Intervention to Improve HIV Care Retention and Antiretroviral Adherence inStigmatized Environments

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，即使获得抗逆转录病毒治疗的机会增加，许多国家仍未走上实现这一目标的轨道。 在阻碍保留艾滋病毒护理、遵守抗逆转录病毒治疗和抑制艾滋病毒的因素中，社会 对艾滋病毒感染的污名化。艾滋病毒的污名和旨在避免污名的行为会产生不利影响 阻止人们寻求治疗、干扰诊所就诊和减少就诊的后果 学习艺术。到目前为止，增加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并未侧重于 关于在艾滋病毒最流行的国家减少污名的不利影响。此应用程序建议 为了测试一种基于理论的手机提供的咨询干预措施，旨在解决艾滋病毒污名问题 为了改善南非的艾滋病毒治疗、保留和遵守情况，人们感到关切。干预措施是 以行为自我调节理论和艾滋病毒污名框架为基础，并于 与南非公共卫生机构建立伙伴关系。干预方法使用健康决策- 旨在解决护理的社会和结构性障碍的制定和解决问题的技能，并交付 由社区卫生工作者/业馀顾问提供，以增加其扩大规模的潜力。为了测试这一方法的有效性 新开发和全面试点测试的干预模式，我们将进行随机临床试验设计 通过增强行为自我，梳理出直接解决耻辱担忧的相加效应 带有污名管理组成部分的法规咨询。我们将在一个月内进行一个三臂临床试验 南非的一个资源有限的小镇，已经显示出高艾滋病毒污名的证据，以进行比较：(A) 行为自律+艾滋病毒治疗保留和坚持的耻辱管理咨询， 与(B)行为自律咨询对艾滋病毒治疗的保留和坚持，与(C)统一 艾滋病患者教育的护理标准。这项试验将招募1200名未被抑制的艾滋病毒携带者 并在南非的艾滋病毒护理系统中接受艾滋病毒治疗。参与者将被跟踪15个月 干预后评估对艾滋病毒护理保留和艾滋病毒抑制的干预效果(初级 结果)和抗逆转录病毒治疗的依从性(第二结果)。条件流程建模将决定 潜在机制(例如，自我效能、行为策略、内化污名、预期污名) 这解释了干预效果以及这些机制如何随基线经验水平的不同而变化 带有艾滋病病毒的污名。该试验还将进行实施研究活动，以告知潜在的 如果干预措施被证明是有效的，就应该扩大规模。这种新开发的干预模式是 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。

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.