Introduction: Secondary prophylaxis for rheumatic heart disease (RHD), in the form of four-weekly intramuscular benzathine benzylpenicillin G (BPG) injections, has remained unchanged since 1955. Qualitative investigations into patient preference have highlighted affinity for therapies to be delivered less frequently, ideally with reduced pain. We describe the experience of healthy volunteers participating in a phase-I safety, tolerability and pharmacokinetic trial receiving subcutaneous infusions of high-dose benzathine penicillin G (SCIP-I).
Methods: Participants in the SCIP I study (n=24) received a 15–30-minute infusion of SCIP into the subcutaneous tissues of the abdominal wall. They were interviewed at four timepoints using a semi-structured interview guide. Interviews were recorded, transcribed verbatim and thematically analysed. Tolerability, specific descriptors of the experience and how the intervention could be improved with reference to planned iterations in a paediatric cohort currently receiving monthly BPG intramuscular injections for RHD were explored.
Results: Participants tolerated the infusion well and were able describe their experiences throughout. Most reported minimal pain, substantiated via quantitative pain scores. The infusion did not impair normal duties, and abdominal bruising at the infusion site did not concern participants. Insight into how SCIP could be improved for children included distraction, amended analgesia location and timing, and reduced infusion speed. Trust in the trial team was high.
Conclusion: Qualitative research is an important adjunct for early clinical trials, particularly when adherence to the planned intervention is a key factor of success. These results have informed the participant information sheets for later-phase SCIP trials in people living with RHD.