Clinical trial NCT04155294: Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Official title: Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention (REACH-UP): a Feasibility Study in Women Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
HPV Infection
HIV Infections
Keywords: HPV infection
Women
HIV Infection
Cervical cancer
Screening
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: British HIV Association (BHIVA)
First posted: 2019-11-07
Enrollment: 71
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of HR HPV in WLWH aged 25-64 years in the UK
timeFrame: baseline
Secondary outcomes:
measure: Rates of enrolment
timeFrame: baseline
measure: Response rate to questionnaires
timeFrame: 1 year
measure: Feasibility of self-sampling
timeFrame: 1 year
measure: Participants retention rate
timeFrame: 1 year
measure: Acceptability of study procedures including self-taken vaginal swabs
timeFrame: 1 year
measure: Awareness of cervical cancer risk
timeFrame: baseline
measure: Compliance to standard screening procedures
timeFrame: baseline
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospital NHS Foundation Trust
state: Oxfordshire
city: High Wycombe
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital Nhs Foundation Trust
city: London
country: United Kingdom
facility: GUY's AND ST THOMAS' NHS FOUNDATION TRUSTS
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University NHS Foundation Trust
city: Slough
country: United Kingdom
facility: ROYAL BERKSHIRE NHS FOUNDATION TRUST, Upton Hospital, Albert Street
Study officials:
affiliation: University of Oxford
name: Paola Cicconi
role: PRINCIPAL_INVESTIGATOR
References: