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

描述（由申请人提供）：自从抗逆转录病毒治疗出现以来，大量艾滋病毒阳性成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效益，但研究表明，45%至62%的人失业，并非所有人都是自愿的。障碍既有结构性的（如基于需求的福利的“金手铐”），也有个人的。鉴于疲劳在HIV人群中的广泛流行，我们进行了为期7年的莫达非尼或阿莫达非尼治疗疲劳的临床试验。然而，我们观察到，疲劳的缓解本身并不能使大多数患者自己找到工作，尽管他们声明有意这样做。我们现在正在完成一项试点可行性（R 34）研究，在该研究中，我们调整和完善了一个用阿莫达非尼治疗疲劳的分步计划;一旦疲劳得到改善，我们就使用行为激活模型（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（有偿或志愿者，兼职或更多）和/或职业培训的个人目标。在44名精力得到改善并接受BA-PEP咨询的患者中，63%找到了工作，而在早期的莫达非尼和阿莫达非尼单独治疗疲劳试验中，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与支持性咨询，在我们的研究诊所和社区诊所进行，针对100名临床上表现出明显疲劳的患者， 使用阿莫达非尼后，40例HIV阳性患者的疲劳症状有所改善，基线时无明显疲劳。所有参与者都是健康状况稳定的艾滋病毒阳性成年人，目前没有使用药物或未经治疗的严重抑郁症，并且希望重返工作或职业培训，但没有自己这样做。除了测试干预措施的有效性，很容易适应其他环境的实施数据，以支持其传播到社区为基础的设置，我们的研究结果可能有助于修改现行的政府政策，严格限制收入，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.