Introduction

Introduction: In Ethiopia, cervical cancer is the second leading cause of morbidity and mortality from all cancers in women. Persistent infection with Human Papillomaviruses (HPV) plays a key role in the development of cervical intraepithelial neoplasia and invasive cervical cancer. To establish baseline data on the population-based prevalence of HPV infection and genotype distribution, we investigated cervical HPV epidemiology among rural women who attended a trial for HPV-based screening of cervical cancer.

Methods

A population-based study was conducted among rural women aged 30-49 years old in Butajira, south-central Ethiopia. A total of 893 samples were tested for HPV DNA from 1020 screened women. A self-sampling device (Evalyn Brush®, Rovers, The Netherlands) was used to collect a cervico-vaginal sample and HPV presence and genotype was determined using the BSGP5+/6+ PCR with MPG-Luminex read out.

Results

The positivity rate for HPV was 23.2% (177/764). Among the evaluated women in this study, 20.5% and 10.3% were high risk and low risk HPV positive, respectively. Fifty five (7.2%) of the women showed multiple high risk HPV infections. Age-specific prevalence of high- risk HPV infection among the studied women showed that the peak frequency of infection was in the age-group 30-34 years old [58.6% (92/157)] and went down to the 45-49 years old [3.8% (6/157)]. The top five prevalent high- risk HPV genotypes in this study population were HPV16 (57.1%), 35 (20.3%), 52 (15.8%), 31 (14.1%), and 45 (9.6%).

Conclusions

The overall HPV prevalence, high-risk HPV infection and multiple HPV infections were high among the investigated population and HPV16, HPV35, HPV 52, HPV 31, and HPV 45 were the most prevalent genotypes in Butajira district. As a first population-based study in the country, our results can serve as valuable reference to guide nationwide cervical cancer screening and HPV vaccination programs in Ethiopia.

Introduction

A cluster randomized cervical cancer screening study was performed in Butajira, south central Ethiopia, where acceptance of self-sampling for HPV DNA testing was compared to visual inspection with acetic acid. (1) As adjunct study, persistently HPV-positively tested women were retested with an innovative assay based on the QuantiGene 2.0 technology platform (Thermo Fisher). The aim was to compare feasibility and precision in detection of dysplasia.

Methods

Women self-sampled cervicovaginal smears using the Evalyn brush (Rovers Medical Devices, Oss, The Netherlands) and multiplexed genotyping (MPG) was performed on extracted DNA. HR-HPV positive women underwent VIA for triage and resampling into Thinprep/PreserveCyte 4-8 months later. MPG retesting and QuantiGene assay were performed on Thinprep samples for detection and quantitation of E7 oncogene and cellular biomarker mRNA expression (e.g. p16, Ki67, Stathmin/oncoprotein 18, MCM2, ALDH1A1, Birc5/Survivin).

Results

Out of 1020 women accepting self-sampling and HPV testing 144 (14.1%) tested HR-HPV positive and 122 attended VIA triage of whom 110 gave a second Thinprep sample. Upon retesting 4-8 months later 84 (76.4%) women had cleared the original HR-HPV genotype and 26 (23.6%) were persistently HR-HPV genotype positive. Colposcopy showed dysplastic changes in 2 women with CIN2+ alterations while the third had a TZ3. QuantiGene test analysis including strength of E7 mRNA and cellular biomarker expression identified these 3 samples with markedly increased expression. The relative screening burden by HPV test (110 positives) versus Quantigene mRNA detection (3 positives) was 36 fold reduced.

Conclusions

Acceptance of self-sampling and HPV screening was high. Clearance of prevalent HPV infections within appx. 6 months was high posing a problem for triage and follow up. Repeated HPV testing rounds may reduce over referral. QuantiGene-based mRNA detection including biomarker evaluation, which is a simple and robust technique, enhanced specificity remarkably.

References

1) Gizaw M, et al., Cancer Prev Res 2019 (9):609-616