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

护士为南非艾滋病毒初级保健中的抑郁症依从性提供 CBT

• 批准号: 9127808
• 负责人: Conall Michael O'Cleirigh
• 金额: $ 59.73万
• 依托单位: UNIVERSITY OF MIAMI CORAL GABLES
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-15 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9127808
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Africa; African; Alcohol or Other Drugs use; Antidepressive Agents; Behavior; Blinded; CD4 Positive T Lymphocytes; Caring; Cell Count; Cessation of life; Chronic; Clinic; Clinical; Clinical Psychology; Cognitive Therapy; Collaborations; Communities; Comorbidity; Cost Effectiveness Analysis; Counseling; Country; Data; Depressed mood; Development; Distress; Doctor of Philosophy; Drug resistance; Effectiveness; Electronics; Ensure; Evidence based intervention; Failure; Feeling; Guidelines; HIV; HIV Infections; Health; Health Personnel; Healthcare; Healthcare Systems; Individual; Intervention; Life; Location; Major Depressive Disorder; Mediating; Mental Depression; Mental Health; Meta-Analysis; Modeling; Monitor; Mood Disorders; Nurse Administrator; Nurses; Office Nursing; Outcome; Participant; Patients; Pharmaceutical Preparations; Population; Prevention strategy; Primary Health Care; Psychologist; Public Health; Qualitative Research; Quality of life; Randomized; Regimen; Research; Research Personnel; Resources; Self Care; Services; South Africa; South African; Students; Testing; Time; Training; Treatment Failure; Treatment Protocols; Treatment outcome; Viral Load result; Wireless Technology; Work; antiretroviral therapy; arm; base; bilingualism; cost; cost effectiveness; demographics; depressive symptoms; design; effectiveness trial; efficacy trial; improved; interest; meetings; neglect; pandemic disease; pill; pilot trial; primary care setting; primary outcome; programs; standard of care; success; therapy adherence; treatment as usual; treatment effect; treatment program; treatment strategy; uptake

 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.

 描述(由申请人提供)：这是一项进行双臂随机有效性试验的建议，调查是否可以使用接受过CBT培训的南非护士来治疗抑郁症并改善失败的一线抗逆转录病毒治疗(ART)患者对ART的依从性的任务转移/分担模式。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，目前公共医疗系统无法获得三线抗逆转录病毒治疗。与其他地方一样，临床抑郁症是艾滋病毒/艾滋病并存程度最高的疾病之一，估计患病率高达34.9%。8在艾滋病毒的情况下，抑郁症会导致不良的自我护理行为，如不坚持抗逆转录病毒治疗和更差的护理，这对治疗的成功至关重要。美国的研究人员已经开发并成功地测试了一种方法，该方法将依从性咨询与认知行为疗法相结合，用于在南方的艾滋病毒感染者中治疗抑郁症。非洲团队与美国团队合作，开展了初步工作，以评估将这种方法整合到南非艾滋病毒治疗环境中的文化适宜性和可行性。因此， 我们1)在开普敦以临床心理学博士生为治疗师对6名HIV感染的抑郁症患者进行了开放试验治疗，2)对抑郁的表现和如何使这种方法适应南非艾滋病毒护理环境进行了形成性定性研究，12 3)成功地培训了两名临床护士进行了调整后的干预版本，以及4)完成了14名患者的开放试验可行性试验，这些护士作为干预者。设计：本研究建立在我们成功的可行性试验的基础上。鉴于CBT是一种有效的抑郁症治疗方法，并且传播基于证据的艾滋病毒干预措施是一个著名的优先事项，13，14我们提出了一种双臂有效性RCT(按抗抑郁药物的开始/使用与否分层)，该疗法由护士提供，用于抑郁症的认知行为疗法，并将其整合到南非的艾滋病毒初级保健环境中。为了确保那些最需要这种干预的人将得到干预，参与者将是那些没有通过一线抗逆转录病毒治疗的艾滋病毒患者，并患有单相抑郁情绪障碍。主要结果(目标1)包括坚持抗逆转录病毒治疗(由WisePill评估)、抑郁(由独立评估者评估)以及每种情况下(二线)治疗失败的比例。将这种综合护理模式与常规护理(一线治疗的增强型依从性咨询--在这种情况下是失败的)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，以检查减少抑郁的成本效益，以及潜在的更好的艾滋病毒结果。在研究开始之前，我们将每年两次召开艾滋病毒患者以及利益相关者(诊所主任、护士服务非政府组织领导人)的社区咨询会议，以最大限度地扩大该模式的可扩展性，如果该模式成功的话。