Anal HPV Infection and Abnormal Cytology in HIV-infected Women

November 16, 2015 updated by: Elizabeth Stier, Boston Medical Center
The population of HIV infected women seen at Boston Medical Center may have a higher frequency of anal cytologic and histologic abnormalities than what is reported for the non-HIV infected population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

BACKROUND FOR THIS STUDY Anal cancer is a growing problem in the US. The incidence of anal cancer has increased among both men (160%) and women (78%) from 1973 to 2000 in the US [1]. In HIV-infected men the incidence of SCCA (squamous cell cancer of the anus) was found to range from 49-92 per 100,000 patient years [2]. This prompted recommendations on screening for anal cancer in this population. HIV-infected women are also at increased risk for developing anal cancer. A study based on data from AIDS and cancer registries found that the risk of anal cancer among women in the general population is about 1.2% and it increases up to 3.9% in the HIV-infected women. In addition, HIV-infected women had eight times the risk of in situ anal cancer compared with the number of expected cases [3].

SCCA appears to have many similarities to cervical cancers. HPV has been detected in 88% of anal cancer specimens with HPV-16 found in 73% of SCCA and HPV-18 in 7% [1]. In addition, SCCA develops in the transformation zone between the squamous epithelium of the anus and the columnar epithelium of the rectum, is frequently associated with dysplasia of the anus and may be preceded by squamous intraepithelial changes which are also associated with HPV.

Cervical cytology, also known as pap smear, can detect cervical cancer and its precursors. Countries who have adopted cervical cancer screening programs have had dramatic decreases in both the morbidity and mortality rates of cervical cancer.

Anal cytology may also be used to screen for HPV associated anal lesions, and among HIV-infected men who have sex with men, an abnormal cytology is frequently associated with a dysplastic squamous cell lesion of the anus. Anal HPV infections (high risk types) have been found in 53 ¿ 95% of HIV-infected men. Abnormal anal cytology has been found in 41-81% of HIV-infected men screened with high-grade cytologic findings in 2-25% of these patients [2].

There have been only a few studies looking at anal cytology in HIV-infected women. The largest study (n=235), by Holly and Palefsky [4], found that HIV positive women had a 26% prevalence of anal cytologic abnormalities (mostly atypical squamous cells of undetermined significance [ASCUS] and low grade squamous intraepithelial lesions [LSIL]). Forty-six of these women with abnormal cytology (60) underwent high resolution anoscopy (HRA) and 14 were found to have biopsy proven HSIL.

Several risk factors for anal cytologic abnormalities in women have been suggested, such as positive anal HPV test, history of anal intercourse, history of cervical squamous intraepithelial lesions (SIL), history of vulvar warts, multifocal cervical SIL, history of sexually transmitted infections, more than 10 sexual partners, history of cervical, vulvar or vaginal cancer, immunosuppression after solid organ transplantation, HIV infection, long-term corticosteroids use and cigarette smoking.

It has been suggested that all HIV-infected women, women with cervical cancer and women with high-grade vulvar disease or cancer should be screened for anal cytologic abnormalities. However, as described above there is very scanty literature describing the prevalence and incidence in this patient population and the largest study was conducted prior to the HAART era.

We plan to estimate the prevalence and 6-12 month incidence of abnormal anal cytology with histologic correlates in the HIV-infected women seen at BMC. We hope that the information will allow us to make screening recommendations for this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HIV infected women aged between 18-64 years presenting for cervical cytologic screening.

Description

Inclusion Criteria:

  • Age 18-64 years
  • HIV infected women
  • due for cervical cytologic screening

Exclusion Criteria:

  • Pregnancy
  • On chronic anticoagulation medication
  • Life expectancy of the woman is less than 1 year
  • If the woman has had a cervical or anal pap test in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
HIV infected women
HIV infected women between ages 18 - 64 years of age due for cervical cancer screening were enrolled.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Primary objective is to determine the rate of anal cytologic and histologic abnormalities in HIV infected women at Boston Medical Center.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Identify risk factors for anal cytologic and histologic abnormalities in HIV infected women at BMC
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth A Stier, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-25758

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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