Return to Work RCT: Counseling after Fatigue Treatment in HIV/AIDS

描述(申请人提供)：自抗逆转录病毒疗法问世以来，相当数量的HIV+成年人享有稳定的健康和延长的寿命。然而，尽管就业带来了经济和社会利益，但研究表明，45%至62%的人失业，并非都是自愿的。障碍既是结构性的(例如，基于需求的福利的“金手铐”)，也是个人的障碍。鉴于疲劳症在HIV人群中普遍存在，我们进行了7年的临床试验，用莫达非尼或阿莫达非尼治疗疲劳，然而，我们观察到，缓解疲劳本身并不能使大多数患者能够独立找到工作，尽管他们声称有这样做的意图。我们现在正在完成一项试点可行性(R34)研究，在该研究中，我们调整和完善了使用阿莫达非尼治疗疲劳的分步计划；一旦疲劳改善，我们将使用行为激活模型(能量和生产力行为激活计划：BA-PEP)提供手动干预，以促进实现就业(带薪或志愿者、兼职或更多)和/或职业培训的个人目标。一些患者接受了支持性咨询，以测试其作为对照手臂的可接受性和可行性。在44名精力得到改善并接受BA-PEP咨询的患者中，63%的患者找到了工作，而在早期仅使用莫达非尼和阿莫达非尼进行疲劳治疗试验的患者中，这一比例为28%。这些发现鼓励我们正式评估BA-PEP的疗效。我们建议进行一项随机临床试验，比较BA-PEP和支持性咨询，将在我们的研究性诊所和社区诊所进行，对象是100名表现出临床上显著疲劳的患者，他们的精力 服用阿莫达非尼后情况有所改善，40名艾滋病毒阳性患者在基线水平上没有明显疲劳。所有参与者都是HIV+成年人，他们的健康状况稳定，没有目前使用药物或未经治疗的严重抑郁症，他们希望重返工作或职业培训，但他们自己并没有这样做。除了用实施数据测试易于适应其他环境的干预措施的有效性，以支持将其传播到基于社区的环境之外，我们的发现可能有助于修改当前的政府政策，对赚取的收入进行严格限制，以保留基于需求的福利。

DESCRIPTION (provided by applicant): Since the advent of antiretroviral therapy, a substantial number of HIV+ adults enjoy stable health and an extended lifespan. However, despite the financial and social benefits of employment, studies show that 45 to 62% are unemployed, not all by choice. Barriers are both structural (e.g. the "golden handcuffs" of needs-based benefits) and personal. In view of the widespread prevalence of fatigue in the HIV population, we conducted clinical trials to treat fatigue with modafinil or armodafinil for 7 years However, we observed that alleviation of fatigue by itself did not enable most patients to find work on their own despite their stated intention to do so. We are now completing a pilot feasibility (R 34) study in which we adapted and refined a stepped program treating fatigue with armodafinil; once fatigue improves, we provide a manualized intervention using the behavioral activation model (Behavioral Activation Program for Energy and Productivity: BA-PEP) to promote achievement of personal goals of employment (paid or volunteer, part-time or more) and/or vocational training. Several patients received supportive counseling to test its acceptability and feasibility as a control arm. Among 44 patients whose energy improved and who received BA-PEP counseling, 63% found work, compared to 28% of patients in earlier fatigue treatment trials of modafinil and armodafinil alone. These findings encourage us to formally assess BA- PEP efficacy. We propose to conduct a randomized clinical trial comparing BA-PEP with supportive counseling, to be conducted in both in our research clinic and a community clinic site, for 100 patients presenting with clinically significant fatigue whose energy has improved with armodafinil, as well as 40 HIV+ patients without significant fatigue at baseline. All participants are HIV+ adults whose health is stable, without current substance use or untreated major depression, and who wish to return to work or vocational training but who have not done so on their own. In addition to testing the efficacy of an intervention easily adapted to other settings with implementation data to support its dissemination to community-based settings, our findings may contribute toward modification of current government policy placing strict limits on earned income to retain needs based benefits.