Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- HIV viral load
研究概览
简要总结
In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Older than 18
- •Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
- •Detectable Viral Load, based on patient's medical record
- •Receiving primary medical care at the AIDS Program at SFGH
- •Able and willing to give informed consent to be randomized to study arms
- •Willing to use the patient portal
- •Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH
排除标准
- •Failure to meet inclusion criteria
研究组 & 干预措施
Receiving SMS alerts
The patients randomized to this arm will have a SMS message sent to them regarding medication adherence for antiretroviral medications, anti-hypertensive medications, anti-depressants, hyperglycemic controlling medications and hypercholesterolemia controlling medications as well as life style supportive suggestions.
干预措施: SMS medication adherence (Behavioral)
No SMS messages
The patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions.
干预措施: No SMS adherence reminder (Behavioral)
结局指标
主要结局
HIV viral load
时间窗: 12 month
The primary analyses of the 12-month trial data will compare the two study groups with respect to (i) change from baseline in CD4 T-cell count; and (ii) proportion of patients whose HIV viral load (VL) level is detectable. We will use repeated-measures analysis techniques to estimate longitudinal prevalence at the population level (via generalized estimating equations) and at the individual levels (via generalized linear mixed models)\[25\].
次要结局
- Level of antiretroviral medication in hair(12 month)