Cervical CancerNCT01209338
Acceptability and Feasibility of Human Papilloma Virus Vaccine
A study testing Health education in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
The overall program goal is to determine the Acceptability and Feasibility of introducing a population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key individual and community factors that would determine the potential acceptability of the vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Health education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2009to Dec 2010
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All married women bearing daughters of the age group 10-18 years and are conversant in either Marathi, Hindi or English will be included in the study.
Who cannot join
- Women with no children or with daughters outside the 10-18 yrs age group have been excluded.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Sharmila A Pimple, MD, +91-22-24154379, drsharmilapatil@yahoo.com
Gauravi A Mishra, MD, +91-22-24157532, gauravi2005@yahoo.co.in
About this study
The overall program goal is to determine the Acceptability and Feasibility of introducing a population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key individual and community factors that would determine the potential acceptability of the vaccine.
Read the detailed description
The eligible participant will be chosen by door-door household visit. Each participant will be given information regarding the study and written informed consent will be obtained from them. Their participation will be entirely voluntary and no pressure or coercion will be used. Our team will help them with questions that are not well understood by them or are ambiguous for them. The questionnaire is in 2 sections. Section one will try and ascertain the mother's Knowledge, Attitude and Perception regarding cervix cancer, HPV infection and HPV Vaccination.
Section 1 will be interviewed for a period of 5-10 minutes followed by an information sheet providing details on HPV infection, its association with cervix cancer and HPV Vaccination against cervix cancer. The information sheet available will be explained to them for a period of 10-15 minutes. Our social workers will be available at all times to allay their misinterpretations. This will be followed by section 2 which will be a post intervention questionnaire comprising of questions regarding their attitude towards HPV vaccination and identifying barriers and motivators for these women towards vaccination.
The post-intervention questionnaire would be interviewed for a period of 10-15 minutes, thus a total of 25-40 minutes will be made available to every participant for the entire session. The team is expected to cover 15 women per day totaling to 300 women per month considering the monthly holidays and time lost in certain administrative issues.
Patients will be recruited for 4 months which will be followed by data entry, data analysis, formulation of results and write -up. Thus the entire study will last for eight months. The questionnaire consists of mostly close ended questions with options in the form of yes/no/do not know. Some questions which require definitive answers have been provided with plausible options. Some questions have been left open ended so as to avoid ambiguity. The questionnaire is simple, in continuity and is translated into Hindi and Marathi languages so as to meet the needs of the local population.
- Conditions
- Cervical Cancer
- Being tested
- Health education
- 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.
Health educationBehavioural
Health education about HPV infection, HPV vaccine and cervix cancer.
| Study group | Role | What they receive |
|---|---|---|
| sensitized group | Active comparator | One arm will be a sensitized group which would have received cancer health awareness sessions and / or screening earlier at least once in the past. Receives: Behavioral: Health education |
| non-sensitized group | No intervention | The second arm will belong to an area which has never been exposed to any form of cancer awareness or screening activities thus this group is a completely non-sensitized group. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV).
- To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV) and HPV Vaccines amongst the target population.
- To promote awareness regarding cervix cancer and its screening amongst the community.
- To assess the feasibility and logistics of various strategies for reaching girls with HPV Vaccines.
Measured: 8 months
Secondary outcomes (1)
. To identify the barriers and facilitators perceived by women for vaccinating their daughters against HPV infection and cervix cancer.
To determine barriers and facilitators for vaccine acceptability between sensitized and non- sensitized group.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Sharmila A Pimple, MD, Principal investigator, Tata Memorial HospitalGauravi A Mishra, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209338
- Sponsor's protocol ID
- 655
- Status last verified
- Sep 2010
- First submitted
- 16 Jun 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Human Papilloma Virus Vaccine
- ClinicalTrials.gov ID
- NCT01209338
- Acronym / sponsor ID
- 655
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Sep 2010 (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.
The overall program goal is to determine the Acceptability and Feasibility of introducing a population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key individual and community factors that would determine the potential acceptability of the vaccine.
Detailed description
The eligible participant will be chosen by door-door household visit. Each participant will be given information regarding the study and written informed consent will be obtained from them. Their participation will be entirely voluntary and no pressure or coercion will be used. Our team will help them with questions that are not well understood by them or are ambiguous for them. The questionnaire is in 2 sections. Section one will try and ascertain the mother's Knowledge, Attitude and Perception regarding cervix cancer, HPV infection and HPV Vaccination.
Section 1 will be interviewed for a period of 5-10 minutes followed by an information sheet providing details on HPV infection, its association with cervix cancer and HPV Vaccination against cervix cancer. The information sheet available will be explained to them for a period of 10-15 minutes. Our social workers will be available at all times to allay their misinterpretations. This will be followed by section 2 which will be a post intervention questionnaire comprising of questions regarding their attitude towards HPV vaccination and identifying barriers and motivators for these women towards vaccination.
The post-intervention questionnaire would be interviewed for a period of 10-15 minutes, thus a total of 25-40 minutes will be made available to every participant for the entire session. The team is expected to cover 15 women per day totaling to 300 women per month considering the monthly holidays and time lost in certain administrative issues.
Patients will be recruited for 4 months which will be followed by data entry, data analysis, formulation of results and write -up. Thus the entire study will last for eight months. The questionnaire consists of mostly close ended questions with options in the form of yes/no/do not know. Some questions which require definitive answers have been provided with plausible options. Some questions have been left open ended so as to avoid ambiguity. The questionnaire is simple, in continuity and is translated into Hindi and Marathi languages so as to meet the needs of the local population.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensitized group | Active comparator | Behavioral: Health educationOne arm will be a sensitized group which would have received cancer health awareness sessions and / or screening earlier at least once in the past. |
| non-sensitized group | No intervention | Behavioral: Health educationThe second arm will belong to an area which has never been exposed to any form of cancer awareness or screening activities thus this group is a completely non-sensitized group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All married women bearing daughters of the age group 10-18 years and are conversant in either Marathi, Hindi or English will be included in the study.
Key exclusion criteria (1 listed)
- Women with no children or with daughters outside the 10-18 yrs age group have been excluded.
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 |
|---|---|---|
| Health educationHealth education about HPV infection, HPV vaccine and cervix cancer. | Behavioural | non-sensitized group, sensitized group |
Primary outcome
To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV).
Time frame: 8 months
1. To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV) and HPV Vaccines amongst the target population. 2. To promote awareness regarding cervix cancer and its screening amongst the community. 3. To assess the feasibility and logistics of various strategies for reaching girls with HPV Vaccines.
1 secondary outcome
. To identify the barriers and facilitators perceived by women for vaccinating their daughters against HPV infection and cervix cancer.
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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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.
Sharmila A Pimple, MD principal investigator
Tata Memorial Hospital
Gauravi A Mishra, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 28 Sep 2010. 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 Sharmila A Pimple, MD (+91-22-24154379, drsharmilapatil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV). (time frame: 8 months). 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 28 Sep 2010.