Syndemics and Loss from the HIV Care Continuum in India - Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acceptability among participants and providers as assessed by semi-structured qualitative interviews
研究概览
简要总结
The investigators will assess the feasibility and acceptability of a pilot intervention to keep people living with HIV (PLHIV) in southern India in care and virologically suppressed. The lack of understanding of the causes of loss from the HIV care continuum in India stifles the armamentarium of effective interventions to keep Indian PLHIV in care. The results of this research will demonstrate the feasibility and acceptability of a pilot intervention targeting the multiple mechanisms by which PLHIV become lost to care. By targeting these mechanisms, this intervention will be designed to be scalable in a setting where access to mental health specialists is limited.
详细描述
This pilot intervention represents the final Aim of the NIMH-sponsored study "Syndemics and Loss from the HIV Care Continuum in India." This trial will be conducted at the Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE), located in Chennai, the capital of Tamil Nadu state and one of the epicenters of the Indian HIV epidemic.
The investigators will recruit 50 adult (age >=18) PLHIV presenting to care at YRG CARE and ART-naïve. Participants will be recruited at their first visit to YRG CARE, at which the participant's HIV diagnosis is established or confirmed and the participant receives initial counseling and clinical care. At this recruitment stage, research assistants will conduct a pre-intervention questionnaire including measures of depressive symptoms, internalized stigma, self-efficacy, mental health, and physical health. The investigators will then randomize the patient to usual care vs. enhanced-care intervention (25 in each arm).
The enhanced-care intervention will be multi-faceted, reflecting the likelihood of multiple syndemic conditions as well as evidence from LMICs suggesting that programs combining multiple approaches are the most effective in improving retention in care.
The enhanced-care intervention will consist of the following components:
- Active outreach, including bidirectional weekly SMS messaging / automated voice messaging (depending on literacy)
- Appointments (specific appointment times/dates).
- Financial support, including free clinic visits, labs, medications, and transportation incentives on a sliding scale based on distance to clinic
- Microenterprise, including bag-making or food-making ventures for women
- Enhanced counseling. Participants in the enhanced-care intervention will participate in an individual enhanced counseling program called Steps to Success, based upon a Life Steps and Problem Solving curriculum.
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
- •Adult PLHIV presenting to care at YRG CARE who are ART-naïve and who plan to follow-up at YRG CARE
- •Speaks Tamil, Telugu, or English
排除标准
- •Previous ART exposure
- •Not competent to provide informed consent or participate in the study
结局指标
主要结局
Acceptability among participants and providers as assessed by semi-structured qualitative interviews
时间窗: 12 months
Acceptability among patients and providers as measured by semi-structured qualitative interviews of participants and providers
Feasibility as assessed by semi-structured qualitative interviews
时间窗: 12 months
Minimal negative impact on clinical work flow and ability to deliver all intervention components, particularly all sessions of enhanced counseling, as measured by semi-structured qualitative interviews of providers
次要结局
- Depressive symptoms as measured by PHQ-9(12 months)
- Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)(3 months)
- ART initiation success (accepted ART and continued ART for at least 6 months)(6 months)
- Food insecurity as measured by Household Food Insecurity Access Scale(12 months)
- Retention in care(12 months)
- Internalized stigma as measured by Internalized AIDS-Related Stigma Scale(12 months)
- Self-efficacy as measured by General Self-Efficacy Scale--shortened version(12 months)
- Social support as measured by Multidimensional Scale of Perceived Social Support(12 months)
研究者
Brian Chan
Associate Physician
Brigham and Women's Hospital