CUSTOMIZE: overall results from a hybrid III implementation-effectiveness study examining implementation of cabotegravir and rilpivirine long-acting injectable for HIV treatment in US healthcare settings; final patient and provider data

BACKGROUND: CUSTOMIZE examined implementation strategies for provider-administered long-acting (LA) injectable ART in diverse US healthcare settings. Findings from staff and patients after 12 months of cabotegravir+rilpivirine (CAB+RPV) LA implementation are reported.
METHODS: Twenty-four staff [physicians, injectors, administrators (n=8 each)] from 8 clinics completed surveys and interviews at baseline, interim (M4), and Month 12 (M12, n=23). All patients received monthly CAB+RPV LA and completed surveys (n=109 and 102), a subset completed interviews at baseline and M12 (n=34 and 31), respectively. Interviews were recorded, transcribed, and analyzed using ATLAS.ti (v8.1).
RESULTS: Staff found CAB+RPV LA acceptable, appropriate, and feasible to implement across clinic types (Table). At baseline, providers' (80.8%) top concern was patient ability to maintain monthly appointments; at M12, only 51.3% had this concern. Most providers (78.3%) felt optimal implementation was achieved within 1-3 months. Providers reported 3 key successful implementation strategies with patient adherence: good communication about target dosing window, appointment reminder systems, and designated staff accountable for appointment tracking. Top strategies for successful clinic implementation were good staff communication, teamwork, and web-based treatment planner. Qualitative insights varied by clinic type. Federally Qualified Health Centers' initial concerns on leadership support were mitigated by clinical data and implementation ease. University-based clinics' initial concern about patients keeping appointments was mitigated through tracking and patient-friendly reminder systems. Private practices were initially concerned about injection visit frequency and length; by M12, visit length was short and increased touchpoints benefited patient-provider relationships. Some clinics noted patients' enthusiasm and monthly compliance were key to success. Sustainability and scalability tactics included increasing/training new staff and effective injection schedule management. By M12, 74% of patients reported nothing interfered with their ability to receive CAB+RPV LA; 94% preferred LA over oral dosing.

Table. Staff Participant Acceptability, Appropriateness, and Feasibility by Clinic Type at Month 12
	Federally Qualified Health Centers (FQHCs) (n=6) Agreed/Completely Agreed % (Mean Scale Score)	University Clinics (n=6) Agreed/Completely Agreed % (Mean Scale Score)	Private Practice (n=5) Agreed/Completely Agreed % (Mean Scale Score)	AIDS Healthcare Foundation (AHF) (n=3) Agreed/Completely Agreed % (Mean Scale Score)	Health Management Organization (HMO) (n=3) Agreed/Completely Agreed % (Mean Scale Score)	Total (n=23) Agreed/Completely Agreed % (Mean Scale Score)
Acceptability of Intervention Measure (AIM)	100% (4.29)	100% (4.75)	100% (4.40)	100% (5.00)	66.7% (3.67)	95.6% (4.45)
Intervention Appropriateness Measure (IAM)	100% (4.33)	100% (4.83)	100% (4.60)	100% (5.00)	100% (4.33)	100% (4.61)
Feasibility of Intervention Measure (FIM)	100% (4.38)	100% (4.75)	80% (4.40)	91.6% (4.58)	100% (4.00)	94.5% (4.46)
AIM, IAM, and FIM are each 4 item measures scored 1-5; 1= completely disagree and 5= completely agree. Mean Scores and Mean proportion who agreed (4) or completely agreed (5) to each of 4 statements for each measure are reported.

CONCLUSIONS: In CUSTOMIZE, LA ART was successfully implemented across a range of US healthcare settings. Barriers were mitigated with minor process adjustments. Patients reported few barriers to monthly appointments and most preferred CAB+RPV LA over daily oral therapy.