Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up
研究概览
简要总结
Conduct an intervention combining social and behavioral health models with digital health technologies to improve their adherence to their medication schedules. The success of the intervention is assessed by comparing adherence rates before and after its implementation to see if there's a notable enhancement in how well patients follow their antiretroviral therapy.
详细描述
This is an intervention strategy for HIV-infected individuals based on their viral load measurements and medication adherence rates, measured by the proportion of days covered (PDC) for the past 365 days. A specific PDC threshold identifies individuals with less than 90% viral suppression at under 200 copies/mL. An intervention approach integrating social and behavioral models with electronic health (eHealth) technology is implemented for cases with a PDC below this threshold. The intervention aims to enhance the patient's adherence to their medication regimen. The effectiveness of this intervention is evaluated by comparing indicators before and after its application to determine if there are significant improvements in the participants' compliance with their antiretroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •1. PLWH with adherence below the specific proportion of days covered (PDC), which is defined as the specific level that corresponds to 90% at viral suppression (< 200 copies/mL).
排除标准
- •Under 18 years of age.
- •Illiterate.
- •Non-consenting individuals.
- •Less than 365 days from the initial use of antiretroviral drugs to the assessment for inclusion in the study.
- •Inability to obtain complete medication records for the 365 days prior to inclusion.
- •Lack of a smart phone.
- •No willingness to return for follow-up at the participating hospital.
结局指标
主要结局
Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up
时间窗: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Comparison of HIV viral load (copies/mL) at baseline, 1st follow-up, and 2nd follow-up. The data will be reported as the mean change in viral load from baseline at each time point
Change in Quality of Life Score (WHOQOL-BREF Taiwan Version) from Baseline to 1st and 2nd Follow-Up
时间窗: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Assessment of participants' quality of life using the WHOQOL-BREF (Taiwan Version) questionnaire at baseline, 1st follow-up, and 2nd follow-up. The results will be reported as the mean score change from baseline at each time point
Change in HIV symptoms index (HIV-SI) in score from Baseline to 1st and 2nd Follow-Up
时间窗: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Assessment of symptoms using the HIV symptoms index (HIV-SI) at baseline, 1st follow-up, and 2nd follow-up. The results will be reported as the mean score change from baseline at each time point
Change in CD4 Count from Baseline to 1st and 2nd Follow-Up
时间窗: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Comparison of CD4 cell count (cells/μL) at baseline, 1st follow-up, and 2nd follow-up. The data will be reported as the mean change in CD4 count from baseline at each time point
Change in Self-Reported Antiretroviral Therapy (ART) Medication Adherence from Baseline to 1st and 2nd Follow-Up
时间窗: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment
Assessment of self-reported ART medication adherence at baseline, 1st follow-up, and 2nd follow-up. The results will be reported as the proportion of participants who were adherent at each time point, as well as the mean adherence score change from baseline
次要结局
- Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up(At baseline and 168th (+-14) day after enrollment)
研究者
Chun-Yuan Lee, MD
Assistant professor
Kaohsiung Medical University Chung-Ho Memorial Hospital