Abstract:
Background: Screening of unvaccinated women remains essential to mitigate the high morbidity/mortality of
cervical cancer. Here, we compared visual inspection with acetic acid (VIA), recommended by WHO as the most
cost-effective screening approach in LMICs, with HPV-based screening, and usage of p16INK4a/Ki-67 dual stain
cytology.
Methods: We prospectively enrolled women participating in a VIA-based cervical cancer screening program in two
peri-urban health centers of Kenya. Consenting women had a VIA examination preceded by collection of a liquid-
based cytology sample from the cervix stored in PreservCyt medium (Hologic®). Analysis of all samples included a
hrHPV DNA test and evaluation of a p16INK4a /Ki-67 (CINtecPLUS®) dual stained slide that was prepared using the
ThinPrep® 2000 Processor and evaluated by a pathologist trained in the methodology.
Results: In 701 of a total of 800 women aged 18–64 years, all three investigations were performed and data could
be analyzed. The HPV, VIA and dual stain cytology positivity were 33%, 7%, and 2% respectively. The HPV positivity rate
of VIA positive cases was 32%. The five most common HPV types were HPV16, 52, 68, 58 and 35. The OR among HIV
infected women of an HPV infection, VIA positivity and positive dual stain cytology were 2.6 (95%CI 1.5–4.3), 1.9 (95%CI
0.89–4.4) and 3.4 (95%CI 1.07–10.9) respectively. The sensitivity of VIA to detect a p16INK4a/Ki-67 positive transforming
infection was 13% (95%CI 2–38).
Conclusions: Primary HPV testing appears feasible and should be considered as a primary screening test also in LMICs.
The poor sensitivity of VIA renders it unsuitable as a triage test for HPV positive women. The utility of p16INK4a/Ki-67
dual stain cytology as a triage test for HPV positive women in LMICs should be further studied.