Effect of Family-centered Model of HIV Care (FAM-CARE) on Viral Suppression and Retention in Care of HIV-positive Children in Swaziland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 742
- 试验地点
- 2
- 主要终点
- Proportion of HIV-positive children on ART virally suppressed
研究概览
简要总结
The study will evaluate the effect of implementing a family-centered care (FAM-CARE) program (where all HIV-positive family members are seen together as a unit and receive care together) on viral suppression and retention in HIV-positive children <15 years through enrollment of a prospective cohort of 660 HIV-positive children and their caregivers at sites that were randomized to either implement the family-care program (intervention sites) or continue the current standard of care (control sites).
详细描述
The proposed study will evaluate the effect of implementing a FAM-CARE program on viral suppression and retention in children through enrollment of a prospective cohort of HIV-positive children and their caregivers at sites implementing the FAM-CARE program and control sites continuing the current standard of care. The study will be conducted in four "clusters" of facilities (2 hospitals and 2 health centers and their filter clinics) in the Hhohho region of Swaziland. Two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the FAM-CARE program with viral load monitoring and two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care sites. A prospective cohort of HIV-positive children and their caregivers will be followed in the FAM-CARE program sites and control sites. Each child will be followed for 18 months following enrollment. The primary objective is to evaluate the effect of the FAM-CARE program on the rates of viral suppression and retention in care, comparing rates of viral suppression and retention in children enrolled in FAM-CARE versus control sites. The study will also evaluate factors associated with viral suppression and retention (including family demographic characteristics), and conduct qualitative interviews to assess the acceptability of the FAM-CARE program by caregivers and health care providers in the intervention sites.
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
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive child aged <15 years receiving HIV care at the study facility.
排除标准
- •At least one family member residing in the household is also HIV-positive and is receiving services at the study facility
结局指标
主要结局
Proportion of HIV-positive children on ART virally suppressed
时间窗: 18 months after study enrollment.
Proportion of HIV-positive children on ART with viral suppression (defined as HIV RNA copies/mL below the level of assay detection) and the proportion with HIV RNA \<1,000 copies/mL at 18 months after enrollment
Proportion of HIV-positive on ART virally unsuppressed
时间窗: 18 months after study enrollment.
Proportion of HIV-positive children on ART with HIV RNA \>1000 copies/mL 18 months after enrollment into the study.
次要结局
- Loss to follow-up(18 months after study enrollment)
- Proportion HIV-positive children on ART virally suppressed (<1,000 copies/mL of HIV RNA) at 6 and 12 months after study enrollment(6 and 12 months after study enrollment)
- Acceptability of the FAM-CARE program based on individual interview responses(18 months after study enrollment)
- Factors associated with HIV viral suppression(18 months after study enrollment)
- ART initiation(18 months after study enrollment)