Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

Screening HIV-Infected Women for Anal Cancer Precursors

This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Anal Cancer; Human Papilloma Virus Infection
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: comparison of screening methods; Other: questionnaire administration; Procedure: quality-of-life assessment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of HPV testing using different methods of detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays (APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening performance of routine anal cytology for the detection of anal high-grade squamous intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL.

II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women.

III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years among HIV infected women undergoing semi-annual anal evaluations.

EXPLORATORY OBJECTIVES:

I. To evaluate the acceptability of anal cancer screening among HIV-infected women.

II. To collect data on quality of life and health care costs (including non-direct health care costs and time costs) for an economic evaluation of the cost-effectiveness of anal cancer screening strategies in HIV-positive women.

OUTLINE:

Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00929-0134
    • University of Puerto Rico Comprehensive Cancer Center
• United States
  • California
    • Los Angeles, California, United States, 90095-1793
      • UCLA Clinical AIDS Research and Education (CARE) Center
    • San Francisco, California, United States, 94115
      • Ucsf Ancre
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Hospital of Cook County
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Cancer Research Center
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10010
      • Weill-Cornell Medical College
    • New York, New York, United States, 10011
      • Laser Surgery Care Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh School of Medicine
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
• Karnofsky performance status > 70%
• Absolute neutrophil count >= 750 cells/mm^3 within 120 days of study entry
• Platelet count >= 75,000 cells/mm^3 within 120 days of study entry

Exclusion Criteria:

• Current or history of anal or perianal carcinoma
• History of anal HSIL cytology or histology
• Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
• For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
• Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
• Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS)
• Inability to provide informed consent
• Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia [AIN]) within 4 months of study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening (HSIL detection); Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.	Other: laboratory biomarker analysis; Correlative studies; Procedure: comparison of screening methods; Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays; Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of Each Other Methods of HSIL Detection for APTIMA Assay	Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay	at baseline
Prevalence of HSIL	The prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL.	at baseline
Sensitivity of Each of the Methods of APTIMA Assay at Baseline	Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive.	at baseline
Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry	The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Anal Cancer Screening	Anal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy	at baseline

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elizabeth Chiao, AIDS Associated Malignancies Clinical Trials Consortium

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2013
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimated): September 19, 2013

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; DNA Virus Infections; Intestinal Neoplasms; Rectal Diseases; Tumor Virus Infections; Colorectal Neoplasms; Neoplasms, Squamous Cell; Rectal Neoplasms; Anus Diseases; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Anus Neoplasms; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: AMC-084 (Other Identifier: CTEP); NCI-2013-01637 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA163103 (U.S. NIH Grant/Contract); U01CA121947 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No