NCT01946139

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

Screening HIV-Infected Women for Anal Cancer Precursors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. EXPLORATORY 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.

Conditions

• Anal Cancer
• HIV Infection
• Human Papilloma Virus Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-12-04
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2013-09-19
• Last updated: 2023-11-07
• Results posted: 2022-09-30

Locations

12 sites across 2 countries: United States, Puerto Rico