NCT02783235

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

May 16, 2016

Last Update Submit

August 3, 2018

Conditions

Cervical Cancer

Keywords

VIACervical CancerTraining

Outcome Measures

Primary Outcomes (1)

  • Improvement in the Post training knowledge about cancer

    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.

    1 year

Secondary Outcomes (1)

  • Satisfaction to the video based tutorials

    1 year

Other Outcomes (1)

  • Clinical skills development

    1 year

Study Arms (1)

cervical cancer

OTHER

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

Interventions

cervical cancer screeningOTHER

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.

cervical cancer

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Gauravi A Mishra, MD

    Tata Memorial Hospital, Mumbai.

    PRINCIPAL INVESTIGATOR

  • Gauravi A Mishra, MD

    ata Memorial Hospital, Mumbai.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gauravi A Mishra, MD

CONTACT

+912224177000gauravi2005@yahoo.co.in

Sharmila A Pimple, MD

CONTACT

+912224177000pimplesharmila@gmail.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
Associate Professor Dept of Preventive Oncology

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 26, 2016

Study Start

January 29, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 6, 2018

Record last verified: 2018-08

Locations

IN(1)