HPV Sampling Study
Research type
Research Study
Full title
A study to evaluate the performance of human papillomavirus (HPV) DNA detection in residual specimens taken for Chlamydia trachomatis/Neisseria gonorrhoea nucleic acid amplification testing in men who have sex with men (MSM)
IRAS ID
234139
Contact name
Diarmuid Nugent
Contact email
Sponsor organisation
Noclor Research Support Service
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This study attempts to find the best method to monitor rates of infection with human papillomavirus (HPV) in gay, bisexual and other men who have sex with men (MSM).
There are over 170 subtypes of HPV virus known as "genotypes". Some can cause benign skin lesions known as warts and other "high-risk genotypes" can cause cancers of the cervix, vulva, vagina, anus, penis and oropharynx. MSM are at particularly high risk of HPV infection and HPV related anal cancer. Since 2016, vaccination against HPV has been offered opportunistically to MSM attending selected sexual health clinics in England. HPV DNA is the genetic material of the virus and is detectable on swabs taken from the anal canal in infected individuals. This test can be used for surveillance of HPV infection in MSM and therefore inform on the impact of the vaccination programme in HPV infection rates in this group.
Anal swabs are performed routinely for Chlamydia trachomatis (CT) and Neisseria gonorrhoea (GC) testing in MSM either as a single sample or by combining with a throat specimen and an aliquot of urine to form a “pooled” specimen. The use of residual sample material from these specimens could be used for HPV surveillance by testing them for HPV DNA. Advantages of this approach would include (i) patient comfort as no additional samples required over those taken for routine care; (ii) greater availability of genital samples for HPV surveillance; and (iii) reduced cost of sampling materials. However the sensitivity of HPV detection in residual rectal or pooled samples in MSM is not known and further data is urgently needed. This study attempts to answer this question by comparing HPV detection rates in residual rectal and pooled specimens taken for CT/GC testing with the gold standard test, a dedicated anal swab for HPV.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0473
Date of REC Opinion
7 Dec 2017
REC opinion
Favourable Opinion