Feasibility, validity and acceptability of self-collected samples for human papillomavirus (HPV) testing in rural Malawi.

Aim: The World Health Organization (WHO) recently endorsed human papillomavirus (HPV) testing as a cervical cancer screening method in countries without established programs. Self-collection for HPV testing may be an effective way to expand screening. Our objective was to assess the feasibility, validity, and acceptability of self-collection for HPV testing in a population of care-seeking, unscreened women in rural Malawi. Methods: We enrolled women reporting to a rural Malawian clinic from January to August 2015. Participants were offered the option to self-collect a vaginal sample and the study clinician collected a cervical sample for HPV testing. Using the clinician-collected sample as the reference standard, we calculated a kappa statistic, sensitivity, and specificity by hr-HPV type. Participants also received a brief survey assessing acceptability of the procedure. Results: Among the 199 enrolled women, 22% had any high risk-HPV. Comparing self- and clinician-collected samples for HPV testing, we found generally high agreement (ϰ = 0.66-0.90) and high specificity (98%-100%), but varied sensitivity (50%-91%) for different types of hr-HPV. We also found that self-collection was acceptable, with 98% of women reporting it was easy to do and 99% reporting willingness to do so again. Conclusions: WHO guidelines recommend that treatment is available immediately after a positive screening test for clinic-based cervical cancer screening programs. Our findings demonstrate that self-collection of samples for HPV testing is a feasible and acceptable method of cervical cancer screening in this rural Malawian population. High agreement between the self- and clinician-collected samples and high levels of acceptability among women in the study suggest that self-collection of vaginal samples for HPV testing may be effectively incorporated into screening programs among rural, largely unscreened populations.