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

HIV Infections Clinical Trial

— REACH-UP  

Official title:

Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention (REACH-UP): a Feasibility Study in Women Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155294
• Other study ID #: IRAS Reference 259611
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. Women's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

INCLUSION CRITERIA

• 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

EXCLUSION CRITERIA

• 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Communicable Diseases
• HIV Infections
• HPV Infection
• Infections
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United Kingdom	Buckinghamshire Healthcare NHS Trust	High Wycombe
United Kingdom	GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS	London
United Kingdom	Royal Free Hospital Nhs Foundation Trust	London
United Kingdom	Milton Keynes University NHS Foundation Trust	Milton Keynes
United Kingdom	Oxford University Hospital NHS Foundation Trust	Oxford	Oxfordshire
United Kingdom	ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street	Slough

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	British HIV Association (BHIVA)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of enrolment	Proportion of eligible women on all the women attending the Clinic	baseline
Secondary	Response rate to questionnaires	Proportion of questionnaires completed	1 year
Secondary	Feasibility of self-sampling	Proportion of HR-HPV self-sample tests returned	1 year
Secondary	Participants retention rate	Proportion of patients who complete the study procedures	1 year
Secondary	Acceptability of study procedures including self-taken vaginal swabs	questionnaire containing closed and opened questions and visual scale from 0 to 100, higher score indicate a better outcome	1 year
Secondary	Awareness of cervical cancer risk	questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome	baseline
Secondary	Compliance to standard screening procedures	questionnaire containing closed and opened questions and visual scale from 0 to 100, where higher scores indicate a better outcome	baseline