Community-based Self-management of HIV and Chronic Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- health-related quality of life (physical, mental health, and social function)
研究概览
简要总结
The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.
详细描述
450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV & AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 50 years or older
- •HIV-positive serostatus
- •currently prescribed antiretroviral medication
- •antiretroviral nonadherence reported in past 30 days
- •provision of oral informed consent
排除标准
- •hearing problems that preclude participation in a telephone study
- •presence of probable dementia or acute psychosis detectable by screening interview
研究组 & 干预措施
Intervention
Individual telephone counseling intervention.
干预措施: Individual Telephone Counseling Intervention (Behavioral)
Group Arm
Attention-matched comparison arm
干预措施: Group Arm (Other)
Book Arm
Information-matched control arm.
干预措施: Book Arm (Other)
结局指标
主要结局
health-related quality of life (physical, mental health, and social function)
时间窗: Baseline, 6, 9, 12 mo f/u
antiretroviral (ART) adherence
时间窗: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
次要结局
- chronic disease treatment adherence(baseline, 6, 9 and 12 months f/u)
- Self-efficacy and readiness to change(baseline, 6, 9, 12 months f/u)
- perceived stress and depression(baseline, 6, 9, and 12 months f/u)