NCT03825952: OAsIS

Optimizing mHealth for Adherence Monitoring and Intervention

Completed NA Last updated 12 December 2022

What this trial tests

NA trial testing MERM - medication event reminder monitor in HIV/AIDS in 174 participants. Completed in 5 August 2022.

Timeline

28 March 2018

Primary endpoint
5 August 2022

5 August 2022

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	174
Start date	28 March 2018
Primary completion	5 August 2022
Estimated completion	5 August 2022
Sites	1 location across Uganda

Drugs / interventions tested

• MERM - medication event reminder monitor

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy of measures for antiretroviral adherence in people living with HIV.
   Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
2. Super learner analysis of real-time electronically monitored adherence to antiretroviral therapy under constrained optimization and comparison to non-differentiated care approaches for persons living with HIV in rural Uganda.
   Benitez AE, Musinguzi N, Bangsberg DR, Bwana MB, et al · · 2020 · cited 12× · PMID 32202067 · DOI 10.1002/jia2.25467
3. Implementation of Electronic Adherence Monitors and Associated Interventions for Routine HIV Antiretroviral Therapy in Uganda: Promising Findings.
   Haberer JE, Baijuka R, Tumuhairwe JB, Tindimwebwa EB, et al · · 2022 · cited 6× · PMID 35937420 · DOI 10.3389/fdgth.2022.899643
4. Factors Affecting the Implementation of Electronic Antiretroviral Therapy Adherence Monitoring and Associated Interventions for Routine HIV Care in Uganda: Qualitative Study.
   Haberer JE, Garrison L, Tumuhairwe JB, Baijuka R, et al · · 2020 · cited 5× · PMID 32687473 · DOI 10.2196/18038
5. Electronic Antiretroviral Therapy Adherence Monitors and Associated Interventions Improve Adolescent-Caregiver Relationships and Self-Efficacy Among Adolescents and Young Adults with HIV in Uganda.
   Adong J, Asiimwe S, Nansera D, Muyindike W, et al · · 2023 · PMID 37862075 · DOI 10.1089/apc.2023.0164