Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa

Abstract Background The introduction of Bedaquiline, the first new antimycobacterial drug in over 40 years, has highlighted the critical importance of medication adherence in drug-resistant tuberculosis (DR-TB) treatment to prevent amplified drug-resistance and derive sustained benefit. Real-time el...

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Main Authors: N. Bionghi, A. Daftary, B. Maharaj, Z. Msibi, K. R. Amico, G. Friedland, C. Orrell, N. Padayatchi, M. R. O’Donnell
Format: Article
Language:English
Published: BMC 2018-04-01
Series:BMC Infectious Diseases
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12879-018-3080-2
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author N. Bionghi
A. Daftary
B. Maharaj
Z. Msibi
K. R. Amico
G. Friedland
C. Orrell
N. Padayatchi
M. R. O’Donnell
author_facet N. Bionghi
A. Daftary
B. Maharaj
Z. Msibi
K. R. Amico
G. Friedland
C. Orrell
N. Padayatchi
M. R. O’Donnell
author_sort N. Bionghi
collection DOAJ
description Abstract Background The introduction of Bedaquiline, the first new antimycobacterial drug in over 40 years, has highlighted the critical importance of medication adherence in drug-resistant tuberculosis (DR-TB) treatment to prevent amplified drug-resistance and derive sustained benefit. Real-time electronic dose monitoring (EDM) accurately measures adherence and allows for titration of adherence support for anti-retroviral therapy (ART). The goal of this study was to evaluate the accuracy and acceptability of a next-generation electronic pillbox (Wisepill RT2000) for Bedaquiline-containing TB regimens. Methods Eligible patients were DR-TB/HIV co-infected adults hospitalized for the initiation of Bedaquiline-containing treatment regimens in KwaZulu-Natal, South Africa. A one-way crossover design was used to evaluate levels of adherence and patient acceptance of EDM. Each patient was given a Wisepill device which was filled with ART, Levofloxacin or Bedaquiline over three consecutive weeks. Medication adherence was measured using Wisepill counts, patient-reported seven-day recall, and weekly pill count. An open-ended qualitative questionnaire at the end of the study evaluated participant acceptability of the Wisepill device. Results We enrolled 21 DR-TB/HIV co-infected inpatients admitted for the initiation of Bedaquiline from August through September 2016. In aggregate patients were similarly adherent to Bedaquiline (100%) compared to Levofloxacin (100%) and ART (98.9%) by pill count. Wisepill was more sensitive (100%) compared to seven-day recall (0%) in detecting non-adherence events (p = 0.02). Patients reported positive experiences with Wisepill and expressed willingness to use the device during a full course of DR-TB treatment. There were no concerns about stigma, confidentiality, or remote monitoring. Conclusion In this pilot study patients were highly adherent to Bedaquiline by all adherence measures. However, there was lower adherence to ART by pill count and Wisepill suggesting a possible challenge for adherence with ART. The use of EDM identified significantly more missed doses than seven-day recall. Wisepill was highly acceptable to DR-TB/HIV patients in South Africa, and is a promising modality to support and monitor medication adherence in complex treatment regimens.
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spelling doaj.art-0922555a650241dbb839a4b17ed3505f2022-12-22T00:45:47ZengBMCBMC Infectious Diseases1471-23342018-04-011811910.1186/s12879-018-3080-2Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South AfricaN. Bionghi0A. Daftary1B. Maharaj2Z. Msibi3K. R. Amico4G. Friedland5C. Orrell6N. Padayatchi7M. R. O’Donnell8Columbia University College of Physicians and SurgeonsCAPRISA MRC- HIV-TB Pathogenesis and Treatment Research UnitCAPRISA MRC- HIV-TB Pathogenesis and Treatment Research UnitCAPRISA MRC- HIV-TB Pathogenesis and Treatment Research UnitUniversity of Michigan School of Public HealthYale School of MedicineDesmond Tutu HIV Centre, University of Cape TownCAPRISA MRC- HIV-TB Pathogenesis and Treatment Research UnitCAPRISA MRC- HIV-TB Pathogenesis and Treatment Research UnitAbstract Background The introduction of Bedaquiline, the first new antimycobacterial drug in over 40 years, has highlighted the critical importance of medication adherence in drug-resistant tuberculosis (DR-TB) treatment to prevent amplified drug-resistance and derive sustained benefit. Real-time electronic dose monitoring (EDM) accurately measures adherence and allows for titration of adherence support for anti-retroviral therapy (ART). The goal of this study was to evaluate the accuracy and acceptability of a next-generation electronic pillbox (Wisepill RT2000) for Bedaquiline-containing TB regimens. Methods Eligible patients were DR-TB/HIV co-infected adults hospitalized for the initiation of Bedaquiline-containing treatment regimens in KwaZulu-Natal, South Africa. A one-way crossover design was used to evaluate levels of adherence and patient acceptance of EDM. Each patient was given a Wisepill device which was filled with ART, Levofloxacin or Bedaquiline over three consecutive weeks. Medication adherence was measured using Wisepill counts, patient-reported seven-day recall, and weekly pill count. An open-ended qualitative questionnaire at the end of the study evaluated participant acceptability of the Wisepill device. Results We enrolled 21 DR-TB/HIV co-infected inpatients admitted for the initiation of Bedaquiline from August through September 2016. In aggregate patients were similarly adherent to Bedaquiline (100%) compared to Levofloxacin (100%) and ART (98.9%) by pill count. Wisepill was more sensitive (100%) compared to seven-day recall (0%) in detecting non-adherence events (p = 0.02). Patients reported positive experiences with Wisepill and expressed willingness to use the device during a full course of DR-TB treatment. There were no concerns about stigma, confidentiality, or remote monitoring. Conclusion In this pilot study patients were highly adherent to Bedaquiline by all adherence measures. However, there was lower adherence to ART by pill count and Wisepill suggesting a possible challenge for adherence with ART. The use of EDM identified significantly more missed doses than seven-day recall. Wisepill was highly acceptable to DR-TB/HIV patients in South Africa, and is a promising modality to support and monitor medication adherence in complex treatment regimens.http://link.springer.com/article/10.1186/s12879-018-3080-2Electronic pillboxDrug-resistant tuberculosisHIVBedaquilineReal-time monitoring
spellingShingle N. Bionghi
A. Daftary
B. Maharaj
Z. Msibi
K. R. Amico
G. Friedland
C. Orrell
N. Padayatchi
M. R. O’Donnell
Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
BMC Infectious Diseases
Electronic pillbox
Drug-resistant tuberculosis
HIV
Bedaquiline
Real-time monitoring
title Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
title_full Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
title_fullStr Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
title_full_unstemmed Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
title_short Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
title_sort pilot evaluation of a second generation electronic pill box for adherence to bedaquiline and antiretroviral therapy in drug resistant tb hiv co infected patients in kwazulu natal south africa
topic Electronic pillbox
Drug-resistant tuberculosis
HIV
Bedaquiline
Real-time monitoring
url http://link.springer.com/article/10.1186/s12879-018-3080-2
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