BACKGROUND: CARISEL is a hybrid implementation-effectiveness study examining the processes for optimizing implementation of CAB+RPV LA for the treatment of HIV-1 in virologically suppressed adults.
METHODS: Quantitative and qualitative data regarding clinic processes were collected from 62 staff study participants (SSPs) from 18 sites across Belgium, France, Germany, the Netherlands, and Spain at Months 1, 5, and 12. Clinic processes used in CARISEL to implement CAB+RPV LA were summarized in three distinct phases: pre-appointment, during appointment, and after clinic visit.
RESULTS: Pre-appointment processes included sending appointment reminders, preparation of paperwork, and arranging medication pick-up process with the pharmacy (Figure). Medication collection processes differed; some SSPs (24%) reported patient participants collected CAB+RPV LA during clinic visits, while others (19%) had staff collect it from the pharmacy prior to visits. Some sites in Germany and France were unique as prescriptions were given to the patient during the previous clinic visit to allow for pick-up prior to their next appointment (discussed by 19% of SSPs). Clinic appointment process flows were similar across countries (example flows shown in Figure): patients consulted with a nurse or doctor, medication was brought to room temperature, injection was administered, and patient was monitored for 10 min. Some clinics scheduled future appointments at the start of the clinic visit, while some scheduled them after injection administration. Post-visit tasks included laboratory work and cleaning up workspace. Over 50% reported spending 20 min or less with patients at visits. Most (76%) spent 20 min or less per week ensuring appointment attendance. The majority (68%) found time spent in clinic for patient appointments very to extremely acceptable.
CONCLUSIONS: Process flows varied slightly, yet there were many common components across clinics and countries. CARISEL data suggest implementation processes were incorporated into routine care and were acceptable compared with other HIV routine appointments in European clinics.