Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04155294
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2019-10-18
Brief Title:
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention REACH-UP a Feasibility Study in Women Living With HIV
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACH-UP
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
Detailed Description:
This pilot study will enrol 70 WLWH aged 25-64 with no history of cervical abnormalities attending 4 HIV clinics in the UK Participants will be asked to complete an entry survey in which behavioural information gynaecological and sexual history will be collected with the aim of characterising the study population for the risk factors of HPV infection Womens attitude towards the current cervical screening and their view on a change to HPV testing will also be assessed Participants relevant clinical data will be collected form their medical notes Women will be instructed to perform a self-taken vaginal swab for the detection of HR HPV while in clinic and they will be reminded of the annual cervical smear which can be offered in clinic or performed at their GP practice as per local policy After six months women will be asked to take another vaginal swab this can be offered in clinic during the regular HIV follow up or can be sent via the post Another sample for HR-HPV testing will be collected one year later at the next routine HIV appointment The annual smear test will be due and this will be offered in clinic or done at the GP practice according to local policies After this visit an exit questionnaire will be undertaken to evaluate the acceptability of the study procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None