Background: The SelfCerv Self-Collection Cervical Health Screening Kit (Ilex Medical Ltd., Johannesburg, South Africa) is an applicator tampon designed for self-collection of vaginal samples for the detection of human papillomavirus (HPV) deoxyribonucleic acid (DNA) and E6/E7 messenger ribonucleic acid (mRNA). The study aimed to evaluate the performance of the SelfCerv applicator tampon for the detection of hr-HPV for cervical cancer screening, and further to investigate women’s experiences and preferences regarding self-sampling. Methods: Vaginal samples were collected from 527 gynecology clinic attendees aged ≥18 years at a tertiary hospital in Gauteng Province, South Africa. Self-samples were collected using the SelfCerv kit, followed by endocervical samples collected by a healthcare professional using Cervex-Brush^® Combi. Participants completed a self-administered questionnaire on self-sampling experiences and preferences. Both samples were tested for 14 high-risk (hr) HPV types and E6/E7 mRNA using the Abbott RealTime HR-HPV and Aptima HR-HPV mRNA assays, respectively. Results: The overall agreement for hr-HPV typing between 527 paired samples was good (87.1%; κ =0.74) with high sensitivity (86.2%) and specificity (88.0%). HPV-16 (96.4%; κ = 0.83) had higher agreement rate than HPV-18 (96.8%; κ = 0.72) and the other 12 hr-HPVs (86.5%; κ = 0.72). Two hundred and eighty-five (285) sample pairs tested for E6/E7 mRNA showed fair agreement (70.2%; κ= 0.34). Furthermore, self-sampling was reported as comfortable (90.5%) and painless (86.7%), with 88.4% of women preferring self-collection. Conclusions: Self-collected samples had good agreement with the healthcare professional-collected samples for the detection of hr-HPV DNA and the procedure was highly preferred by women. Self-sampling using SelfCerv can be used as an alternative to healthcare professional sampling in clinic-based routine cervical cancer screening.

Background: Cervical cancer is mainly caused by human papillomavirus (HPV). Worldwide, knowledge of HPV and cervical cancer among women is reported to be inadequate. The study aimed to assess the knowledge and awareness of HPV and cervical cancer among women attending gynecology clinics at a tertiary hospital in Pretoria, South Africa. The study also intended to identify socio-demographic factors influencing women’s knowledge about HPV and cervical cancer risk factors. Methods: This was a clinic-based analytic cross-sectional study conducted among women aged 18 years and older. Participants were enrolled in the clinic waiting rooms while waiting to be attended to by the clinician. A self-administered questionnaire to assess knowledge of HPV, cervical cancer, and risk factors for developing cervical cancer was distributed to the participants. Results: A total of 527 women aged ≥18 years and older were randomly enrolled with a 99.8% response rate. Less than half (47.1%) of the participants had been previously screened for cervical cancer using a Papanicolaou (Pap) test. Few (18.8%) women correctly mentioned cervical cancer risk factors. Unemployed women were less likely to have correct knowledge of cervical cancer causes/risk factors (OR: 0.63; 95% CI 0.40–0.97) compared to employed women. Divorced/separated/widowed women were more likely to have good HPV knowledge compared to single participants (OR: 2.74; 95% CI 1.46–5.15). Conclusion: From this study, it is evident that cervical cancer screening is very low, and women lack knowledge of HPV and cervical cancer disease symptoms and its risk factors. There is a need for policies to prioritize providing accurate information to the public to reduce cervical cancer morbidity and mortality.

Background: Persistent high-risk (hr) human papillomavirus (HPV) infection is a necessary cause of cervical cancer. Cervical cancer is a major public health problem in Sub-Saharan Africa including South Africa. This study investigated the prevalence of and factors associated with hr-HPV infection among women attending a tertiary hospital in Gauteng Province, South Africa. Methods: Cervical samples were collected from 526 participants aged ≥ 18 years using a Cervex Brush® Combi and tested for hr-HPV types on the Abbott m2000 analyzer using the Abbott RealTime HR HPV assay. Samples that tested hr-HPV deoxyribonucleic acid (DNA)-positive were further tested for hr-HPV E6/E7 messenger ribonucleic acid (mRNA) using the APTIMA® HPV assay on the Panther system (Hologic, Inc.). Sociodemographic data were collected using a self-administered questionnaire. Binomial regression analysis was used to assess factors associated with hr-HPV infection. Results: Overall hr-HPV DNA prevalence was 48.1% (95%CI: 43.8–52.4%). Of the hr-HPV DNA-positives, 24.5% (95%CI: 19.3–30.1) had HPV-16; 12.3% (95%CI: 8.5–16.9) had HPV-18 and 87.4% (95%CI: 82.6–91.2) had other 12 h-HPVs. Of the samples positive for hr-HPV DNA, 84.2% (95%CI: 79.1–88.5) (213/253) were positive for hr-HPV E6/E7 mRNA. Advanced age was an important factor linked to hr-HPV E6/E7 mRNA positivity. Based on multivariate binomial regression analysis, unemployment (PR: 1.50; 95%CI: 1.23–1.83) and being married (PR: 0.61; 95%CI: 0.47–0.81) were identified as statistically significant (p < 0.0001) predictive and protective factors, respectively, for hr-HPV infection. Conclusions: The prevalence of hr-HPV infection was high. Furthermore, hr-HPV DNA-positive samples had a high hr-HPV E6/E7 mRNA prevalence. The presence of hr-HPV E6/E7mRNA indicates active infection and thus a greater risk of developing the cervical disease. Therefore, HPV mRNA testing could be a better test to monitor women who are positive with Pap smear before colposcopy is performed to reduce the burden of referrals.

Background: In 2017, the South African National Department of Health (NDoH) Cervical Cancer Prevention and Control Policy was revised. Human papillomavirus (HPV) testing on self-collected samples may offer improved screening uptake. The objectives of the study were to compare the positivity of high-risk (hr)-HPV deoxyribonucleic acid (DNA) and hrHPV viral messenger ribonucleic acid (mRNA) between healthcare worker-collected cervical and self-collected vaginal samples and investigate the accuracy of the applicator-tampon-based self-collected samples in detecting hrHPV DNA and hrHPV mRNA. Methods: A total of 527 women aged 18 years and older and seeking gynecology services at a tertiary hospital in Pretoria, South Africa, were enrolled. Vaginal samples were self-collected using SelfCerv applicator tampon, followed by cervical samples collected by a healthcare worker using a Cervex Brush® Combi. Both samples were tested with the Abbott m2000 analyzer for 14-hrHPV types and 285 paired samples were tested for hrHPV E6/E7 mRNA using the Aptima HR-HPV mRNA assay. The prevalence of hrHPV DNA and hrHPV E6/E7 mRNA was estimated and the positivity between the two collection methods was compared for the total group as well as per age group. Results: HrHPV prevalence was 48.0% (95% CI 43.7–52.4) among healthcare worker collected samples and 47.6% (95% CI 43.3–52.0) among self-collected samples. There was no difference in positivity between healthcare worker collection (48.0%) and applicator-tampon-based self-collection, 47.6% (p-value = 0.90). The proportions of hrHPV were equal between the age groups as shown by the McNemar test (p = 0.9036) results for correlated proportions. The prevalence of hrHPV mRNA was 78.6% (95% CI 73.4–83.2) and 58.6% (95% CI 52.6–64.4) for healthcare worker- and self-collection, respectively. The McNemar test for correlated proportions was highly significant (p < 0.0001), indicating that the hrHPV mRNA proportions are not comparable, although this differed between age groups. Conclusions: Applicator-tampon-based self-collection has a comparable hrHPV DNA positivity rate as healthcare worker collection but different positivity rates for hrHPV mRNA. Self-sampling showed high concordance with healthcare worker-collected sampling for hrHPV DNA detection, especially regarding HPV 16/18 detection. HrHPV DNA was equally detected between the total group as well as per age group. Implementation of self-sampling using an applicator tampon as a primary screening tool may be considered.

Background: The South African Cervical Cancer Prevention and Control Policy was updated in June 2017, recommending liquid‐based cytology (LBC) as the preferred screening method and the investigation of self‐sampling for cervical cancer screening.Aim: To compare the performance of the Self Collection Cervical Health Screening Kit [SelfCerv (applicator tampon)] to the Cervex‐Brush Combi for cytology screening. The study further aimed to compare high‐risk (hr‐) human papillomavirus (HPV) and LBC test results from both methods.Methods: The study included 446 paired samples, comprising self‐collected (SelfCerv) and healthcare provider‐collected (Cervex‐Brush Combi) samples from women aged ≥ 18 years attending gynaecology outpatient clinics at a tertiary hospital in Pretoria, South Africa. LBC slides were prepared using the ThinPrep 5000 processor and manually stained with Hematoxylin and Eosin (H&E). Detection of 14 hr‐HPV types was performed using the Abbott RealTime HR‐HPV assay. Statistical analyses were performed using STATA version 17.0 (Stata Corp., College Station, Texas, USA).Results: A statistically significant difference in cervical cytology detection between the two methods was observed (p = 0.0025). The Cervex‐Brush Combi was more effective in collecting endocervical cells (73.4%; 95% CI: 69.0–77.9) compared to the SelfCerv applicator tampon (7.3%; 95% CI: 4.7–9.9); (p < 0.001). Cytological abnormalities were detected in 65.4% (136/208) of participants who tested positive for hr‐HPV by healthcare provider sampling compared to 40.8% (84/206) by self‐sampling. A fair agreement (κ: 0.35) with a concordance rate of 96.2% (95% CI: 94.4–98.0) was observed for specimen adequacy and diagnosis parameters [κ: 0.34, with a concordance rate of 67.7% (95% CI: 63.2–72.1)] between the two methods.Conclusion: The findings of this study do not support the implementation of applicator tampon‐based self‐collection as a method for cytology‐based cervical cancer screening.

Background and Aim: Human papillomavirus (HPV)-related cancers, especially cervical cancer, remain highly prevalent in low- and middle-income countries, despite the availability of preventive measures such as vaccination and self-sampling screening, due to limited HPV awareness. The study aimed to assess the knowledge of HPV, HPV vaccination practices, and HPV self-sampling awareness and perceptions among female students at the University of the Free State in Bloemfontein, South Africa. Methods: Data were collected from female university students through a self-administered questionnaire distributed via the secure web-based platform Research Electronic Data Capture (REDCap). HPV infection and vaccination knowledge were measured using a self-administered questionnaire. Knowledge was assessed by assigning one (1) point for each correct answer, while incorrect or “don't know” responses received a score of zero (0). A knowledge score above 75% was categorized as “good knowledge.” The data were analyzed using SAS version 9.4. Results: The study included 381 participants with a median age (interquartile range, IQR) of 23.0 (20–26) years. The findings showed that while 40.9% of participants had good knowledge of HPV infection, only 9.7% demonstrated good knowledge of HPV vaccination, and 13.3% had good overall knowledge. Only 13.4% of participants reported having received the HPV vaccine, while 19.1% expressed unwillingness to receive the vaccine. Barriers to vaccine uptake included lack of information about the HPV vaccine (46.0%) and safety concerns (46.0%). The majority (78.2%) were unaware of HPV self-sampling. Having heard about HPV self-sampling was predictive for HPV knowledge (OR: 2.684, 95% CI: 1.389–5.188, p = 0.003). Conclusion: These findings suggest that while some participants are informed about HPV infection, the majority are not well-informed about HPV vaccination and are unaware of HPV self-sampling. Additionally, barriers to HPV vaccination persist. Targeted educational interventions are needed to address awareness and knowledge gaps and vaccine hesitancy. These interventions could significantly improve HPV and cervical cancer prevention outcomes.