Validation of home-based cervical and vaginal self-sampling for the diagnosis of female genital schistosomiasis (FGS) in Zambian women with and without HIV seroconversion

Female genital schistosomiasis (FGS) affects more than 45 million women worldwide and in sub-Saharan Africa it is possibly the most underestimated gynaecological affliction caused by an infectious agent, the water-borne parasite S. haematobium (Sh). FGS is associated with infertility with compelling evidence of increased HIV prevalence in women infected with Sh. FGS diagnosis is extremely challenging as it relies on expensive equipment that is seldom available in areas with limited resources. The overall aim of this project is to test the performance and acceptability of home-based genital self-sampling procedures for the detection of Sh DNA, and to validate novel molecular diagnostic assays to diagnose FGS in Zambia, with and without HIV seroconversion. The project will also explore novel biomarkers of inflammation from vaginal fluid as potential markers of disease severity.

This study is a proof of principle study that can lead to future expansion of community-based diagnosis for FGS. The study has high feasibility as it will take advantage of resources nested in the largest HIV longitudinal cohort study ever conducted to date. Results can provide the groundwork for the design of large cluster randomised trials for the community diagnosis of FGS.