Table 1 RE-AIM framework applied to study outcomes
Dimension | Description | Outcome assessment |
|---|---|---|
Reach | Intervention ability to reach participants who have both SU problems and ART nonadherence | • % of patients screened who meet eligibility criteria for study enrollment |
Effectiveness | ART adherence (primary) | • Number of doses missed divided by the number of prescribed doses (measured via Wisepill) |
SU (primary) | • Urinalysis (yes/no) and self-reported total score on the WHO-ASSIST score | |
Viral suppression (exploratory) | • Viral load copies per ml of blood | |
Adoption | Provider and organization perceptions of feasibility/acceptability and future uptake | • Qualitative interviews with providers and organizational leadership based on RE-AIM to assess perceptions and likelihood of uptake following the trial; longer-term adoption to be assessed in the subsequent trial following from this pilot study |
Implementation | Feasibility | • Pragmatic implementation science measure based on RE-AIM (14-item feasibility subscale) [31] • % assigned to the intervention who agree to enroll • Qualitative interviews with patients structured based on RE-AIM |
Acceptability | • Pragmatic implementation science measure based on RE-AIM (15-item acceptability subscale) [31] • Retention: % attending ≥ 1 session, % attending ≥ 75% of sessions, uptake of booster sessions, and % who dropped out of the intervention • Qualitative interviews with patients structured based on RE-AIM | |
Intervention fidelity | • Independent rater and interventionist self-report on randomly selected 20% of intervention sessions | |
Maintenance | Provider continued usage of Khanya to treat co-occurring SU and ART nonadherence | • To be evaluated in the subsequent trial following from this pilot study |