Optimizing mHealth for Adherence Monitoring and Intervention
NCT ID: NCT03825952
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2018-03-28
2022-08-05
Brief Summary
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This study is an implementation science-driven assessment of strategies to improve uptake of electronic adherence monitoring and associated interventions for routine, clinical delivery of ART in Uganda. The study consists of two aims. In Aim 1, the investigators will conduct multi-level formative interviews to design a preliminary implementation strategy. In Aim 2, the investigators will use an iterative approach to optimize the implementation strategy. All work will be guided by the Consolidated Framework for Research Implementation.
Detailed Description
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Populations: 1) Health care administrators and clinicians and 2) individuals taking ART
Study site: Kabwohe Clinical Research Centre (KCRC)
Approach The electronic adherence monitors to be assessed in this study are pill containers that record each opening as a proxy for pill taking behavior. They provide day-to-day information about adherence that can be used to provide informed counseling at clinic visits, as well as SMS reminders and notifications for missed or late doses. For Aim 1, the study team will recruit up to 35 health care administrators and clinicians from various levels of the Ugandan health care system (Health Center IV to the national hospital level), as well as 15 individuals taking ART at the KCRC. Research assistants will conduct individual, in depth qualitative interviews to define a preliminary implementation strategy for these electronic adherence monitors to be used in routine HIV clinical care. In Aim 2 (iteration 1), investigators will deploy the electronic adherence monitors and associated interventions per the strategy identified in Aim 1 among 30 individuals taking ART at the KCRC. Study staff will monitor their adherence for 3 months, during which time they will quantify multiple metrics of the deployment. The investigators will review these metrics with the same health care administrators and clinicians from Aim 1, as well as up to 15 individuals who used the adherence monitors in the Aim 2 deployment. Research assistants will then interview both groups to develop an improved implementation strategy for deployment in a second iteration. In Aim 2 (iteration 2), study staff will utilize the revised implementation strategy to deploy the electronic adherence monitors and associated interventions among a new cohort of 30 individuals taking ART at the KCRC. The study team will then repeat the assessment of the implementation strategy with the same health care administrators and clinicians from Aims 1 and 2 (iteration 1), as well as up to 15 individuals who used the adherence monitors in the Aim 2 (iteration 2) deployment. The investigators will conclude the study with recommendations for wide-scale uptake of this technology in routine HIV clinical care.
Aims Aim 1. Define a preliminary implementation strategy for real-time electronic adherence monitoring plus associated interventions for routine HIV clinical care in Uganda
Aim 2. Deploy and optimize an implementation strategy for real-time electronic ART adherence monitoring plus associated interventions in routine HIV clinical care in Uganda
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Participants using MERM device
Participants will use an electronic medication monitor to measure their adherence to ART in routine clinical care.
MERM - medication event reminder monitor
The MERM will help measure adherence to ART in routine clinical care.
Interventions
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MERM - medication event reminder monitor
The MERM will help measure adherence to ART in routine clinical care.
Eligibility Criteria
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Inclusion Criteria
* engagement in HIV care
* For individuals taking ART:
* HIV infection per clinic records
* own a cellular phone
Exclusion Criteria
* intention to move \>100 km away from KCRC during the three-month study period
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Jessica Haberer, MD
Director of Research
Principal Investigators
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Jessica Haberer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Kabwohe Clinical Research Center
Kabwohe, Sheema District, Uganda
Countries
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References
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Adong J, Asiimwe S, Nansera D, Muyindike W, Tumuhairwe JB, Baijuka R, Tindimwebwa E, Garrison LE, Haberer JE. Electronic Antiretroviral Therapy Adherence Monitors and Associated Interventions Improve Adolescent-Caregiver Relationships and Self-Efficacy Among Adolescents and Young Adults with HIV in Uganda. AIDS Patient Care STDS. 2023 Oct;37(10):489-494. doi: 10.1089/apc.2023.0164.
Haberer JE, Baijuka R, Tumuhairwe JB, Tindimwebwa EB, Tinkamanyire J, Tuhanamagyezi E, Musoke L, Garrison LE, DelSignore M, Musinguzi N, Asiimwe S. Implementation of Electronic Adherence Monitors and Associated Interventions for Routine HIV Antiretroviral Therapy in Uganda: Promising Findings. Front Digit Health. 2022 Jul 22;4:899643. doi: 10.3389/fdgth.2022.899643. eCollection 2022.
Haberer JE, Garrison L, Tumuhairwe JB, Baijuka R, Tindimwebwa E, Tinkamanyire J, Burns BF, Asiimwe S. Factors Affecting the Implementation of Electronic Antiretroviral Therapy Adherence Monitoring and Associated Interventions for Routine HIV Care in Uganda: Qualitative Study. J Med Internet Res. 2020 Sep 10;22(9):e18038. doi: 10.2196/18038.
Other Identifiers
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