Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment

Abstract

Background: Adherence is critical to achieve the benefits of antiretroviral therapy. A smart-pill bottle service that transmits real-time adherence data via cellular networks to a central service and prompts nonadherent patients with phone or text messages may improve adherence.

Methods: Adults with HIV taking a tenofovir-containing regimen with suboptimal adherence were randomized to adherence counseling ± a smart-pill bottle service for 12 weeks. Tenofovir diphosphate (TFV-DP) levels by dried blood spot, HIV RNA levels, CD4 cell counts, and self-reported adherence were collected.

Results: Sixty-three participants (22% women; 48% black, 25% Latino) were randomized: 30 to the smart-pill bottle (2 of whom were lost to follow-up before the baseline visit), and 33 to control arms. At baseline, 49% of participants had HIV RNA ≤20 copies/mL and 61% reported 100% adherence with ART over 4 days. From baseline to week 12, median TFV-DP levels were +252 and -41 fmol/punch in the bottle and control arms, respectively (P = 0.10). Exploratory exclusion of 3 participants with known or suspected drug-drug interactions found median TFV-DP levels of +278 and -38 fmol/punch, respectively (P = 0.04). There were no differences in study discontinuations, HIV RNA suppression, CD4 cell counts, or self-reported adherence at week 12.

Conclusions: In a diverse group of participants with suboptimal adherence to ART, the smart-pill bottle service was associated with higher TFV-DP levels.

Trial registration: ClinicalTrials.gov NCT03772327.

Figures

Figure 1.

Smart pill bottle (AdhereTech, New York, NY).

Figure 2.

Diagram of study participant flow and scheduled interventions.

Figure 3.

Median TFV-DP (IQR) over time by study arm in a) the intention to treat analysis. b) Exploratory analysis excluding those with drug-drug interactions and those with unstable (or unpredictable) TFV-DP levels due to ART changes (TDF-based to TAF-based) within 12 weeks of the baseline or week 12 visit.