Cervical screening Cancer
Conditions
Interventions
This study will see if a urine or vaginal at-home self-sample test can improve cervical screening uptake in non-attenders.
Women, and people with a cervix, who are registered at GP Practices, who m
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 25-65 years 2. Person with a cervix 3. Written, informed consent to participate* 4. Overdue routine cervical screening by 6 months or more 5. Reside in the catchment for laboratory (Aces Choice only) *Does not apply for data extraction for all invited participants
Exclusion criteria
Exclusion criteria: 1. Pregnant 2. Person without a uterus 3. Unable to provide vaginal or a urine sample, including indwelling urinary catheter (for offering urine HPV testing only) 4. Unable to understand the Participant Information Sheet and consent form 5. Any condition that would compromise participant safety or data integrity 6. Due screening in the next 3 months 7. Type 1 objectors (i.e. those who dissent from their medical data being shared)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACES AT Home: Improvement in uptake is measured by the number of individuals returning an adequate self-sample within the study period. The preference for urine testing will be measured by the proportion of individuals opting for urine self-sampling in the choice arm during the study period. ACES Choice sub-study: Preference for type of self-sampling is measured by the proportion of individuals requesting a urine or vaginal self-sampling pack during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| ACES At Home: 1. The proportion of individuals who test HPV+; who attend follow-up procedures; referred for colposcopy; CIN2+ on histology measured by medical record follow-up 2. The proportion of individuals with inadequate samples providing repeat samples during the study period 3. The acceptability of urine and vaginal self-sampling to individuals who are overdue cervical screening and previous barriers to screening measured using study questionnaire at the point of sample collection 4. The impact of age, gender, sexual identity, disability status, time since last cervical screen, ethnicity, religion, education/ employment status and postcode (as a measure of socioeconomic deprivation) on uptake of urine and vaginal self-sampling measured using study questionnaire at the point of sample collection 5. The proportion of invited individuals who attend cervical screening during the study period measured by medical record data extraction at baseline and end of study 6. The proportion of non-responders from ACES at Home who respond to ACES Choice measured 6 months and onwards following ACES At Home invitation ACES Choice: 1. The proportion of individuals who return a self-sampling kit within the study period 2. The proportion of individuals who return a self-sampling kit within the study period based on method of approach (in the community, via social media, at GP practice or clinic) 3. The acceptability of urine and vaginal self-sampling to women who are overdue cervical screening and previous barriers to screening measured using study questionnaire at the point of sample collection (baseline) 4. The impact of age, ethnicity, religion, disability status, gender, sexual orientation, education/ employment status, socioeconomic status and time since last screen on uptake of urine or vaginal self-sampling measured using study questionnaire at the point of sample collection | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Carter
Outcome results
None listed