Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Imperial College London
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Prevalence of Abnormal Cervical Cytology
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.
Detailed Description
This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prevalence of Abnormal Cervical Cytology
Time Frame: 1 year
Cervical sample taken in the clinic setting and sent to the laboratory for cytological examination. Prevalence of abnormal cytology is reported as the number of samples that had a non-normal cytology result (e.g. dyskaryotic cells) out of the total number tested
Secondary Outcomes
- Prevalence of High Risk HPV by Subtype(1 year)
- Prevalence of CIN2+(1 year)
- HPV Serology (16/18)(1 year)