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Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

Primary Purpose

Cervical Cancer, Human Papillomavirus, Human Immunodeficiency Virus

Status
Terminated
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
Portable colposcopy (Cerviscope)
Conventional colposcopy (Wallach Zoomscope)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring cervical cancer, colposcopy, human papillomavirus, human immunodeficiency virus

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Blanchard Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Portable colposcopy

Conventional colposcopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
The number of correct diagnoses of HSIL by eventual pathologic diagnosis will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Rates of detection of these abnormal vascular patterns will be compared between 8x magnification (Cerviscope) and 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and between both and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Concordance between these visualized vascular patterns and eventual pathologic diagnosis from biopsy will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).

Secondary Outcome Measures

Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
HPV genotypes will be performed for patients and reported as percentages isolated for the differing lesion grades of HSIL vs. non-HSIL cervical lesions based on genotype results and correlation with biopsy results.
Prevalence of HPV genotypes by HIV status
HPV genotypes will be performed for patients and reported as percentages isolated for HIV positive and negative women based on genotype results after HIV status is determined. This will be further reported by HIV status in women with different lesion severities.

Full Information

First Posted
December 30, 2014
Last Updated
April 27, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02338141
Brief Title
Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women
Official Title
Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Funding unavailable to perform study.
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Human Papillomavirus, Human Immunodeficiency Virus
Keywords
cervical cancer, colposcopy, human papillomavirus, human immunodeficiency virus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Portable colposcopy
Arm Type
Experimental
Arm Description
Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid
Arm Title
Conventional colposcopy
Arm Type
Active Comparator
Arm Description
Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid
Intervention Type
Device
Intervention Name(s)
Portable colposcopy (Cerviscope)
Other Intervention Name(s)
Cerviscope
Intervention Description
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
Intervention Name(s)
Conventional colposcopy (Wallach Zoomscope)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
Description
The number of correct diagnoses of HSIL by eventual pathologic diagnosis will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Time Frame
Point-of-care (at time of examination, approximately one hour)
Title
Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
Description
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Rates of detection of these abnormal vascular patterns will be compared between 8x magnification (Cerviscope) and 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and between both and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Time Frame
Point-of-care (at time of examination, approximately one hour)
Title
Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method
Description
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Concordance between these visualized vascular patterns and eventual pathologic diagnosis from biopsy will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Time Frame
Point-of-care (at time of examination, approximately one hour)
Secondary Outcome Measure Information:
Title
Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
Description
HPV genotypes will be performed for patients and reported as percentages isolated for the differing lesion grades of HSIL vs. non-HSIL cervical lesions based on genotype results and correlation with biopsy results.
Time Frame
Point-of-care (at time of examination, approximately one hour)
Title
Prevalence of HPV genotypes by HIV status
Description
HPV genotypes will be performed for patients and reported as percentages isolated for HIV positive and negative women based on genotype results after HIV status is determined. This will be further reported by HIV status in women with different lesion severities.
Time Frame
Point-of-care (at time of examination, approximately one hour)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David K Walmer, MD, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blanchard Clinic
City
Port-au-Prince
Country
Haiti

12. IPD Sharing Statement

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Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

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