Table 1 Summary of trial procedures by time point
Baseline assessment (pre-randomisation) | Randomisation | Follow-up (time from randomisation) | ||||
|---|---|---|---|---|---|---|
Pathway 1 | Pathways 2 and 3 | Day 1 | Day 14 | Week 4 | Week 12 | |
Procedure | ||||||
a – Eligibility screen | X | X | ||||
b – Informed consent | X (paper) | X (electronic) | ||||
c – Baseline data collection | X | X | ||||
d – Randomisation | X | |||||
e – Prescribe usual care treatment | X | X | ||||
f – Issue randomised trial treatment | X For remote pathways, ‘issue’ refers to the shipment of treatment to the participant | |||||
g – Vaginal swab for STI testing | X | X ~ Self-taken, posted by a participant | ||||
h – Vaginal smear for microscopy | X (following local procedures) | X Self-taken, posted by a participant | X Remote only Self-taken, posted by participant | |||
i – Vaginal swab for future study of vaginal microbiota* | X* Self-taken, posted by a participant | X* Remote only Self-taken, posted by a participant | ||||
Interventions | ||||||
j – Dequalinium chloride (intervention group) | X (days 1–6) | |||||
k – Usual care antibiotics (control group) | X (duration of treatment in accordance with usual care) | |||||
Follow-up | ||||||
l –Treatment adherence text message | X | |||||
m – Participant questionnaire (online or postal based on preference) | X | X | ||||
n – Pregnancy outcome# | The outcome of participants pregnant at the time of randomisation or found to have conceived between randomisation and week 4 follow- up will be collected throughout the duration of the trial | |||||