Clinical trial NCT01213459: Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 15 Years of Age, in the Kingdom of Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Cervical Cancer
Keywords: Human papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 420
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women \>=15 years of age attending out-patient departments of primary, secondary or tertiary care centers for routine cervical screening, in the Kingdom of Saudi Arabia.

Brief summary: This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women \>= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.


Eligibility criteria: Inclusion Criteria:

* Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
* Women \>=15 years of age attending a clinic for routine cervical screening,
* Written informed consent obtained from the subject and/or subject's parent/guardian.

Exclusion Criteria:

* Referral for abnormal cervical sample at the current visit,
* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,
* No cervical sample provided,
* History of hysterectomy,
* Known diagnosis of immunosuppression, or patient on immunosuppressives,
* Pregnant female \>=25 years of age.

Primary outcomes:
measure: Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.
timeFrame: At least 12 months from the date of subject enrolment
Secondary outcomes:
measure: Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.
timeFrame: At least 12 months from the date of subject enrolment
measure: Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).
timeFrame: At least 12 months from the date of subject enrolment
measure: Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.
timeFrame: At least 12 months from the date of subject enrolment
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: GSK Investigational Site
city: Riyadh
country: Saudi Arabia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: AlObaid A, Al-Badawi IA, Al-Kadri H, Gopala K, Kandeil W, Quint W, Al-Aker M, DeAntonio R. Human papillomavirus prevalence and type distribution among women attending routine gynecological examinations in Saudi Arabia. BMC Infect Dis. 2014 Dec 14;14:643. doi: 10.1186/s12879-014-0643-8.