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

August 4, 2022 updated by: Imperial College London

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

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of abnormal cervical cytology
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of high risk HPV by subtype
Time Frame: 1 year
1 year
Prevalence of CIN2+
Time Frame: 1 year
1 year
HPV type-specific antibody titres (16/18)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Public Health England

Investigators

  • Study Chair: Tamara Elliott, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 19, 2021

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

December 1, 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 (ACTUAL)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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