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Optimizing mHealth for Adherence Monitoring and Intervention (OAsIS)

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ClinicalTrials.gov Identifier: NCT03825952
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jessica Haberer, MD, Massachusetts General Hospital

Brief Summary:

High and sustained adherence is critical for achieving the individual and public health benefits of HIV antiretroviral therapy (ART). Electronic adherence monitors provide a detailed understanding of adherence and enable real-time interventions. Research has shown the benefit of these monitors and low-cost models have recently become available; however, their use to date has largely been confined to the research context.

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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Device: MERM - medication event reminder monitor Not Applicable

Detailed Description:

Design: Prospective mixed-method assessment with iterative improvements for program implementation

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing mHealth for Adherence Monitoring and Intervention
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Participants using MERM device
Participants will use an electronic medication monitor to measure their adherence to ART in routine clinical care.
Device: MERM - medication event reminder monitor
The MERM will help measure adherence to ART in routine clinical care.




Primary Outcome Measures :
  1. Adherence to ART [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years
  • engagement in HIV care
  • For individuals taking ART:
  • HIV infection per clinic records
  • own a cellular phone

Exclusion Criteria:

  • unwillingness or inability to provide informed consent
  • intention to move >100 km away from KCRC during the three-month study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825952


Contacts
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Contact: Lindsey Garrison, MPH 617-643-9195 legarrison@mgh.harvard.edu
Contact: Jessica Haberer, MD, MS 617-643-9195 jhaberer@partners.org

Locations
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Uganda
Kabwohe Clinical Research Center Recruiting
Kabwohe, Sheema District, Uganda
Contact: Stephen Asiimwe, MD    256-4854-33795    irc@must.ac.ug   
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jessica Haberer, MD, MS Massachusetts General Hospital

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Responsible Party: Jessica Haberer, MD, Director of Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03825952     History of Changes
Other Study ID Numbers: K24MH114732 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Haberer, MD, Massachusetts General Hospital:
adherence