Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 748
- 试验地点
- 1
- 主要终点
- HIV disclosure rate
研究概览
简要总结
The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.
详细描述
In this 5-year study, the investigators would like to build upon the successful Sankofa trial by testing the intervention in a larger scale study delivered in "real-world" clinic conditions over time in Ghana.
The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure. The study will recruit dyads of 720 children (ages 7-18) and their caregivers from twelve (12) clinics, which will be randomly assigned to each of the four roll-out schedules ("wedge steps"), with three clinics per step.
The two groups in the study are usual care and disclosure intervention. During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. No formal pediatric disclosure guidelines or educational materials exist in Ghana.
During the intervention period, the manualized, with standard operation procedures, Sankofa intervention will be delivered. The intervention is guided by the disclosure model and contains key elements to target well-documented, modifiable barriers to promote disclosure.
The primary outcome is disclosure after one year (48 weeks) of the intervention. Secondary outcomes are antiretroviral medication adherence, health (virologic, immunologic, psychosocial, behavioral), cost, and implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected children
- •Children between the ages of 7-18 who do not know their HIV diagnosis (based on caregiver account and medical records confirmation) and their caregivers will be eligible to participate in the study
排除标准
- •HIV-infected children less than 7 years
- •HIV-infected children with congenital or developmental disorders
- •HIV-infected children with comorbidities such as sickle cell disease or diabetes that require frequent clinic visits or hospitalizations
- •Children with AIDS-defining illness or end stage AIDS.
研究组 & 干预措施
Usual Care
During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated.
干预措施: Usual Care (Behavioral)
Disclosure intervention
Participants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS).
干预措施: Disclosure intervention (Behavioral)
结局指标
主要结局
HIV disclosure rate
时间窗: 1 year after intervention
Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed.
次要结局
- Antiretroviral medication adherence - Pharmacy refill measurement(5 year)
- Change in Antiretroviral medication adherence(5 year)
- Beck Depression Inventory(5 year)
- Antiretroviral medication adherence - HIV-1 RNA(5 year)
- Child Depression Inventory (CDI)(5 year)
- Implementation - Caregiver 6-month log(6 month)
- Incremental cost-effectiveness ratio(5 year)
- Immunologic health(5 year)
- Behavioral health - CBCL parent version(5 year)
- Implementation - Retention(5 year)
- Change in HIV -1 RNA Viral Load(5 years)
- Behavioral health - CBCL child version(5 year)