Acceptability and Validity of Self Sampling for High Risk HPV Detection Among Women in Maharashtra
NCT ID: NCT03386695
Last Updated: 2018-08-06
Study Results
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Basic Information
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UNKNOWN
NA
1600 participants
INTERVENTIONAL
2018-09-30
2020-01-31
Brief Summary
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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.
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Detailed Description
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Step 1: They will be interviewed to collect the baseline Knowledge, Attitude and Practices (KAP) regarding cervical cancer, screening and HPV. The information will be recorded on a structured questionnaire.
Step 2: Half of the women in each group will be invited to specially organized camps in their neighborhood for Health Education and distribution of self samplers while the other half 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. Similar personal interviews, collection of used/unused self sampler and collection of HPV samples by health worker will be followed for both groups of women.
Intervention one: (Health Education Group) Detailed health education programme explaining them the risk factors, methods of early detection, prevention, signs and symptoms of cervical cancer will be conducted. They will be explained the importance of getting screened for cervical cancer and will be encouraged to undergo screening at any nearby screening centre. They will be given information regarding HPV self samplers and will be taught the method of its use and storage in detail. Any queries with this regard will be answered.
Intervention two: (Both Groups) HPV self samplers will be distributed free of cost to the women and the social workers will instruct them to return it to the clinic or will collect the samplers from their houses, either on the same day or the following day as per the convenience of the woman. For HPV self collection the participating women will be asked to collect the sample specimen as per instructions provided during the health education session/ pamphlets and store it at room temperature till the time of collection by the social worker. The willingness to use self sampler or refusal to use the HPV self sampler will be captured. Also, the reasons for their refusal shall be captured.
Step 3: (Both Groups) During the visit by social worker to collect the samples, the women will be again interviewed by the social worker for their experience about collecting the sample at home. Personal interviews will be conducted also to assess their acceptability of self sampling for HPV detection. Various queries regarding difficulties in obtaining, storing and transporting the samples as well as other potential factors likely to affect the acceptability of the self sampling methods will be assessed. Any injuries, barriers and motivators for self sampling will be recorded. The women who refuse to use self samplers at this stage will also be interviewed to understand the barriers. HPV sample will be collected by the health worker when the woman comes to return the sampler kit. It will also be collected for women who refuse self sampling but are ready for health worker collected sample.
Information about the post-intervention KAP regarding cervical cancer, screening and HPV will be again recorded on a structured questionnaire from all women.
Step 4: (Both Groups) HPV testing will be performed with the Hybrid Capture System II {Digene}, which detects 13 different high-risk HPV types {16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68}. The test will run according to the manufacturer's protocol. HPV determination will be quantitative, and women with samples producing readings of one or more times the positive control (1pg/ml HPV DNA) will be considered as HPV test positive.
Step 5: (Both Groups) The reports of self sampling HPV will be distributed to the women after 15 days. The women who test positive on either test will be contacted personally by staff or by telephone and will be offered free Preventive Oncology check up, Colposcopy and necessary work up either at Tata Memorial Hospital. The women not willing to avail facility at TMH will be referred to the nearby municipal or private hospital offering these services.
The women who are positive or negative on colposcopy will undergo further diagnosis and management as per departmental service protocol. The health worker will co-ordinate between the field staff and the various departments at TMH. The health worker will submit the samples to the department of Microbiology at the TMH, will collect the reports and send it to the field social workers for distribution, will assist the HPV positive patients for further investigations and diagnosis at the TMH.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Education by Pamphlets
Half 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.
Education by Pamphlets
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 programme
Half of the women in each group will be invited to specially organised camps in their neighbourhood for Health Education and distribution of self samplers.
Health education programme
Health education program explaining about prevention and early detection of cancer and education on method of collection of cervical self sample for HPV.
Interventions
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Education by Pamphlets
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 programme
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
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Inclusion Criteria
Exclusion Criteria
* Women having frank cervical cancer
* Women who have undergone total hysterectomy
30 Years
55 Years
FEMALE
Yes
Sponsors
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Tata Memorial Hospital
OTHER_GOV
Responsible Party
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Gauravi Ashish Mishra
Physician&Professor
Principal Investigators
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Gauravi A Mishra, MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Hospital, Mumbai
Locations
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Tata Memorial Hospital
Mumbai, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TMHPO 1686
Identifier Type: -
Identifier Source: org_study_id
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