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

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 ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study is funded through a UKRI Future Leaders Fellowship (MR/T041900/1) awarded to Prof. AL Bustinduy. Prof E Webb and Prof R Hayes received funding from MRC Grant Reference MR/K012126/1. This award is jointly funded by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement and is also part of the EDCTP2 programmme supported by the European Union. Funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: 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. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes . 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. * AE : Adverse Event EDC : Electronic Data Capture FGS : Female Genital Schistosomiasis CAA : Circulating anodic antigen CIN : Cervical intraepithelial neoplasia ICC : Invasive Cervical Cancer LLETZ : Large loop excision of the transformation zone CW : Community workers HR-HPV : High Risk Human Papilloma Virus ODK : Open Data Kit PCR : Polymerase Chain Reaction RPA : Recombinase Polymerase Amplification SCW : Schista Community Worker SRH : Sexual and Reproductive Health Sh : Schistosoma haematobium SSA : Sub-Saharan Africa STI : Sexually transmitted infections Tv : Trichomonas vaginalis VIA : Visual inspection with acetic acid