NCT03825952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

4.4 years

First QC Date

January 30, 2019

Last Update Submit

December 9, 2022

Conditions

HIV/AIDS

Keywords

adherence

Outcome Measures

Primary Outcomes (1)

  • Adherence to ART

    3 months

Study Arms (1)

Participants using MERM device

EXPERIMENTAL

Participants will use an electronic medication monitor to measure their adherence to ART in routine clinical care.

Device: MERM - medication event reminder monitor

Interventions

MERM - medication event reminder monitorDEVICE

The MERM will help measure adherence to ART in routine clinical care.

Participants using MERM device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kabwohe Clinical Research Center

Kabwohe, Sheema District, Uganda

Location

Related Publications (3)

  • 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.

    PMID: 37862075DERIVED

  • 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.

    PMID: 35937420DERIVED

  • 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.

    PMID: 32687473DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jessica Haberer, MD, MS

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

March 28, 2018

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Locations

UG(1)