A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Viral Suppression
研究概览
简要总结
Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities.
详细描述
Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities. TE facilitates patient navigation through the medical system and provides treatment education and client-centered counseling to improve adherence and retention in care. TE targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers, and referring patients to mental health and social services.
A total of 350 Black participants will be recruited through APLA Health and randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 13-months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 13-months post-baseline. It is hypothesized that the intervention group will show better adherence and have a greater likelihood of suppressed viral load than the control group over time.
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
- Single (Investigator)
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
- •HIV-positive
- •18 years of age or older
- •Self-identified as African American/Black
- •Been prescribed antiretroviral therapy (ART) in the past 12 months
- •Self-reported adherence problems (i.e. missed at least 1 ART dose in the past month) and/or detectable viral load
- •Willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
排除标准
- •HIV-negative
- •17 years of age or younger
- •Not self-identified as African American/Black, not on antiretroviral therapy (ART) or not prescribed ART therapy in the last than 12 months
- •No self-reported adherence problems and/or no detectable viral load
- •Not willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
结局指标
主要结局
Viral Suppression
时间窗: baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline. For 7M, medical records were used if within 90 days of survey completion; for 13 months, medical records were used if within 90 days before or 180 days after survey
Viral load undetectable per venipuncture or medical records
Dichotomous Adherence
时间窗: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
Number of Participants who Reported Taking Greater Than or Equal to 75% of Prescribed Dosage, based on electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline.
Continuous Adherence
时间窗: baseline (pre-treatment) and post-treatment observations at 7, 8, 9, 10, 11, and 12 months post-baseline
Percentage of doses taken of those prescribed from electronic monitoring. Here we present all data collected at all time points used in analysis. Evaluation of intervention efficacy was performed with repeated measures regression using continuous adherence measurements at all 6 months post-intervention (7th through 12th month post-baseline) and was restricted to those with adherence data at baseline.
次要结局
- Medical Mistrust(baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline)
- Internalized HIV Stigma(baseline (pre-treatment) and post-treatment observations at 7 and 12 months post-baseline)