Impact of point-of-care testing on the management of sexually transmitted infections in South Africa: Evidence from the HVTN702 HIV vaccine trial.
Asare K., Andine T., Naicker N., Dorward J., Singh N., Spooner E., Andriesen J., Osman F., Ngcapu S., Vandormael A., Mindel A., Abdool Karim SS., Bekker L-G., Gray G., Corey L., Tomita A., Garrett N.
BACKGROUND: Alternative approaches to syndromic management are needed to reduce high rates of sexually transmitted infections (STI) in resource-limited settings. We aimed to determine the impact of point-of-care (POC) versus central laboratory-based testing on early STI treatment initiation and reporting of adverse events (AEs) that were STIs (STI-AE). METHODS: We used Kaplan-Meier and Cox regression models to compare times to STI treatment initiation and STI-AE reporting among HVTN702 HIV vaccine trial participants at three research clinics in South Africa. Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) were diagnosed with POC assays at eThekwini clinic and with central laboratory-based systems at Verulam and Isipingo clinics. All clinics used POC assays for Trichomonas vaginalis (TV) testing. RESULTS: Among 959 women (median age 23 years, IQR 21-26), median days (95%CI) to NG/CT treatment initiation and NG/CT-AE reporting were 0.20 (0.16-0.25) and 0.24 (0.19-0.27) at eThekwini versus 14.22 (14.12-15.09) and 15.12 (13.22-21.24) at Verulam/Isipingo clinics (all p 0.05). Cox regression analysis revealed that NG/CT treatment initiation (aHR = 39.62, 95%CI 15.13-103.74) and NG/CT-AE reporting (aHR = 3.38, 95%CI 2.23-5.13) occurred faster at eThekwini compared to Verulam/Isipingo clinics, while times to TV treatment initiation (aHR = 0.93, 95%CI 0.59-1.48) and TV-AE reporting (aHR = 1.38, 95%CI 0.86-2.21) were similar between clinics. CONCLUSIONS: POC testing led to prompt STI management with potential therapeutic and prevention benefits, highlighting the utility as diagnostic tools in endemic resource-limited settings.