An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain

Completed

• Conditions: Human Papillomavirus Infection
• Interventions: Procedure: Endocervical samples

• Registration Number: NCT01205412
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Study Start: 2010-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 552

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Assessed Cohort	Endocervical samples	Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up

Primary Outcome Measures

Name	Time	Method
Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.	Average time frame: 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇭 Manama, Bahrain