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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01946139
First received: September 17, 2013
Last updated: May 22, 2014
Last verified: May 2014

September 17, 2013
May 22, 2014
December 2013
June 2017   (final data collection date for primary outcome measure)
  • Sensitivity of each of the methods of HSIL detection (anal cytology APTIMA, HC2 and OncoHealth HPVE6/E7 oncoprotein) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The binomial proportion and its 95% confidence interval will be used. Among patients who are high resolution anoscopy (HRA) positive for HSIL, McNemar's test will be used to compare routine anal cytology with each of the other methods of detection to determine if sensitivity in the diagnosis of HSIL is improved with the other methods. Positive and negative predictive values will be estimated for each method of detection.
  • Specificity of each other methods of HSIL detection (anal cytology, APTIMA, HC2, and OncoHealth HPVE6/7) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Among patients who are HRA negative for HSIL, McNemar's test will be used to compare routine anal cytology with each of the other methods of HPV detection to improve specificity. Positive and negative predictive values will be estimated for each method of detection.
  • Prevalence of HSIL [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.
  • Incidence of HSIL among women who were HRA negative for HSIL at study entry [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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. Behavioral risk factors will be assessed by research staff administered surveys at each study visit. Logistic regression will be used to evaluate potential risk factors for incidence of HSIL.
  • Incidence of anal HPV among women who were negative for anal HPV at study entry [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The Poisson rate and its 95% confidence interval will be estimated from the number of anal HPV cases detected divided by the cumulative years of follow-up across these cases. Logistic regression will be used to evaluate potential risk factors for incidence of anal HPV.
Same as current
Complete list of historical versions of study NCT01946139 on ClinicalTrials.gov Archive Site
Acceptability of anal cancer screening among HIV-infected women based on survey responses regarding patient satisfaction and phone call surveys [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Descriptive statistics will be used to characterize subjects' acceptability of undergoing anal screening with cytology/HPV and HRA throughout the study to evaluate changes in perceptions. Generalized estimating equations (GEE) will be used to assess acceptability over time adjusting for intrapatient variability. Acceptability will be correlated with clinical and behavioral risk factors, e.g., history of sexual assault, depression, anxiety, medication compliance, sexual behaviors using GEE methods.
Same as current
Not Provided
Not Provided
 
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.

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.

SECONDARY 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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Anal Cancer
  • HIV Infection
  • Human Papilloma Virus Infection
  • Procedure: comparison of screening methods
    Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: questionnaire administration
    Ancillary studies
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
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.
Interventions:
  • Procedure: comparison of screening methods
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT01946139
AMC-084, NCI-2013-01637, AMC-084, AMC-084, R01CA163103, U01CA121947
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: Elizabeth Chiao AIDS Associated Malignancies Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP