Community ART for Retention in Zambia: Evaluating the Feasibility, Effectiveness, and Efficiency of Decentralized and Streamlined Antiretroviral Therapy Care Models
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,100
- 试验地点
- 2
- 主要终点
- Retention in care (Time to first missed pharmacy pick-up)
研究概览
简要总结
This study seeks to create generalizable knowledge about the implementation process as well as the effectiveness and efficiency of a differentiated care system, by measuring patient health outcomes and implementation outcomes such as acceptability, feasibility, fidelity, and costs
详细描述
This is a joint endeavor of the Zambian Ministry of Health (MoH), Ministry of Community Development, Mother & Child Health (MCDMCH) and the Centre for Infectious Disease Research in Zambia (CIDRZ) with funding from the Bill & Melinda Gates Foundation.
The study evaluates four models of streamlined HIV care in reducing patients' time and cost: (1) community adherence groups (CAG), (2) urban adherence groups (UAG), (3) Fast-Track clinic visits and (4) streamlined ART initiation (START). CAG and UAG are assessed using a cluster-randomized design; Fast-Track and START using an observational approach to compare changes in the outcome through a difference in difference approach.
1. Specific Objectives
Objective 1:
To determine acceptability, appropriateness, and feasibility of a differentiated care system in Zambia, by assessing perspectives of (1) patients and family members (2) health care workers and (3) government and local leaders.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive adolescents and adults (> 14 years of age)
- •Last CD4 count (obtained within the last six months) > 200
- •Not acutely ill
- •For CAGs, UAGs, and Fast-Track models: on ART for at least 6 months
- •For the START model: ART naïve and meet the Zambian HIV guidelines for treatment initiation
排除标准
- •For CAGs, UAGs: Inability to participate in the group activities due to cognition deficits or mental illness.
- •Unable to provide consent or unwilling to participate in study
- •Pregnancy
研究组 & 干预措施
CAG (intervention)
CAG intervention, consists of facilitated groups of six people based on geographic proximity of home address and patient preference. This group of six people, will meet monthly at a designated place in the community to provide support and receive medications. Each month one of the members will rotate visiting the clinic for their routine medical visit and will pick up medications for the entire CAG and bring them back to the community. This rotation schedule will recur every six months. Lay health care workers will provide brief symptom screening to identify patients in the group that need of higher-level care.
干预措施: CAG (Other)
UAG (intervention)
Urban sites will be eligible for the UAG model in which patients will be joined into a UAG group consisting of 30 people. Each UAG group will meet every two to three months at a designated site (either at the clinic facility or another site in the community). Patients will receive (a) group adherence counseling led by a lay HCW (b) two to three month supply of ART medications via a pharmacy tech (c) attendance record and symptom assessment. As in the CAG model, patients may be referred up-referred for care based on acute illness or patient preference. Patients will continue to visit the facility for a routine medical visit with a professional HCW every six months.
干预措施: UAG (Other)
UAG (comparison)
Eligible patients at control sites will be approached for willingness to participate in the study. Those who are willing will be enrolled in the study and consent will be obtained to use patient data within SmartCare to evaluate the primary outcome of retention.
干预措施: UAG (Other)
START
The START model aims to deliver a higher intensity of treatment services by offering same-day CD4 testing and results, streamlined adherence counseling, and quicker initiation of life-long ART to patients enrolling in HIV care and treatment services.
干预措施: START (Other)
FAST Track
In the FAST-TRACK model a pharmacy technician will dispense drugs) and lay health care workers will provide brief symptom screening to identify patients in need of higher-level care. If there is no need of higher-level care, then the clinic visit is over.
干预措施: FAST-TRACK (Other)
CAG (comparison)
Eligible patients at control sites will be approached for willingness to participate in the study. Those who are willing will be enrolled in the study and consent will be obtained to use patient data within SmartCare to evaluate the primary outcome of retention.
干预措施: CAG (Other)
结局指标
主要结局
Retention in care (Time to first missed pharmacy pick-up)
时间窗: 12 months
Time to first missed pharmacy pick-up (\>7 days)
次要结局
- Retention rate disaggregated by sex (male and female)(12 months)
- Feasibility of implementing differentiated care from stakeholder perspectives(12 months)
- Research Costs (cost of conducting implementation science)(12 months)
- Proportion of patients virally suppressed at one year among those exposed to the intervention compared to control conditions using mixed effects logistic regression(12 months)
- Activity Based Costing (cost per activity based on Time and Motion)(12 months)
- Access to care (time in days from positive symptom screen to appropriate referral)(12 months)
- Efficiency (Difference between cost per additional patient retained and the cost per death averted divided by the difference in their effect)(12 months)
- Proportion of patients with appropriate laboratory monitoring (CD4 count testing)(every 6 months for a year)
- Retention rate disaggregated by age (adult and adolescent)(12 months)
- Feasibility of implementing differentiated care based on ART availability(12 months)
- Cost to patient based on semi-structured interviews(12 months)
- Proportion of patients with appropriate laboratory monitoring through viral load testing(12 months)
- Proportion of patients with appropriate symptom screening(Every 1-3 months for 12 months)
- Fidelity by monitoring the proportion of eligible patients successfully enrolled and retained in a model.(12 months)
- Patient satisfaction using patient exit-survey(12 months)