Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Average difference in mean antiretroviral therapy adherence between 2 and 6 months
研究概览
简要总结
The aim of the study is to examine the effect of a psychological intervention on antiretroviral therapy outcomes and symptoms of common mental health disorders among adults living with HIV and common mental disorders in rural Zimbabwe.
详细描述
Common mental disorders are highly prevalent among people living with HIV. Left untreated, common mental disorders cause substantial disability and undermine individuals' ability to adhere to antiretroviral therapy, leading to poor antiretroviral therapy outcomes.
A recent cluster-randomized controlled trial from Harare, Zimbabwe showed that the friendship bench intervention (i.e. six sessions of problem-solving therapy delivered by lay health workers followed by a peer support group) effectively reduced symptoms of common mental disorders, but the effect of the intervention on antiretroviral therapy outcomes and its effectiveness in the rural setting has not been studied.
To examine the effect of the friendship bench intervention on antiretroviral therapy outcomes and symptoms of common mental disorders among adults living with HIV and common mental disorders in rural Zimbabwe, a cluster-randomized trial is conducted.
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
- •Age ≥18 years
- •Use of first-line antiretroviral therapy for at least 6 months
- •Resident in Bikita District
- •Knowledge of English or Shona language
- •Ability to comprehend the information on the study
- •Positive screening for common mental disorders (SSQ-14 score ≥9)
- •Providing informed consent
排除标准
- •Current psychosis / cognitive impairment
- •Clinical AIDS (WHO clinical stage 4)
- •Known pregnancy or ≤3 months postpartum
研究组 & 干预措施
Problem-Solving Therapy
Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care.
干预措施: Friendship bench intervention (Behavioral)
Problem-Solving Therapy
Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care.
干预措施: Enhanced Standard of Care (Other)
Enhanced Standard of Care
Participants in the control group receive enhanced standard of care.
干预措施: Enhanced Standard of Care (Other)
结局指标
主要结局
Average difference in mean antiretroviral therapy adherence between 2 and 6 months
时间窗: 2-6 months
Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
次要结局
- Difference in mean antiretroviral therapy adherence between 1 and 12 months(1-12 months)
- Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score(At month 3, 6, 9, and 12)
- Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score(At month 3, 6, 9, and 12)
- Viral load suppression (<1000 copies per milliliter)(At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days))