Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

NCT02338141 | Terminated FDA Device

• 1 other identifier: Pro00055627
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Human Papillomavirus; Human Immunodeficiency Virus

Keywords

cervical cancer; colposcopy; human papillomavirus; human immunodeficiency virus

Outcome Measures

Primary Outcomes (3)

• 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).

  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

  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

  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 Outcomes (2)

• Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity

  Point-of-care (at time of examination, approximately one hour)

• Prevalence of HPV genotypes by HIV status

  Point-of-care (at time of examination, approximately one hour)

Study Arms (2)

Portable colposcopy

EXPERIMENTAL

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

Device: Portable colposcopy (Cerviscope)

Conventional colposcopy

ACTIVE COMPARATOR

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

Device: Conventional colposcopy (Wallach Zoomscope)

Interventions

Portable colposcopy (Cerviscope) 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.

Also known as: Cerviscope

Portable colposcopy

Conventional colposcopy (Wallach Zoomscope) 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.

Conventional colposcopy

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Blanchard Clinic

Port-au-Prince, Haiti

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• David K Walmer, MD, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 14, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2016-11

Locations

HA (1)