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Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women

NCT02338141 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2017-04-28

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • David K Walmer, MD, PhD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-02-29
Completion
2016-02-29
FDA Device
Yes

Countries

  • Haiti

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02338141 on ClinicalTrials.gov