Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,244
- 试验地点
- 1
- 主要终点
- Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
研究概览
简要总结
Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.
详细描述
Community-based accompaniment with directly observed antiretroviral therapy (DOT-HAART) may improve adherence and clinical outcomes among impoverished individuals starting HAART in resource-poor settings. Furthermore, the utilization of community health workers may build social capital. This is cluster-randomized trial, with randomization at the level of health centers. Individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. In addition, individuals residing in intervention clusters will receive 12 months of community-based DOT-HAART. We will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Patient Cohort:
- •Age greater than or equal to 18;
- •Diagnosis if HIV and meeting criteria for HAART;
- •Lives in poverty;
- •EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure;
- •Documentation of baseline CD4 cell count and HIV load;
- •Residence and receipt of HIV healthcare within the study catchment area
排除标准
- •for Patient Cohort:
- •Imprisoned or cannot give informed consent.
- •Inclusion Criteria for Community Cohort:
- •Working in a health establishments in study region;
- •If health personnel, contracted employee caring for people living with HIV/AIDS.
- •Exclusion Criteria for Community Cohort:
- •Cannot give informed consent
研究组 & 干预措施
Intervention: DOT-HAART
Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
干预措施: DOT-HAART (Other)
No DOT-HAART
Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.
结局指标
主要结局
Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
时间窗: 18 and 24 months
次要结局
- Identify mediating mechanisms of CASA effect on individual outcomes.(24 months)
- Identify subgroups who respond best to CASA intervention.(24 months)
研究者
Sonya Sunhi Shin
Dr.
Brigham and Women's Hospital