Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

April 27, 2017 updated by: Duke University

Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Haiti
      • Port-au-Prince, Haiti
        • Blanchard Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Portable colposcopy
Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid
Device: 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.
Other Names:
  • Cerviscope
Active Comparator: Conventional colposcopy
Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
Time Frame: Point-of-care (at time of examination, approximately one hour)
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).
Point-of-care (at time of examination, approximately one hour)
Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
Time Frame: Point-of-care (at time of examination, approximately one hour)
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).
Point-of-care (at time of examination, approximately one hour)
Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method
Time Frame: Point-of-care (at time of examination, approximately one hour)
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).
Point-of-care (at time of examination, approximately one hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
Time Frame: Point-of-care (at time of examination, approximately one hour)
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.
Point-of-care (at time of examination, approximately one hour)
Prevalence of HPV genotypes by HIV status
Time Frame: Point-of-care (at time of examination, approximately one hour)
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.
Point-of-care (at time of examination, approximately one hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: David K Walmer, MD, PhD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

December 30, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00055627

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on Portable colposcopy (Cerviscope)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe