Table 2 Outcome measures and timepoints of data collection
Outcomes | Measure | Data collection timepoints |
|---|---|---|
Primary outcomes | ||
 Retention in PrEP care | Number of participants completed clinical follow-ups | 3, 6, 9, 12 months |
 PrEP adherence | 1. Self-report in follow-up surveys: During the past 7 days and 30 days: (1) self-report taking once daily regimen: number of missed pills; perceptions of whether they had taken < 60%, 60–90%, or > 90% doses. (2) self-report taking on-demand regimen: number of sex events that are not covered by any PrEP (0 pills taken); correctly covered by PrEP (2 pills on the sex day (X) and X + 1, X + 2; or at least one pill taken on days X, X + 1, and X + 2 if the days between two sex events are less than one week); partially covered by PrEP (any other use). 2. Pill count at clinical visits: number of unused pills counted at each clinical follow-up (in-person or via phone) 3. Medical possession ratio: [(total days between first fill and end of follow-up) – (number of days without TDF-FTC in possession)] / total days of follow-up, based on medical refilling records | 3, 6, 9, 12 months |
 PrEP discontinuation | 120 days without TDF-FTC in possession based on medical refilling records. | 3, 6, 9, 12 months |
 PrEP reinitiation | Number of participants who discontinued TDF-FTC according to the study definition and then successfully restart PrEP, based on self-report and medical refilling records. | 3, 6, 9, 12 months |
Secondary outcomes | ||
 HIV testing | Frequency of participants, defined as the number of participants who reported being tested for HIV during the previous three months | 3, 6, 9, 12 months |
 Sexual and mental health mini-app use | Frequency of participants, defined as the number of participants who reported using the mini-app in the past three months to receive information about sexual and mental health comparing their pre-intervention and post-intervention engagement | 3, 6, 9, 12 months |
 PrEP self-efficacy | Frequency of participants, defined as number of participants who had an increase in PrEP self-efficacy when comparing their pre-intervention and post-intervention self-efficacy | 3, 6, 9, 12 months |
 HIV incidence | Frequency of participants, defined as number of participants who reported who have newly diagnosed with HIV in the previous three months | 3, 6, 9, 12 months |