Phase I of the DiaVACCS screening trial: Study design, methods, population demographics and baseline results

Abstract


 
 
 
 Background. Human papillomavirus (HPV)-based primary screening guidelines are based on screening test performance and prevalence data generated in high-resource areas with low HIV infection rates. There is an urgent need for local data on infection and disease prevalence, as well as screening test performance, among both HIV-positive and HIV-negative South African (SA) women, in order to inform updated screening guidelines.
 Objectives. This study describes the baseline characteristics of participants in the cross-sectional phase of the multicentric DIAgnosis in Vaccine And Cervical Cancer Screen (DiaVACCS) screening trial. The objective was to determine the prevalence of positive screening and pre-invasive disease using different tests and strategies in the SA HIV-positive and HIV-negative population.Methods. A total of 1 104 women aged 25 - 65 years and eligible for screening were included, 465 HIV positive and 639 HIV negative. Visual inspection and molecular and cytological screening tests were done on self-sampled and healthcare worker-collected specimens. All participants who screened positive and 49.1% of those who screened negative were invited for colposcopy and biopsy, and those qualifying for treatment were recalled for large loop excision of the transformation zone as part of the trial. The worst histology result for each participant was used, and for untested women, multiple imputation was used to estimate verification bias- adjusted histology values.
 Results. Visual inspection was positive in 50.4% of HIV-positive v. 20.9% of HIV-negative women, cytology (atypical squamous cells of undetermined significance) in 39.9% v. 17.0%, and high-risk HPV DNA in 41.2% v. 19.6%. Overall, high-grade squamous intraepithelial lesion-positive cytology peaked in the age group 30 - 39 years at 16.7%. After adjustment for verification bias, histological diagnosis of cervical intraepithelial neoplasia (CIN)2+ was suspected in 44.7% v. 23.5% and CIN3+ in 23.3% v. 10.2% of HIV-positive and negative women, respectively. Invasive cancer was diagnosed in 15 women (1.95% of histological studies performed), and verification bias adjustment suggested 20 cases (1.8% of the study population).
 Conclusion. The baseline findings from the DiaVACCS trial confirm a high prevalence of HPV-related cervical pathology in the SA HIV-negative screening population, showing a clear need to reach these women with a screening programme. Among HIV-positive women, prevalence values were almost doubled. The prevalence of existing invasive cervical cancer was 1 - 2% of all women. Further analysis of the performance of single and multiple screening tests between the two subgroups will contribute to the choice of the most effective strategies to identify women at risk of developing invasive cancer.
 
 
 

Cytology compared with Hybrid Capture 2 human papilloma virus cervical cancer screening in HIV positive and HIV negative South African women

“…This difference was also clearly demonstrated in the HPV test results and confirms the findings of similar studies in the rural Eastern Cape and elsewhere in Africa 23 24. Prevalence rates of HPV and abnormal cytology exceeded the expected rates in HIV negative women compared with other studies 25…”

“…Patients attending various clinics at Steve Biko Academic Hospital and Kalafong Provincial Tertiary Hospital in the Gauteng Province, and Tygerberg Academic Hospital in the Western Cape Province of South Africa, were recruited to the study. The detailed methods section has been published and will be summarized below 17…”

Examining the Prevalence and Risk Factors of Genital Warts among HIV-Infected and HIV-Negative Women: A Cross-Sectional Study in Cameroon

“…The heightened prevalence of genital warts among HIV-positive women underscores the elevated cervical cancer rates observed in Africa (Ba et al, 2021). Notably, HIV-positive individuals exhibit a higher prevalence of high-risk HPV, highlighting HIV as a potential risk factor for genital cancer (Dreyer et al, 2022; Hlahla, 2023; Riddell IV et al, 2022; Sosso et al, 2020). The weakened immune system in HIV facilitates HPV replication and progression, leading to cervical intraepithelial lesions and genital warts (Taku et al, 2020).…”

Examining the Prevalence and Risk Factors of Genital Warts among HIV-Infected and HIV-Negative Women: A Cross-Sectional Study in Cameroon

“…Notably, HIV-positive individuals exhibit a higher prevalence of high-risk HPV, highlighting HIV as a potential risk factor for genital cancer (Dreyer et al, 2022;Hlahla, 2023;Riddell IV et al, 2022;Sosso et al, 2020). The weakened immune system in HIV facilitates HPV replication and progression, leading to cervical intraepithelial lesions and genital warts (Taku et al, 2020).…”