Trial Outcomes & Findings for INcentives and ReMINDers to Improve Long-term Medication Adherence (NCT NCT05131165)

In a randomized, parallel controlled trial, a sample of 166 participants who met the inclusion criteria were recruited at Mildmay Uganda between October, 2021 and April, 2022. Participants were excluded if a) they did not own an phone, b) they started ARTs \> 3 months prior to enrollment, c) they were not at Mildmay general or planned to transfer our during the study period, d) could not offer informed consent, or e) could not commit to study activities

After recruitment but prior to random assignment and baseline assessment, enrolled participants were given a MEMS cap to screen for non-use (recorded adherence \< 30% over a month). Of 166 enrolled, 3 participants were excluded due to MEMS non-use, 3 did not return for baseline, and 1 withdrew consent at baseline, leaving 159 participants to randomize. Of these, 2 in the control group and 1 in the Messages group withdrew consent after baseline and thus their data are not reported in the flow.

Race and Ethnicity were not collected from any participant.

MEMS-data was collected continuously over the course of the three-month intervention period allowing us to investigate mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).

MEMS-data was collected continuously over the course of the six-month post intervention period allowing for the investigation of post-intervention mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).

A novel measure of routine adherence (that it is explicitly based on the temporal pattern of pill-taking), calculated as the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, was calculated. This measure provides an objective way for determining behavioral automaticity of pill-taking.

This measure would be calculated as a fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, for all visits made post-intervention.

Retention in care was measured as the fraction of participants recruited who are still active clients at the clinic at month 9.

HIV RNA (viral load) was the secondary outcome measure. For each participant, viral loads taken just prior to baseline and viral loads taken just after month-9 were compared; if participant was virally suppressed (with \< 200 copies of HIV per millilitre (mL) of blood) at baseline, but had a viral load of \>= 200 copies/mL after month-9, then the indicator was assigned "-1"; if there was no change in viral suppression status (i.e., if participant either had \>= 200 copies of virus/mL at baseline and month-9 OR if participant had \< 200 copies/mL at baseline and month-9), then the indicator was assigned "0". If, however, the participant's viral load went from \>= 200 copies/mL at baseline to \< 200 copies/mL after month-9, then the indicator was assigned "1".