Trial design and pre-implementation | |
â–ª Increased sample size to account for potential contamination (up to 15%) | |
â–ª Focus group discussions and literature reviews have explored types, extent of, and measures to reduce possible contamination sources. Overall risk of contamination deemed to be very small | |
â–ª Focus group discussions identified video recall items to measure contamination | |
â–ª Trial staff and trial clinic training emphasizes the implications of contamination, how to avoid it, how to address questions using non-biased explanations, and the need to ensure VITAL Start and SOC are delivered in separate places | |
Implementation | |
â–ª VITAL Start and SOC occur in separate locations, and intervention is delivered by trained RAs | |
â–ª Participants will be escorted between counseling and survey locations | |
â–ª Level and extent of patient-reported contamination is measured at follow-up visits | |
â–ª Video is on password-protected tablet that is stored at the health facility and not available through other channels | |
â–ª Information packs with VITAL Start materials are clearly labeled and stored separately from SOC materials | |
â–ª Any accidental contamination by trial or health facility staff will be recorded on Unanticipated Problems Forms that are reviewed monthly at site-level meetings and supervisions | |
â–ª Site Research Supervisor to confirm trial participants only receive assigned intervention | |
â–ª Rationale and techniques for reducing contamination discussed at monthly site meetings with health facility and trial staff | |
▪ Information regarding participant’s trial arm allocation is kept in a locked drawer that can only be accessed by RA | |
â–ª Contamination is measured quarterly as a component of checklist to measure the degree of fidelity [63] | |
Strategies to ensure treatment fidelity | |
â–ª Fidelity checklists completed by RA (self-administered) and observer. Key issues discussed at quarterly staff meetings | |
â–ª Intervention sessions audio recorded, and 10% reviewed centrally | |
â–ª Electronic time-stamps of session start and end time and bi-monthly supervisions by trial coordinator | |
â–ª Unannounced trial coordinator visits | |
â–ª Plans for implementation setbacks which include two providers (RAs) per site, back-up tablets, paper forms, power banks, and back-up physical space for intervention implementation | |
Analysis | |
â–ª If contamination occurs, we will perform contamination-adjusted intention-to-treat analysis [64] | |
â–ª The degree, nature, and effects of contamination will be included in final manuscripts |