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Clinical trial

Assessing the Population Level Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

ID
Name
SMIMS/IEC/C/2020-09
Description
This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine.
Trial arms
Trial start
2020-10-01
Estimated PCD
2025-06-01
Trial end
2025-12-31
Status
Recruiting
Treatment
The study being observational in nature, there is no intervention. The investigators will only collect cervical samples from married women within a specified age range at different intervals.
Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons. After signing the informed consent, the participants will fill in a risk factor questionnaire to study the socio-demographic information, sexual history and HPV vaccination history and the determinent of HPV infection. The questionnaire will be administered by a trained social worker or nurse. A gynecologist will collect cervical cells from the participant's cervix during a gynecological examination. The cervical specimen will be examined for presence of specific HPV genotypes and Chlamydia infection.
Size
5500
Primary endpoint
The reduction in the point prevalence of genotype-specific HPV infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
7 years
The difference in the point prevalence of chlamydia trachomatis infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
7 years
Eligibility criteria
Inclusion Criteria: * Women aged 18 to 22 years, resident of Sikkim and married. * Pregnancy will not be considered as exclusion criteria. * Sample collection should be avoided during active menstruation. Exclusion Criteria: * Women who do not provide written consent * Women who are not able to cooperate in collection of cervical cell sample or respond to questions due to any acute or severe mental and physical illnesses. * Women who had undergone hysterectomy. * Vaccinated in research project
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cervical cells'}, 'enrollmentInfo': {'count': 5500, 'type': 'ESTIMATED'}}
Updated at
2023-09-28

1 organization

Organization
International Agency for Research on Cancer