N/A
N=159
INcentives and ReMINDers to Improve Long-term Medication Adherence
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT05131165 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3) — 0.860; 0.916; 0.914 Proportion of pills taken as prescribed — p=0.056
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Daily Text Messages (Behavioral); Incentivization based on timely ART adherence (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RAND
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3) |
0.860; 0.916; 0.914 | 0.056 |
| PRIMARY Proportion of Pills Taken as Prescribed Over the Post-intervention Period (Months 4-9) |
0.800; 0.842; 0.835 | 0.364 |
| PRIMARY Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Intervention Period (Baseline - Month 3) |
0.685; 0.755; 0.81 | 0.158 |
| PRIMARY Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Post-Intervention Period (Months 4-9) |
0.546; 0.573; 0.680 | 0.654 |
| SECONDARY Retention in Care |
48; 50; 57 | — |
| SECONDARY Change in Viral Suppression Status |
0.03; 0; 0 | 0.5468 |
Summary
The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. The intervention phase of the three-phased study will constitute the pilot RCT. A sample of 150 clients who have initiated ART in the preceding three months will be randomized to either usual care (C = 50) or one of the two INMIND intervention groups (daily text message reminders with or without incentives) for three months (T1 = 50; T2=50). Subsequently, behavioral persistence will be evaluated for six months post-intervention. Assessments will be conducted at baseline, month 3, and month 9. The primary outcomes are 1) electronically measured mean medication adherence during the intervention and 2) six months post intervention, along with 3) timeliness of medication adherence during the intervention and 4) six months post-intervention.
Eligibility Criteria
Inclusion Criteria
- Male and female clients age 18 and older.
- Started ART at Mildmay or another clinic within the preceding three months but have since been receiving care at Mildmay.
- Able to speak and understand either English or Luganda.
- Have their own cell phone or have consistent access to someone else's phone.
- Willing to receive daily text messages for the 3 months of intervention duration.
- Willing and able to use the MEMS caps distributed for adherence verification for the duration of the study.
Exclusion Criteria
- Not mentally fit to consent.
- Language other than Luganda or English.
- Not willing to consistently use the MEMS caps device for adherence measurement.
Data sourced from ClinicalTrials.gov (NCT05131165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.