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## Complete Summary

#### GUIDELINE TITLE

Human papillomavirus (HPV).

#### BIBLIOGRAPHIC SOURCE(S)

New York State Department of Health. Human papillomavirus (HPV). New
York (NY): New York State Department of Health; 2007 Oct. 11 p. \[19
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 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

-   Human papillomavirus (HPV) infection

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Screening\
Treatment

#### CLINICAL SPECIALTY

Allergy and Immunology\
Family Practice\
Infectious Diseases\
Internal Medicine\
Obstetrics and Gynecology\
Pediatrics\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Health Care Providers\
Physician Assistants\
Physicians\
Public Health Departments

#### GUIDELINE OBJECTIVE(S)

To provide guidelines for prevention, diagnosis, and treatment of human
papillomavirus (HPV) infection in human immunodeficiency virus
(HIV)-infected patients

#### TARGET POPULATION

Human immunodeficiency virus (HIV)-infected patients with human
papillomavirus (HPV) coinfection

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation/Screening**

1.  Screening for human papillomavirus (HPV) infection including visual
    inspection, cervical and anal cytology

2.  High-resolution anoscopy, Pap test (for women)

3.  Biopsy of abnormal findings

4.  HPV deoxyribonucleic acid (DNA) testing (not recommended)

**Management/Treatment**

1.  Patient-applied treatment (podophyllotoxin, imiquimod, cidofovir
    gel)

2.  Provider-applied treatments (cryotherapy, podophyllin resin,
    trichloroacetic acid, bichloroacetic acid, interferon-alfa-2b,
    electrodessication, surgical excision, laser, loop electrosurgical
    excision procedure, infrared coagulation)

3.  Management of sex partners (assistance with partner notification,
    management of human immunodeficiency virus \[HIV\] and HPV exposure)

**Prevention**

1.  HPV vaccine in HIV-infected female patients aged 9 to 26 years

2.  Pap tests in HIV-infected women

3.  Counseling HIV-infected patients on safe sexual practices and
    reduction in number of sexual partners

#### MAJOR OUTCOMES CONSIDERED

-   Prevalence of human papillomavirus (HPV) infection in human
    immunodeficiency virus (HIV)-infected patients

-   Impact of HIV infection on the manifestation of HPV infection

-   Usefulness of diagnostic procedures

-   Effectiveness of treatment in terms of clearance rates

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

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

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

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

Expert Consensus (Committee)

#### 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

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 Committee

-   Women\'s Health Committee

-   Substance Use Committee

-   Physician\'s Prevention Advisory Committee

-   Pharmacy Committee

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

Not applicable

#### COST ANALYSIS

The guideline developers reviewed published cost analyses.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

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.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Diagnosis, treatment, and follow-up of human papillomavirus
(HPV)-related lesions in human immunodeficiency virus (HIV)-infected
patients should be performed in consultation with a clinician
experienced in the management of HPV and HIV.

**Prevention of HPV**

**HPV Vaccine**

Clinicians should offer the HPV vaccine to HIV-infected women between
the ages of 9 and 26 years.

Clinicians should continue to obtain cervical Pap tests on the
recommended schedule in HIV-infected women who have been vaccinated with
HPV vaccine (see \"Screening for HPV\" section below). Vaginal and
vulvar visual inspection should be continued at regularly scheduled
pelvic examinations.

HPV typing prior to administering the vaccine is not recommended.

There currently are no recommendations to vaccinate males against HPV.

**Other Strategies to Prevent HPV Infection**

Clinicians should counsel HIV-infected patients on practices that may
reduce the risk of acquiring HPV infection, including safe sexual
practices and reduction in number of sexual partners.

**Screening for HPV**

**Visual Inspection**

Clinicians should examine the anogenital area, including the vulva and
vagina in women, to assess for visible HPV lesions at baseline and as
part of the annual comprehensive physical examination.

**Cervical Cytology**

Clinicians should obtain cervical Pap tests in HIV-infected women at
baseline, 6 months after baseline, and then annually as long as results
are normal. Colposcopy should be performed for women with abnormal Pap
tests (atypical squamous cells of uncertain significance \[ASC-US\],
atypical squamous cells: cannot exclude high grade squamous
intraepithelial lesion ASC-H, low-grade squamous intraepithelial lesion
\[LSIL\], or high-grade squamous intraepithelial lesion \[HSIL\], or the
World Health Organization (WHO) or cervical intraepithelial neoplasia
\[CIN\] equivalent); treatment would then vary according to individual
colposcopy results. After treatment, Pap tests should be repeated every
3 to 6 months until there have been two successive normal Pap tests.

*For Women Who Have Undergone Hysterectomy*

Clinicians should obtain at least an annual cervical Pap test in
HIV-infected women who have undergone a hysterectomy when:

-   The hysterectomy was performed because of high-grade dysplasia,
    HPV-related anogenital dysplasia of the cervix, or carcinoma

-   A supracervical hysterectomy (uterus removed and cervix left in
    place) was performed

-   The reason for the hysterectomy cannot be determined by patient
    self-report or other means

-   Any cervical tissue remains

Annual Pap tests are not recommended for HIV-infected women who have
undergone a total hysterectomy for reasons not related to cervical
abnormalities.

**Anal Cytology**

Clinicians should perform anal Pap tests at baseline and annually in the
following populations:

-   Men who have sex with men

-   Any patient with a history of anogenital condylomas

-   Women with abnormal cervical/vulvar histology

**HPV Deoxyribonucleic Acid (DNA) Testing**

HPV DNA testing in HIV-infected patients is *not* recommended at this
time.

**Presentation and Diagnosis**

Clinicians should include HPV in the differential diagnosis of
anogenital symptoms, such as itching, bleeding, pain, or spotting after
sexual intercourse.

Patients with abnormal anogenital physical findings, such as warts,
hypopigmented or hyperpigmented plaques/lesions, lesions that bleed, or
any other lesions of uncertain etiology, should be referred for
high-resolution anoscopy, a cervical Pap test (for women), and/or
examination with biopsy of abnormal findings.

**Treatment**

Clinicians should use the same therapeutic modalities to treat HPV in
HIV-infected patients as those used in non-HIV-infected patients (see
Table 1 below). The following factors should be considered when choosing
treatment:

-   Patient preference

-   Clinician experience and available resources

-   Size of wart(s) and number of warts

-   Anatomic site of wart(s)

-   Adverse effects of treatment

Clinicians should switch treatment modalities if warts have not improved
substantially within 3 months of therapy. For condyloma that have not
responded to treatment, clinicians should obtain biopsy to exclude
dysplasia or cancer.

Clinicians should not use podophyllotoxin or interferon in pregnant
women.

Clinicians should refer patients with lesions that are resistant to
simple therapies, lesions that change in appearance, and lesions with
ulceration, irregular shape, or variegated coloration to clinicians
experienced in the management of HPV and HIV.

Primary care clinicians should refer HIV-infected patients with
cervical, vulvar, or anal cancer to an oncologist for treatment (see the
[New York State Department of Health
(NYSDOH)](http://www.hivguidelines.org/Content.aspx?pageID=1) guidelines
\"Neoplastic Complications\" and \"Anogenital Neoplasia\" for further
discussion regarding treatment of cancer).

**Table 1. Available Treatment Options for Condyloma**

+------------------------+---------------------------------------------+
| **Patient-Applied      | **Provider-Applied Treatments**             |
| Treatments**           |                                             |
+========================+=============================================+
| -   Podophyllotoxin\*  | -   Cryotherapy                             |
|                        |                                             |
| -   Imiquimod\*\*      | -   Podophyllin resin\*                     |
|                        |                                             |
| -   Cidofovir gel      | -   Trichloroacetic acid (TCA)              |
|                        |                                             |
|                        | -   Bichloroacetic acid (BCA) 80%-90%       |
|                        |                                             |
|                        | -   Interferon alfa-2b\*                    |
|                        |                                             |
|                        | -   Electrodesiccation                      |
|                        |                                             |
|                        | -   Surgical excision                       |
|                        |                                             |
|                        | -   Laser (carbon dioxide, pulsed-dye)      |
|                        |                                             |
|                        | -   Loop electrosurgical excision procedure |
|                        |     (LEEP)                                  |
|                        |                                             |
|                        | -   Infrared coagulation                    |
+------------------------+---------------------------------------------+

\*Should not be used in pregnant women. TCA or BCA can be used to treat
small external warts during pregnancy but may not be as effective.

\*\* May decrease likelihood of recurrences.

**Management of Sex Partners**

Clinicians should consider both the HIV exposure and the sexually
transmitted infection (STI) exposure to partners when HIV-infected
patients present with a new STI. Clinicians should also assess for the
presence of other STIs.

**Management of HIV Exposure**

When HIV-infected patients present with a new STI, clinicians should
encourage their partner(s) to undergo HIV testing at baseline, 1, 3, and
6 months. In New York State, if the test result is positive, a Western
blot assay must be performed to confirm diagnosis of HIV infection.

Clinicians should be vigilant for any post-exposure acute febrile
illness accompanied by rash, lymphadenopathy, myalgias, and/or sore
throat. If the partner presents with signs or symptoms of acute HIV
seroconversion, a quantitative ribonucleic acid polymerase chain
reaction (RNA PCR) should be obtained, and consultation with an HIV
Specialist should be sought. Positive RNA tests should be confirmed with
HIV antibody testing performed within 6 weeks of the RNA test.

Clinicians should offer assistance with partner notification if needed.

**Management of HPV Exposure**

For sex partners of patients with genital warts, clinicians should:

-   Examine sex partners for the presence of genital warts and other
    STIs

-   Counsel female sex partners about the importance of cervical
    cytologic screening

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate prevention, diagnosis, and treatment of human papillomavirus
(HPV) infection in human immunodeficiency virus (HIV)-infected patients

**Subgroups Most Likely to Benefit**

Current studies demonstrate that the preventive efficacy of the HPV
vaccine is greatest in women who are not yet sexually active and thus
have not been exposed to HPV.

#### POTENTIAL HARMS

Podophyllotoxin and interferon should not be used in pregnant women.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

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 HIV
infection; primary and secondary prevention in medical settings; and
include informational brochures for care providers and the public.

**Guidelines Dissemination**

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, 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.

**Guidelines Implementation**

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 Clinical Education Initiative (CEI)
and the AIDS Education and Training Centers (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.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

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

Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

New York State Department of Health. Human papillomavirus (HPV). New
York (NY): New York State Department of Health; 2007 Oct. 11 p. \[19
references\]

#### ADAPTATION

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

#### DATE RELEASED

2007 Oct

#### GUIDELINE DEVELOPER(S)

New York State Department of Health - State/Local Government Agency
\[U.S.\]

#### SOURCE(S) OF FUNDING

New York State Department of Health

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [New York State Department of
Health AIDS Institute Web
site](http://www.hivguidelines.org/Content.aspx?PageID=257).

#### AVAILABILITY OF COMPANION DOCUMENTS

This guideline is available as a Personal Digital Assistant (PDA)
download from the [New York State Department of Health AIDS Institute
Web site](http://hivguidelines.org/Content.aspx?pageID=257).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on October 31, 2007.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the guideline developer. See the [New York State
Department of Health AIDS Institute Web
site](http://www.hivguidelines.org/Content.aspx?pageID=451) for terms of
use.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
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All guidelines summarized by NGC and hosted on our site are produced
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Guidelines represented on the NGC Web site are submitted by guideline
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<http://www.guideline.gov/about/inclusion.aspx> .

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Readers with questions regarding guideline content are directed to
contact the guideline developer.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008