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) |