Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

NCT ID: NCT02338141

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-02-29

Brief Summary

This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.

Detailed Description

This research is a randomized, prospective trial designed to evaluate the value of magnification in making a diagnosis of high grade intraepithelial lesions of the cervix. The overall goal is to evaluate a cervical cancer screening protocol that provides the highest level of care possible for low-resource communities and hard-to-reach areas. Currently, a national cervical cancer screening and diagnosis program does not exist within Haiti.

All women meeting inclusion criteria will be randomized to portable (8x magnification with the Cerviscope) or conventional (25x magnification) colposcopy. After application of acetic acid to the cervix, the physician will record naked eye observations of the cervix by: 1) recording the location of all white lesions; 2) describing the vascular pattern; and 3) stating his/her clinical impression of a diagnosis. The physician will then follow-up with use of either the portable or the conventional colposcope to: 1) record the location of all white lesions; 2) describe the vascular pattern; and 3) state a clinical impression of diagnosis. Women will have biopsies in all four quadrants of the cervix even if no cervical lesions are seen to evaluate the accuracy of the visualization techniques against the gold standard of biopsy pathologic results. Treatment options will be dictated by biopsy results.

Biopsy material will also be evaluated for specific HPV genotype using lab-based measures. Results of these genotypes will be compared between women with high-grade disease vs. low-grade disease and in the subset of women with HIV compared to the HIV-negative population.

Conditions

Cervical Cancer; Human Papillomavirus; Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Portable colposcopy

Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid

Group Type: EXPERIMENTAL

Portable colposcopy (Cerviscope)

Intervention Type: DEVICE

HPV-positive women will be evaluated with portable colposcopy (with a novel portable colposcope known as the Cerviscope) after visual inspection with acetic acid and prior to biopsy in the experimental group.

Conventional colposcopy

Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid

Group Type: ACTIVE_COMPARATOR

Conventional colposcopy (Wallach Zoomscope)

Intervention Type: DEVICE

HPV-positive women will be evaluated with conventional colposcopy (with the Wallach Zoomscope) after visual inspection with acetic acid and prior to biopsy per usual standard of care.

Interventions

Portable colposcopy (Cerviscope)

HPV-positive women will be evaluated with portable colposcopy (with a novel portable colposcope known as the Cerviscope) after visual inspection with acetic acid and prior to biopsy in the experimental group.

Intervention Type: DEVICE

Conventional colposcopy (Wallach Zoomscope)

HPV-positive women will be evaluated with conventional colposcopy (with the Wallach Zoomscope) after visual inspection with acetic acid and prior to biopsy per usual standard of care.

Intervention Type: DEVICE

Other Intervention Names

Cerviscope

Eligibility Criteria

Inclusion Criteria

• Female
• 25-60 years old
• Pre-tested as positive for human papillomavirus (HPV)

Exclusion Criteria

• Pre-tested as negative for human papillomavirus (HPV)
• Pregnant at time of enrollment
• Prior hysterectomy
• < 25 or > 60 years old
• Male

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David K Walmer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Blanchard Clinic

Port-au-Prince, , Haiti

Countries

Haiti

Other Identifiers

Pro00055627

Identifier Type: -

Identifier Source: org_study_id