Screening for Human Papilloma virus (HPV) Infection in Kidney Transplant Recipients for Anal Neoplasia (TAN) - A Prevalence and Feasibility Study

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 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.
Primary outcome(s): Prevalence of type-specific anal human papilloma virus (HPV) infection in renal transplant recipients, using PCR amplification of target DNA, and hybridization with a reverse line blot system.[ Anal swab will be performed within 14 days after completion of baseline questionnaire. Genotyping will be performed in batches, for every 20 participant samples.];Prevalence and type of anal cytological abnormalities in renal transplant recipients, using ThinPrep (Hologic) standard procedure.
[ Anal swab will be performed within 14 days after completion of baseline questionnaire. Cytology testing will be performed within 7 days of sample collection.];Feasibility of use of anal swabs as a screening tool for the detection of HPV infection and abnormal cytological abnormalities. This will be assessed through enrolment rates from all eligible approached participants and also feedback given in the baseline questionnaires.[ Feasibility will be assessed after all participants have been tested, and followed up if needed.]
Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy