This trial is active, not recruiting.

Conditions anal cancer, hiv infection, human papilloma virus infection
Treatments comparison of screening methods, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment
Sponsor AIDS Malignancy Consortium
Collaborator National Cancer Institute (NCI)
Start date December 2013
End date May 2018
Trial size 276 participants
Trial identifier NCT01946139, AMC-084, NCI-2013-01637, R01CA163103, U01CA121947


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
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.
comparison of screening methods
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Sensitivity of each of the methods of HSIL detection (anal cytology APTIMA, HC2 and OncoHealth HPVE6/E7 oncoprotein)
time frame: Up to 2 years
Specificity of each other methods of HSIL detection (anal cytology, APTIMA, HC2, and OncoHealth HPVE6/7)
time frame: Up to 2 years
Prevalence of HSIL
time frame: Up to 2 years
Incidence of HSIL among women who were HRA negative for HSIL at study entry
time frame: Up to 2 years
Incidence of anal HPV among women who were negative for anal HPV at study entry
time frame: Up to 2 years

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Screening HIV-Infected Women for Anal Cancer Precursors
Principal investigator Elizabeth Chiao
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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by AIDS Malignancy Consortium.
Location data was received from the National Cancer Institute and was last updated in October 2016.