Summary of the PRELUDE study procedures
| Data collection round | Screening Visit 0* | Baseline Visit 1 | Follow-up 1 Visit 2 | Follow-up 2 Visit 3 | Follow-up 3 Visit 4 | Follow-up 4 Visit 5 | Follow-up 5 Visit 6 | Follow-ups 6–10 Visits 7–11 | Follow-up 11 Visit 12 | Post-PrEP assessment | Data collection round |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Timeline | Week 2 | 0 | Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | Months 15–27 | Month 30/discontinuation | 3 months post discontinuation | 6 months post discontinuation |
| Consent | X | ||||||||||
| Review eligibility | X | X | X | X | X | X | X | X | |||
| Medical history | X | X | |||||||||
| Adverse events | X | X | X | X | X | X | X | X | |||
| Lab tests | X | X | X† | X | X† | X | X† | X | X | X | |
| Dispense medication | X | X | X | X | X | X | X | ||||
| STI testing‡ | X§ | X | X | X | X | X | X | X | X | ||
| HIV testing | X | X | X | X | X | X | X | X | X | X¶ | X¶ |
| Survey | X | X | X | X | X | X | X | X | X | X | X |
*Visits 0 and 1 may be combined.
†Blood collected for plasma/PBMCs/serum at months 1, 6 and 12.
‡Obtained per standard of care.
§Hepatitis B status obtained prior to baseline.
¶HIV status post-PrEP discontinuation may be obtained via data linkage.
PBMCs, peripheral blood mononuclear cells; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.