The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection—study protocol for a two-stage randomised phase II trial

Table 3 Trial assessment schedule for Stage 2 (arm B only)

1. Visit prefix nomenclature: Screening ‘S’; During TI ‘A’; After First Rebound ‘B’; After Second Rebound ‘C’
2. 4-weekly visits repeated until viral rebound occurs
3. UNS: patients may request an additional ‘unscheduled’ visit to have HIV VL measured any time while still unsuppressed
4. ^#SARS-Cov-2 PCR will be conducted up to 72 h prior to ATI visit (B20) and for the rest of the visits PCR will only be performed if participants exhibit COVID-19 (SARS-Cov-2) symptoms
5. Visit B1 can be conducted as an onsite or telephone visit for arm B participants. The safety bloods and physical examination can be conducted at the confirmatory viral rebound visit if participant chooses B1 to be a telephone visit.
6. Research bloods can be taken at the dosing visit or the viral rebound visit at Stage 1—not at both visits
7. Visits B11-19 can be 4-weekly visits if participant has had two previous undetectable viral load while on ART

ISSN: 1745-6215