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

IntroductionMultiplathogen 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 ofmulti-pathogenself-sampling for genital infections among women in Zambia.Methods and AnalysisThis 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 andTvself-testing and cervicovaginal self-swabs for (i) HPV by GeneXpert and, (ii)ShDNA detection by conventional (PCR) and isothermal (RPA) molecular methods.Schistosomaova 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. Acost-effectivenessanalysis is conducted in parallel.Ethics and disseminationThe 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 LimitationsFirst 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 addressingcost-effectivenessof community-based integration of FGS within the wider sexual and reproductive health screening in ZambiaExisting sexually transmitted infection related stigma in the communities may difficult recruitmentLimited availability of histopathology laboratories may delay results

Female genital schistosomiasis burden and risk factors in two endemic areas in Malawi nested in the Morbidity Operational Research for Bilharziasis Implementation Decisions (MORBID) cross-sectional study

“…Schistosome DNA retrieval from the genital tract could be used as a proxy marker for FGS-related morbidity in some women. Molecular testing of genital samples for FGS screening has been previously piloted in research settings across SSA countries and showed high diagnostic accuracy [2,12,13]. However, cost, and high-technology laboratory needs limit its scalability.…”

“…Overall, these limitations hinder the ability to obtain accurate FGS prevalence estimates [1]. Molecular diagnostic methods such as the polymerase chain reaction (PCR) for parasite DNA detection from genital samples, collected either at home or in clinic, have been validated in a study in Zambia and are being used in different countries, as an alternative, more accurate and less invasive method of FGS diagnosis in field settings [2,12,13]. To the best of our knowledge, no study has assessed molecular methods for FGS screening and diagnosis in Malawi.…”