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Recruiting NCT04588402

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

— Observational Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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..
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: 18 years — 22 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The investigators would like to estimate the prevalence of HPV infections based on cervical samples collected from the Sikkimese women aged 18 to 22 years at baseline (i.e. when the study participants are expected to have no benefit of vaccination) and seven years after the launch of the HPV vaccination programme, by which time the initial vaccinated cohorts will be aged 18 to 22 years and many of them will be sexually active. If the vaccination programme continues with the current high coverage rate, the cohort of women in the second age group are expected to be protected due to herd immunity, irrespective of whether any individual woman receives the vaccine or not. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys.

Interventions

  • Biological 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

Primary outcome measures

  • 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 [Time frame: 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 [Time frame: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

India · 1 center
  • Sikkim Manipal Hospital — Gangtok

Identifiers

NCT: NCT04588402 · SMIMS/IEC/C/2020-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗