The Strategic Analysis, Research & Training (START) Center team was tasked by the Reproductive Health Technologies team at the Gates Foundation to evaluate the relationship between vaginal microbiome dysbiosis/bacterial vaginosis (BV) and HIV/STI acquisition/transmission, and the relationship between vaginal microbiome dysbiosis/BV and preterm birth (PTB). The goal of this evaluation was to translate findings into concrete guidance for future intervention trials.
The START team used a two-phase approach. Phase I was a rapid, tiered review of PubMed-indexed literature, anchored in the most recent systematic reviews/meta-analyses and extended with newer high-quality studies. Phase II was a deeper examination of clinical-trial evidence supplemented by three key-informant interviews. Given the client’s priorities, the START team evaluated intermediate microbiota (e.g., Nugent 4–6), diagnostic methods (Amsel vs. Nugent), symptom status, timing of sampling and outcomes, and the power and sample-size implications for VMB-product trials aimed at reducing HIV/STI risk or PTB.
Primary deliverables included a final presentation with clear takeaways, detailed appendices (study tables, DAG, trial-design considerations, sample-size frameworks), and a comprehensive literature-extraction workbook.
