Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 704
- 试验地点
- 1
- 主要终点
- Number of Participants With Viral Suppression
研究概览
简要总结
Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority country, has an estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90 goal for population-level viral suppression. Feasible, scalable and cost-effective approaches to maximizing durability of first-line ART and ensuring viral load (VL) suppression in HIV-infected children are urgently needed. This pilot study will evaluate two critical components related to viral suppression in children via: 1) Point-of-care (POC) VL testing (Aim 1) and 2) targeted drug resistance mutation (DRM) testing (Aim 2) among children on first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with access to POC VL testing and time to suppression shorter compared to children with standard VL testing and 2) DRM testing will shorten time to viral suppression and that the investigators will observe high levels of 1st line antiretroviral DRMs among children on ART without viral suppression. This proposal directly addresses the urgent need to find interventions to maximize viral suppression among children on ART and achieve the UNAIDS 90-90-90 goals.
详细描述
The study design will be a randomized, controlled study to pilot the use of POC VL and DRM testing in children aged 1-14 years on first-line ART. Children enrolling at each site will be randomized 1:1 to two study arms.
Standard of Care Arm:
Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care VL and DRM testing based on the existing Kenyan national guidelines. VL testing will be 6 months after ART initiation (then every 3 months if unsuppressed, otherwise every 12 months) with DRM testing only if failing second-line ART. Children who have a high lab-based HIV VL (≥1,000 copies/mL) will receive intensive adherence counseling and be asked to return to the clinic in 3 months for repeat HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL), the children will be managed per Kenya national guidelines.
Intervention Arm:
Children in the intervention arm will undergo POC VL testing every 3 months for a total of 12 months. "Targeted" DRM testing will include DRM testing for each child on the first detection of lack of viral suppression (VL > 1000 copies/mL) and in children newly initiating ART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and those conducting the analysis will be blinded to arm allocation
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-14 years living with HIV (documented HIV positive)
- •On first-line ART per Kenyan National Guideline or
- •Newly initiating ART
排除标准
- •On second-line, third-line, or non-standard first-line ART
结局指标
主要结局
Number of Participants With Viral Suppression
时间窗: 12 months after enrollment
Viral Load \<1000 copies/mL at 12 months after enrollment
次要结局
- Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed(12 months post enrollment)
- Number of Children With Any or Major Drug Resistance Mutations (DRMs)(12 months post enrollment)
- Number of Participants Who Underwent POC VL Testing(Every 3 months within the 12 months study period)
- Turn-around Time for the VL Testing Results(Every 3 months within the 12 months study period)
研究者
Rena Patel
Principal Investigator
University of Alabama at Birmingham