Dataset Information

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. OBJECTIVE:The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. METHODS:Individuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. RESULTS:A total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility-the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. The intervention was found to be technically feasible, as data were obtained from most participants as expected most of the time. Potential challenges included the impact of the technology on confidentiality, shared phone ownership, usability skills, and availability of electricity. CONCLUSIONS:Real-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. TRIAL REGISTRATION:ClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa).

SUBMITTER: Musiimenta A

PROVIDER: S-EPMC5981052 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial.

Musiimenta Angella A Atukunda Esther C EC Tumuhimbise Wilson W Pisarski Emily E EE Tam Melanie M Wyatt Monique A MA Ware Norma C NC Haberer Jessica E JE

JMIR mHealth and uHealth 20180517 5

<h4>Background</h4>Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited.<h4>Objective</h4>The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) r ...[more]

PMID: 29773527

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Project description:We conducted a pilot randomized controlled trial among patients initiating treatment for drug-sensitive tuberculosis (TB). Participants received real-time electronic adherence monitors and were randomized (1:1:1) to: (i) daily SMS (reminders to TB patients and notifications to social supporters sent daily for 3 months, then triggered by late or missed dosing for 3 months); (ii) weekly SMS (reminders to TB patients and notifications to social supporters sent weekly for 3 months, then triggered by late or missed dosing for 3 months); or (iii) control (no SMS). Feasibility was mainly verified by the technical function of the intervention at Month 6. The primary outcome was percent adherence as ascertained by the real time monitor. Quantitative feasibility/acceptability data were summarized descriptively. Percentage adherence and adherence patterns were assessed and compared by linear regression models. Qualitative acceptability data was collected through interviews and analyzed using content analysis. Among 63 participants, the median age was 35 years, 75% had no regular income, and 84% were living with HIV. Feasibility was demonstrated as most of the daily [1913/2395 (80%)] and weekly [631/872 (72%)] SMS reminders to TB patients were sent successfully. Also, most of the daily [1577/2395 (66%)] and weekly [740/872 (85%)] SMS notifications to social supporters and adherence data (96%) were sent successfully. Challenges included TB status disclosure, and financial constraints. All patients perceived the intervention to be useful in reminding and motivating them to take medication. Median adherence (IQR) in the daily SMS, weekly SMS, and control arms was 96.1% (84.8, 98.0), 92.5% (80.6, 96.3), and 92.2% (56.3, 97.8), respectively; however, differences between the intervention and control arms were not statistically significant. Real-time monitoring linked to SMS was feasible and acceptable and may have improved TB medication adherence. Larger studies are needed to further assess impact on adherence and clinical outcomes. Trial registration. ClinicalTrials.gov registration number: NCT03800888. https://ichgcp.net/clinical-trials-registry/NCT03800888.

Project description:Due to marked reductions in morbidity and mortality, antiretroviral (ARV) adherence monitoring is of high interest. Researchers and clinicians often resort to the most feasible and cost-effective adherence methods possible, which may result in biased or inaccurate estimates and require the physical presence of a participant at a research or clinic site. The objective of our study was to evaluate the feasibility and acceptability of three objective, innovative, and remote methods to estimate ARV adherence which may be conducted with less time and financial resources in a wide range of clinic and research settings. These three methods included: (a) text-messaged photographs of pharmacy refill dates to measure refill-based adherence, (b) text-messaged photographs of ARV medications to estimate pill-count-based adherence, and (c) home-collected hair samples for the measurement of ARV concentration to determine pharmacologic-based adherence. We conducted a pilot study from March through October 2017 to examine the feasibility and acceptability of these three adherence measures and the remotely conducted study procedures in 93 adults living with HIV nationwide. From our diverse national sample of participants, 95.7% were retained until the end of the study, 89.9% sent all text messages, and 84.3% sent all hair samples. Approximately 74.2% of participants reported excellent overall experience with the study, 60.2% were very or extremely satisfied with participating in a hair collection study, and 76.3% noted extremely high likelihood of participating in a similar study including text messaging pictures of medications or refill dates. We noted high levels of feasibility and acceptability with the remote study methodology, collection of photographed and text messaged pharmacy refill dates and pill counts, and home-collected hair samples. Here we describe the feasibility and acceptability metrics, results from the exit qualitative interviews with the participants, and lessons learned. These adherence measures represent innovative approaches to expand monitoring tools for HIV treatment and prevention adherence in future research.

Project description:BackgroundA shortage of community health workers to triage sick neonates and poor recognition of neonatal illness by mothers contribute significantly toward neonatal deaths in low- and middle-income countries. Providing low-resource communities with the tools and knowledge to recognize signs of neonatal distress can lead to early care-seeking behavior. To empower and educate mothers to recognize signs of neonatal illness, we developed a neonatal health assessment device consisting of a smartphone app and a wearable sensor (the NeMo system).ObjectiveThe aim of this study was to determine if mothers in rural Uganda were willing and able to use the NeMo system during the first week of their infant's life. We also assessed mothers' responses to the device's recommendation to seek care.MethodsA total of 20 mothers were enrolled in the study after giving birth in the Iganga District Hospital. Each mother was trained to use the NeMo system to assess her infant for signs of illness before leaving the hospital and was given the NeMo system to use at home for 1 week. Throughout the week, the smartphone tracked the mothers' usage of NeMo, and the study team visited twice to observe mothers' ability to use NeMo. Each mother was interviewed at the end of 1 week to gather qualitative feedback on her experience with the NeMo system.ResultsIn total, 18 mothers completed the study; 2 mothers were withdrawn during the week because of extenuating health circumstances. Moreover, 1 day after enrollment and training, 75% (15/20) of mothers used NeMo properly with no mistakes. Three days after enrollment and training, only 1 mother placed the wearable sensor improperly on her infant. On the final study day, only 1 mother connected the device improperly. Mothers used NeMo an average of 11.67 (SD 5.70) times on their own at home during the 5 full study days. Although the frequency of use per day decreased from day 1 to day 5 of the study (P=.04), 72% (13/18) of mothers used NeMo at least once per day. In total, 64% (9/14) of mothers who received an alert from the NeMo system to seek care for their infants either called the health care professional working with the study team or reused the system immediately and found no danger signs. All 18 mothers agreed or strongly agreed that the NeMo system was easy to use and helped them know when to seek care for their babies.ConclusionsNeMo is a feasible and acceptable tool to aid mothers in rural Uganda to assess their infant's health.

Project description:Telehealth education has the potential to serve as an important, low-cost method of expanding healthcare worker education and support, especially in rural settings of low- and middle-income countries. We describe an innovative educational strategy to strengthen a long-term health professional capacity building partnership between Guatemalan and US-based partners. In this pilot evaluation, community health nurses in rural Guatemala received customized, interactive education via telehealth from faculty at the supporting US-based institution. Program evaluation of this 10 lecture series demonstrated high levels of satisfaction among learners and instructors as well as knowledge gain by learners. An average of 5.5 learners and 2 instructors attended the 10 lectures and completed surveys using a Likert scale to rate statements regarding lecture content, technology, and personal connection. Positive statements about lecture content and the applicability to daily work had 98% or greater agreement as did statements regarding ease of technology and convenience. The learners agreed with feeling connected to the instructors 100% of the time, while instructors had 86.4% agreement with connection related statements. Instructors, joining at their respective work locations, rated convenience statements at 100% agreement. This evaluation also demonstrated effectiveness with an average 10.7% increase in pre- to posttest knowledge scores by learners. As the global health community considers efficiency in time, money, and our environment, telehealth education is a critical method to consider and develop for health worker education. Our pilot program evaluation shows that telehealth may be an effective method of delivering education to frontline health workers in rural Guatemala. While larger studies are needed to quantify the duration and benefits of specific knowledge gains and to perform a cost-effectiveness analysis of the program, our initial pilot results are encouraging and show that a telehealth program between a US-based university and a rural community health program in a low- and middle-income country is both feasible and acceptable.

Dataset Information

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial.

Publications

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial.

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