Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial

Honghu Liu; Yan Wang; Yilan Huang; Di Xiong; Jie Shen; Lisa Siqueiros; Veenu Bala; George M. Savage; Mario Guerrero; Katya Corado; Marc I. Rosen; Courtney V. Fletcher; Eric S. Daar

doi:10.1016/j.ebiom.2022.104330

Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial

Honghu Liu, Yan Wang, Yilan Huang, Di Xiong, Jie Shen, Lisa Siqueiros, Veenu Bala, George M. Savage, Mario Guerrero, Katya Corado, Marc I. Rosen, Courtney V. Fletcher, Eric S. Daar

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Background: Co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. We evaluated the acceptability, effectiveness, and sustainability of the IS system with real-time text reminders. Methods: Participants were recruited from HIV clinics in Los Angeles and were randomised 1:1 to IS or usual care (UC) group. Adherence to ARVs (primary outcome) was measured by IS system (IS group only), plasma ARV concentration, and self-report. IS-measured adherence was clustered by group-based trajectory model and was validated by ARV concentration summarized by integrated pharmacokinetic adherence measure (IPAM) score. HIV RNA viral load (VL) was compared between IS and UC group. Findings: A total of 112 (IS = 54, UC = 58) participants who completed baseline with at least one follow-up data collection were included in analyses. Overall satisfaction rate for the IS system was >90%. The IPAM score was higher (0.018, 95% CI: −0.098–0.134, p = 0.75) and VL decayed faster (−0.020, 95% CI: −0.042–0.002, p = 0.08) in the IS group compared with the UC group. The ingestible sensor system was well tolerated by study participants. Interpretation: The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL. The findings provide a potentially effective strategy for improving adherence. Funding: This work was supported by grant R01-MH110056 from the National Institute of Mental Health (NIMH)/National Institutes of Health (NIH). Y. Wang was in part supported by the NIMH/NIH award T32MH080634. E. Daar was in part supported by the National Center for Advancing Translational Sciences through UCLA CTSI Grant UL1TR001881. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Original language	English (US)
Article number	104330
Journal	EBioMedicine
Volume	86
DOIs	https://doi.org/10.1016/j.ebiom.2022.104330
State	Published - Dec 2022

Keywords

Adherence
HIV
Ingestible sensor
Pharmacokinetic
Viral load

ASJC Scopus subject areas

Biochemistry, Genetics and Molecular Biology(all)

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10.1016/j.ebiom.2022.104330

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Liu, H., Wang, Y., Huang, Y., Xiong, D., Shen, J., Siqueiros, L., Bala, V., Savage, G. M., Guerrero, M., Corado, K., Rosen, M. I., Fletcher, C. V., & Daar, E. S. (2022). Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial. EBioMedicine, 86, Article 104330. https://doi.org/10.1016/j.ebiom.2022.104330

Liu, H, Wang, Y, Huang, Y, Xiong, D, Shen, J, Siqueiros, L, Bala, V, Savage, GM, Guerrero, M, Corado, K, Rosen, MI, Fletcher, CV & Daar, ES 2022, 'Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial', EBioMedicine, vol. 86, 104330. https://doi.org/10.1016/j.ebiom.2022.104330

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title = "Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial",

abstract = "Background: Co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. We evaluated the acceptability, effectiveness, and sustainability of the IS system with real-time text reminders. Methods: Participants were recruited from HIV clinics in Los Angeles and were randomised 1:1 to IS or usual care (UC) group. Adherence to ARVs (primary outcome) was measured by IS system (IS group only), plasma ARV concentration, and self-report. IS-measured adherence was clustered by group-based trajectory model and was validated by ARV concentration summarized by integrated pharmacokinetic adherence measure (IPAM) score. HIV RNA viral load (VL) was compared between IS and UC group. Findings: A total of 112 (IS = 54, UC = 58) participants who completed baseline with at least one follow-up data collection were included in analyses. Overall satisfaction rate for the IS system was >90%. The IPAM score was higher (0.018, 95% CI: −0.098–0.134, p = 0.75) and VL decayed faster (−0.020, 95% CI: −0.042–0.002, p = 0.08) in the IS group compared with the UC group. The ingestible sensor system was well tolerated by study participants. Interpretation: The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL. The findings provide a potentially effective strategy for improving adherence. Funding: This work was supported by grant R01-MH110056 from the National Institute of Mental Health (NIMH)/National Institutes of Health (NIH). Y. Wang was in part supported by the NIMH/NIH award T32MH080634. E. Daar was in part supported by the National Center for Advancing Translational Sciences through UCLA CTSI Grant UL1TR001881. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.",

keywords = "Adherence, HIV, Ingestible sensor, Pharmacokinetic, Viral load",

author = "Honghu Liu and Yan Wang and Yilan Huang and Di Xiong and Jie Shen and Lisa Siqueiros and Veenu Bala and Savage, {George M.} and Mario Guerrero and Katya Corado and Rosen, {Marc I.} and Fletcher, {Courtney V.} and Daar, {Eric S.}",

note = "Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = dec,

doi = "10.1016/j.ebiom.2022.104330",

language = "English (US)",

volume = "86",

journal = "EBioMedicine",

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TY - JOUR

T1 - Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy

T2 - An open-label, usual care-controlled, randomised trial

AU - Liu, Honghu

AU - Wang, Yan

AU - Huang, Yilan

AU - Xiong, Di

AU - Shen, Jie

AU - Siqueiros, Lisa

AU - Bala, Veenu

AU - Savage, George M.

AU - Guerrero, Mario

AU - Corado, Katya

AU - Rosen, Marc I.

AU - Fletcher, Courtney V.

AU - Daar, Eric S.

PY - 2022/12

Y1 - 2022/12

N2 - Background: Co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. We evaluated the acceptability, effectiveness, and sustainability of the IS system with real-time text reminders. Methods: Participants were recruited from HIV clinics in Los Angeles and were randomised 1:1 to IS or usual care (UC) group. Adherence to ARVs (primary outcome) was measured by IS system (IS group only), plasma ARV concentration, and self-report. IS-measured adherence was clustered by group-based trajectory model and was validated by ARV concentration summarized by integrated pharmacokinetic adherence measure (IPAM) score. HIV RNA viral load (VL) was compared between IS and UC group. Findings: A total of 112 (IS = 54, UC = 58) participants who completed baseline with at least one follow-up data collection were included in analyses. Overall satisfaction rate for the IS system was >90%. The IPAM score was higher (0.018, 95% CI: −0.098–0.134, p = 0.75) and VL decayed faster (−0.020, 95% CI: −0.042–0.002, p = 0.08) in the IS group compared with the UC group. The ingestible sensor system was well tolerated by study participants. Interpretation: The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL. The findings provide a potentially effective strategy for improving adherence. Funding: This work was supported by grant R01-MH110056 from the National Institute of Mental Health (NIMH)/National Institutes of Health (NIH). Y. Wang was in part supported by the NIMH/NIH award T32MH080634. E. Daar was in part supported by the National Center for Advancing Translational Sciences through UCLA CTSI Grant UL1TR001881. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

AB - Background: Co-encapsulated antiretrovirals (ARVs) with ingestible sensor (IS) has the capacity to monitor adherence in real-time using a sensor patch, a mobile device, and supporting software. We evaluated the acceptability, effectiveness, and sustainability of the IS system with real-time text reminders. Methods: Participants were recruited from HIV clinics in Los Angeles and were randomised 1:1 to IS or usual care (UC) group. Adherence to ARVs (primary outcome) was measured by IS system (IS group only), plasma ARV concentration, and self-report. IS-measured adherence was clustered by group-based trajectory model and was validated by ARV concentration summarized by integrated pharmacokinetic adherence measure (IPAM) score. HIV RNA viral load (VL) was compared between IS and UC group. Findings: A total of 112 (IS = 54, UC = 58) participants who completed baseline with at least one follow-up data collection were included in analyses. Overall satisfaction rate for the IS system was >90%. The IPAM score was higher (0.018, 95% CI: −0.098–0.134, p = 0.75) and VL decayed faster (−0.020, 95% CI: −0.042–0.002, p = 0.08) in the IS group compared with the UC group. The ingestible sensor system was well tolerated by study participants. Interpretation: The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL. The findings provide a potentially effective strategy for improving adherence. Funding: This work was supported by grant R01-MH110056 from the National Institute of Mental Health (NIMH)/National Institutes of Health (NIH). Y. Wang was in part supported by the NIMH/NIH award T32MH080634. E. Daar was in part supported by the National Center for Advancing Translational Sciences through UCLA CTSI Grant UL1TR001881. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

KW - Adherence

KW - HIV

KW - Ingestible sensor

KW - Pharmacokinetic

KW - Viral load

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ER -

Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial

Abstract

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