Kinyanda Eugene, Kyohangirwe Leticia, Mpango Richard S, Tusiime Christine, Ssebunnya Joshua, Katumba Kenneth, Tenywa Patrick, Mugisha James, Taasi Geoffrey, Sentongo Hafsa, Akena Dickens, Laurence Yoko, Muhwezi Wilson, Weiss Helen A, Neuman Melissa, Greco Giulia, Knizek Birthe, Levin Jonathan, Kaleebu Pontiano, Araya Ricardo, Ssembajjwe Wilber, Patel Vikram
MRC/UVRI & LSHTM Uganda Research Unit, Mental Health Section, Entebbe, Uganda.
Butabika National Referral Mental Hospital, Kampala, Uganda.
Int J Ment Health Syst. 2021 May 12;15(1):45. doi: 10.1186/s13033-021-00469-9.
An estimated 8-30 % of people living with HIV (PLWH) have depressive disorders (DD) in sub-Saharan Africa. Of these, the majority are untreated in most of HIV care services. There is evidence from low- and middle- income countries of the effectiveness of both psychological treatments and antidepressant medication for the treatment of DD among PLWH, but no evidence on how these can be integrated into routine HIV care. This protocol describes a cluster-randomised trial to evaluate the effectiveness and cost-effectiveness of the HIV + D model for the integration of a collaborative stepped care intervention for DD into routine HIV care, which we have developed and piloted in Uganda.
Forty public health care facilities that provide HIV care in Kalungu, Masaka and Wakiso Districts will be randomly selected to participate in the trial. Each facility will recruit 10-30 eligible PLWH with DD and the total sample size will be 1200. The clusters will be randomised 1:1 to receive Enhanced Usual Care alone (EUC, i.e. HIV clinicians trained in Mental Health Gap Action Programme including guidelines on when and where to refer patients for psychiatric care) or EUC plus HIV + D (psychoeducation, Behavioural Activation, antidepressant medication and referral to a supervising mental health worker, delivered in a collaborative care stepwise approach). Eligibility criteria are PLWH attending the clinic, aged ≥ 18 years who screen positive on a depression screening questionnaire (Patient Health Questionnaire, PHQ-9 ≥ 10). The primary outcome is the mean depressive disorder symptom severity scores (assessed using the PHQ-9) at 3 months' post-randomisation, with secondary mental health, disability, HIV and economic outcomes measured at 3 and 12 months. The cost-effectiveness of EUC with HIV + D will be assessed from both the health system and the societal perspectives by collecting health system, patient and productivity costs and mean DD severity scores at 3 months, additional to health and non-health related quality of life measures (EQ-5D-5 L and OxCAP-MH).
The study findings will inform policy makers and practitioners on the cost-effectiveness of a stepped care approach to integrate depression management in routine care for PLWH in low-resource settings.
ISRCTN, ISRCTN86760765. Registered 07 September 2017, https://doi.org/10.1186/ISRCTN86760765 .
在撒哈拉以南非洲地区，估计有8%-30%的艾滋病毒感染者（PLWH）患有抑郁症（DD）。其中，大多数在大多数艾滋病毒护理服务中未得到治疗。低收入和中等收入国家有证据表明心理治疗和抗抑郁药物对治疗PLWH中的DD均有效，但尚无关于如何将这些治疗方法纳入常规艾滋病毒护理的证据。本方案描述了一项整群随机试验，以评估艾滋病毒+抑郁症（HIV+D）模式将DD的协作式逐步护理干预措施纳入常规艾滋病毒护理的有效性和成本效益，该模式是我们在乌干达开发并进行过试点的。
将从卡伦古、马萨卡和瓦基索区随机选择40家提供艾滋病毒护理的公共卫生保健机构参与试验。每个机构将招募10-30名符合条件的患有DD的PLWH，总样本量为1200。这些群组将按1:1随机分组，分别接受单纯强化常规护理（EUC，即接受过精神卫生差距行动计划培训的艾滋病毒临床医生，包括关于何时何地将患者转诊至精神科护理的指南）或EUC加HIV+D（心理教育、行为激活、抗抑郁药物治疗以及转诊至督导精神卫生工作者，采用协作护理逐步方法提供）。纳入标准为在诊所就诊的PLWH，年龄≥18岁，在抑郁症筛查问卷（患者健康问卷，PHQ-9≥10）上筛查呈阳性。主要结局是随机分组后3个月时的平均抑郁症症状严重程度评分（使用PHQ-9评估），次要心理健康、残疾、艾滋病毒和经济结局在3个月和12个月时进行测量。将从卫生系统和社会角度评估EUC加HIV+D的成本效益，方法是收集卫生系统、患者和生产力成本以及3个月时的平均DD严重程度评分，此外还包括与健康和非健康相关的生活质量指标（EQ-5D-5L和OxCAP-MH）。
研究结果将为政策制定者和从业者提供信息，说明在资源匮乏环境下，将抑郁症管理纳入PLWH常规护理的逐步护理方法的成本效益。
ISRCTN，ISRCTN86760765。2017年9月7日注册，https://doi.org/10.1186/ISRCTN86760765 。
