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Acceptability and Validity of Self Sampling for High Risk HPV Detection Among Women in Maharashtra

NCT03386695 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2018-08-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Gauravi A Mishra, MD · Tata Memorial Hospital, Mumbai

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386695 on ClinicalTrials.gov