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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cervical Cancer; Human Papillomavirus Infection
• Intervention / Treatment: Diagnostic test: Human papillomavirus testing; Diagnostic test: Cervical cytology; Diagnostic test: HPV serology

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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women living with perinatally acquired HIV aged 18 years or older

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Women with HIV sexually active; 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
Cohort 2: Women with HIV not sexually active; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Abnormal Cervical Cytology	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of High Risk HPV by Subtype	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	1 year
Prevalence of CIN2+	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+	1 year
HPV Serology (16/18)	Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested	1 year

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Public Health England
• Investigators: Study Chair: Tamara Elliott, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: HPV vaccination; Cervical screening
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Infections; Communicable Diseases; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: 19SM5242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No