ClinicalTrials.gov
ClinicalTrials.gov Menu

Cervical Cancer Screening : Video Based Tutorials for ANMs/ASHAs/PHWs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02783235
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gauravi Ashish Mishra, Tata Memorial Hospital

Brief Summary:

This study aims at creating video-based tutorials for developing skills in performing cervical cancer screening using VIA for the Auxillary Nurse Midwives (ANMs), Accredited Social Health Activists (ASHAs) and Primary Health Workers (PHWs). Cervical cancer screening is mainly done by the following three methods: Visual inspection with acetic acid (VIA), Cervical Smear Cytology (PAP) and HPV DNA test. VIA is a low cost, low resource cervical cancer screening method and especially useful for low middle income countries (LMICs) like India.

We propose to develop video-based tutorials, such that the ANMs/ASHAs/PHWs could be trained in performing and interpreting VIA with the use of this tutorial. The ANMs/ASHAs/PHWs have important roles in delivering health in rural/ semi urban areas and they will be trained using this tutorial.

The video-based tutorials will be made according to the 'Spoken Tutorials' methodology, developed at IIT Bombay. Video-based Tutorials has given skills based training to over 2 lakh students in the past four years on IT based topics. The tutorials are made available online free of cost. They are designed to be used without the need of an expert being physically present.


Condition or disease Intervention/treatment Phase
Cervical Cancer Other: cervical cancer screening Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cervical Cancer Screening: Video-based Tutorials for Skills Development of ANMs/ASHAs/PHWs
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
cervical cancer
cervical cancer screening and training for ANMs/ASHAs/PHWs To develop video-based tutorials to train ANMs/ASHAs/PHWs in conducting cervical cancer related health education, screening for cervical cancers using VIA, collection of PAP smears and HPV samples.
Other: cervical cancer screening
for 50 ANMs/ASHAs/PHWs/ in conducting cervical cancer related health education , screening for cervical cancers using VIA, collection of PAP smears and HPV samples.




Primary Outcome Measures :
  1. Improvement in the Post training knowledge about cancer [ Time Frame: 1 year ]

    Questionnaire: that will compare pre-training knowledge with post training and assess the improvement in the Post training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc.

    These will be measured with the help of test scores. Each question in the test will have marks assigned to it based on difficulty level. (Easy 1 mark, Intermediate 2 marks, Hard 3 marks, Very hard 4 marks). The ANMs will be assigned marks depending on the number of correct responses.

    The ANMs will have to take the tests before the training, immediately after the training, and three months after the training is complete.



Secondary Outcome Measures :
  1. Satisfaction to the video based tutorials [ Time Frame: 1 year ]

    Questionnaire: that will assess the satisfaction level and feed back of the trainees with the course provided.

    The satisfaction level with the mode of teaching will be done on a survey based on a likert scale.



Other Outcome Measures:
  1. Clinical skills development [ Time Frame: 1 year ]
    Scores will be assigned and the ability to correctly identify a VIA positive lesion will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: ANMs /ASHAs/PHWs attached to the TMC, District Hospitals and PHCs who have not learned VIA based cervical cancer screening before.

Exclusion Criteria: ANMs /ASHAs/PHWs attached to the TMC, District Hospitals and PHCs who have learnt VIA based cervical cancer screening before.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783235


Contacts
Contact: Gauravi A Mishra, MD +912224177000 ext 4634 gauravi2005@yahoo.co.in
Contact: Sharmila A Pimple, MD +912224177000 ext 4631 pimplesharmila@gmail.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Gauravi A Mishra, MD    +912224177000 ext 4634    gauravi2005@yahoo.co.in   
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Gauravi A Mishra, MD Tata Memorial Hospital, Mumbai.
Principal Investigator: Gauravi A Mishra, MD ata Memorial Hospital, Mumbai.

Additional Information:
Responsible Party: Gauravi Ashish Mishra, Associate Professor Dept of Preventive Oncology, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02783235     History of Changes
Other Study ID Numbers: TMH1605 Video Based Tutorials
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data entry will be done in IIT Bombay and in the Department of Preventive Oncology, Tata Memorial Hospital, using SPSS version 18.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gauravi Ashish Mishra, Tata Memorial Hospital:
VIA
Cervical Cancer
Training

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female