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

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：
9927034
负责人：
SETH C KALICHMAN
金额：
$ 62.41万
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/9927034
关键词：
Address Adherence Adoption Adverse effects Anti-Retroviral Agents Behavior Behavior Therapy Behavioral Car Phone Caring Clinic Clinical Clinical Services Clinical Trials Design Communities Community Health Aides Counseling Country Data Decision Making Enrollment Environment Evaluation Evidence based intervention Frequencies Future Gender Goals HIV HIV Infections Health Homophobia Informal Social Control Institutes International Intervention Investigation Mediating Modeling Modification Outcome Participant Patient Education Patient Recruitments Patients Penetration Problem Solving Process Professional counselor Provider Public Health Randomized Randomized Clinical Trials Recording of previous events Research Research Activity 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 base behavior test care seeking care systems cost design efficacy testing efficacy trial evidence base experience follow-up implementation research improved intervention effect male medication compliance men post intervention preservation primary endpoint primary outcome recruit scale up secondary outcome skills social social stigma social structure 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.

全球扩大抗逆转录病毒疗法（ART）的目标是在全球范围内实现90%的艾滋病毒抑制。然而，即使增加了抗逆转录病毒治疗的机会，许多国家仍然没有走上实现这一目标的轨道。在阻碍艾滋病毒护理、抗逆转录病毒疗法坚持和艾滋病毒抑制的因素中，对艾滋病毒感染者的污名化。艾滋病毒的耻辱感和旨在避免耻辱感的行为阻止人们寻求护理的后果，干扰诊所出勤，到目前为止，提高艾滋病毒护理保留率和ART依从性的干预措施尚未得到关注在艾滋病毒最流行的国家减少耻辱的不利影响。本申请提出测试一项基于理论的手机咨询干预措施，旨在解决艾滋病毒污名问题，在南非，艾滋病毒治疗的保留率和坚持率都有所提高。述干预基于行为自我调节理论和艾滋病毒污名框架，与南非公共卫生机构合作。干预方法使用健康决策- 制定和解决问题的技能，旨在解决社会和结构性障碍的照顾，并提供由社区卫生工作者/非专业顾问提供，以增加其扩大规模的潜力。为了测试这个的功效新开发的并经过充分试点测试的干预模型，我们将进行一项随机临床试验，通过增强行为自我，规范咨询与耻辱管理组件。我们将进行一项3组临床试验，南非资源有限的乡镇，有证据表明艾滋病毒的高耻辱感，以比较：（a）行为自我调节+污名管理咨询艾滋病毒治疗的保留和坚持， vs. (b)行为自我调节咨询对艾滋病毒治疗的保留和坚持，与（c）统一艾滋病患者护理标准教育。该试验将招募1200名未受抑制的艾滋病毒感染者并在南非的艾滋病护理系统接受艾滋病治疗。参与者将被跟踪15个月干预后评估干预对艾滋病毒护理保留和艾滋病毒抑制的影响（初级结果）和ART依从性（次要结果）。条件过程建模将确定基础机制（例如，自我效能、行为策略、内化污名、预期污名解释干预效果以及这些机制如何因基线经验水平而异艾滋病的耻辱感。该试验还将进行实施研究活动，以告知潜在的如果干预措施显示有效，则扩大规模。这种新开发的干预模式是旨在与世卫组织确定的艾滋病毒差别化护理系统中的现有临床资源一起使用。