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

基本信息

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
项目类别：
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

项目摘要

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（由适用提供）：这是一项提议，旨在进行两项ARM随机有效性试验，研究调查抑郁症的任务转移/共享模型是否可以使用在CBT接受过CBT的南非培训的南非培训的护士进行一线抗逆转录病毒疗法（ART）的患者中对ART的依从性。南非是世界上艾滋病毒感染数量最多的国家，艾滋病毒/艾滋病相关的死亡人数最多，5-7，在公共医疗保健系统中无法获得第三线艺术治疗。与其他地方一样，临床抑郁症是艾滋病毒/艾滋病的最高合并症之一，估计率高达34.9％。8在艾滋病毒的背景下，抑郁症会导致自我保健行为不佳，例如对艺术的不遵守和护理中的保留率较差，这对于治疗成功至关重要。9.9初步工作。美国的研究人员已经开发并成功地测试了一种将依从性咨询纳入艾滋病毒抑郁症的认知行为疗法的方法。10,11南方。与美国的团队合作，基于非洲的团队已经进行了初步工作，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。根据，我们有1）使用临床心理学博士学位学生作为治疗师进行了6例HIV感染抑郁症患者的抑郁症患者的敞开式治疗，2）关于抑郁症表现的形成性定性研究，以及适应这种方法，以适应这种方法，以适应南非HIV护理环境，12 3）成功地培训了两名临床护理人员，并在这些临床上进行了培训，并在室内培训了14次临床训练，并在4号临床上进行了操纵，并在4）中试用了4）4）4）4）4）4）护士作为干预措施。设计：当前的研究以我们成功的可行性飞行员为基础。 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.为了确保最需要这种干预的人将接受它，参与者将是艾滋病毒的患者，他们失败了第一线艺术，并患有单极抑郁情绪障碍。主要结果（目标1）包括遵守艺术（由Wisepill评估），抑郁症（通过独立评估评估）以及（第二行）治疗失败的比例。将这种综合护理模型与常规护理进行比较（在此环境中增强了对一线治疗失败的依从性咨询），将允许在AIM 2中进行逐步的成本效益分析。我们将收集资源利用率和成本数据，以研究减少抑郁症的成本效益，并有潜在的HIV效果。在研究启动之前，每年两次，我们将召集艾滋病毒患者以及利益相关者（临床主管，护士AIDS服务NGO领导者）的社区咨询会议，以最大程度地提高模型的吸收可伸缩性的机会。