Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 investigators will estimate difference in the prevalence of genotype-specific HPV infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program).
• 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
  The investigators will estimate difference in the prevalence of chlamydia trachomatis infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program). The estimate will allow the investigators to understand any change in the background risk of sexually transmitted infection in the population over time.

Trial sites (1)

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