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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on August 27, 2014