A Pilot Study on HPV and Cervical Cancer Screening in Mumbai

NCT03229603 | Unknown DMC

• 1 other identifier: TMHPO1763
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief 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

HPV Infection

Keywords

HPV infection and Cervical cancer

Outcome Measures

Primary Outcomes (1)

• The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.

  This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.

  3 months

Secondary Outcomes (6)

• Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests

  3 months

• The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.

  3 months

• The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.

  3 months

• Documentation of six different genotypes/ genotype families of HPV from cervical tissue samples, which will inform the development of HPV vaccinations specific to the strains of HPV in India.

  3 months

• Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.

  3 months

Study Arms (1)

Cluster of 3000 women

OTHER

Cluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas.

Other: Cluster of 3000 women

Interventions

Cluster of 3000 women OTHER

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.

Cluster of 3000 women

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 30 to 55 years (the age when screening for HPV and cervical cancer is recommended) who participate in the TMH cancer screening outreach program.

You may not qualify if:

• Women with a known diagnosis of cancer, any other terminal diagnosis, or who are pregnant

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• University of Arizona: collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Gauravi A Mishra, M.D PSM

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gauravi A Mishra, M.D PSM

CONTACT

+912224177000; gauravi2005@yahoo.co.in

Sharmila A Pimple, M.D PSM

CONTACT

+912224177000; drsharmilapatil@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Physician

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: July 25, 2017
• Study Start: April 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 22, 2017

Record last verified: 2017-07

Locations

IN (1)