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Table 2 DSMB recommendations

From: Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial

Primary data analysis recommendation

Communication strategy probable components

1. That the study continues as planned.

Routine action indicated

• Routine communication to PIs and critical collaborators

• Distribution of primary data analysis minutes to relevant parties

2. That the study be modified because policy changes now recommend single-dose vaccination.

3. That the study be stopped due to concerns about participant safety, including social harms.

Urgent action indicated

• Expedited communication to PIs, critical collaborators, regulators, and associates

• Key messages and briefing materials

• Protocol modifications

• Participant information

• IRB and regulatory approvals

• Distribution materials to relevant organizations