Electronic Antiretroviral Therapy Adherence Monitors and Associated Interventions Improve Adolescent-Caregiver Relationships and Self-Efficacy Among Adolescents and Young Adults with HIV in Uganda.

Many adolescents and young adults with HIV (AYWH) struggle with antiretroviral therapy (ART) adherence and experience poorer outcomes than adults. Relevant factors include forgetfulness and poor self-efficacy related to their evolving neurobiology. We qualitatively explored experiences of AYWH-caregivers dyads using real-time ART adherence monitors and associated reminder functions in the home setting. As part of an implementation science-oriented study, AYWH used the Wisepill adherence monitor for 3 months. AYWH could also opt for short message service (SMS) self-reminders, a self-selected social supporter for delayed or missed doses, or an alarm reminder. We conducted in-depth interviews with randomly selected AYWH-caregiver dyads regarding their experience using the monitor. Qualitative data were analyzed using inductive content analysis. We completed 15 AYWH-caregiver dyad interviews. Of the AYWH, 67% were female, mean age was 16 years, 56% lived with their biological mother, and 86% were virologically suppressed. AYWH and their caregivers generally found the adherence monitors acceptable, though some had privacy concerns. AYWH felt the monitors helped them take charge of their medication, largely through the real-time alarm and SMS reminders; this took the burden of adherence reminders away from the caregivers, improving strained AYWH-caregiver relationships. Two adolescents reported rebound poor adherence after monitor withdrawal. ART adherence monitors and associated tools were largely acceptable to AYWH and their caregivers in home settings. The intervention helped improve AYWH self-efficacy and alleviated burden from some AYWH-caregiver relationships. Rebound poor adherence suggests the need for on-going support and/or other means to achieve intrinsic mechanisms for sustained adherence. Clinical Trial Registration number: NCT03825952.

Implementation of Electronic Adherence Monitors and Associated Interventions for Routine HIV Antiretroviral Therapy in Uganda: Promising Findings.

Background: High, sustained adherence is critical for achieving the individual and public health benefits of HIV antiretroviral therapy (ART). Electronic monitors provide detailed adherence information and can enable real-time interventions; however, their use to date has largely been confined to research. This pilot study (NCT03825952) sought to understand feasibility and acceptability a relatively low-cost version of this technology and associated interventions for routine ART delivery in sub-Saharan Africa. Methods: We provided two ART clinics in rural, southwestern Uganda with electronic adherence monitors for data-informed counseling as well as optional SMS messages to clients and/or social supporters (daily or triggered by missed or delayed doses) and/or an alarm. Clinic and ART client experiences were observed for 3 months per client, including time and motion studies. Qualitative interviews among clients, clinicians, and healthcare administrators were informed by the Consolidated Framework for Implementation Research. Results: Fifty-one ART clients were enrolled; 57% were male and the median age was 34 years. Choice of associated intervention varied among participants. The median number of visits during follow-up was two per client. Counselors reviewed the adherence data with 90% of clients at least once; 67% reviewed data at all visits. Average adherence was 94%; four clients had adherence gaps >1 week. Acceptability was high; all but one client found the monitor "very useful" and all found SMS "very useful." Clinic visits among clients with the intervention lasted 4 min longer on average than those in standard care. The monitors and daily SMS generally functioned well, although excess SMS were triggered, primarily due to cellular network delays. Overall, participants felt the technology improved adherence, clinic experiences, and clinician-client relationships. Few worried about stigma and privacy. Cost was a concern for implementation, particularly at scale. Conclusion: We successfully implemented a relatively low-cost electronic ART adherence monitor and associated interventions for routine care in rural Uganda. Feasibility and acceptability were generally high, and individuals were identified who could benefit from adherence support. Future work should involve longitudinal follow-up of diverse populations, clinical outcomes, and detailed cost-effectiveness analysis to help drive policy decisions around the uptake of this technology for routine clinical care. Clinical Trial Registration: identifier: NCT03825952.

Factors Affecting the Implementation of Electronic Antiretroviral Therapy Adherence Monitoring and Associated Interventions for Routine HIV Care in Uganda: Qualitative Study.

BACKGROUND: High, sustained adherence to HIV antiretroviral therapy (ART) is critical for achieving viral suppression, which in turn leads to important individual health benefits and reduced secondary viral transmission. Electronic adherence monitors record a date-and-time stamp with each opening as a proxy for pill-taking behavior. These monitors can be combined with interventions (eg, data-informed adherence counseling, SMS-based adherence support, and/or alarms) and have been shown to improve adherence in multiple settings. Their use, however, has largely been limited to the research context. OBJECTIVE: The goal of the research was to use the Consolidated Framework for Implementation Research (CFIR) to understand factors relevant for implementing a low-cost electronic adherence monitor and associated interventions for routine HIV clinical care in Uganda. METHODS: We conducted in-depth qualitative interviews with health care administrators, clinicians, and ART clients about likes and dislikes of the features and functions of electronic adherence monitors and associated interventions, their potential to influence HIV care, suggestions on how to measure their value, and recommendations for their use in routine care. We used an inductive, content analysis approach to understand participant perspectives, identifying aspects of CFIR most relevant to technology implementation in this setting. RESULTS: We interviewed 34 health care administrators/clinicians and 15 ART clients. Participants largely saw the monitors and associated interventions as favorable and beneficial for supporting adherence and improving clinical outcomes through efficient, differentiated care. Relevant outside factors included structural determinants of health, international norms around supporting adherence, and limited funding that necessitates careful assessment of costs and benefits. Within the clinic, the adherence data were felt likely to improve the quality of counseling and thereby morale, as well as increase the efficiency of care delivery. Existing infrastructure and care expenditures and the need for proper training were other noted considerations. At the individual level, the desire for good health and a welcomed pressure to adhere favored uptake of the monitors, although some participants were concerned with clients not using the monitors as planned and the influence of poverty, stigma, and need for privacy. Finally, participants felt that decisions around the implementation process would have to come from the Ministry of Health and other funders and would be influenced by sustainability of the technology and the target population for its use. Coordination across the health care system would be important for implementation. CONCLUSIONS: Low-cost electronic adherence monitoring combined with data-informed counseling, SMS-based support, and/or alarms have potential for use in routine HIV care in Uganda. Key metrics of successful implementation will include their impact on efficiency of care delivery and clinical outcomes with careful attention paid to factors such as stigma and cost. Further theory-driven implementation science efforts will be needed to move promising technology from research into clinical care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03825952; https://clinicaltrials.gov/ct2/show/NCT03825952.