权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

DOSE DETERMINATION TRIAL FOR IMPLEMENTING EVIDENCE-BASEDBEHAVIORAL INTERVENTIONS

实施循证行为干预的剂量确定试验

基本信息

批准号：
10089484
负责人：
SETH C KALICHMAN
金额：
$ 59.04万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-02-01 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10089484
关键词：
Adherence Behavior Therapy Behavioral Behavioral Model Behavioral Research Benchmarking Caring Centers for Disease Control and Prevention (U.S.)Characteristics Clinical Clinical Trials Cost Effectiveness Analysis Counseling Development Dose Emotional Enrollment Evidence based intervention Glare Goals HIV Health Health Policy Health Services Individual Informal Social Control Intervention Intervention Trial Life Link Literature Masks Mental Health Modeling Monitor Outcome Participant Patients Plasma Policies Policy Maker Population Poverty Randomized Reporting Research Resource Allocation Resources Structure Subgroup Telephone Testing Time Viral Viral Load result antiretroviral therapy barrier to care base behavioral adherence behavioral clinical trial cost cost effectiveness design effective intervention evidence base flexibility follow up assessment implementation intervention implementation science improved longitudinal analysis novel patient response patient subsets primary endpoint programs resource guides response scale up secondary outcome service providers skills social social factors social structure substance use theories therapy adherence therapy design viral rebound

项目摘要

The proposed research will conduct the first ever dose-determination trial of a behavioral intervention to improve engagement in HIV care, antiretroviral therapy (ART) adherence and HIV viral suppression. The trial is designed to inform the implementation of behavioral interventions, including several in CDC’s Compendium of Evidence-Based Interventions. Behavioral counseling has the flexibility and reach to overcome numerous challenges to HIV care, including social, emotional, and structural barriers. However, basic questions of how to best implement and scale-up interventions remain unanswered, such as “how much intervention is needed to achieve HIV suppression in subgroups of patients facing individual and social challenges?” There are currently no dose-determination trials in the HIV behavioral intervention literature to guide implementation decisions and health service policy. In the proposed research we specifically aim to: (a) determine the minimum effective dose of an evidence-based HIV treatment engagement and adherence intervention, (b) identify subgroups of patients requiring greater and fewer intervention resources to achieve and sustain viral suppression, and (c) the costs associated with intervention dose-response. Participants who are receiving ART and confirmed HIV unsuppressed (>200 copies/mL) will be randomized to either: (a) the dose determination condition of weekly evidence-based behavioral self-regulation counseling until achieving HIV suppression (<200 copies/mL), or (b) fixed dose 5-weekly sessions of evidence-based behavioral self-regulation counseling sessions. The dose determination condition adjusts to patient needs and determines the dose to achieve HIV suppression, in contrast to the fixed dose condition that does not adjust to patient response. The trial is therefore designed to determine the number of behavioral counseling intervention sessions needed to achieve and sustain HIV suppression. Once viral suppressed, counseling in the dose-determination condition is suspended. In contrast, the fixed-dose condition is delivered in five prescribed sessions as disseminated by the CDC. Follow-up assessments commence for 12-months from baseline with the primary endpoint of 12-month blood plasma HIV viral load and secondary outcome of ART adherence. Response to counseling is defined by achieving viral suppression (<200 copies/mL) and non-response is defined by not achieving viral suppression (>200 copies/mL). Participants in both the dose-determination and fixed-session conditions who initially respond and rebound to unsuppressed viral load will receive additional counseling with redose-response monitored and analyzed. Longitudinal analyses will examine intervention dose for key patient subgroups and dose-response cost-effectiveness analyses to guide resource allocation and implementation decisions. This research is aimed at informing health policy makers and programmatic decisions regarding intervention implementation to increase the likelihood of sustained HIV suppression.

拟议的研究将进行有史以来第一次行为干预的剂量测定试验