Genital inflammation screening for predicting sexually transmitted infections and bacterial vaginosis: an updated cost analysis from the GIFT study in Madagascar, South Africa, and Zimbabwe.

Abstract

Sexually transmitted infections (STIs) and bacterial vaginosis (BV) are significant public health issues, particularly in sub-Saharan Africa, and are associated with genital inflammation and increased HIV acquisition risk. A substantial proportion of these infections are asymptomatic, limiting the effectiveness of syndromic management. The Genital InFlammation Test (GIFT), a novel rapid point-of-care (POC) test, was developed to detect elevated inflammatory biomarkers associated with genital inflammation. The first-in-field prototype of the GIFT device was evaluated in a multicenter observational study conducted in South Africa, Zimbabwe, and Madagascar. This study updates prior cost estimates using a hypothetical GIFT prototype in South Africa and extends the analysis to routine family planning services in Madagascar, and Zimbabwe. A provider-perspective, combining a top-down and bottom-up costing approach, was conducted at device evaluation observational study sites in Madagascar, South Africa, and Zimbabwe (n = 1 per country). Economic costs, including capital and recurrent expenditures, were collected through facility records, interviews, and self-reported provider timesheets to determine the incremental cost of integrating GIFT screening into family planning consultations. Research-related costs were excluded. A probabilistic sensitivity analysis using Monte Carlo simulation was performed to address parameter uncertainty, particularly around GIFT's estimated market price of US$5.00. The incremental cost per woman screened with GIFT was estimated to be US $6.46 (95% CI: US $1.98 - US $12.22) in Madagascar, US $9.05 (95% CI: US $3.78 - US $15.83) in South Africa, and US $8.28 (95% CI: US $3.04 - US $16.52) in Zimbabwe, slightly higher than previous estimates for South Africa (US $3.53 - US$ 5.32). Recurrent costs (personnel, supplies, and overheads) constituted more than 98% of this cost, with the GIFT device being the primary cost driver. Updated costs suggest slightly higher implementation costs than previous estimates. This analysis suggests that the affordability and potential scale-up of GIFT and other novel POC screening tools will depend heavily on their final market price. These findings provide essential economic evidence to inform further analyses on cost-effectiveness, affordability, and optimal integration of GIFT into routine sexual and reproductive healthcare services in low- and middle-income countries.