A Systems-Level Approach to Improving Medication Adherence in Hypertensive Latinos: a Randomized Control Trial

Background Non-adherence to Tuberculosis (TB) medication is a serious threat to TB prevention and control programs, especially in resource-limited settings. The growth of the popularity of mobile phones provides opportunities to address non-adherence, by facilitating direct communication more frequently between healthcare providers and patients through SMS texts and voice phone calls. However, the existing evidence is inconsistent about the effect of SMS interventions on TB treatment adherence. Such interventions are also seldom developed based on appropriate theoretical foundations. Therefore, there is a reason to approach this problem more rigorously, by developing the intervention systematically with evidence-based theory and conducting the trial with strong measurement methods. Methods This study is a single-blind parallel-group design individual randomized control trial. A total of 186 participants (93 per group) will be individually randomized into one of the two groups with a 1:1 allocation ratio by a computer-generated algorithm. Group one (intervention) participants will receive daily SMS texts and weekly phone calls concerning their daily medication intake and medication refill clinic visit reminder and group two (control) participants will receive the same routine standard treatment care as the intervention group, but no SMS text and phone calls. All participants will be followed for two months of home-based self-administered medication during the continuation phases of the standard treatment period. Urine test for the presence of isoniazid (INH) drug metabolites in urine will be undertaken at the random point at the fourth and eighth weeks of intervention to measure medication adherence. Medication adherence will also be assessed by self-report measurements using the AIDS Clinical Trial Group adherence (ACTG) and Visual Analogue Scales (VAS) questionnaires, and clinic appointment attendance registration. Multivariable regression model analysis will be employed to assess the effect of the Ma-MAS intervention at a significance level of P-value < 0.05 with a 95% confidence interval. Discussion For this trial, a mobile-assisted medication adherence intervention will first be developed systematically based on the Medical Research Council framework using appropriate behavioural theory and evidence. The trial will then evaluate the effect of SMS texts and phone calls on TB medication adherence. Evidence generated from this trial will be highly valuable for policymakers, program managers, and healthcare providers working in Ethiopia and beyond. Trial registration The trial is registered in the Pan-Africa Clinical Trials Registry with trial number PACTR202002831201865.

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Effect of Occupational Therapy in Promoting Medication Adherence in Primary Care: A Randomized Control Trial

American Journal of Occupational Therapy ◽

10.5014/ajot.2020.74s1-po5403 ◽

2020 ◽

Vol 74 (4_Supplement_1) ◽

pp. 7411520485p1

Author(s):

Traci Garrison ◽

Jaclyn Schwartz ◽

Elizabeth Moore ◽

Todd Daniel

Keyword(s):

Primary Care ◽

Medication Adherence ◽

Occupational Therapy ◽

Randomized Control Trial ◽

Randomized Control

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Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial

Journal of General Internal Medicine ◽

10.1007/s11606-016-3858-0 ◽

2016 ◽

Vol 32 (3) ◽

pp. 256-261 ◽

Cited By ~ 10

Author(s):

Ashok Reddy ◽

Tiffany L. Huseman ◽

Anne Canamucio ◽

Steven C. Marcus ◽

David A. Asch ◽

...

Keyword(s):

Medication Adherence ◽

Randomized Control Trial ◽

Randomized Control ◽

Statin Medication

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A multifaceted prospective memory intervention to improve medication adherence: Design of a randomized control trial

Contemporary Clinical Trials ◽

10.1016/j.cct.2012.09.005 ◽

2013 ◽

Vol 34 (1) ◽

pp. 45-52 ◽

Cited By ~ 30

Author(s):

Kathleen C. Insel ◽

Gilles O. Einstein ◽

Daniel G. Morrow ◽

Joseph T. Hepworth

Keyword(s):

Medication Adherence ◽

Prospective Memory ◽

Randomized Control Trial ◽

Improve Medication Adherence ◽

Randomized Control ◽

Memory Intervention

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Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp)

BMC Public Health ◽

10.1186/s12889-020-09688-0 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Gabriella Flynn ◽

Haomiao Jia ◽

Nancy R. Reynolds ◽

David C. Mohr ◽

Rebecca Schnall

Keyword(s):

United States ◽

Viral Load ◽

Medication Adherence ◽

Randomized Control Trial ◽

The United States ◽

Self Management ◽

Pill Bottle ◽

Randomized Control ◽

Fitness Tracker ◽

Living With Hiv

Abstract Background Poor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City. Methods This ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness. Discussion The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins. Trial registration This trial was registered with ClinicalTrials.gov (NCT03205982) on July 2, 2017.

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