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.

全球范围内扩大抗逆转录病毒治疗 (ART) 的目标是在全球范围内实现 90% 的 HIV 抑制。然而，即使增加了抗逆转录病毒治疗的机会，许多国家仍未走上实现这一目标的轨道。阻碍艾滋病毒护理、抗逆转录病毒治疗依从性和艾滋病毒抑制的因素包括社会因素对艾滋病毒感染者的污名化和旨在避免污名化的行为会产生不利影响。阻碍人们寻求护理、干扰就诊以及分散注意力的后果迄今为止，尚未重点关注提高艾滋病毒护理保留率和抗逆转录病毒治疗依从性的干预措施。该申请提出了关于减少艾滋病毒最流行国家的耻辱的不利影响。测试基于理论的手机提供的咨询干预措施，旨在解决艾滋病毒耻辱问题为了提高南非艾滋病毒治疗的保留率和依从性，我们采取了干预措施。以行为自我调节理论和艾滋病毒耻辱框架为基础，并于与南非公共卫生机构的合作伙伴关系采用健康决策- 旨在解决护理方面的社会和结构性障碍的制定和解决问题的技能，并提供由社区卫生工作者/非专业顾问进行，以增加其扩大规模的潜力，以测试其功效。新开发并经过全面试点测试的干预模型，我们将进行设计的随机临床试验通过增强行为自我来梳理出直接解决耻辱问题的附加效应带有耻辱管理成分的监管咨询我们将在一个项目中进行三组临床试验。南非资源有限的城镇已显示出高艾滋病毒耻辱的证据，可供比较：(a) 行为自我调节+耻辱管理咨询，以确保艾滋病毒治疗的保留和依从性，对比 (b) 针对 HIV 治疗保留和依从性的行为自我调节咨询，对比 (c) 制服该试验将招募 1200 名艾滋病毒未受抑制的男性和女性。并在南非艾滋病毒护理系统中接受艾滋病毒治疗的参与者将被跟踪 15 个月。干预后评估干预措施对艾滋病毒护理保留和艾滋病毒抑制的影响（主要结果）和 ART 依从性（次要结果）将确定。潜在机制（例如自我效能、行为策略、内在耻辱、预期耻辱）解释了干预效果以及这些机制如何根据基线经验水平而变化该试验还将开展实施研究活动，以告知潜在的情况。如果干预措施有效，则可以扩大规模。旨在与世卫组织定义的差异化艾滋病毒护理系统中的现有临床资源一起使用。