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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