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NCT04587050 Clinical Trial

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

HIV Infections Clinical Trial

— SHiP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04587050
Other study ID # 19SM5242
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 19, 2021
Est. completion date December 2023

Study information
Verified date August 2022
Source Imperial College London
Contact Tamara Elliott
Phone 02075943931
Email tamara.elliott04@imperial.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Human papillomavirus testing
HPV test from cervical sample using Cepheid GeneXpert HPV
• Cervical cytology
Cervical cytology
• HPV serology
HPV type specific serology (16/18) using ELISA from serum samples

Locations
Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (2)
Lead Sponsor Collaborator
Imperial College London Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of abnormal cervical cytology 1 year
Secondary Prevalence of high risk HPV by subtype 1 year
Secondary Prevalence of CIN2+ 1 year
Secondary HPV type-specific antibody titres (16/18) 1 year
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