AIMS Study: Cost-effectiveness of a Nurse-based Intervention to Support HIV-treatment Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 14
- 主要终点
- Effectiveness: Viral load
研究概览
简要总结
The objectives of the main study are to evaluate the effectiveness and the cost-effectiveness of a counseling intervention to support medication intake among patients treated for HIV. The aim is that through the availability of medication intake reports collected through electronic monitoring, more adherence problems can be identified and medical decision-making improves.
A substudy focuses on the broader range of nursing care in HIV-treatment, examining the content of care delivered to support physical, mental, sexual and social well-being; whether the delivery of the AIMS intervention affects the quality of care on domains other than adherence; and whether the content of care on these various domains can be linked to patient well-being and satisfaction.
详细描述
**MAIN STUDY**
BACKGROUND: Adherence to HIV-medication is an important predictor of treatment success, yet between 25-40% of the patients does not always take the medication as prescribed. A nurse-delivered counseling intervention (AIMS: Adherence Improving self-Management Strategy) to optimize patient adherence has shown promising results in a pilot study and a randomized controlled trial among Caucasian, treatment-experienced patients. AIMS is a patient-centered counseling intervention to support self-regulation of medication intake, using feedback reports of electronically monitored adherence. AIMS has been evaluated positively by patients and nurses, and has been developed to be implemented in usual patient care against minimal time and monetary investments.
OBJECTIVE: To examine the cost-effectiveness of the AIMS intervention compared to "care-as-usual" in Dutch HIV-clinics among a representative sample of patients (all ethnicities, starting or already on treatment).
SETTING AND PARTICIPANTS: The study will be conducted in seven HIV-clinics in the Netherlands and select 230 patients (details regarding sample size calculation: see below) eligible for intervention based on the following criteria: 1- All treatment experienced patients who started combination AntiRetroviral Therapy (cART) ≥1996, are >9 months on treatment, are continuing treatment, and had at least one detectable viral load (blips included) during the last 3 years (count starts after 9 months cART). 2- All treatment-naïve patients initiating treatment.
After initial inclusion, treatment experienced patients with suboptimal adherence measured during a 2-month electronic monitoring baseline period will be eligible for randomization to the intervention or the control group. Treatment-initiating patients will be randomized directly after consenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Effectiveness: Viral load
时间窗: Month 4-14
The combined viral load at 3 pre-determined time points after the initial intervention phase will serve as the primary outcome measure. Depending on the distribution, data will be kept continuous (log transformed) or recoded to detectable versus undetectable. Planned measurements naive patients at 6-7 months, 9-10 months, and 12-14 months post-randomization. For treatment experienced patients: 4-5 months, 8-10 months, and 12-15 months after randomization.
Cost-effectiveness: Costs per point increase in viral load
时间窗: Month 0-14
The costs and savings over the whole intervention period (post randomization until end of study) will be weighed against any gains observed in viral load (continuous or dichotomous: see primary effectiveness outcomes).
次要结局
- Cost-effectiveness: Costs per point increase in adherence(Month 0-14)
- Cost-effectiveness: Costs per quality adjusted life year gained(month 0-14)
- Effectiveness: Adherence(Month 0-4, Month 5-8, Month 9-12)
研究者
Marijn de Bruin
Professor
University of Aberdeen