AzTrials
AzTrials

Cervical CancerNCT02783235

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

A study testing cervical cancer screening in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
cervical cancer screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndia
Study dates
29 Jan 2018to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

India1 site, 1 recruiting
  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

    Gauravi A Mishra, MD, +912224177000 ext. 4634, gauravi2005@yahoo.co.in

    Recruiting

Other trials in India

About this study

Official title: Cervical Cancer Screening: Video-based Tutorials for Skills Development of ANMs/ASHAs/PHWs

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.

Read the detailed description

Aim of the study:

  1. 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.
  2. To reduce the training time required by an expert to train ANMs/ASHA/PHWs as compared to the traditional training methods.
  3. To evaluate the efficacy of the training tool by conducting a pre-test and post-test and practical test for lesion identification.
  4. To assess the satisfaction levels of ANMs/ASHAs/PHWs for learning through video-based tutorials.

Methodology:

  1. Creating the Tutorials
  2. The video-based tutorials will be created with the help of domain experts, Content generators and Animators.
  3. Conducting the Training
  4. TMH will recruit Medical Social Workers and Health Workers to provide training to 50 ANMs/ASHAs/PHWs at their own centres.
  5. The training will be staggered into different modules, and will be completed for each trainee over a period of approximately 3 months.

The investigators will also obtain images after due permissions, of the clinic, preparations for examination like arrangements of trolleys, preparation of dilute acetic acid, etc. and the cervical pictures/ videos of the patients before and after VIA after obtaining due consents (there will be no revealing of identity) to aid the animation and the tutorials.

The effectiveness of the tutorials will be checked by a pre- and post- tutorial assessment quiz.

Sample Size and power estimates:

For this study, sampling method is a convenience sample of 50 ANMs/ASHAs/PHWs attached to the TMC, District, Municipal Hospitals and PHCs who have not learned VIA based cervical cancer screening before.

Three MSWs will be appointed to co-ordinate with the respective officials of BMC, State Government, District hospitals etc. and explain the importance of the project.

The Social Workers will approach different BMC hospitals in Mumbai and PHCs and district hospitals around Mumbai to relieve their ANMs/ASHAs/PHWs to participate in this training. Newly recruited PHWs in the Preventive Oncology projects will also be enrolled for this training.

  1. Pre training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc.
  2. The satisfaction level and feed back of the trainees with the course provided.
  3. 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. The satisfaction level with the mode of teaching will be done on a survey based on a likert scale.
  4. Ability to correctly identify a VIA positive lesion.

This will be measured based on marks they score during the tests and assignments, where they will do an image based diagnosis of 15 VIA cases. This will also be scored based on observation sessions they will have with a doctor who performs VIA on 10 patients. They will be assessed based on the number of correct identifications of VIA lesions.

Data entry and analysis:

Data entry will be done in IIT Bombay and in the Department of Preventive Oncology, Tata Memorial Hospital, using SPSS version 18. Checks for consistency, data safety and analysis will be carried out at regular intervals. Both descriptive and inferential statistics will be generated for describing variables under the study objectives.

Agreement of test scores, pre-training and post-training will be estimated using kappa statistics.

Conditions
Cervical Cancer
Being tested
cervical cancer screening
Keywords
VIA, Cervical Cancer, Training
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02783235
Study groupRoleWhat they receive
cervical cancerOthercervical 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.
Receives: Other: cervical cancer screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)
  1. Satisfaction to the video based tutorials

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2016 (estimated)
  2. Study start29 Jan 2018
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783235
Sponsor's protocol ID
TMH1605 Video Based Tutorials
Status last verified
Aug 2018
First submitted
16 May 2016
Last updated
6 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data entry will be done in IIT Bombay and in the Department of Preventive Oncology, Tata Memorial Hospital, using SPSS version 18.

Questions about this trial

What is this clinical trial studying?

A study testing cervical cancer screening in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gauravi A Mishra, MD (+912224177000 ext. 4634, gauravi2005@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in the Post training knowledge about cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018; AzTrials last refreshed its copy on 3 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in