The Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multi-pathogen screening in women, including female genital schistosomiasis, HPV, Trichomonas and HIV in Zambia

ABSTRACT Introduction Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment. Infections include sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus [HPV] for cervical precancer detection) and non-sexually transmitted pathogens ( Schistosoma haematobium (Sh)) pathogens, in endemic settings with high co-infection prevalence. Chronic infection may lead to disability (female genital schistosomiasis (FGS) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multi-pathogen self-sampling for genital infections among women in Zambia. Methods and Analysis This is a longitudinal cohort study aiming to enrol 2,500 non-pregnant, sexually active and non-menstruating women aged 15-50 years from two districts in Zambia with two year follow up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (i) HPV by GeneXpert and, (ii) Sh DNA detection by conventional (PCR) and isothermal (RPA) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up midwifes perform same procedures and obtain hand-held colposcopic images. High-risk -HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel. Ethics and dissemination The University of Zambia Biomedical Research Ethics Committee (UNZABREC) approved the study in September 2021 (reference: 1858-2021), the London School of Hygiene and Tropical Medicine(LSHTM) (reference: 25258) and Ministry of Health and local superintendents. Written informed consent was obtained from all participants prior to enrolment. Data will be available upon request on LSHTM Data Compass. Identifiable data collected is stored securely and their confidentiality protected in accordance with the Data Protection Act 1998. Strenghts and Limitations First longitudinal cohort study of female genital schistosomiasis (FGS) Home ‘package’ testing for validation and acceptability of self-sampling (FGS, HR-HPV) and self-testing (HIV and Trichomonas) First study addressing cost-effectiveness of community-based integration of FGS within the wider sexual and reproductive health screening in Zambia Existing sexually transmitted infection related stigma in the communities may difficult recruitment Limited availability of histopathology laboratories may delay results