NCT04587050

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Human Papillomavirus Infection
• Cervical Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-19
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-10-14
• Last updated: 2024-12-10
• Results posted: 2024-12-10

Locations

1 site across 1 country: United Kingdom