Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV

NCT04155294 | Completed

• 1 other identifier: IRAS Reference 259611
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 6

Brief Summary

Current British HIV Association (BHIVA) guidelines recommend annual cervical screening (with a cervical smear) for women living with HIV (WLWH). NHS guidelines for women in England will, however, change soon. Women will initially be tested for human papilloma virus (HPV), a virus which causes virtually all cervical cancer. Only those who are infected with HPV will then undergo the smear testing. The BHIVA guidelines, however, taking the view that HIV infection (and its ability to weaken the immune system) increases the risk of persistent HPV infection and of cancer in those who are infected, consider safer for all WLWH to go straight to annual smear testing. Most WLWH in the UK are now receiving treatment which protects their immune system - this suggests that less WLWH could be HPV infected. The identification of a group of WLWH who could benefit from less frequent screening could improve quality of life, and allow the NHS to reduce unnecessary tests and costs. A large study is needed to collect robust evidence that would support changes to standard practice. Before investing huge resources, the investigators need to know if a study would be feasible, conducting a pilot study on 70 WLWH aged 25-64, regularly attending clinics for HIV care. Participants will be asked to complete an entry survey and they will undergo routine cervical smears (baseline and after 1 year). At baseline, after six months, and one year women will take their own vaginal swabs for the detection of HR-HPV. An exit questionnaire will be undertaken at the last visit.

Conditions

Cervical Cancer; HPV Infection; HIV Infections

Keywords

HPV infection; Women; HIV Infection; Cervical cancer; Screening

Outcome Measures

Primary Outcomes (1)

• Prevalence of HR HPV in WLWH aged 25-64 years in the UK

  HPV DNA detected by PCR on vaginal self-taken swab

  baseline

Secondary Outcomes (7)

• Rates of enrolment

  baseline

• Response rate to questionnaires

  1 year

• Feasibility of self-sampling

  1 year

• Participants retention rate

  1 year

• Acceptability of study procedures including self-taken vaginal swabs

  1 year

Eligibility Criteria

• Age: 25 Years - 64 Years
• Gender Eligibility Details: gender at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 25-64 years living with HIV for at least 6 months with annual cervical smear due, in accordance with national guidelines. The majority of HIV women \>25 years in 2019 will not have been vaccinated against HPV.

You may qualify if:

• Women aged 25-64
• HIV diagnosis ≥ 6 months
• No previous diagnosis of CIN 2/3 and/or treatment for cervical dysplasia
• Last smear test done ≥1 year before baseline
• Able to speak and understand English
• Willing and able to provide informed consent

You may not qualify if:

• Suspected or known invasive cervical malignancy
• Currently pregnant or breast-feeding
• Any other condition, which, in the opinion of the Investigator, would make participation in the study unsafe or interfere with interpretation of the study outcomes.

Sponsors & Collaborators

• University of Oxford: lead
• British HIV Association (BHIVA): collaborator

Study Sites (6)

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Buckinghamshire Healthcare NHS Trust

High Wycombe, United Kingdom

Location

Royal Free Hospital Nhs Foundation Trust

London, NW3 2QG, United Kingdom

Location

GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS

London, SE1 9RT, United Kingdom

Location

Milton Keynes University NHS Foundation Trust

Milton Keynes, United Kingdom

Location

ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street

Slough, SL1 2BJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mucosal cells obtained by a vaginal swabs will be stored in Microbiology lab before analysis. Specimens will be destroyed after the study analysis if performed according to local regulation.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Paola Cicconi

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 7, 2019
• Study Start: October 28, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)