A Pilot Study on HPV and Cervical Cancer Screening in Mumbai

NCT ID: NCT03229603

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2018-05-31

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

Detailed Description

In this pilot study, Investigators will assess the feasibility and acceptability of point of care HPV testing in an existing SVA program. There is no control group since neither the efficacy nor effectiveness is to be tested. In the pilot study the screen positive women will be referred to the Tata Memorial Hospital for further diagnostic work-up to restrict the programme logistics. While in the main study, Colposcopy and Cryotherapy will be conducted at the community level. The evaluation framework will be based on a robust D&I model called REAIM.

i.TMH staff will hold health camps to mobilize women to attend. Providers already trained in the TMH outreach program will identify women eligible for screening. After obtaining the consent, the medical social worker will collect baseline data and record the results of the GeneXpert HPV testing on self sample and health care provider collected sample.

Data Collection:

ii. Quantitative data: Data will be collected in-person by the Medical Social worker. De-identified data will be uploaded to Own Cloud, a file-sharing program in the University of Arizona, College of Nursing.

ii. Qualitative data: There will be a discussion on cultural appropriateness and possible adjustments to the procedures based on the healthcare providers' experiences with a small subset of the 227 women already screened. Between one to two focus groups will be conducted by the study investigators with assistance from local staff with a subset of women, separately to qualitatively assess acceptability of HPV testing using GeneXpert.

The focus group discussions with women participants will be audio-recorded and transcribed verbatim. The moderator will be guided by a semi-structured set of questions to facilitate discussion, and will specifically probe to elicit distinctive/ unusual behaviors or symptoms related to the program, screening and HPV testing.

In keeping with standards for objective evaluation, Dr. Menon or Kue will conduct a focus group discussion with Medical Social workers at the end of the study period for program evaluation (i.e., acceptability, potential changes in delivery, etc.). Discussions will be recorded by a note-taker, not previously associated with the study.

Given the small numbers, a think-aloud group, in a question and answer format with a note-taker to record the main points will be simply conducted with the providers. Both the facilitator and note-taker will not be among TMH staff as this may introduce bias to the conversation.

iii: Training of TMH staff to use GeneXpert: Personnel from the India office of Cepheid will train providers on how to use GeneXpert using standardized training protocols. The quality of the self- collected sample will be compared to the quality of the provider collected sample (by running two separate GeneXpert tests on each sample) to establish the feasibility of self-sampling.

Conditions

HPV Infection

Keywords

HPV infection and Cervical cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cluster of 3000 women

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.

Group Type: OTHER

Cluster of 3000 women

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gauravi Ashish Mishra

Professor and Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gauravi A Mishra, M.D PSM

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Countries

India

Central Contacts

Gauravi A Mishra, M.D PSM

Role: CONTACT

Phone: +912224177000

Email: gauravi2005@yahoo.co.in

Sharmila A Pimple, M.D PSM

Role: CONTACT

Phone: +912224177000

Email: drsharmilapatil@yahoo.com

Facility Contacts

Gauravi A Mishra, M.D PSM

Role: primary

Other Identifiers

TMHPO1763

Identifier Type: -

Identifier Source: org_study_id