Joska John A, Andersen Lena S, Smith-Alvarez Rosana, Magidson Jessica, Lee Jasper S, O'Cleirigh Conall, Safren Steven A
HIV Mental Health Research Unit, Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
Department of Psychology, University of Miami, Coral Gables, FL, United States.
JMIR Res Protoc. 2020 Feb 3;9(2):e14200. doi: 10.2196/14200.
BACKGROUND: There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). OBJECTIVE: This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. METHODS: This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). RESULTS: The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. CONCLUSIONS: Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals. TRIAL REGISTRATION: ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14200.
背景：在低收入和中等收入国家（LMIC），为感染艾滋病毒者中依从性差和患有抑郁症的人群开发有效、可行且可扩展的干预措施的需求尚未得到满足。 目的：本研究旨在调查由护士提供的认知行为疗法（CBT）干预对南非开普敦一线抗逆转录病毒疗法（ART）治疗失败的艾滋病毒感染者的依从性和抑郁症（CBT-AD）的有效性。 方法：本研究是一项双臂随机对照试验，将CBT-AD纳入南非的艾滋病毒初级保健环境。共有160名未从一线抗逆转录病毒治疗中实现病毒抑制且患有单相抑郁情绪障碍的参与者将被随机分组，分别接受8次CBT-AD治疗或强化常规治疗。在基线以及4个月（month）、8个月和12个月时，使用《迷你国际神经精神访谈》对参与者进行重度抑郁症评估。主要结局是在4个月评估时汉密尔顿抑郁量表（HAM-D；由盲法评估者评估）上的抑郁情况，以及基线至4个月评估期间抗逆转录病毒治疗依从性的变化（通过Wisepill实时电子监测评估）。次要结局是在12个月评估时的艾滋病毒病毒载量和CD4细胞计数，以及随访期间（4个月、8个月和12个月评估）的抗逆转录病毒治疗依从性（Wisepill）和抑郁情况（HAM-D）。 结果：该试验于2015年8月开始，招募工作于2016年7月开始。2019年6月完成入组。 结论：本研究结果将为是否可以在低收入和中等收入国家由经过培训且接受持续监督的护士有效实施现有干预措施（CBT-AD）提供依据。这将带来独特的机会，进一步探索扩大行为干预规模，以提高高流行环境中患有重度抑郁症的艾滋病毒感染者的抗逆转录病毒治疗依从性，朝着实现联合国艾滋病规划署90-90-90目标迈进。 试验注册：ClinicalTrials.gov NCT02696824；https://clinicaltrials.gov/ct2/show/NCT02696824。 国际注册报告识别码（IRRID）：DERR1-10.2196/14200。
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