Intervention to Improve HIV Care Retention and Antiretroviral Adherence inStigmatized Environments

在污名化环境中改善艾滋病毒护理保留和抗逆转录病毒治疗依从性的干预措施

基本信息

批准号：
10533746
负责人：
SETH C KALICHMAN
金额：
$ 60.33万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-12-16 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10533746
关键词：
Address Adherence Adoption Adverse effects Anti-Retroviral Agents Behavior Behavior Therapy Behavioral Caring Cellular Phone Clinic Clinical Clinical Services Clinical Trials Design Communities Community Health Aides Consolidated Framework for Implementation Research Counseling Country Data Decision Making Dedications Enrollment Environment Evidence based intervention Frequencies Future Gender Goals HIV HIV Infections Health Homophobia Informal Social Control International Intervention Investigation Mediating Modeling Modification Outcome Participant Patient Education Patient Recruitments Patients Penetration Persons Problem Solving Process Professional counselor Provider Public Health Randomized Recording of previous events Research Research Activity Resource-limited setting Resources Same-sex Self Efficacy Self Management Services South Africa South African Stigmatization System Technology Testing Viral Woman adverse outcome antiretroviral therapy arm barrier to care behavior test care seeking care systems cost design efficacy testing efficacy trial evidence base experience follow-up implementation evaluation implementation research improved internalized stigma intervention effect male medication compliance men patient engagement pilot test post intervention preservation primary endpoint primary outcome randomized, clinical trials recruit scale up secondary outcome skills social social stigma standard of care theories therapy adherence therapy design three-arm clinical trial three-arm trial trial design

项目摘要

The global scale-up of antiretroviral therapy (ART) is aimed to achieve 90% HIV suppression worldwide. However, even with increased access to ART, many countries are not on track to achieving this goal. Among the factors that impede retention in HIV care, ART adherence and HIV suppression is the social stigmatization of HIV infection. HIV stigmas and behaviors intended to avoid stigma have the adverse consequences of deterring people from seeking care, interfering with clinic attendance, and detracting from taking ART. Interventions to increase HIV care retention and ART adherence have not thus far focused on reducing the adverse effects of stigma in countries where HIV is most prevalent. This application proposes to test a theory-based mobile-phone delivered counseling intervention designed to address HIV-stigma concerns in order to improve HIV treatment retention and adherence in South Africa. The intervention is grounded in Behavioral Self-Regulation Theory and the HIV Stigma Framework and was developed in partnership with South African public health agencies. The intervention approach uses health decision- making and problem-solving skills aimed at resolving social and structural barriers to care, and is delivered by community health worker/lay counselors to increase its potential for scale-up. To test the efficacy of this newly developed and fully pilot tested intervention model, we will conduct a randomized clinical trial designed to tease-out the additive effects of directly addressing stigma concerns by augmenting a Behavioral Self- Regulation Counseling with stigma management components. We will conduct a 3-arm clinical trial in a resource limited township in South Africa that has shown evidence of high-HIV stigma to compare: (a) Behavioral Self-Regulation + Stigma Management Counseling for HIV treatment retention and adherence, vs. (b) Behavioral Self-Regulation Counseling for HIV treatment retention and adherence, vs. (c) Uniform standard of care HIV patient education. The trial will enroll 1200 men and women with unsuppressed HIV and receiving HIV treatment in South Africa’s HIV care system. Participants will be followed for 15-months post-intervention to assess intervention effects on HIV care retention and HIV suppression (primary outcomes) and ART adherence (secondary outcome). Conditional process modeling will determine underlying mechanisms (e.g., self-efficacy, behavioral strategies, internalized stigma, anticipated stigma) that account for intervention effects and how these mechanisms may vary by level of baseline experiences with enacted HIV stigma. The trial will also perform implementation research activities to inform potential scale-up should the intervention be shown efficacious. This newly developed intervention model is designed for use with existing clinical resources in WHO defined systems of differentiated HIV care.

抗逆转录病毒疗法（ART）的全球量表旨在在全球范围内实现90％的HIV抑制。但是，即使获得艺术品的机会增加，许多国家也没有达到实现这一目标的目标。在阻碍艾滋病毒护理中保留的因素中，艺术依从性和抑制艾滋病毒是社会 HIV感染的污名化。艾滋病毒的污名和行为旨在避免污名具有对立确定人们寻求护理，干扰诊所出勤和损害的后果来自艺术。到目前在减少艾滋病毒最普遍的国家的污名不利影响时。此申请建议测试基于理论的移动电话提供的咨询干预措施，旨在解决HIV污名为了改善南非的艾滋病毒治疗保留和依从性而引起关注。干预是基于行为自我调节理论和HIV污名框架，并在与南非公共卫生机构的合作伙伴关系。干预方法使用健康决策 - 旨在解决社会和结构性护理障碍的制作和解决问题的技能，并提供由社区卫生工作者/外行硬币提高了扩大规模的潜力。测试效率新开发和完全试验测试的干预模型，我们将进行一项随机临床试验通过增强行为自我的行为，弄清直接解决污名问题的额外影响使用污名管理组件进行监管咨询。我们将在南非资源有限的乡镇，显示出高HIV污名的证据以进行比较：（a）行为自我调节 + HIV治疗保留和依从性的污名管理咨询， vs.（b）艾滋病毒治疗保留和依从性的行为自我调节咨询，vs.（c）统一护理标准艾滋病毒患者教育。该审判将注册1200名未受艾滋病毒的男女并在南非的艾滋病毒护理系统中接受艾滋病毒治疗。参与者将持续15个月干预后评估干预对HIV护理保留和抑制HIV的影响（主要结果）和艺术依从性（次要结果）。有条件的过程建模将确定基本机制（例如自我效能感，行为策略，内在的污名，预期的污名）该解释了干预效果以及这些机制如何因基线体验水平而变化颁布的HIV污名。该试验还将执行实施研究活动，以告知潜在扩大干预措施应有效。这个新开发的干预模型是专为与现有的临床资源一起使用，该资源定义了差异化的艾滋病毒护理系统。