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Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

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ClinicalTrials.gov Identifier: NCT02338141
Recruitment Status : Terminated (Funding unavailable to perform study.)
First Posted : January 14, 2015
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Human Papillomavirus Human Immunodeficiency Virus Device: Portable colposcopy (Cerviscope) Device: Conventional colposcopy (Wallach Zoomscope) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: 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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338141


Locations
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Haiti
Blanchard Clinic
Port-au-Prince, Haiti
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: David K Walmer, MD, PhD Duke University Health System

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02338141     History of Changes
Other Study ID Numbers: Pro00055627
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: November 2016

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Duke University:
cervical cancer
colposcopy
human papillomavirus
human immunodeficiency virus

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Acetic Acid
Retinol acetate
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents