Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment. (1st January 2021)

• Record Type: Journal Article
• Authors: Ellsworth, Grant B.; Burke, Leah A.; Wells, Martin T.; Mishra, Satish; Caffrey, Matthew; Liddle, David; Madhava, Malika; O'Neal, Curtis; Anderson, Peter L.; Bushman, Lane; Ellison, Lucas; Stein, Josh; Gulick, Roy M.
• Is Part Of: Journal of acquired immune deficiency syndromes. Volume 86:Number 1(2021)
• Publication Date: 2021-01-01
• Subjects: HIV -- antiretrovirals -- medication adherence -- tenofovir -- drug monitoring -- reminder systems; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome -- Periodicals; AIDS (Disease); Periodicals; 616.9792005
• DOI: 10.1097/QAI.0000000000002519
• Languages: English
• ISSNs: 1525-4135

Abstract

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.