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Completed

NCT Number: NCT04587050

Screening for HPV 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human papillomavirus testing

Diagnostic Test

HPV test from cervical sample using Cepheid GeneXpert HPV

Cervical cytology

Diagnostic Test

Cervical cytology

HPV serology

Diagnostic Test

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

Primary outcomes

  1. Prevalence of Abnormal Cervical Cytology

    Time frame: 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 outcomes

  1. Prevalence of High Risk HPV by Subtype

    Time frame: 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

  2. Prevalence of CIN2+

    Time frame: 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+

  3. HPV Serology (16/18)

    Time frame: 1 year

    Number of participants testing positive for HPV 16 and 18 antibodies out of the those tested

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Public Health England

Registry information

Official study title

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

Acronym: SHiP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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