1. Design

How participants were allocated to interventions (eg "random allocation", "randomised", or "randomly assigned"), specifying that allocation was based on clusters.

A, B, C, E, G, H, J, K, L

2. Background

Scientific background and explanation of rationale, including rationale for using a cluster design.

A, B, C, E, G, H, J, K

3. Participants

Eligibility criteria for participants and clusters and the settings and locations where data were collected.

A, B, C, E, G, H, J, K, L

4. Interventions

Precise details of the interventions intended for each group, whether they pertain to the individual level, the cluster level, or both, and how and when they were actually administered.

A, B C, D, E, F, G, H, I, J, K, L

5. Objectives

Specific objectives and hypotheses and whether they pertain to the individual level, the cluster level, or both.

A, B C, D, E, F, G, H, I, J, K, L

6. Outcomes

Clearly defined primary and secondary outcome measures, and whether they pertain to the individual level, the cluster level, or both.

B, F, G, H, K, L


And, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors)

Not assessed/judged

7a. Sample size

How total sample size was determined including method of calculation, number of clusters, cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty).

B, E, J, K, L

7b. Sample size

And, when applicable, calculation of interim analyses and stopping rules.

K (no other article calculated interim analyses)

8. Sequence generation

Method used to generate the random allocation sequence, including details of any restriction, (eg blocking, stratification, matching).

A, B, C, E, F, H, K, L

9. Allocation concealment

Method used to implement the random sequence (eg, numbered containers or central telephone), specifying that allocation was based on cluster rather than individuals and clarifying whether the sequence was concealed until interventions were assigned.

None

10. Implementation

Who generated the allocation sequence, who enrolled participants and who assigned participants to their groups.

G, H

11a. Blinding

Whether or not participants, those administering the interventions and those assessing the outcomes were blinded to group assignment.

J, K

11b. Blinding

If done, how the success of blinding was evaluated.

F (no others assessed blinding)

12a. Statistical methods

Statistical methods used to compare groups for primary outcome(s), indicating how clustering was taken into account.

A, B, C, D, E, F, G, H, J, K, L

12b. Statistical methods^{iii}

Methods for additional analyses, such as subgroup analyses and adjusted analyses

F

13. Participant flow^{iv}

Flow of clusters and individual participants through each stage. Specifically for each group report the numbers of clusters and participants randomly assigned, receiving intended treatment, completing the study protocol and analysed for the primary outcome.

B, D, F, H (see footnote for further explanation)


Describe protocol deviations from study as planned, together with reasons.

Not assessed/judged

14. Recruitment

Dates defining the periods of recruitment and followup

B, F, G, H, K, L

15. Baseline data

Baseline demographic and clinical characteristics for the individual and cluster levels as applicable.

A, B C, E, G, H, I, J, K, L

16. Numbers analysed^{v}

Number of clusters and participants (denominator) in each group included in [recovery] analyses and whether analysis [not specific to recovery] was by "intention to treat". State the results in absolute numbers when feasible (eg, 10/20 not 50%)

B, D, F, J, L

7. Outcomes and estimation^{v}

For [recovery analyses], a summary of results for each group for the individual or cluster level as applicable and the estimated effect size and its precision (eg, 95% CI)".

None

18. Ancillary analyses

Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory.

None (N/A for L)

19. Adverse events

All important adverse events or side effects in each intervention group.

None

20. Interpretation

Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes.

None

21. Generalisability

Generalisability (external validity) to individuals and/or clusters (as relevant) of the trial findings.

A, C, D, E, F, G, H, I, J, K, L

22. Overall evidence

General interpretation of results in the context of current evidence

A, B, D, E, F, G, H, I, J, K, L
