Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Human Papilloma Virus Infection
Procedure: comparison of screening methods
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Screening HIV-Infected Women for Anal Cancer Precursors|
- 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.
- 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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
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.
Procedure: comparison of screening methods
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assaysOther: laboratory biomarker analysis
Correlative studiesOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessment
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946139
|United States, California|
|UCLA Clinical AIDS Research and Education (CARE) Center||Recruiting|
|Los Angeles, California, United States, 90095-1793|
|Contact: Marisol Gonzalez 301-557-3729 firstname.lastname@example.org|
|Principal Investigator: Ronald Mitsuyasu, MD|
|San Francisco, California, United States, 94115|
|Contact: Rachel Silverstein 415-353-7443 email@example.com|
|Principal Investigator: Joel Palefsky, MD|
|United States, Illinois|
|John H. Stroger Hospital of Cook County||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Erika Radeke 312-864-5204|
|Principal Investigator: Paul Rubinstein, MD|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ayad Hamdan, MD 617-667-2153 firstname.lastname@example.org|
|Principal Investigator: Ayad Hamdan, MD|
|Boston University Cancer Research Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Elizabeth Stier, MD 617-414-5175|
|Principal Investigator: Elizabeth Stier, MD|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Marisol Rivera 718-405-8397|
|Contact: Mary Sanvardeker 718-405-8394|
|Principal Investigator: Mark Einstein, MD|
|Weill-Cornell Medical College||Recruiting|
|New York, New York, United States, 10010|
|Contact: Christina Megill 212-746-7163 email@example.com|
|Principal Investigator: Timothy Wilkin, MD, MPH|
|Laser Surgery Care Center||Recruiting|
|New York, New York, United States, 10011|
|Contact: Stephen Goldstone 212-242-6500 firstname.lastname@example.org|
|Principal Investigator: Stephen Goldstone, M.D.|
|United States, North Carolina|
|Wake Forest University Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Melissa Trader 336-716-8918 email@example.com|
|Principal Investigator: Luis Barroso, MD|
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Carol Oriss 412-383-1434 firstname.lastname@example.org|
|Principal Investigator: Ross Cranston, MD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Susan Bobbitt 713-873-4105 email@example.com|
|Principal Investigator: Elizabeth Y. Chiao|
|University of Puerto Rico Comprehensive Cancer Center||Recruiting|
|San Juan, Puerto Rico, 00929-0134|
|Contact: Maribel Tirado-Gomez, MD 787-772-8300 ext 1108 firstname.lastname@example.org|
|Principal Investigator: Vivian Tamayo, MD|
|Principal Investigator:||Elizabeth Chiao||AIDS Associated Malignancies Clinical Trials Consortium|