An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Number of participants diagnosed
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.
详细描述
All staff will be trained in mental health screening prior to the trial launch, and all clinics will be equipped with health education materials to raise awareness of mental health, self-care and available resources in the clinic and community
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient at a participating HIV clinic site
- •Currently living in Uganda with no intention of moving abroad in next 2 years
- •Access to a mobile phone
- •Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.
排除标准
- •No access to a mobile phone
- •Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW
- •Healthcare Workers/Caregivers Criteria:
- •Age >=18 years
- •Healthcare worker at participating site or caregiver for study participant at site
- •Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant
研究组 & 干预措施
SAMU intervention
Participants will receive the SAMU digital mental health screening intervention and SMS reminders to complete a SAMU session over the duration of trial consistent with their level of need.
干预措施: Syndemic-Adapted Medly Uganda (SAMU) (Device)
Control
Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility.
结局指标
主要结局
Number of participants diagnosed
时间窗: up to 18 months
Number of participants screened and diagnosed with anxiety and/or depression.
次要结局
- Mean diastolic blood pressure(Baseline and 6, 12 months)
- Number of participants linked to care(up to 18 months)
- Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C)(Baseline and 6, 12, 18 months)
- Mean systolic blood pressure(Baseline and 6, 12 months)
- Number of participants with HIV viral load suppression(Baseline and 6, 12 months)
- Self-reported medication adherence(Baseline and 6, 12 months)