Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Screening HIV-Infected Women for Anal Cancer Precursors
4 other identifiers
interventional
276
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedStudy Start
First participant enrolled
December 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedResults Posted
Study results publicly available
September 30, 2022
CompletedNovember 7, 2023
April 1, 2023
4.9 years
September 17, 2013
June 28, 2022
October 24, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Acceptability of Anal Cancer Screening
at baseline
Study Arms (1)
Screening (HSIL detection)
EXPERIMENTALPatients 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
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
Study Sites (12)
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90095-1793, United States
Ucsf Ancre
San Francisco, California, 94115, United States
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Weill-Cornell Medical College
New York, New York, 10010, United States
Laser Surgery Care Center
New York, New York, 10011, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15261, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Puerto Rico Comprehensive Cancer Center
San Juan, 00929-0134, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kimberly Mosby-Griffin
- Organization
- Emmes Company, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Chiao
AIDS Associated Malignancies Clinical Trials Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 19, 2013
Study Start
December 4, 2013
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
November 7, 2023
Results First Posted
September 30, 2022
Record last verified: 2023-04