Time Between Potential AE Text and Follow-up
Among the 2wT participants, there were 7111 responses to the daily SMS text message, of which 559 (7.9%) responses were a 1, or a potential AE. The nurse completed 704 potential AE forms, which included reports stemming from men who conveyed issues or concerns first via a free text and not the daily response; 649 potential AE forms were completed and were unique to 1 client per day. Potential AE forms included the documentation of concerns (AE type or severity) and triage (education, reassurance, wound care instructions, etc). The nurse could refer with or without suspicion of an AE, allowing them flexibility to assess each client individually. Referrals to care created a task for the site team to complete an in-person review. From the 649 filled potential AE forms, 50 (7.7%) referrals were made (including for 3 moderate and 1 severe potential AEs): 32 returned within 3 days, and 4 AEs were ascertained (moderate: 3/4, 75% and severe: 1/4, 25%).