Evaluation of genital self-sampling methods for HPV detection in males

Abstract

Background: There are no population-based HPV prevalence estimates in males because optimal sampling methods are unclear.

Objectives: To evaluate the acceptability, feasibility, and validity of different male genital self-sampling methods for HPV detection.

Study design: A total of 450 males, 14-59 years old, were randomly assigned to one of three genital sampling methods: (1) dry polyester-tipped swab; (2) dry foam swab; and (3) emery paper and wetted polyester-tipped swab. Samples were both self-collected and collected by a clinician. Subjects were queried on the acceptability of sampling methods. HPV was genotyped using an L1 consensus PCR assay.

Results: Specimen adequacy (92-96%, p=0.28) and HPV detection (44-49%, p=0.68) were comparable across the three methods. Concordance for HPV detection was observed between self- and clinician-collected specimen pairs for all methods (κ=0.70-0.80). The collection procedure was reported to be very easy by 69% of dry polyester-tipped swab users and 64% of dry foam swab users compared to 48% of emery-wet swab users (p=0.004). Similarly, 43-44% of dry swab and foam users reported the collection to be very comfortable compared to 24% of emery-wet swab users (p=0.002). Pain was reported by 10% of emery-wet swab users compared to 3% and 5% of dry swab and foam users, respectively (p=0.03). Self-collection by the emery-wet swab method required an average of 6 min compared to 3.3-3.5 min for the two dry methods (p<0.0001).

Conclusions: The dry collection methods are optimal for use in large epidemiologic studies or surveillance efforts based on their acceptability and feasibility.

Keywords: Genital; HPV; Males; Self-sampling.