Acceptability and Validity of Self Sampling for High Risk HPV Detection Among Women in Maharashtra
HPV
1 other identifier
interventional
1,600
1 country
1
Brief Summary
The study goals are,
- 1.To determine the test characteristics (sensitivity, specificity, positive predictive value, negative predictive value, false positivity rates, false negativity rates) of health personnel collected and self collected HPV samples for Hybrid capture explained by two different methods (pamphlets/ health education programme).
- 2.To evaluate the agreement between self collected HPV samples and health personnel collected HPV samples for Hybrid capture with two different methods of education (pamphlets/ health education programme).
- 3.To study the attitudes, acceptability and barriers of self-collection of specimens for HPV DNA testing in three sub groups of population in Maharashtra with two different methods of education (pamphlets/ health education programme).
- 4.To determine the predictors of self-sampling preference.
- 5.To determine the Knowledge, Attitudes and Practices (KAP) regarding cervical cancer and HPV infection among these women in pre-intervention and post-intervention period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2017
CompletedFirst Posted
Study publicly available on registry
December 29, 2017
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedAugust 6, 2018
August 1, 2018
4 months
April 18, 2017
August 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement rate between health care personnel collected samples and self collected samples in these two groups.
Results obtained out of the health care personnel collected samples Vs self collected samples and correspondingly results of the test among women taught to use self samplers with the aid of pamphlets as compared to a well conducted health education programme will be evaluated using kappa statistics.
18 months
Secondary Outcomes (2)
Test characteristics of HPV self sample and health care worker collected sample by HPV HC 2.
18 months
Acceptability and barriers for self-collection of specimens for HPV DNA testing in an urban population.
18 months
Study Arms (2)
Education by Pamphlets
OTHERHalf of the women in each group will be provided an information pamphlet on the risk factors, methods of early detection, prevention, signs and symptoms of cervical cancer and how to use the self samplers at home.
Health education programme
OTHERHalf of the women in each group will be invited to specially organised camps in their neighbourhood for Health Education and distribution of self samplers.
Interventions
Distribution of pamphlets with information of prevention and early detection of cervical cancer and written as well as pictorial depiction on how to collect cervical self sample for HPV detection.
Health education program explaining about prevention and early detection of cancer and education on method of collection of cervical self sample for HPV.
Eligibility Criteria
You may qualify if:
- Sexually active women in the age group of 30-55 years in the selected areas.
You may not qualify if:
- Pregnant women
- Women having frank cervical cancer
- Women who have undergone total hysterectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gauravi A Mishra, MD
Tata Memorial Hospital, Mumbai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician&Professor
Study Record Dates
First Submitted
April 18, 2017
First Posted
December 29, 2017
Study Start
September 1, 2018
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
August 6, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share