Strengthening Families Living With HIV in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 843
- 试验地点
- 2
- 主要终点
- Post-Traumatic Stress Disorder
研究概览
简要总结
This study seeks to use a group-based microfinance/internal lending model to develop social capital among people with HIV in Kenya. This will create a context to deliver validated curriculum targeting intimate partner violence, positive parenting, agriculture, small business entrepreneurship, group-interpersonal therapy, and other determinants of well-being and ART adherence among people with HIV. The primary outcomes are viral suppression, ART adherence, and common mental disorders.
详细描述
It is anticipated that involvement in an internal savings and lending program will create social capital among people with HIV and their guardians (in case of adolescents w HIV). This social capital accrual will be leveraged to support and disseminate social skills (i.e. positive parenting, conflict resolution), economic skills (i.e. entrepreneurship, farming), and health skills (i.e. ART adherence, retention in care to produce viral suppression). The overall outcome is improved social, health, and economic well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria for inclusion of subjects include:
- •testing positive for HIV, confirmed by the Ministry of Health clinics
- •being at or older than 13 years of age
- •initiating care at a qualified Ministry of Health clinic in the catchment area, or intending to initiate care at such a clinic (see below for definition)
- •Any gender, age (13+ years), and comorbid disease states
- •Provide informed consent if adult, emancipated minor or mature minor
- •Provide assent if minor with guardian, who must provide informed consent
- •Qualified clinical locations include
- •those with accessible and usable public land to convene weekly meetings,
- •no current program targeting families with HIV known to the Ministry of Health
排除标准
- •Refusal to participate
- •Current participation in a similar program
- •Residing in a location with a similar program targeting patients with HIV
- •Not covered by inclusion criteria.
结局指标
主要结局
Post-Traumatic Stress Disorder
时间窗: Change from baseline to 3 years
Post-traumatic stress disorder (PTSD) will be measured using the PTSD symptom scale. Higher scores mean more PTSD symptoms present.
Anti-retroviral therapy Adherence
时间窗: Change from baseline to 3 years
Anti-retroviral therapy (ART) adherence will be measured by patient report using the adherence portions of the AIDS Clinical Trial Group (ACTG) Adherence tool and by refill history.
Depression
时间窗: Change from baseline to 3 years
Depression will be measured using the Beck's Depression Inventory. Higher scores mean more depressive symptoms present.
Viral Suppression
时间窗: Change from baseline to 3 years
Viral suppression is measured as an undetectable viral load using standard clinic procedures.
Anxiety
时间窗: Change from baseline to 3 years
Anxiety will be measured using the Generalized Anxiety Disorder (GAD7) instrument. Higher score means more anxiety symptoms present.
次要结局
- Intimate partner violence(Change from baseline to 3 years)
- Group entitativity(Change from baseline to 3 years)
- Food insecurity(Change from baseline to 3 years)
- Social trust(Change from baseline to 3 years)
- Expectations of mutual support(Change from baseline to 3 years.)
- Child-guardian conflict(Change from baseline to 3 years.)