An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain

GlaxoSmithKline1 site in 1 country552 target enrollmentOctober 2010

ConditionsHuman Papillomavirus Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Human Papillomavirus Infection
Sponsor: GlaxoSmithKline
Enrollment: 552
Locations: 1
Primary Endpoint: Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

November 2011

Last Updated

13 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women ≥ 20 years of age attending a clinic for routine cervical screening OR
•Women ≥ 16 years of age presenting for post-natal check-ups
•Women providing a cervical sample
•Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject

Exclusion Criteria

•Referral for abnormal cervical sample at the current visit
•Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)
•Pregnant women
•History of hysterectomy
•Known diagnosis of immunosuppression, or patient on immunosuppressives
•Having received one or more doses of human papillomavirus vaccine prior to participating in the study

Outcomes

Primary Outcomes

Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.

Time Frame: Average time frame: 12 months

Secondary Outcomes

Behavioural risk factors(During visit 1 (day 0))
Awareness of HPV in relation to transmission and cause of cervical cancer(Average time frame: 12 months)
Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.(Average time frame: 12 months)