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. Author manuscript; available in PMC: 2018 Oct 1.
Published in final edited form as: Contemp Clin Trials. 2017 Jul 5;61:55–62. doi: 10.1016/j.cct.2017.07.007

Table 1.

LOVED Aims and Structure

Phase 1 Formative analysis Conduct 9 total focus groups using: i) LDKT recipients; ii) LDKT donors; iii) ESRD patients who declined to approach potential donors (PDs); and, iv) transplant healthcare providers/staff.

Program Development

Phase 2 Proof of Concept (n=27) 2a. Conduct an 8-week single-arm proof of concept trial with African American ESRD patients (0–10 years on dialysis) to assess intervention fidelity, tolerability (% adherence, % drop out), and increases in LDKT related knowledge, attitudes and self-efficacy at baseline and 8 weeks.
2b. Conduct post-trial interviews/focus groups with: 1) navigators and providers; 2) LOVED participants to assess facilitators/barriers, attitudes/behaviors, cultural competency, and feedback on mHealth, navigator, and supportive components for LOVED optimization.

Program Iterative Development and Refinement

Phase 3 Feasibility Trial (n = 60) 1a. Conduct a 6-month feasibility RCT with African American ESRD patients (0–10 years on dialysis) comparing LOVED to standard of care (SOC) to assess feasibility indices of % adherence, % drop out and increases in knowledge, attitudes, self-efficacy at baseline, 8-weeks and 6 months. Secondary outcomes are % of patients who identify PDs, and % of those who elect to be screened, and % who complete LDKT.
2b. Conduct post-trial focus groups with: i) navigators/providers/staff; ii) random sample of 15 ESRD patients who received LOVED to assess facilitators/barriers, cultural competence, and recommendations for LOVED refinement.