Mfangano Island Healthy Networks Impact Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 883
- 试验地点
- 1
- 主要终点
- Antiretroviral therapy (ART) Adherence
研究概览
简要总结
This pilot study is a non-randomized controlled cohort study evaluating the impact of social network-based HIV education on antiretroviral therapy (ART) adherence, clinical outcomes, food security, social support, HIV knowledge, and risk behaviors among people living with HIV/AIDS, as well as members of their associated social support networks. The intervention, known as the Mfangano Health Net Microclinic Pilot Program, consists of a 6-month education program on HIV biology, interpersonal communication and community mobilization for both HIV positive individuals and their self-selected social network members selected irrespective of HIV status. Investigators hypothesize that participation in the microclinic program will improve ART adherence, cluster of differentiation 4 (CD4) count, social support, HIV knowledge and food insecurity and will reduce HIV-related stigma, as compared to participants in control communities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •HIV positive patient on ART at Sena Health Center or member of patient's social network
- •Resident of Mfangano Island
- •18 years of age or older
- •conversant in DhoLuo or English languages
排除标准
- 未提供
结局指标
主要结局
Antiretroviral therapy (ART) Adherence
时间窗: change from baseline to 6-months
change in ART drug levels measured in small hair samples from baseline to 6 months
Disengagement from care
时间窗: From time of study enrollment to first instance of 90-day gap in care, censorship (death, transfer outside study area) or end of study (up to 22 months)
Incidence of missing a clinic appointment by ≥90 days without having first transferred care to another clinic or died.
次要结局
- Social support(change from baseline to 6-months)
- HIV knowledge(change from baseline to 6-months)
- Time in care(From time of study enrollment until study closure (22 months) or censorship (death or transfer of care to facility outside study area))
- ART adherence - end of study(change from baseline to end of study (22 months))
- Stigma(change from baseline to 6-months)