Comparing dedicated and designated approaches to integrating task-shared psychological interventions into chronic disease care in South Africa: a three-arm, cluster randomised, multicentre, open-label trial

Community health workers (CHWs) are increasingly providing task-shared psychological interventions for depression and alcohol use in primary health care in low-income and middle-income countries. We aimed to compare the effectiveness of CHWs dedicated to deliver care with CHWs designated to deliver care over and above their existing responsibilities and with treatment as usual for patients with a chronic physical disease.We did a three-arm, cluster randomised, multicentre, open-label trial done in 24 primary health-care clinics (clusters) within the Western Cape province of South Africa. Clinics were randomly assigned (1:1:1) to implement dedicated care, designated care, or treatment as usual, stratified by urban-rural status. Patients with HIV or type 1 or type 2 diabetes were eligible if they were 18 years old or older, taking antiretroviral therapy for HIV or medication to manage their diabetes, had an Alcohol Use Disorders Identification Test (AUDIT) score of eight or more or a Center for Epidemiologic Studies Depression Scale score of 16 or more, and were not receiving mental health treatment. In the intervention arms, all participants were offered three sessions of an evidence-based psychological intervention, based on motivational interviewing and problem-solving therapy, delivered by CHWs. Our primary outcomes were depression symptom severity and alcohol use severity, which we assessed separately for the intention-to-treat populations of people with HIV and people with diabetes cohorts and in a pooled cohort, at 12 months after enrolment. The Benjamini-Hochberg procedure was used to adjust for multiple testing. The trial was prospectively registered with the Pan African Clinical Trials Registry, PACTR201610001825403.Between May 1, 2017, and March 31, 2019, 1340 participants were recruited: 457 (34·1%) assigned to the dedicated group, 438 (32·7%) assigned to the designated group, and 445 (33·2%) assigned to the treatment as usual group. 1174 (87·6%) participants completed the 12 month assessment. Compared with treatment as usual, the dedicated group (people with HIV adjusted mean difference -5·02 [95% CI -7·51 to -2·54], p<0·0001; people with diabetes -4·20 [-6·68 to -1·72], p<0·0001) and designated group (people with HIV -6·38 [-8·89 to -3·88], p<0·0001; people with diabetes -4·80 [-7·21 to -2·39], p<0·0001) showed greater improvement on depression scores at 12 months. By contrast, reductions in AUDIT scores were similar across study groups, with no intervention effects noted.The dedicated and designated approaches to delivering CHW-led psychological interventions were equally effective for reducing depression, but enhancements are required to support alcohol reduction. This trial extends evidence for CHW-delivered psychological interventions, offering insights into how different delivery approaches affect patient outcomes.British Medical Research Council, Wellcome Trust, UK Department for International Development, the Economic and Social Research Council, and the Global Challenges Research Fund.