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Table 2 Trial secondary outcomes categorized using the RE-AIM framework

From: Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda

RE-AIM Domain Outcome
Reach • Proportion of eligible PLHIV offered 3HP who accept to initiate treatment
Effectiveness/cost-effectiveness Effectiveness of intervention
• Proportion of participants who initiate 3HP for whom treatment is discontinued due to adverse events or intolerance
• Cumulative 16-month incidence of active TB
Cost-effectiveness
• Incremental cost of each delivery strategy per disability adjusted life year (DALY) averted
• Incremental health system cost per DALY averted
• Incremental patient cost per DALY averted
Adoption • Thematic results from healthcare provider key informant interviews
Implementation Fidelity of intervention and delivery strategy implementation
• Proportion who complete at least 11 of 12 3HP doses within 16 weeks of starting treatment
• Proportion reimbursed overall and on the same day as each 3HP clinic visit
• Time spent at each clinic visit
• Time spent on shared decision-making tool
• Proportion of IVR phone call reminders delivered to participants for clinic visits or medication dosing
• Proportion of IVR phone call reminders delivered to participants for missed appointments
• Proportion of participants screened for active TB during DOT or refill visits
• Proportion of participants screened for side effects during DOT or refill visits.
• Proportion of doses confirmed using digital adherence technology. Doses directly observed (i.e., during initial or refill visits) will not be included in the denominatora
• Proportion of IVR phone call reminders delivered to participants following missed dosesa
• Proportion of weekly IVR phone call check-ins delivered to participantsa
• Proportion of responses to weekly IVR phone call check-ins received from participantsa
• Proportion of participants who receive appropriate follow-up (phone call or home visit) for lack of response/negative response to weekly check-in IVR phone calla
Patient costs
• Total direct and indirect patient costs related to TB preventive care services
Acceptability of delivery strategy
• Median scores for domains within the patient satisfaction survey
• Median scores for domains within the SDM-Q-9 validated questionnaire on implementation of the shared decision-making tool
Modification of targeted barriers
• Self-reported patient barriers to TB preventative care services
• Patient satisfaction with TB preventive care services
• Provider- and clinic-level barriers to delivery of 3HP
• Thematic results from patient in-depth interviews
  1. aParticipants taking 3HP by SAT only