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

NCT ID: NCT04587050

Last Updated: 2024-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-19

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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HIV Infections Human Papillomavirus Infection Cervical Cancer

Keywords

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Cervical screening HPV vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort 1: Women with HIV sexually active

Women with perinatally acquired HIV aged 18 or over who are sexually active

Human papillomavirus testing

Intervention Type DIAGNOSTIC_TEST

HPV test from cervical sample using Cepheid GeneXpert HPV

Cervical cytology

Intervention Type DIAGNOSTIC_TEST

Cervical cytology

HPV serology

Intervention Type DIAGNOSTIC_TEST

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

HPV serology

Intervention Type DIAGNOSTIC_TEST

HPV type specific serology (16/18) using ELISA from serum samples

Interventions

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Human papillomavirus testing

HPV test from cervical sample using Cepheid GeneXpert HPV

Intervention Type DIAGNOSTIC_TEST

Cervical cytology

Cervical cytology

Intervention Type DIAGNOSTIC_TEST

HPV serology

HPV type specific serology (16/18) using ELISA from serum samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Perinatally acquired HIV aged 18+
* Sexually active
* Able to give informed consent


* Perinatally acquired HIV aged 18+
* Able to give informed consent

Exclusion Criteria

* Pregnancy
* Not sexually active
* Previous total abdominal hysterectomy
* Unable to give informed consent


* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Public Health England

OTHER_GOV

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Elliott

Role: STUDY_CHAIR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19SM5242

Identifier Type: -

Identifier Source: org_study_id