SHiP: Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 (n=50) or (2) non-sexually active women, blood sampling only (n=30). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Cohort 1 Women with perinatally acquired HIV aged 18 or over who are sexually active |
Diagnostic Test: Human papillomavirus testing
HPV test from cervical sample using Cepheid GeneXpert HPV
Diagnostic Test: Cervical cytology
Cervical cytology
Diagnostic Test: HPV serology
HPV type specific serology (16/18) using ELISA from serum samples
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Cohort 2 Women with perinatally acquired HIV aged 18 or over who are not sexually active |
Diagnostic Test: HPV serology
HPV type specific serology (16/18) using ELISA from serum samples
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Outcome Measures
Primary Outcome Measures
- Prevalence of abnormal cervical cytology [1 year]
Secondary Outcome Measures
- Prevalence of high risk HPV by subtype [1 year]
- Prevalence of CIN2+ [1 year]
- HPV type-specific antibody titres (16/18) [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria - Cohort 1:
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Perinatally acquired HIV aged 18+
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Sexually active
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Able to give informed consent
Inclusion Criteria - Cohort 2:
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Perinatally acquired HIV aged 18+
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Able to give informed consent
Exclusion Criteria - Cohort 1:
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Pregnancy
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Not sexually active
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Previous total abdominal hysterectomy
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Unable to give informed consent
Exclusion Criteria - Cohort 2:
- Unable to give informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Imperial College Healthcare NHS Trust | London | United Kingdom |
Sponsors and Collaborators
- Imperial College London
- Public Health England
Investigators
- Study Chair: Tamara Elliott, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19SM5242