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

NCT04155294 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2022-05-24

No results posted yet for this study

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

Sponsors & Collaborators

  • British HIV Association (BHIVA)

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Paola Cicconi · University of Oxford

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155294 on ClinicalTrials.gov