A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

项目总结/摘要 与白人相比，感染艾滋病毒的黑人不太可能坚持抗逆转录病毒治疗， 被病毒性抑制。我们的研究确定了造成男女之间不平等的文化相关因素。 艾滋病毒阳性的美国黑人，包括耻辱和医疗不信任（例如，“阴谋论”，艺术是 中毒），除了与贫困，医疗保健获得和精神疾病有关的结构和心理社会因素外， 健康然而，抗逆转录病毒疗法坚持干预很少是文化一致的，这可能解释了为什么 相对较少的干预措施显示出对依从性或病毒抑制的强有力的效果。我们建议 对Rise进行随机对照试验（RCT），Rise是一种文化一致的依从性咨询干预措施 艾滋病毒阳性的黑人男女。Rise咨询师拥有专门的艾滋病毒治疗知识， 接受动机访谈（MI）技能培训，以克服与文化相关的依从性障碍， 继续接受护理;他们还协助与社会服务联系。Rise最好在社区中实施 组织，使客户能够在非医疗环境中寻求服务，这有助于克服对组织的不信任。 医疗保健，并提高依从性的准备。在一项试点RCT中，Rise导致依从性增加（测量 通过电子监测）相对于等待列表控制组，随着时间的推移，显示出较大的效应量（Cohen's d=.87）。然而，该试验没有评估对病毒抑制的影响，也没有包括长期随访。因此，在本发明中， 我们建议开展一项Rise随机对照试验，遵循循证艾滋病治疗的最佳实践 依从性干预设计和测试。具体目的是：（1）进行随机对照研究， 一项检验文化一致的依从性干预对抗逆转录病毒治疗效果的试验 艾滋病毒感染者中的黑人男性和女性的依从性、保持护理和病毒抑制;（2） 检查文化相关的调解人（例如，医学上的不信任，耻辱），这可能有助于解释的影响， 对黑人男性抗逆转录病毒治疗依从性、继续护理和病毒抑制的干预 （3）对干预措施进行成本效益分析。共有350 黑人男性和女性将被随机分配到干预组或常规护理对照组（175人/人）。 组）。从基线至12- 24周，每天（每两个月下载一次）以电子方式监测依从性。 基线后月。将在基线以及6个月和12个月时通过静脉穿刺评估病毒载量 基线后。如果发现Rise有效，下一步将进行研究，以确定 采取有效和可行的方法实施干预措施并向社区传播。

PROJECT SUMMARY/ABSTRACT Compared to Whites, Black people living with HIV are less likely to adhere to antiretroviral treatment (ART) and be virally suppressed. Our research has identified culturally relevant factors contributing to disparities among HIV-positive Black Americans, including stigma and medical mistrust (e.g., “conspiracy beliefs,” that ART is poison), in addition to structural and psychosocial factors related to poverty, healthcare access, and mental health. However, ART adherence interventions have rarely been culturally congruent, which may explain why relatively few interventions have shown robust effects on adherence or viral suppression. We propose to conduct a randomized controlled trial (RCT) of Rise, a culturally congruent adherence counseling intervention for HIV-positive Black men and women. Rise counselors possess specialized HIV treatment knowledge and are trained in motivational interviewing (MI) skills to overcome culturally relevant barriers to adherence and retention in care; they also assist with linkage to social services. Rise is ideally implemented in community organizations, enabling clients to seek services in non-medical settings, which helps to overcome mistrust of healthcare, and increase readiness for adherence. In a pilot RCT, Rise led to increased adherence (measured by electronic monitoring) relative to a wait-list control group over time, showing a large effect size (Cohen’s d=.87). However, the pilot did not evaluate effects on viral suppression or include long-term follow-up. Thus, we propose to conduct an RCT of Rise that follows best practices for evidence-based HIV treatment adherence intervention design and testing. The Specific Aims are: (1) To conduct a randomized controlled trial to examine the effects of a culturally congruent adherence intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; (2) To examine culturally relevant mediators (e.g., medical mistrust, stigma) that may help to explain the effects of the intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; and (3) To conduct a cost effectiveness analysis of the intervention. A total of 350 Black men and women will be randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 12- months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 12-months post-baseline. If Rise is found to be effective, the next step would be to conduct research to determine effective and feasible methods for intervention implementation and dissemination to community settings.