Nurse-Delivered CBT for Depression-Adherence in HIV Primary Care S. Africa

 描述（由申请人提供）：这是一项进行两组随机有效性试验的提案，旨在调查在南非接受过CBT培训的护士是否可以使用任务转移/共享模式治疗抑郁症并改善一线抗逆转录病毒治疗（ART）失败患者对ART的依从性。南非是世界上艾滋病毒感染人数最多和艾滋病毒/艾滋病相关死亡人数最多的国家，5-7人，目前公共卫生系统无法提供三线抗逆转录病毒治疗。临床抑郁症，像其他地方一样，是艾滋病毒/艾滋病最高的合并症之一，估计发病率高达34.9 ‰。8在艾滋病毒的背景下，抑郁症导致自我护理行为不良，如不坚持ART和更差的护理保留，这对治疗成功至关重要。美国的研究人员已经开发并成功测试了一种将坚持咨询纳入艾滋病毒抑郁症认知行为治疗的方法。设在非洲的小组与设在美国的小组合作，进行了初步工作，以评估将这种方法纳入南非艾滋病毒治疗环境的文化适当性和可行性。因此，委员会认为， 我们已经1）在开普敦使用临床心理学博士生作为治疗师对6名患有抑郁症的HIV感染患者进行了开放式试点治疗，2）对抑郁症的表现和如何将这种方法适应南非HIV护理环境进行了形成性定性研究，12 3）成功地培训了两名诊所护士适应干预版本，4）在14名患者中完成了一项开放性试点可行性试验，这些护士作为干预者。设计：目前的研究建立在我们成功的可行性试点。鉴于CBT是一种有效的抑郁症治疗方法，并且在HIV中传播循证干预措施是一个值得注意的优先事项，13，14我们提出了一项双臂有效性RCT（按抗抑郁药物的开始/使用与否分层），将护士提供的抑郁症认知行为治疗和依从性纳入S.非洲为了确保那些最需要这种干预的人能够得到它，参与者将是一线抗逆转录病毒治疗失败的艾滋病毒患者，并且患有单相抑郁情绪障碍。主要结局（目标1）包括ART依从性（由WisePill评估）、抑郁症（由独立评估者评估）和每种情况下（二线）治疗失败的比例。将这种综合护理模式与常规护理（在这种情况下加强一线治疗失败的依从性咨询）进行比较，将允许在目标2中进行增量成本效益分析。我们将收集资源利用和成本数据，以检查减少抑郁症的成本效益，以及潜在的更好的艾滋病毒结果。在研究启动之前，我们将每年召开两次艾滋病毒患者和利益相关者（诊所主任、护士艾滋病服务非政府组织领导人）的社区咨询会议，以最大限度地提高该模型在成功时的可扩展性。

 DESCRIPTION (provided by applicant): This is a proposal to conduct a two arm randomized effectiveness trial investigating whether a task shifting/sharing model of treating depression and improving adherence to ART in patients who fail first line antiretroviral therapy (ART) can occur using nurses in South Africa trained in CBT. South Africa is the country with the highest number of HIV infections in the world and the highest number of HIV/AIDS-related deaths,5-7 and where access to third line ART treatment is not currently available in the public healthcare system. Clinical depression, like elsewhere, is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent.8 Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success.9 Preliminary work. The U.S. based investigators have developed and successfully tested an approach integrating adherence counseling into cognitive- behavioral therapy for depression in HIV.10,11 The South. Africa based team, in collaboration with the U.S. based team, has conducted preliminary work to evaluate the cultural appropriateness and feasibility of integrating this approach into the South African HIV treatment setting. Accordingly, we have 1) conducted an open-pilot of the treatment in Cape Town with 6 HIV-infected patients with depression using a clinical psychology PhD student as the therapist, 2) conducted formative qualitative research on the manifestation of depression and ways to adapt this approach for the South Africa HIV care setting,12 3) successfully trained two clinic nurses in the adapted version of the intervention, and 4) completed an open pilot feasibility trial with 14 patients with these nurses as interventionists. Design: The current study builds on our successful feasibility pilot. Given that CBT is a validated treatment for depression, and that dissemination of evidenced-based interventions in HIV is a noted priority,13,14 we propose a two-arm effectiveness RCT (stratified by antidepressant medication initiation/use or not) of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who have failed first line ART, and have a unipolar depressive mood disorder. Primary outcomes (Aim 1) include adherence to ART (assessed by WisePill), depression (assessed by an independent evaluator), and proportion of (second line) treatment failures in each condition. Comparing this integrated care model to usual care (enhanced adherence counseling for first-line treatment-failures in this setting), will allow for an incremental cost-effectiveness analysis in Aim 2. We will collect resource utilization and cost data to examine the cost- effectiveness of reduced depression, and potentially, better HIV outcomes. Before study start-up, and twice a year, we will convene community advisory meetings of HIV patients as well as stakeholders (clinic directors, Nurses AIDS service NGO leaders) to maximize the chances of uptake scalability of the model should it be successful.