The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.
The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.
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DOI：
10.2196/resprot.8925
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发表时间：
2017-12-11
影响因子：
1.7
通讯作者：
Mills E
中科院分区：
文献类型：
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作者：
Nakimuli-Mpungu E;Musisi S;Wamala K;Okello J;Ndyanabangi S;Mojtabai R;Nachega J;Harari O;Mills E
关于艾滋病毒感染者心理健康服务任务转移的有效性的信息有限。本试验的目的是评估小组支持心理治疗的有效性，由训练有素的非专业卫生工作者提供的艾滋病毒感染者（PLWH）与抑郁症的初级保健。随机分配了三个地区的30个合格的初级保健卫生中心，让他们的非专业卫生工作者接受培训，向患有抑郁症的PLWH提供团体支持心理治疗（干预组）或团体艾滋病毒教育和治疗（对照组）。将在基线、治疗结束后以及此后每6个月评价一次治疗的PLWH，持续2年。主要结局将是治疗结束后6个月，干预组和对照组中符合重度抑郁症简明国际神经精神访谈标准的受试者的随访比例差异以及受试者的随访功能评分差异。次要结果将包括自尊，创伤后应激症状，社会支持，耻辱，坚持抗逆转录病毒治疗，病毒载量和残疾天数，资产拥有指数和成本效益数据的措施。主要和次要结局以及亚组分析将在个体水平上进行，使用多水平随机效应回归分析调整健康中心的聚类。将使用混合方法进行过程评价，以评估试验中的可接受性、可行性、保真度、因果中介过程和背景影响。该试验已获得Makerere健康科学学院健康科学研究伦理委员会、艾滋病支持组织和乌干达国家科学技术理事会的批准。已经设立了一个数据和安全监测委员会来监测试验进展。共有1 140名艾滋病毒感染者被招募参加试验。正在对基线和6个月数据进行分析。这项试验的结果不仅将在国家和国际会议上发表，还将提交给同行评审期刊发表，并作为报告提交给资助机构。这项随机分组试验将为支持撒哈拉以南非洲地区抑郁症治疗的文化敏感性群体心理治疗提供关键证据。过程评价结果将提供背景信息，卫生保健和公共卫生利益相关者可以使用这些信息来指导其特定环境的实施决策。泛非临床试验注册中心（PACTR）：201608001738234; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry？dar=true&tNo= PACTR 201608001738234（互联网档案馆存档，网址：http://www.webcitation.org/ 6vUAgAQlj）
There is limited information on the effectiveness of task shifting of mental health services in populations with HIV. This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care. Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression. Treated PLWH will be evaluated at baseline, after the end of treatment, and at 6-month intervals thereafter for 2 years. Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment. Secondary outcomes will include measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data. Primary and secondary outcomes as well as subgroup analyses will be conducted at the individual level using multilevel random effects regression analyses adjusting for clustering in health centers. A process evaluation using mixed methods to assess acceptability, feasibility, fidelity, causal mediating processes, and contextual influences in the trial will be conducted. The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, the AIDS Support Organization, and the Uganda National Council of Science and Technology. A data and safety monitoring board has been put in place to monitor trial progress. A total of 1140 persons living with HIV have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies. This cluster randomized trial will provide critical evidence to support culturally sensitive group-based psychotherapy for depression treatment in sub-Saharan Africa. Process evaluation outcomes will provide contextual information that health care and public health stakeholders can use to guide implementation decisions for their particular setting. Pan African Clinical Trials Registry (PACTR): 201608001738234; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?dar=true&tNo=PACTR201608001738234 (Archived by WebCite at http://www.webcitation.org/ 6vUAgAQlj)