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.
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
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Gauravi A Mishra, MD, +912224177000 ext. 4634, gauravi2005@yahoo.co.in
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:
- 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.
- To reduce the training time required by an expert to train ANMs/ASHA/PHWs as compared to the traditional training methods.
- To evaluate the efficacy of the training tool by conducting a pre-test and post-test and practical test for lesion identification.
- To assess the satisfaction levels of ANMs/ASHAs/PHWs for learning through video-based tutorials.
Methodology:
- Creating the Tutorials
- The video-based tutorials will be created with the help of domain experts, Content generators and Animators.
- Conducting the Training
- TMH will recruit Medical Social Workers and Health Workers to provide training to 50 ANMs/ASHAs/PHWs at their own centres.
- 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.
- Pre training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc.
- The satisfaction level and feed back of the trainees with the course provided.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: cervical cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted26 May 2016 (estimated)
- Study start29 Jan 2018
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gauravi Ashish Mishra, Tata Memorial Hospital
- Investigators
- Gauravi A Mishra, MD, Principal investigator, Tata Memorial Hospital, Mumbai.Gauravi A Mishra, MD, Principal investigator, ata Memorial Hospital, Mumbai.
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Screening: Video-based Tutorials for Skills Development of ANMs/ASHAs/PHWs
- ClinicalTrials.gov ID
- NCT02783235
- Acronym / sponsor ID
- TMH1605 Video Based Tutorials
- Conditions
- Cervical Cancer
- Keywords
- VIA, Cervical Cancer, Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim of the study:
- 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.
- To reduce the training time required by an expert to train ANMs/ASHA/PHWs as compared to the traditional training methods.
- To evaluate the efficacy of the training tool by conducting a pre-test and post-test and practical test for lesion identification.
- To assess the satisfaction levels of ANMs/ASHAs/PHWs for learning through video-based tutorials.
Methodology:
- Creating the Tutorials
- The video-based tutorials will be created with the help of domain experts, Content generators and Animators.
- Conducting the Training
- TMH will recruit Medical Social Workers and Health Workers to provide training to 50 ANMs/ASHAs/PHWs at their own centres.
- 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.
- Pre training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc.
- The satisfaction level and feed back of the trainees with the course provided.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervical cancer | Other | Other: cervical cancer screeningcervical 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical cancer screeningfor 50 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 |
Primary outcome
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.
1 secondary outcome
Satisfaction to the video based tutorials
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Tata Memorial Centre, Mumbai Official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data entry will be done in IIT Bombay and in the Department of Preventive Oncology, Tata Memorial Hospital, using SPSS version 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauravi A Mishra, MD principal investigator
Tata Memorial Hospital, Mumbai.
Gauravi A Mishra, MD principal investigator
ata Memorial Hospital, Mumbai.
1 site in 1 country: see every site and its status.
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.