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. Author manuscript; available in PMC: 2024 Apr 1.
Published in final edited form as: Contemp Clin Trials. 2023 Feb 24;127:107134. doi: 10.1016/j.cct.2023.107134

Table 5.

Changes to study components after the launch of the trial.

Component Original Design Amended Design
Eligibility
 Age 18 – 29 18 – 34
 HIV status HIV negative test result HIV negative test result OR self-report HIV negative or unknown status
 Condomless anal sex Self-report in previous 6 months No requirement
 Location (DTC arm) 22 US counties Nationwide
Delivery
 Session Breaks
 (Sessions 1 – 3)
8-h breaks Optional breaks
 Follow-up Content Timepoint 3- and 6-months 6- and 12-weeks
 Follow-up Survey Timepoint 3-, 6-, and 12-months 12-weeks
 Follow-up Testing Timepoint 12-months 12-weeks
Incentives
 CBO $200 survey raffle; At CBO discretion (sessions 1 – 3 and at 6-weeks) Original design incentives plus $20 (12-week survey) and $20 (12-week at-home STI testing)
 DTC $200 survey raffle Original design incentives plus $50 (sessions 1 – 3); $10 (6-week); $20 (12-week survey); $20 (12-week STI testing)