
    an opportunistic illness characteristic of acquired immune
    deficiency syndrome (AIDS) should be tested for HIV.

-   Clinicians should maintain a high level of suspicion for acute HIV
    infection in all patients who have a compatible clinical syndrome
    and who report recent high-risk behavior. When acute retroviral
    syndrome is a possibility, a plasma RNA test should be used in
    conjunction with an HIV antibody test to diagnose acute HIV
    infection (Panel on Clinical Practices for Treatment of HIV
    Infection, 2006. (Also see NGC summary of DHHS guideline,
    [Guidelines for the Use of Antiretroviral Agents in HIV-1-infected
    Adults and
    Adolescents](http://www.guideline.gov/summary/summary.aspx?doc_id=12195&nbr=006292))

-   Patients or persons responsible for the patient\'s care should be
    notified orally that testing is planned, advised of the indication
    for testing and the implications of positive and negative test
    results, and offered an opportunity to ask questions and to decline
    testing. With such notification, the patient\'s general consent for
    medical care is considered sufficient for diagnostic HIV testing.

**[Recommendations for Pregnant Women]{.underline}**

These guidelines reiterate the recommendation for universal HIV
screening early in pregnancy but advise simplifying the screening
process to maximize opportunities for women to learn their HIV status
during pregnancy, preserving the woman\'s option to decline HIV testing,
and ensuring a provider-patient relationship conducive to optimal
clinical and preventive care. All women should receive HIV screening
consistent with the recommendations for adults and adolescents. HIV
screening should be a routine component of preconception care,
maximizing opportunities for all women to know their HIV status before
conception. In addition, screening early in pregnancy enables
HIV-infected women and their infants to benefit from appropriate and
timely interventions (e.g., antiretroviral medications, scheduled
cesarean delivery, and avoidance of breastfeeding\*). These
recommendations are intended for clinicians who provide care to pregnant
women and newborns and for health policy makers who have responsibility
for these populations.

\*To eliminate the risk for postnatal transmission, HIV-infected women
in the United States should not breastfeed. Support services for use of
appropriate breast milk substitutes should be provided when necessary.
In international settings, UNAIDS and World Health Organization
recommendations for HIV and breastfeeding should be followed.

**HIV Screening for Pregnant Women and Their Infants**

*Universal Opt-Out Screening*

-   All pregnant women in the United States should be screened for HIV
    infection.

-   Screening should occur after a woman is notified that HIV screening
    is recommended for all pregnant patients and that she will receive
    an HIV test as part of the routine panel of prenatal tests unless
    she declines (opt-out screening).

-   HIV testing must be voluntary and free from coercion. No woman
    should be tested without her knowledge.

-   Pregnant women should receive oral or written information that
    includes an explanation of HIV infection, a description of
    interventions that can reduce HIV transmission from mother to
    infant, and the meanings of positive and negative test results and
    should be offered an opportunity to ask questions and to decline
    testing.

-   No additional process or written documentation of informed consent
    beyond what is required for other routine prenatal tests should be
    required for HIV testing.

-   If a patient declines an HIV test, this decision should be
    documented in the medical record.

*Addressing Reasons for Declining Testing*

-   Providers should discuss and address reasons for declining an HIV
    test (e.g., lack of perceived risk; fear of the disease; and
    concerns regarding partner violence or potential stigma or
    discrimination).

-   Women who decline an HIV test because they have had a previous
    negative test result should be informed of the importance of
    retesting during each pregnancy.

-   Logistical reasons for not testing (e.g., scheduling) should be
    resolved.

-   Certain women who initially decline an HIV test might accept at a
    later date, especially if their concerns are discussed. Certain
    women will continue to decline testing, and their decisions should
    be respected and documented in the medical record.

*Timing of HIV Testing*

-   To promote informed and timely therapeutic decisions, health-care
    providers should test women for HIV as early as possible during each
    pregnancy. Women who decline the test early in prenatal care should
    be encouraged to be tested at a subsequent visit.

-   A second HIV test during the third trimester, preferably \<36 weeks
    of gestation, is cost-effective even in areas of low HIV prevalence
    and may be considered for all pregnant women. A second HIV test
    during the third trimester is recommended for women who meet one or
    more of the following criteria:

    -   Women who receive health care in jurisdictions with elevated
        incidence of HIV or AIDS among women aged 15 to 45 years. In
        2004, these jurisdictions included Alabama, Connecticut,
        Delaware, the District of Columbia, Florida, Georgia, Illinois,
        Louisiana, Maryland, Massachusetts, Mississippi, Nevada, New
        Jersey, New York, North Carolina, Pennsylvania, Puerto Rico,
        Rhode Island, South Carolina, Tennessee, Texas, and
        Virginia.\*\*

    -   Women who receive health care in facilities in which prenatal
        screening identifies at least one HIV-infected pregnant woman
        per 1,000 women screened.

    -   Women who are known to be at high risk for acquiring HIV (e.g.,
        injection-drug users and their sex partners, women who exchange
        sex for money or drugs, women who are sex partners of
        HIV-infected persons, and women who have had a new or more than
        one sex partner during this pregnancy).

    -   Women who have signs or symptoms consistent with acute HIV
        infection. When acute retroviral syndrome is a possibility, a
        plasma RNA test should be used in conjunction with an HIV
        antibody test to diagnose acute HIV infection (DHHS, 2006).
        (Also see NGC summary of DHHS guideline, [Guidelines for the Use
        of Antiretroviral Agents in HIV-1-infected Adults and
        Adolescents](http://www.guideline.gov/summary/summary.aspx?doc_id=12195&nbr=006292).)

\*\* A second HIV test in the third trimester is as cost-effective as
other common health interventions when HIV incidence among women of
childbearing age is [\>]{.underline}17 HIV cases per 100,000
person-years. In 2004, in jurisdictions with available data on HIV case
rates, a rate of 17 new HIV diagnoses per year per 100,000 women aged 15
to 45 years was associated with an AIDS case rate of at least nine AIDS
diagnoses per year per 100,000 women aged 15 to 45 years. As of 2004,
the jurisdictions listed above exceeded these thresholds. The list of
specific jurisdictions where a second test in the third trimester is
recommended will be updated periodically based on surveillance data.

*Rapid Testing During Labor*

-   Any woman with undocumented HIV status at the time of labor should
    be screened with a rapid HIV test unless she declines (opt-out
    screening).

-   Reasons for declining a rapid test should be explored (see
    \"Addressing Reasons for Declining Testing,\" above).

-   Immediate initiation of appropriate antiretroviral prophylaxis
    should be recommended to women on the basis of a reactive rapid test
    result without waiting for the result of a confirmatory test
    (Perinatal HIV Guidelines Working Group, 2006). (Also see NGC
    summary of [Public Health Service Task Force Recommendations for Use
    of Antiretroviral Drugs in Pregnant HIV-1-infected Women for
    Maternal Health and Interventions to Reduce Perinatal HIV-1
    Transmission in the United
    States](http://www.guideline.gov/summary/summary.aspx?doc_id=12825&nbr=006627).)

*Postpartum/Newborn Testing*

-   When a woman\'s HIV status is still unknown at the time of delivery,
    she should be screened immediately postpartum with a rapid HIV test
    unless she declines (opt-out screening).

-   When the mother\'s HIV status is unknown postpartum, rapid testing
    of the newborn as soon as possible after birth is recommended so
    antiretroviral prophylaxis can be offered to HIV-exposed infants.
    Women should be informed that identifying HIV antibodies in the
    newborn indicates that the mother is infected.

-   For infants whose HIV exposure status is unknown and who are in
    foster care, the person legally authorized to provide consent should
    be informed that rapid HIV testing is recommended for infants whose
    biologic mothers have not been tested.

-   The benefits of neonatal antiretroviral prophylaxis are best
    realized when it is initiated [\<]{.underline}12 hours after birth
    (Wade et al., 1998).

*Confirmatory Testing*

-   Whenever possible, uncertainties regarding laboratory test results
    indicating HIV infection status should be resolved before final
    decisions are made regarding reproductive options, antiretroviral
    therapy, cesarean delivery, or other interventions.

-   If the confirmatory test result is not available before delivery,
    immediate initiation of appropriate antiretroviral prophylaxis
    should be recommended to any pregnant patient whose HIV screening
    test result is reactive to reduce the risk for perinatal
    transmission (USPHS, 2006). (Also see NGC summary of [Public Health
    Service Task Force Recommendations for Use of Antiretroviral Drugs
    in Pregnant HIV-1-infected Women for Maternal Health and
    Interventions to Reduce Perinatal HIV-1 Transmission in the United
    States](http://www.guideline.gov/summary/summary.aspx?doc_id=12825&nbr=006627).)

**[Additional Considerations for HIV Screening]{.underline}**

**Test Results**

-   *Communicating test results*. The central goal of HIV screening in
    health-care settings is to maximize the number of persons who are
    aware of their HIV infection and receive care and prevention
    services. Definitive mechanisms should be established to inform
    patients of their test results. HIV-negative test results may be
    conveyed without direct personal contact between the patient and the
    health-care provider. Persons known to be at high risk for HIV
    infection also should be advised of the need for periodic retesting
    and should be offered prevention counseling or referred for
    prevention counseling. HIV-positive test results should be
    communicated confidentially through personal contact by a clinician,
    nurse, mid-level practitioner, counselor, or other skilled staff.
    Because of the risk of stigma and discrimination, family or friends
    should not be used as interpreters to disclose HIV-positive test
    results to patients with limited English proficiency. Active efforts
    are essential to ensure that HIV-infected patients receive their
    positive test results and linkage to clinical care, counseling,
    support, and prevention services. If the necessary expertise is not
    available in the health-care venue in which screening is performed,
    arrangements should be made to obtain necessary services from
    another clinical provider, local health department, or
    community-based organization. Health-care providers should be aware
    that the Privacy Rule under the Health Insurance Portability and
    Accountability Act of 1996 (HIPAA) prohibits use or disclosure of a
    patient\'s health information, including HIV status, without the
    patient\'s permission.

-   *Rapid HIV tests*. Because of the time that elapses before results
    of conventional HIV tests are available, providing patients with
    their test results can be resource intensive and challenging for
    screening programs, especially in episodic care settings (e.g., EDs,
    urgent-care clinics, and STD clinics) in which continuing
    relationships with patients typically do not exist. The use of rapid
    HIV tests can substantially decrease the number of persons who fail
    to learn their test results and reduce the resources expended to
    locate persons identified as HIV infected. Positive rapid HIV test
    results are preliminary and must be confirmed before the diagnosis
    of HIV infection is established.

-   *Participants in HIV vaccine trials*. Recipients of preventive HIV
    vaccines might have vaccine-induced antibodies that are detectable
    by HIV antibody tests. Persons whose test results are HIV positive
    and who are identified as vaccine trial participants might not be
    infected with HIV and should be encouraged to contact or return to
    their trial site or an associated trial site for the confirmatory
    testing necessary to determine their HIV status.

-   *Documenting HIV test results*. Positive or negative HIV test
    results should be documented in the patient\'s confidential medical
    record and should be readily available to all health-care providers
    involved in the patient\'s clinical management. The HIV test result
    of a pregnant woman also should be documented in the medical record
    of her infant. If the mother\'s HIV test result is positive,
    maternal health-care providers should, after obtaining consent from
    the mother, notify pediatric care providers of the impending birth
    of an HIV-exposed infant and of any anticipated complications. If
    HIV is diagnosed in the infant first, health-care providers should
    discuss the implications for the mother\'s health and help her to
    obtain care.

**Clinical Care for HIV-Infected Persons**

Persons with a diagnosis of HIV infection need a thorough evaluation of
their clinical status and immune function to determine their need for
antiretroviral treatment or other therapy. HIV-infected persons should
receive or be referred for clinical care promptly, consistent with DHHS
and USPHS guidelines for management of HIV-infected persons. (See NGC
summary of DHHS guideline, [Guidelines for the Use of Antiretroviral
Agents in HIV-1-infected Adults and
Adolescents](http://www.guideline.gov/summary/summary.aspx?doc_id=12195&nbr=006292).)
HIV-exposed infants should receive appropriate antiretroviral
prophylaxis to prevent perinatal HIV transmission as soon as possible
after birth (See NGC summary of [Public Health Service Task Force
Recommendations for Use of Antiretroviral Drugs in Pregnant
HIV-1-infected Women for Maternal Health and Interventions to Reduce
Perinatal HIV-1 Transmission in the United
States](http://www.guideline.gov/summary/summary.aspx?doc_id=12825&nbr=006627).)
and begin trimethoprim-sulfamethoxazole prophylaxis at age 4-6 weeks to
prevent *Pneumocystis* pneumonia. They should receive subsequent
clinical monitoring and diagnostic testing to determine their HIV
infection status (See NGC summary of DHHS [Guidelines for the Use of
Antiretroviral Agents in Pediatric HIV
Infection](http://www.guideline.gov/summary/summary.aspx?doc_id=12938&nbr=006652)).

**Partner Counseling and Referral**

When HIV infection is diagnosed, health-care providers should strongly
encourage patients to disclose their HIV status to their spouses,
current sex partners, and previous sex partners and recommend that these
partners be tested for HIV infection. Health departments can assist
patients by notifying, counseling, and providing HIV testing for
partners without disclosing the patient\'s identity. Providers should
inform patients who receive a new diagnosis of HIV infection that they
might be contacted by health department staff for a voluntary interview
to discuss notification of their partners.

**Special Considerations for Screening Adolescents**

Although parental involvement in an adolescent\'s health care is usually
desirable, it typically is not required when the adolescent consents to
HIV testing. However, laws concerning consent and confidentiality for
HIV care differ among states. Public health statutes and legal
precedents allow for evaluation and treatment of minors for STDs without
parental knowledge or consent, but not every state has defined HIV
infection explicitly as a condition for which testing or treatment may
proceed without parental consent. Health-care providers should endeavor
to respect an adolescent\'s request for privacy. HIV screening should be
discussed with all adolescents and encouraged for those who are sexually
active. Providing information regarding HIV infection, HIV testing, HIV
transmission, and implications of infection should be regarded as an
essential component of the anticipatory guidance provided to all
adolescents as part of primary care. (See the NGC summary of the
American Academy of Pediatrics guideline [Adolescents and Human
Immunodeficiency Virus Infection: The Role of the Pediatrician in
Prevention and
Intervention](http://www.guideline.gov/summary/summary.aspx?doc_id=2776&nbr=002002).)

**Prevention Services for HIV-Negative Persons**

-   *Risk screening*. HIV screening should not be contingent on an
    assessment of patients\' behavioral risks. However, assessment of
    risk for infection with HIV and other STDs and provision of
    prevention information should be incorporated into routine primary
    care of all sexually active persons when doing so does not pose a
    barrier to HIV testing. Even when risk information is not sought,
    notifying a patient that routine HIV testing will be performed might
    result in acknowledgement of risk behaviors and offers an
    opportunity to discuss HIV infection and how it can be prevented.
    Patients found to have risk behaviors (e.g., MSM or heterosexuals
    who have multiple sex partners, persons who have received a recent
    diagnosis of an STD, persons who exchange sex for money or drugs, or
    persons who engage in substance abuse) and those who want assistance
    with changing behaviors should be provided with or referred to HIV
    risk-reduction services (e.g., drug treatment, STD treatment, and
    prevention counseling).

-   *Prevention counseling*. In health-care settings, prevention
    counseling need not be linked explicitly to HIV testing. However,
    because certain patients might be more likely to think about HIV and
    consider their risks at the time of HIV testing, testing might
    present an ideal opportunity to provide or arrange for prevention
    counseling to assist with behavior changes that can reduce risks for
    acquiring HIV infection. Prevention counseling should be offered or
    made available through referral in all health-care facilities
    serving patients at high risk for HIV and at facilities (e.g., STD
    clinics) in which information on HIV risk behaviors is elicited
    routinely.

**HIV/AIDS Surveillance**

-   *Risk-factor ascertainment for HIV-infected persons*. CDC recommends
    that providers ascertain and document all known HIV risk factors.
    Health-care providers can obtain tools and materials to assist with
    ascertainment and receive guidance on risk factors as defined for
    surveillance purposes from HIV/AIDS surveillance professionals in
    their state or local health jurisdiction. This risk-factor
    information is important for guiding public health decisions,
    especially for prevention and care, at clinical, local, state, and
    national levels.

-   *HIV/AIDS case reporting*. All states require that health-care
    providers report AIDS cases and persons with a diagnosis of HIV
    infection to the state or local health department. Case report forms
    are available from the state or local health jurisdiction.

-   *Pediatric exposure reporting*. CDC and the Council for State and
    Territorial Epidemiologists recommend that all states and
    territories conduct surveillance for perinatal HIV exposure and
    contact providers after receiving reports of exposed infants to
    determine the infant\'s HIV-infection status. Information concerning
    dates of maternal HIV tests, receipt of prenatal care, maternal and
    neonatal receipt of antiretroviral drugs, mode of delivery, and
    breastfeeding is collected on the pediatric HIV/AIDS case report
    form.

**Monitoring and Evaluation**

Recommended thresholds for screening are based on estimates of the
prevalence of undiagnosed HIV infection in U.S. health-care settings,
for which no accurate recent data exist. The optimal frequency for
retesting is not yet known. Cost-effectiveness parameters for HIV
screening were based on existing program models, all of which include a
substantial counseling component, and did not consistently consider
secondary infections averted as a benefit of screening. To assess the
need for revised thresholds for screening adults and adolescents or
repeat screening of pregnant women and to confirm their continued
effectiveness, screening programs should monitor the yield of new
diagnoses of HIV infection, monitor costs, and evaluate whether patients
with a diagnosis of HIV infection are linked to and remain engaged in
care. With minor modifications, laboratory information systems might
provide a practical alternative for clinicians to use in determining HIV
prevalence among their patients who are screened for HIV.

Refer to the original guideline document for discussion of primary
prevention and HIV testing in nonclinical settings, regulatory and legal
considerations, and issues addressed by other guidelines.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=9799)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically
stated.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Appropriate screening for human immunodeficiency virus (HIV)

-   Earlier detection of HIV infection

-   Appropriate identification and counseling of persons with
    unrecognized HIV infection

-   Linking of persons infected with HIV to appropriate clinical and
    prevention services

-   Reduction of perinatal transmission of HIV

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

These public health recommendations are based on best practices and are
intended to comply fully with the ethical principles of informed
consent. Legislation related to human immunodeficiency virus (HIV) and
acquired immune deficiency syndrome (AIDS) has been enacted in every
state and the District of Columbia, and specific requirements related to
informed consent and pretest counseling differ among states. Certain
states, local jurisdictions, or agencies might have statutory or other
regulatory impediments to opt-out screening, or they might impose other
specific requirements for counseling, written consent, confirmatory
testing, or communicating HIV test results that conflict with these
recommendations. Where such policies exist, jurisdictions should
consider strategies to best implement these recommendations within
current parameters and consider steps to resolve conflicts with these
recommendations.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Staff Training/Competency Material

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Timeliness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB,
Clark JE, Centers for Disease Control and Prevention (CDC). Revised
recommendations for HIV testing of adults, adolescents, and pregnant
women in health-care settings. MMWR Recomm Rep 2006 Sep
22;55(RR-14):1-17; quiz CE1-4. \[119 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16988643)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2001 Nov 9 (revised 2006 Sep 22)

#### GUIDELINE DEVELOPER(S)

Centers for Disease Control and Prevention - Federal Government Agency
\[U.S.\]

#### SOURCE(S) OF FUNDING

United States Government

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

**Consultants, Membership List, November 2005**

*Chairpersons*: Bernard M. Branson, MD, National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention (proposed), CDC; H. Hunter
Handsfield, MD, National Center for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (proposed) and University of Washington, Seattle,
Washington

*Presenters*: Terje Anderson, National Association of People with AIDS,
Silver Spring, Maryland; Yvette Calderon, MD, Albert Einstein College of
Medicine, Bronx, New York; Carlos del Rio, Emory University School of
Medicine, Atlanta, Georgia; Bambi Gaddist, PhD, South Carolina African
American HIV/AIDS Council, Columbia, South Carolina; Roberta Glaros, MA,
New York State Department of Health, Albany, New York; Howard A.
Grossman, MD, American Academy of HIV Medicine, Washington, DC; Sara
Guerry, MD, Los Angeles Sexually Transmitted Disease Program, Los
Angeles, California; Scott D. Halpern, MD, PhD, University of
Pennsylvania, Philadelphia, Pennsylvania; Kim Hamlett-Berry, PhD,
Department of Veterans Affairs, Washington, DC; Scott Kellerman, MD, New
York City Bureau of HIV/AIDS Prevention and Control, New York, New York;
James H. Lee, Texas Department of State Health Services, Austin, Texas;
Jason Leider, MD, PhD, Albert Einstein College of Medicine, Bronx, New
York; A. David Paltiel, PhD, Yale University School of Medicine, New
Haven, Connecticut; Liisa Randall, PhD, Michigan Department of Community
Health, Okemos, Michigan; Cornelis A. Rietmeijer, MD, PhD, Denver Public
Health Department, Denver, Colorado; Robert A. Weinstein, MD, Rush
Medical College, Chicago, Illinois; Noel Zuniga, Bienestar Human
Services, Inc., Los Angeles, California

*Moderators*: John Blevins, Emory University School of Medicine,
Atlanta, Georgia; William C. Page, William C. Page, Inc., Albuquerque,
New Mexico

*Consultants*: Chris Aldridge, National Alliance of State and
Territorial AIDS Directors, Washington, DC; Terje Anderson, National
Association of People with AIDS, Silver Spring, Maryland; Arlene
Bardeguez, MD, University of Medicine and Dentistry of New Jersey,
Newark, New Jersey; Ronald Bayer, PhD, Mailman School of Public Health,
Columbia University, New York, New York; Guthrie Birkhead, MD, Council
of State and Territorial Epidemiologists and New York State Department
of Health, Albany, New York; Lora Branch, MS, Chicago Department of
Public Health, Chicago, Illinois; Daniel Bush, North Jersey Community
Research Initiative, Newark, New Jersey; Ahmed Calvo, MD, Health
Resources and Services Administration, Rockville, Maryland; Sheldon
Campbell, MD, PhD, College of American Pathologists and Yale University
School of Medicine, New Haven, Connecticut; Suzanne Carlberg-Racich,
MPH, Midwest AIDS Training and Education Center, Chicago, Illinois;
Sandra Chamblee, Glades Health Initiative, Belle Glade, Florida; James
Coleman, Whitman Walker Clinic, Inc., Takoma Park, Maryland; Kevin
DeCock, MD, Global AIDS Program, Nairobi, Kenya; Andrew De Los Reyes,
Gay Men\'s Health Crisis, Inc., New York, New York; Carlos del Rio,
Emory University School of Medicine, Atlanta, Georgia; Marisa Duarte,
MPH, Centers for Medicare and Medicaid Services, Atlanta, Georgia; Wayne
Duffus, MD, PhD, South Carolina Department of Health and Environmental
Control, Columbia, South Carolina; Enid Eck, Kaiser Permanente,
Pasadena, California; Magdalena Esquivel, Los Angeles Department of
Health Services, Los Angeles, California; Joe Fuentes, Houston Area
Community Services, Inc., Houston, Texas; Donna Futterman, MD, American
Academy of Pediatrics and Albert Einstein College of Medicine, Bronx,
New York; Bambi Gaddist, PhD, South Carolina African American HIV/AIDS
Council, Columbia, South Carolina; Roberta Glaros, MA, New York State
Department of Health, Albany, New York; Howard A. Grossman, MD, American
Academy of HIV Medicine, Washington, DC; Sara Guerry, MD, Los Angeles
Sexually Transmitted Disease Program, Los Angeles, California; Scott D.
Halpern, MD, PhD, University of Pennsylvania, Philadelphia,
Pennsylvania; Kim Hamlett-Berry, PhD, Department of Veterans Affairs,
Washington, DC; Celine Hanson, MD, Baylor College of Medicine, Houston,
Texas; Wilbert Jordan, MD, National Medical Association and Drew
University, Los Angeles, California; Scott Kellerman, MD, New York City
Bureau of HIV/AIDS Prevention and Control, New York, New York; David
Lanier, MD, Agency for Healthcare Research and Quality, Rockville,
Maryland; James H. Lee, Texas Department of State Health Services,
Austin, Texas; Jason Leider, MD, PhD, Albert Einstein College of
Medicine, Bronx, New York; Elisa Luna, MSW, Washington, DC; Robert
Maupin, MD, American College of Obstetricians and Gynecologists and LSU
Health Sciences Center, New Orleans, Louisiana; Jenny McFarlane, Texas
Department of State Health Services, Austin, Texas; Lynne Mofenson, MD,
National Institute of Child Health and Human Development, Rockville,
Maryland; Eve Mokotoff, MPH, Council of State and Territorial
Epidemiologists and Michigan Department of Community Health, Detroit,
Michigan; Susan Moskosky, MS, Office of Population Affairs, Rockville,
Maryland; Doralba Muñoz, Union Positiva, Inc., Miami, Florida; George
Odongi, Dorchester Community Health Center, Quincy, Massachusetts; Debra
Olesen, JSI Research and Training, Denver, Colorado; A. David Paltiel,
PhD, Yale School of Medicine, New Haven, Connecticut; Paul Palumbo, MD,
Newark, New Jersey; Jim Pickett, AIDS Foundation of Chicago, Chicago,
Illinois; Pam Pitts, MPH, Tennessee Department of Health, Nashville,
Tennessee; Borris Powell, Gay Men of African Descent, New York, New
York; Liisa Randall, PhD, Michigan Department of Community Health,
Okemos, Michigan; Mobeen Rathore, MD, University of Florida,
Jacksonville, Florida; Cornelis A. Rietmeijer, MD, PhD, Denver Public
Health Department, Denver, Colorado; Sam Rivera, Fortune Society, New
York, New York; Ruth Roman, MPH, Health Resources and Services
Administration, Rockville, Maryland; Richard Rothman, MD, Johns Hopkins
University and American College of Emergency Physicians, Baltimore,
Maryland; Gale Sampson-Lee, National Black Leadership Commission on
AIDS, New York, New York; John Schneider, MD, PhD, American Medical
Association, Flossmoor, Illinois; Deya Smith-Starks, AIDS Healthcare
Foundation, Los Angeles, California; Nilda Soto, PROCEED, Inc.,
Elizabeth, New Jersey; Alice Stek, MD, University of Southern California
School of Medicine, Los Angeles, California; Monica Sweeney, MD, Bedford
Stuyvesant Family Health Center, Inc., and National Association of
Community Health Centers, Brooklyn, New York; Donna Sweet, MD, Wichita,
Kansas; Wanda Tabora, Iniciativa Communitaria de Investigacion, San
Juan, Puerto Rico; Mark Thrun, MD, Denver Public Health, Denver,
Colorado; Robert A. Weinstein, MD, Rush Medical College, Chicago,
Illinois; Carmen Zorilla, MD, University of Puerto Rico School of
Medicine, San Juan, Puerto Rico; Noel Zuniga, Bienestar Human Services,
Inc., Los Angeles, California

*Peer Reviewers*: Connie Celum, MD, University of Washington, Seattle,
Washington; Daniel Kuritzkes, MD, HIV Medicine Association and Brigham
and Women\'s Hospital, Cambridge, Massachusetts; Thomas C. Quinn, MD,
National Institute of Allergy and Infectious Disease and Johns Hopkins
University, Baltimore, Maryland

**CDC, Division of HIV/AIDS Prevention Revised Recommendations for HIV
Testing in Health-Care Settings Project**

*Coordinator*: Bernard M. Branson, MD, National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention (proposed), CDC

*Project Manager*: Samuel A. Martinez, MD, National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention (proposed), CDC

*CDC Presenters*: Brian Boyett, MS, Bernard M. Branson, MD, H. Irene
Hall, PhD, Margaret A. Lampe, MPH, Sheryl B. Lyss, MD, Duncan A.
Mackellar, MPH, Stephanie L. Sansom, PhD, Allan W. Taylor, MD, National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (proposed)

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The Centers for Disease Control and Prevention (CDC), their planners,
and content experts wish to disclose they have no financial interests or
other relationships with the manufacturers of commercial products,
suppliers of commercial services, or commercial supporters.
Presentations will not include any discussion of the unlabeled use of a
product or a product under investigational use.

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates two previous versions:

-   Centers for Disease Control and Prevention (CDC). Revised guidelines
    for HIV counseling, testing, and referral. MMWR Recomm Rep 2001 Nov
    9;50(RR-19):1-58. \[151 references\]

-   Revised recommendations for HIV screening of pregnant women. MMWR
    Recomm Rep 2001 Nov 9;50(RR-19):59-86. \[87 references\]

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the Centers for Disease Control and
Prevention (CDC) Web site:

-   [HTML Format](http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm)

-   [Portable Document Format
    (PDF)](http://www.cdc.gov/mmwr/PDF/rr/rr5514.pdf)

Print copies: Available from the Centers for Disease Control and
Prevention, MMWR, Atlanta, GA 30333. Additional copies can be purchased
from the Superintendent of Documents, U.S. Government Printing Office,
Washington, DC 20402-9325; (202) 783-3238.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   A continuing education activity is available in the appendix to the
    [original guideline
    document](http://www.cdc.gov/mmwr/PDF/rr/rr5514.pdf).

-   A comprehensive Spanish-language Web site featuring information
    about HIV treatment and clinical trials is available at
    <http://aidsinfo.nih.gov/infoSIDA/>.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on September 27, 2006.

#### COPYRIGHT STATEMENT

No copyright restrictions apply.

### DISCLAIMER

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Date Modified: 11/10/2008