A Pilot Study on HPV and Cervical Cancer Screening in Mumbai

NCT03229603 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2017-12-22

No results posted yet for this study

Summary

The Study goals are to test feasibility and acceptability of point of care HPV testing with 227 women already accessing an existing cancer screening program in Mumbai, India. Describe HPV infection types in women screened. Compare if the quality of HPV clinician-collected and self-collected samples are equally efficient to detect HPV and cervical cancer precursor lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the clinician-collected sample

Conditions

Interventions

OTHER

Cluster of 3000 women

An evaluation of the feasibility, reach, adoption and implementation of a cervical cancer screening program where we diagnose HPV using the GeneXpert point of care testing kit prior to VIA and cryotherapy.

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER
  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Gauravi A Mishra, M.D PSM · Tata Memorial Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2018-04-30
Completion
2018-05-31

Countries

  • India

Study Locations

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Entities

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 NCT03229603 on ClinicalTrials.gov