UNCPM 21609 Project SOAR Mental Health: Evaluation of the Impact of a Depression Treatment Program on Mental Health and HIV Care Outcomes in Malawi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,082
- 试验地点
- 2
- 主要终点
- Proportion of participants who are virally suppressed
研究概览
简要总结
Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. However, the potential for depression treatment to improve HIV care outcomes has received little attention in the region, in part because of limited mental health infrastructure. In this study, the investigators will evaluate the impact of a depression treatment program integrated within existing HIV clinics on depression response, retention in HIV care, and viral suppression. It is expected that this evaluation will yield important evidence on the impact of depression treatment integrated with HIV care for improving HIV care and mental health outcomes in Malawi.
详细描述
Study population:
The evaluation will abstract screening data for adult (≥18 years old) patients newly initiating antiretroviral therapy (ART) who are screened for depression at the two clinics before and after the integration of the depression treatment program, and additional treatment and outcome data for those patients who screen positive for depression.
Study Size:
Across the two clinics, the investigators expect to abstract depression screening data for approximately 2,300 patients. The investigators expect to abstract further treatment and outcome data for approximately 640 patients who screen positive for mild, moderate, or severe depression.
Study Duration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Adult (≥18 years)
- •HIV-infected
- •Newly initiating antiretroviral treatment at one of the program sites
- •Screened for depression
排除标准
- 未提供
结局指标
主要结局
Proportion of participants who are virally suppressed
时间窗: 6 months after ART initiation
Viral suppression is defined as HIV RNA viral load of \<1,000 copies/mL. Viral loads are measured approximately 6 months after ART initiation.
Proportion of participants who are retained in care
时间窗: 6 months after ART initiation
Retention in care is defined as attending sufficient HIV appointments to maintain ART supply through the first 6 months on ART.
次要结局
- Proportion of scheduled ART visits attended(6 months after ART initiation)
- Proportion of participants who achieve depression remission (PHQ-9 score less than 5)(6 months after ART initiation)