Clinical trial NCT04588402: Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India
Official title: Assessing the Population Level Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Department of Health and Family welfare, Government of Sikkim
name: Sikkim Manipal Institute
name: Rajiv Gandhi Centre for Biotechnology
First posted: 2020-10-19
Enrollment: 5500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons.

Brief 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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 7 years
measure: 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
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gangtok
country: India
facility: Sikkim Manipal Hospital
state: Sikkim
Study officials:
affiliation: Sikkim Manipal Inst., Sikkim, India
name: Yogesh Verma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of H & FW, Govt. of Sikkim, India
name: Phumzay Denzongpa, MD
role: PRINCIPAL_INVESTIGATOR
References: