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Table 2 Trial assessment schedule for Stage 1 (both arms A and B)

From: 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

  1. 1. Visit prefix nomenclature: Screening ‘S’; During ATI ‘A’; After Rebound ‘B’ After Second Rebound ‘C’
  2. 1. Screening and Enrolment visit may be combined into one visit where possible
  3. 2. 4-weekly visits repeated until viral rebound occurs
  4. 3. UNS: patients may request an additional ‘unscheduled’ visit to have HIV VL measured any time while still unsuppressed
  5. 4. bNAb sensitivity visit at screening not required if done as part of the HEATHER study
  6. 5. Arm B/Placebo participants (if they agree) will move to Stage 2 after viral rebound to continue with the study visits, B1 visit procedure will be conducted as per Stage 2 schedule, otherwise participants will follow Stage 1 visit schedule until the end of the study
  7. 6. #SARS-Cov-2 PCR will be conducted up to 72 h prior to randomisation/dosing visit and for the rest of the visits PCR will only be performed if participants exhibit COVID-19 (SARS-Cov-2) symptoms, however SARS-CoV-2 PCR testing can be offered to any asymptomatic participant attending at any study visit in accordance with local NHS guidelines, and participant or clinical team choice.
  8. 7. ATI Start visit (A2) can be conducted as an onsite or telephone visit if participant prefers
  9. 8. Arm B: Research bloods can be taken at the viral rebound visit or the Stage 2 dosing visit – not both visits.
  10. 9. SARS-Cov-2 antibodies blood test at screening is an optional test and is not used to determine if the patient is eligible for the study