Human Papillomavirus Infection
Conditions
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.
Interventions
PROCEDUREEndocervical samples
Endocervical samples collection during routine gynaecological examinations
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Bahrain
Outcome results
None listed