Table 2 Summary of key changes from original stepped-wedge design to parallel arm wait-list trial
Trial component | Original stepped-wedge design | Parallel arm waitlist design |
|---|---|---|
Intervention implementation | Delivery to all clusters in two steps. 50% of clusters to receive the intervention from month 1 and the remaining 50% to receive the intervention from month 12. | Delivered to all clusters in two steps. 50% of clusters (i.e. intervention arm) to receive the intervention from month 1 and the remaining 50% (i.e. control arm) to receive the intervention after the trial end at approx. month 30. |
Up to 216 PLA community groups meeting on a monthly basis to progress through a schedule of 18 meetings over approx. 18 months. | Up to 216 PLA community groups meeting twice per month to progress through a schedule of a minimum of 13 meetings over a period of approx. 30 months. | |
Total duration of implementation across all 12 clusters to be approx. 24 months. | Total duration of implementation across all 12 clusters to be approx. 30 months (including periods of ‘lockdown’ where intervention was paused. | |
Timing of survey data collection | At baseline (month 1), month 12, and month 24. | At baseline (month 1) and post intervention implementation in intervention clusters (approx. month 30). |
Cluster exposure over time | Depends on timing - all clusters contribute data to both control and intervention exposure. | No change over time, i.e. intervention arm contributes to intervention exposure only, control arm contributes to control only. |
Total duration of project | 36 months | 54 months |