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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01205412
First received: September 16, 2010
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Human Papillomavirus Infection
 Procedure: Endocervical samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up. [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
  • Behavioural risk factors [ Time Frame: During visit 1 (day 0) ] [ Designated as safety issue: No ]
  • Awareness of HPV in relation to transmission and cause of cervical cancer [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Endocervical samples


Enrollment: 552
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Assessed Cohort
Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up
 Procedure: Endocervical samples
Endocervical samples collection during routine gynaecological examinations

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205412

Locations
Bahrain
GSK Investigational Site
Manama, Bahrain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01205412     History of Changes
Other Study ID Numbers: 112710
Study First Received: September 16, 2010
Last Updated: November 21, 2012
Health Authority: Kingdom of Bahrain: Ministry of Health

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013