None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the feasibility of providing screening for human papilloma virus (HPV) infection of the anus in patients who have had or who are on the waiting list for a kidney transplant at Westmead Hospital. The trial also aims to provide initial estimates of the prevalence of HPV infection in this population. Who is it for? You may be eligible to enroll in this trial if you are aged over 18 years, and you have had or are on the waiting list for a kidney transplant at Westmead Hospital. Study details At a routine assessment visit, all participants will complete a questionnaire for demographic and sexual behaviour information, and have an anal swab taken. The sample will be analysed for different types of HPV infection and to see if any abnormal cells are present. Any participant with either a significant cytological abnormality, or in whom high risk HPV is detected, will be referred for further investigation at a specialist clinic. It is hoped that this trial will provide information on whether it is feasible to collect this information in transplant recipients, as well as providing initial estimates of the prevalence of HPV.
Interventions
Brief name: anal swab
Kidney transplant recipients attending routine review appointments will be approached to participate. They will be provided a participant information and consent form (PICF) detailing the purpose, methods and risks and benefits of the study. The study will include adults willing and able to give informed consent in English. Consented participants will complete an initial coded demographic and behavioural questionnaire. Trained staff will then take an anal swab taken using
Brief name: anal swab Kidney transplant recipients attending routine review appointments will be approached to participate. They will be provided a participant information and consent form (PICF) detailing the purpose, methods and risks and benefits of the study. The study will include adults willing and able to give informed consent in English. Consented participants will complete an initial coded demographic and behavioural questionnaire. Trained staff will then take an anal swab taken using a moistened Dacron swab for subsequent HPV testing. The Dacron swab will be vigorously eluded into a ThinPrep (Hologic) vial containing PreservCyt fixative medium. Any participant with either a significant cytological abnormality, or in whom high risk HPV is detected, will be referred for further investigation at a specialist clinic. A letter will be sent to participants with negative or low-risk results as well as their nominated GP. This pilot study will evaluate the feasibility of collecting potentially sensitive behavioural data, taking anal swab specimens and performing rectal examinations, in order to identify those at high risk of serious disease.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to give written, informed consent in English 2. Female and male adults, aged 18 years or over 3. Attending the site for either assessment for a kidney transplant, on the kidney transplant waiting list, or for follow-up care as a kidney transplant recipient
Exclusion criteria
1. Unable to provide informed consent 2. Previous anal cancer 3. Other anal pathology likely to be associated with significant anal bleeding when the anal swab is taken
Outcome results
None listed