Trial results investigating the Tel-Me-Box device for monitoring HIV medication adherence were posted on ClinicalTrials.gov on 2025-08-22. The study found that a Tel-Me-Box with reminder features showed a median adherence of 10 days out of 30, which was lower than the 16.5 days observed with a Tel-Me-Box without reminder features.
Background
Effective management of HIV relies heavily on consistent medication adherence to antiretroviral (ARV) treatment. Poor adherence can lead to treatment failure, drug resistance, and disease progression. Current methods for monitoring ARV adherence, such as self-report, pill counts, and electronic monitoring systems (MEMS), often have limitations, including potential for over-reporting, inability to confirm pill ingestion, and issues with device size or cost. To address these challenges, a multidisciplinary research team developed the "Tel-Me-Box," a new adherence-monitoring device designed to be small, low-cost, rechargeable, and inconspicuous, aiming to provide real-time adherence data.
Trial design
This completed study, designated as Phase NA, enrolled 131 participants in India to test the Tel-Me-Box device. The conditions studied included HIV and Medication Adherence. The trial compared a pillbox device ('Tel-me-box') with reminder features against a pillbox device ('Tel-me-box') without reminder features, evaluating their impact on medication adherence.
Key results
The study collected several key measurements related to Tel-me-box adherence and HIV viral load:
- Tel-me-box Adherence (Median days out of 30):
- For the 'Tel-me-box' With Reminder Features, the median adherence was 10 days.
- For the 'Tel-me-box' Without Reminder Features, the median adherence was 16.5 days.
- Other median adherence measurements for 'Tel-me-box' With Reminder Features included 1.5, 0, and 0 days.
- Other median adherence measurements for 'Tel-me-box' Without Reminder Features included 7, 1, and 0 days.
- HIV Viral Load (VL) (Number of participants):
- Among participants using the 'Tel-me-box' With Reminder Features, 37 had undetectable viral load and 34 had detectable viral load.
- Among participants using the 'Tel-me-box' Without Reminder Features, 34 had undetectable viral load and 45 had detectable viral load.
Key analyses revealed:
- The Odds Ratio (OR) for having 0 openings in the intervention group (with reminders) compared to the control group (without reminders) was 1.32 (95% Confidence Interval: 0.9 to 1.93). This suggests a higher likelihood of zero openings with reminder features.
- The incidence rate ratio (IRR) for the number of days with box opening was 0.77 (95% Confidence Interval: 0.61 to 0.98) for the intervention group compared to the control group. This indicates a lower rate of box openings with reminder features.
- A Chi-squared analysis for HIV Viral Load (VL) showed a p-value of 0.08 for the interaction effect between intervention and time.
- A t-test for Mean Difference (Net) was 0.16 (95% Confidence Interval: -0.11 to 0.43), with a p-value of 0.05.
- A Chi-squared analysis for optimal adherence showed a p-value of 0.08 for the interaction effect between intervention and time.
What this means
The results of this study suggest that the Tel-Me-Box device, when equipped with reminder features, did not improve HIV medication adherence compared to the device without such features. In fact, the median adherence observed with reminder features was notably lower (10 days) than without (16.5 days). Furthermore, the incidence rate ratio of 0.77 (95% CI: 0.61, 0.98) indicates that participants using the device with reminder features had a lower rate of box openings, implying reduced adherence. The odds ratio of 1.32 (95% CI: 0.9, 1.93) also points to a higher likelihood of complete non-adherence (zero openings) in the reminder group. While the analyses for HIV viral load and optimal adherence showed p-values of 0.08, these did not reach conventional statistical significance, suggesting no clear benefit in these outcomes from the reminder features within the study's scope. These findings highlight the complexity of adherence interventions and suggest that the specific reminder features implemented in this Tel-Me-Box design may not have been effective, or could have had an unexpected impact on patient behavior.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03086655, titled "Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India", were posted on 2025-08-22 on clinicaltrials.gov.