Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV

Conditions
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Cervical Cancer, HIV Infections, Human Papillomavirus Infection

Intervention / Treatment
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* Diagnostic Test: Human papillomavirus testing
* Diagnostic Test: Cervical cytology
* Diagnostic Test: HPV serology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Cohort 1: Perinatally acquired HIV aged 18+ Sexually active Able to give informed consent Inclusion Criteria - Cohort 2: Perinatally acquired HIV aged 18+ Able to give informed consent Exclusion Criteria - Cohort 1: Pregnancy Not sexually active Previous total abdominal hysterectomy Unable to give informed consent Exclusion Criteria - Cohort 2: Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Women with perinatally acquired HIV aged 18 or over who are sexually active | Diagnostic Test: Human papillomavirus testing<br>* HPV test from cervical sample using Cepheid GeneXpert HPV<br>Diagnostic Test: Cervical cytology<br>* Cervical cytology<br>Diagnostic Test: HPV serology<br>* HPV type specific serology (16/18) using ELISA from serum samples<br>|
| Cohort 2<br>Women with perinatally acquired HIV aged 18 or over who are not sexually active | Diagnostic Test: HPV serology<br>* HPV type specific serology (16/18) using ELISA from serum samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of abnormal cervical cytology |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of high risk HPV by subtype |  | 1 year | 
| Prevalence of CIN2+ |  | 1 year | 
| HPV type-specific antibody titres (16/18) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical screening, HPV vaccination