Reaching 90% Target of HIV Viral Suppression: The Role of Point-of-Care Viral Load Monitoring in Resource-Constrained Settings in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 543
- 试验地点
- 2
- 主要终点
- Proportion of patients with VL<1000 copies/mL at month 12 post-initiation of ART (range 11-15 months) in SOC VL versus POC VL
研究概览
简要总结
The UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired immunodeficiency syndrome (AIDS) epidemic by 2020 [UNAIDS, 2015]. While viral load (VL) quantification is the gold standard of HIV treatment monitoring, it is only routinely available and employed in resource-rich countries. The use of an affordable, reliable, point-of-care (POC) VL assay has been considered a "game-changer", where increased access, minimal lab worker training, and same day results could be addressed in a single solution. To date, POC VL assays have been evaluated by their manufacturers with reference panels of samples with some in-country laboratory evaluations. While these are appropriate and critical first steps, it is also important to evaluate the impact of this new technology against the standard of care (SOC) method of VL monitoring in an actual resource-limited setting.
Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million infected and serves as a relevant setting for testing feasibility and efficacy of POC VL monitoring [UNAIDS, 2016]. In order to present the case for implementing the use of POC VL testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC testing for VL monitoring are needed. To address this need, the investigators have designed a randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the Nigerian National Guidelines, to provide operational evidence for implementation of POC VL testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC VL monitoring in HIV-infected patients newly initiating ART will improve overall ART outcomes, increase ART adherence and program retention rates, and result in faster switches to second-line treatment of patients failing first-line ART.
详细描述
The investigators will conduct an un-blinded randomized implementation trial comparing POC VL monitoring, using the Cepheid Gene Xpert HIV-1 VL®, to SOC VL monitoring, using the Roche AmpliPrep/COBAS Taqman system. The trial will be conducted at two sites in Plateau State, Nigeria.
ART-naïve patients initiating ART will be randomized on a 1:1 basis to the SOC VL monitoring control arm or the POC VL monitoring arm. VL monitoring will occur according to the current Nigerian ART guidelines-recommended algorithm, with the addition of a baseline VL test. For the month 6 and 12 visits, patients that are enrolled in the POC VL monitoring arm will be provided their VL results. Participants in the SOC arm will receive their Roche VL test results after the results become available per SOC protocol. All other aspects of their HIV care and treatment will be identical to services that they would normally receive at these treatment centers.
The investigators will follow all patients up through their Month 12 follow-up visit. At trial exit, the investigators will ask patients, caregivers of patients under the age of 18 years, and providers for their participation in surveys on the operational performance and acceptability of the POC versus SOC VL monitoring. Following that time point, the patients will continue receiving HIV care and treatment utilizing the SOC procedures for the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All HIV-infected patients newly initiating ART
排除标准
- •Previous ARV experience
结局指标
主要结局
Proportion of patients with VL<1000 copies/mL at month 12 post-initiation of ART (range 11-15 months) in SOC VL versus POC VL
时间窗: 12 months (range 11-15 months)
Proportion of patients that have undetectable viral load at the end of observation (month 12) will be compared by treatment arm
次要结局
- Difference in time from ART initiation to the confirmation of virologic failure in SOC versus POC VL monitoring arms(ART Initiation to Month 12)
- Difference in ART adherence patterns in patients in the SOC versus POC VL arms(From ART initiation to month 12)
- Difference in time from ART initiation to switch to 2L treatment in patients in VF in SOC versus POC VL monitoring arms(ART Initiation to Month 12)
- Difference in time from specimen collection to availability of VL results in patient charts in SOC versus POC VL monitoring arms(All follow-up visits at which VL monitored up to Month 12)
- Difference in HIV DRM patterns in patients failing 1L ART in the SOC versus POC VL monitoring arm(Month 12)
- Difference in loss to follow-up rates by 12 months post-initiation of ART between patients monitored with SOC versus POC VL arms(Month 12)
- Impact of trial site on differences in virologic suppression rates within patients receiving SOC VL monitoring(Month 12)
- Difference in time from lab confirmation of first unsuppressed VL to adherence counseling provided and switch to 2L in SOC versus POC VL monitoring arms(All follow-up visits at which VL monitored up to Month 12)
- Health care worker (HCW) satisfaction level with POC versus SOC VL monitoring(Month 12)
- Difference in time from specimen collection to delivery of VL results to patient in SOC versus POC VL monitoring arms(All follow-up visits at which VL monitored up to Month 12)
- POC VL arm patient satisfaction with POC vs SOC VL testing(Month 12)
研究者
Phyllis Kanki
Professor of Immunology & Infectious Diseases
Harvard School of Public Health (HSPH)