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临床试验/NCT03825952
NCT03825952已完成不适用

Optimizing mHealth for Adherence Monitoring and Intervention

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2018年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
1
主要终点
Adherence to ART

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Adherence to ART

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Haberer, MD

Director of Research

Massachusetts General Hospital

研究点 (1)

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