Zani Babalwa, Fairall Lara, Petersen Inge, Folb Naomi, Bhana Arvin, Hanass-Hancock Jill, Selohilwe One, Petrus Ruwayda, Georgeu-Pepper Daniella, Mntambo Ntokozo, Kathree Tasneem, Carmona Sergio, Lombard Carl, Lund Crick, Levitt Naomi, Bachmann Max, Thornicroft Graham
Knowledge Translation Unit, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Knowledge Translation Unit, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; School of Life Course & Population Sciences, Faculty of Life Sciences and Medicine, King's College London, United Kingdom; Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.
J Affect Disord. 2025 Feb 1;370:499-510. doi: 10.1016/j.jad.2024.10.061. Epub 2024 Oct 21.
HIV is characterised by high rates of comorbidity with mental health conditions including depression, as such, the detection and treatment of comorbid depression is critical to achieve viral load suppression. This study evaluated the effectiveness of a collaborative care intervention for depression among adults with comorbid depression symptoms receiving ART in primary health care (PHC) facilities.
We conducted a pragmatic cluster-randomised trial in 40 clinics in the North West province of South Africa. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Participants were ≥ 18 years, receiving ART, and had depression symptoms indicated by Patient Health Questionnaire-9 (PHQ-9) score ≥ 9. Intervention clinics received: i) supplementary mental health training and clinical communication skills for PHC nurses; ii) workshops for PHC doctors on treating depression; and iii) lay counselling services. Using mixed effects regression models, we assessed co-primary outcomes of PHQ-9 response at 6 months (≥50 % reduction in baseline PHQ-9 score) and viral load suppression at 12 months (viral load<1000 copies/mL).
The intervention had no effect in PHQ-9 response (49 % vs 57 %, risk difference (RD) = -0.08, 95 % CI = -0.19; 0.03, p = 0.184) or viral load suppression (85 % vs 84 %, RD = 0.02, 95 % CI = -0.01; 0.04, p = 0.125). Nurses referred 4298 clinic patients to counsellors, however, only 66/1008 (7 %) of intervention arm participants were referred to counsellors at any point during the study.
The highly pragmatic approach of this trial limited exposure to the counselling component of the intervention and referral to doctors for initiation of antidepressant treatment was extremely low.
The trial showed no effect of a district-based intervention to strengthen collaborative care for depression. The trial revealed the extent of the treatment gap in the context of scaling up mental health services.
ClinicalTrials.gov (NCT02407691); Pan African Clinical Trials Registry (201504001078347).
HIV的特点是与包括抑郁症在内的心理健康状况合并症发生率高，因此，合并症抑郁症的检测和治疗对于实现病毒载量抑制至关重要。本研究评估了在初级卫生保健（PHC）机构中，针对接受抗逆转录病毒治疗（ART）且伴有抑郁症症状的成年人，开展协作护理干预对抑郁症的治疗效果。
我们在南非西北省的40家诊所进行了一项实用的整群随机试验。PHC诊所按分区进行分层，并以1:1的比例随机分组。参与者年龄≥18岁，正在接受ART治疗，且患者健康问卷-9（PHQ-9）评分≥9表明有抑郁症状。干预诊所接受了以下措施：i）为PHC护士提供补充心理健康培训和临床沟通技巧；ii）为PHC医生举办治疗抑郁症的研讨会；iii）非专业咨询服务。我们使用混合效应回归模型，评估了6个月时PHQ-9反应（基线PHQ-9评分降低≥50%）和12个月时病毒载量抑制（病毒载量<1000拷贝/毫升）这两个共同主要结局。
干预措施在PHQ-9反应方面没有效果（49%对57%，风险差（RD）=-0.08，95%置信区间（CI）=-0.19；0.03，p=0.184），在病毒载量抑制方面也没有效果（85%对84%，RD=0.02，95%CI=-0.01；0.04，p=0.125）。护士将4298名门诊患者转介给咨询师，然而，在研究期间的任何时候，干预组中只有66/1008（7%）的参与者被转介给咨询师。
本试验高度实用的方法限制了对干预措施咨询部分的接触，而且转介给医生开始抗抑郁治疗的比例极低。
该试验表明，基于地区的加强抑郁症协作护理干预没有效果。该试验揭示了在扩大心理健康服务背景下治疗差距的程度。
ClinicalTrials.gov（NCT02407691）；泛非临床试验注册中心（201504001078347）。
