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Cervical Cancer ScreeningNCT00933140

Anal HPV Infection and Abnormal Cytology in HIV-infected Women

An observational study of Cervical Cancer Screening and HIV Infections, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years, women only
Conditions the study is for
Cervical Cancer Screening, HIV Infections
How many people
100 participants
Where
1 siteUnited States
Study dates
Oct 2006to Sep 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

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.

Read the 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.

Keywords
HIV, women, anal cytology
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00933140
Study groupRoleWhat they receive
HIV infected womenHIV infected women between ages 18 - 64 years of age due for cervical cancer screening were enrolled.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary objective is to determine the rate of anal cytologic and histologic abnormalities in HIV infected women at Boston Medical Center.

    Measured: 2 years

Secondary outcomes (1)
  1. Identify risk factors for anal cytologic and histologic abnormalities in HIV infected women at BMC

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2009 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933140
Sponsor's protocol ID
H-25758
Status last verified
Nov 2015
First submitted
2 Jul 2009
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer Screening and HIV Infections, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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