Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of participants in each arm achieving viral suppression to <50 copies/ml
研究概览
简要总结
ART is given to people living with HIV in order to suppress the virus, resulting in improved health for the individual and decreased transmission of the virus to others. Success of ART is dependent on adherence. Currently, adherence is assessed by asking patients directly and then confirming with a viral load test, which is expensive and is often only done when the viral load is already raised. Therefore there is a need to find a method to detect problems with adherence early before the viral load rises.
A urine-based test was recently developed, called UTRA (urine tenofovir rapid assay). This test can give clinic staff immediate results about a person's adherence to the antiretroviral medication Tenofovir (TDF). The study will compare the results of this urine test to drug levels found in blood, self-reported adherence and pharmacy collection records to see if this test can be used as part of routine care in ART clinics. If the test is effective it would allow clinic staff to identify people with adherence difficulties early and give them the necessary support before their viral load rises.
详细描述
This is a randomised study, recruiting 200 people taking TDF-based ART. Participants will be randomised 1:1 to intervention versus standard enhanced adherence counselling. Intervention participants will receive an adherence support package informed by feedback from the urine-based test. The investigators will assess the impact of the adherence test on VL suppression rates in each arm (without necessitating a regimen switch) at 12 months after enrolment. Enrolling participants with adherence challenges increases efficiency and mirrors the population requiring adherence support in our setting.
The UTRA device used for this study has received a FDA Non-Significant Risk (NSR) designation and is IDE exempt.
FEASIBILITY:
The investigators will track retention in the study among participants in each arm, missed visits, and the number of urine assessments performed in the intervention arm.
ACCEPTABILITY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Willing and able to provide written informed consent
- •HIV-infected, receiving or (re-)starting a tenofovir-based ART regimen
- •Current ART regimen includes at least one drug with a high genetic barrier to resistance e.g. dolutegravir, atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir.
- •Any previous raised viral load >50 copies/ml (after ART initiation).
- •Willing and able to comply with laboratory tests and other study procedures
排除标准
- •Not willing or able to provide informed consent in any of the languages provided
- •Not receiving a tenofovir-based ART regimen
- •Any other clinical condition that in the opinion of an investigator puts the patient at increased risk if participating in the study.
研究组 & 干预措施
Intervention
POC adherence testing by a urine TFV assay with feedback
干预措施: UTRA (Device)
Intervention
POC adherence testing by a urine TFV assay with feedback
干预措施: UTRA feedback (Behavioral)
Standard of Care
Standard enhanced adherence counselling, SA Department of Health, March 2020
结局指标
主要结局
Proportion of participants in each arm achieving viral suppression to <50 copies/ml
时间窗: 21 months
Assess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Plasma will be stored an enrolment, month 6 and month 12 for viral load assay completion after the study. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures
Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml
时间窗: 12 months
Assess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Plasma will be stored an enrolment, month 6 and month 12 for viral load assay completion after the study. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures
次要结局
- The proportion of participants indicating "strongly agree" or "agree" averaged across 10 items, each using a five-point Likert scale to measure aspects of the adherence support intervention (i.e., by arm: UTRA-informed or standard of care)(21 months)
- Viral suppression (<50 copies/mL)(21 months)
- Retention in care(21 months)
- Number of Participants Retained in Care(12 months)
- Viral Suppression (<50 Copies/mL)(6 months)
- The Proportion of Participants Indicating "Strongly Agree" or "Agree" Averaged Across 10 Items, Each Using a Five-point Likert Scale to Measure Aspects of the Adherence Support Intervention (i.e., by Arm: UTRA-informed or Standard of Care)(12 months)