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

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04587050
Collaborator
Public Health England (Other)
80
1
28.4
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 (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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV
Actual Study Start Date :
Jul 19, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Cohort 1

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 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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of abnormal cervical cytology [1 year]

Secondary Outcome Measures

  1. Prevalence of high risk HPV by subtype [1 year]

  2. Prevalence of CIN2+ [1 year]

  3. HPV type-specific antibody titres (16/18) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College Healthcare NHS Trust London United Kingdom

Sponsors and Collaborators

  • Imperial College London
  • Public Health England

Investigators

  • Study Chair: Tamara Elliott, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT04587050
Other Study ID Numbers:
  • 19SM5242
First Posted:
Oct 14, 2020
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022