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

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Brief Title

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

Official Title

Screening HIV-Infected Women for Anal Cancer Precursors

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.
    

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.

      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.
    


Study Type

Interventional


Primary Outcome

Sensitivity of each of the methods of HSIL detection (anal cytology APTIMA, HC2 and OncoHealth HPVE6/E7 oncoprotein)

Secondary Outcome

 Acceptability of anal cancer screening among HIV-infected women based on survey responses regarding patient satisfaction and phone call surveys

Condition

Anal Cancer

Intervention

comparison of screening methods

Study Arms / Comparison Groups

 Screening (HSIL detection)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

276

Start Date

December 4, 2013

Completion Date

October 31, 2018

Primary Completion Date

October 31, 2018

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elizabeth Chiao, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT01946139

Organization ID

AMC-084

Secondary IDs

NCI-2013-01637

Responsible Party

Sponsor

Study Sponsor

AIDS Malignancy Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Elizabeth Chiao, Principal Investigator, AIDS Associated Malignancies Clinical Trials Consortium


Verification Date

July 2020