A Practical Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia: Protocol for a Usability Study and Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Adherence to antiretroviral therapy (ART)
研究概览
简要总结
The goal of this usability study and a cluster randomised controlled trial is to investigate the effectiveness of an adherence toolkit as a decision support tool to improve adherence to antiretroviral therapy. The main questions it aims to answer are: 1) is the adherence toolkit useable and acceptable among HIV care providers in Indonesian clinical practice? and 2) is the adherence toolkit superior than the usual care in improving adherence to antiretroviral therapy among people living with HIV in Indonesia? HIV clinics in Surabaya, Indonesia, will be recruited to participate in the study. HIV care providers will be included in the usability study, whereas people living with HIV will be enrolled in the cluster randomised controlled trial. People living with HIV will be randomly assigned in a 1:1 ratio to the control group receiving usual HIV care and the intervention group receiving an intervention using the adherence toolkit in addition to usual HIV care.
详细描述
Consistent adherence to antiretroviral therapy (ART) is important to maintain viral suppression and good quality of life among people living with HIV. However, maintaining a high level of ART adherence is challenging because adherence is a complex behaviour and many factors contribute to nonadherence. Therefore, a decision support tool is proposed to help HIV care providers in addressing the barriers and providing the adherence-promoting interventions tailored to the individual needs. The present study comprises a usability assessment followed by a cluster randomised controlled trial to investigate the effectiveness of the adherence toolkit as a decision support tool on improving adherence to ART. Twelve HIV clinics in Surabaya, Indonesia, will be randomised 1:1 to the control (usual care) and intervention (adherence toolkit and usual care) group. The intervention period will last for 12 months, with outcome measures will be collected at initiation, 3-, 6-, and 12-month post-initiation. The primary outcome is adherence to ART measured using a self-reported adherence questionnaire and pharmacy refill records. The secondary outcomes include clinical outcomes (viral load, CD4), HIV treatment knowledge, medication beliefs, and health-related quality of life. The findings will enable HIV care providers, people living with HIV, and policy makers to make informed decision about the value of the adherence toolkit for being used in daily clinical practice.
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
- •Doctors, nurses, and pharmacists who have been trained to provide HIV care and treatment by the Indonesian Ministry of Health
- •People living with HIV who have been receiving any ART regimens for at least six months, aged 18 years and older, with any coinfection or comorbidity, suspected to be nonadherent to HIV medications (e.g., having sustained treatment interruptions, inconsistent prescription refill, increased viral load >1,000 copies/ml, decreased CD4 count <200 cells/mm3, or developed opportunistic infections), and provided informed consent
排除标准
- •People who have severe mental or physical constraints, drop-out or withdraw after the commencement of the trial
结局指标
主要结局
Adherence to antiretroviral therapy (ART)
时间窗: 0, 3, 6, and 12 months
The primary outcome of the trial is the difference in the changes of adherence rates between the intervention and the control group. The outcome will be repeatedly measured as proportion of people who adhere to ART in the intervention and control groups at study initiation and during the follow-up periods using a previously validated self-reported adherence questionnaire and pharmacy refill data.
次要结局
- CD4 cell count(0 and 12 months)
- HIV treatment knowledge(0, 3, 6, and 12 months)
- Health-related quality of life(0, 3, 6, and 12 months)
- Usability(1 month)
- Acceptability(12 months)
- Viral load(0 and 12 months)
- Medication beliefs(0, 3, 6, and 12 months)
研究者
Zamrotul Izzah
PhD candidate
University of Groningen