Background: Cervical cancer causes over 300,000 deaths annually, mainly in low- and middle-income countries. Current screening methods face high cost, subjectivity, and feasibility challenges. The EASTER project aims to develop two point-of-care technologies: the n-Gyn device for the diagnosis and treatment of precancerous lesions and a urine-based spectroscopy method for HPV screening.
Objectives: The aims of this preliminary analysis was to assess the prevalence of HPV infection, including high-risk genotypes, and examine differences by HIV status, as well as to evaluate the occurrence and genotype distribution of cervical precancerous lesions (CIN2+) and invasive cancer among HPV-positive women.
Methods: The EASTER study comprises two phases—design and validation—and is being conducted in Harare, Zimbabwe. By December 2024, a total of 1,098 women aged 25–49 had been enrolled in Phase 1. Participants provided self-collected vaginal and urine samples. Vaginal samples were tested using ScreenFire, while urine samples were analyzed with ScreenFire and AI-driven FTIR spectroscopy. Clinical management of participants was based solely on cervical test results; all other tests using urine samples were conducted for research purposes only. During colposcopy, cervical images were captured using the nGyn system, an AI tool under development to predict precancerous lesions and guide treatment. Women diagnosed with CIN2+ on cytology were referred for treatment with LETZ or cancer management as indicated, following local guidelines.
Results: A total of 1,098 participants were enrolled in phase 1(99.8% of those approached), with valid vaginal HPV results available for 1,089 women (99.2%). HIV status was available for 861 participants, with a prevalence of 20.6% (177/861); 99.4% of HIV-positive women reported receiving ART (176/177). Overall, HPV positivity among the 1,089 women was 28.2% (307/1,089). Specifically, 53 women were positive for HPV16 only, 61 for HPV18 and/or 45 (excluding HPV16), 7 for both HPV16 and 18/45, and 186 for other high-risk HPV (HrHPV) types. HrHPV prevalence was higher in HIV-positive women (42.4%, 75/177) than in HIV-negative women (26.5%, 181/684). All HrHPV-positive women were invited for colposcopy, with 83.1% attendance overall (255/307) and 78.7% among HIV-positive women (59/75). Local clinical assessment identified 62 cases of cervical intraepithelial neoplasia grade 2 or higher (CIN2+), including 14 among HIV-positive women. Forty cases have been confirmed by external expert review, with full review ongoing. HPV16 was the most frequently detected genotype in CIN2 (19.2%), CIN3 (35.3%), and invasive cancer (50.0%). Other HrHPV types (excluding 16/18/45) were common in CIN2 (61.5%) and CIN3 (47.1%) but absent in invasive cancer, while HPV18/45 (excluding 16) was less frequent—15.4% in CIN2, 8.8% in CIN3, and 50% in invasive cancer. Coinfections with HPV16 and 18/45 were rare. Similar genotype distributions were observed among HIV-negative women.
Conclusion: During phase 1, HPV was detected in 28.2% of women, higher in HIV-positive (42.4%) than HIV-negative (26.5%). CIN2+ lesions were common among HrHPV-positive women, with HPV16 predominating in CIN2, CIN3, and invasive cancer. Other HrHPV types were frequent in precancer but absent in cancer, while HPV18/45 mainly contributed to invasive cancer. Results highlight the need for targeted HPV screening by genotype and HIV status.