Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
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|ClinicalTrials.gov Identifier: NCT01946139|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : June 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer HIV Infection Human Papilloma Virus Infection||Procedure: comparison of screening methods Other: laboratory biomarker analysis Other: questionnaire administration Procedure: quality-of-life assessment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screening HIV-Infected Women for Anal Cancer Precursors|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||June 2019|
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
- Sensitivity of each of the methods of HSIL detection (anal cytology APTIMA, HC2 and OncoHealth HPVE6/E7 oncoprotein) [ Time Frame: Up to 2 years ]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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946139
|United States, California|
|UCLA Clinical AIDS Research and Education (CARE) Center|
|Los Angeles, California, United States, 90095-1793|
|San Francisco, California, United States, 94115|
|United States, Illinois|
|John H. Stroger Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Weill-Cornell Medical College|
|New York, New York, United States, 10010|
|Laser Surgery Care Center|
|New York, New York, United States, 10011|
|Montefiore Medical Center|
|The Bronx, New York, United States, 10461|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15261|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|University of Puerto Rico Comprehensive Cancer Center|
|San Juan, Puerto Rico, 00929-0134|
|Principal Investigator:||Elizabeth Chiao||AIDS Associated Malignancies Clinical Trials Consortium|