Table 1.

GIFT study objectives

	Diagnostic study	Integration into care study
Primary objective	To assess the sensitivity and specificity of the GIFT device at the point-of-care in South Africa, Zimbabwe and Madagascar	To evaluate how the GIFT device could be integrated into routine care
Secondary objectives	To assess the predictive values of the GIFT device at the point-of-care To assess the performance of the GIFT device at the point-of-care To assess the performance of the device vs syndromic management without any laboratory testing (standard of care in South Africa, Zimbabwe and Madagascar) To determine the robustness of the device by comparing results read by clinicians with those read by laboratory professionals, and with the results obtained using an automated reader To evaluate the accuracy of the GIFT device by comparing the GIFT device results with ELISA results using previously validated concentration cut-offs as the gold standard, including validation of the GIFT cytokine concentration cut-offs for each cytokine biomarker	To qualitatively and quantitatively assess the user experience, usability and acceptability of the GIFT device at the point of care To examine patient preferences for various STI management aspects (attributes) to inform the development of STI management algorithms that integrate the GIFT device To generate algorithms that integrate the GIFT device to optimise case finding and STIs/vaginal infection management in women, using the complete dataset from the study To determine the cost and budget impact of the identified screening or diagnostic algorithm with the GIFT device, and to model the cost-effectiveness of different strategies of integration of GIFT into care
Exploratory objectives	Determine if other determinants (such as intermediate microbiota (Nugent 4–6), age, parity, sexual activity) improve the prediction of STI/BV status in women To use 16S rRNA gene sequencing and vaginal bacteria specific quantitative NAATs to evaluate the proportion of cases of genital inflammation explained by vaginal dysbiosis that was not diagnosed as an STI or BV by NAATs or Nugent scoring To explore the performance of the device in the presence of vaginal Candida spp colonisation

BV, bacterial vaginosis; GIFT, Genital InFlammation Test; NAAT, nucleic acid amplification test; STI, sexually transmitted infection.