Optimizing mHealth for Adherence Monitoring and Intervention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV/AIDS
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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
Tracking Information
- NCT #
- NCT03825952
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Principal Investigator: Jessica Haberer, MD, MS Massachusetts General Hospital