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

Completed

• Conditions: HIV Infections; Cervical Cancer; Human Papillomavirus Infection
• Interventions: Diagnostic Test: HPV serology; Diagnostic Test: Human papillomavirus testing; Diagnostic Test: Cervical cytology

• Registration Number: NCT04587050
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Study Start: 2021-07-19
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Results First Submitted: 2024-07-18
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Results First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	HPV serology	Women with perinatally acquired HIV aged 18 or over who are not sexually active
Cohort 1	Cervical cytology	Women with perinatally acquired HIV aged 18 or over who are sexually active
Cohort 1	Human papillomavirus testing	Women with perinatally acquired HIV aged 18 or over who are sexually active
Cohort 1	HPV serology	Women with perinatally acquired HIV aged 18 or over who are sexually active

Primary Outcome Measures

Name	Time	Method
Prevalence of Abnormal Cervical Cytology	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 Outcome Measures

Name	Time	Method
Prevalence of High Risk HPV by Subtype	1 year	Cervical sample taken in the clinic setting and tested for high-risk HPV on site using the Cepheid GeneXpert. Prevalence reported as the number of samples that were positive for any high-risk HPV out of all those tested
Prevalence of CIN2+	1 year	Participants with abnormal cytology and/or tested positive for high-risk HPV were referred for colposcopy. Prevalence reported as the number of participants who were diagnosed with CIN2+
HPV Serology (16/18)	1 year	Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom