Effectiveness of a Task-Sharing Collaborative Care Model for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in Primary Care Facilities in South Africa: A Pragmatic Cluster Randomised Controlled Trial

Abstract

Background: HIV is characterised by high rates of comorbidity with mental health conditions, including depression. Depression is associated with non-adherence to antiretroviral treatment (ART), and its detection and treatment is critical to achieving 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 care facilities.

Methods: We conducted a pragmatic cluster-randomised trial in 40 primary health care (PHC) facilities in the North West province of South Africa. Participants were ≥18 years, receiving ART, and had depression symptoms indicated by Patient Health Questionnaire-9 (PHQ-9) score ≥9.  The trial statistician randomised PHC clinics within strata to the intervention or usual care. Intervention clinics received: i) supplementary mental health training and clinical communication skills for PHC nurses; ii) two 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). All participants were analysed in their allocated group, irrespective of intervention receipt. The trial is registered with ClinicalTrials.gov (NCT02407691) and the Pan African Clinical Trials Registry (201504001078347).

Findings: Between April 28, 2015 and December 14, 2016, we assessed 6623 patients, of whom 2002 were enrolled in the intervention (n=1008) or control clinics (n=994). PHQ-9 response rate at 6-months was 49% (439/892) in the intervention and 57% (498/868) in control. Viral load suppression at 12-months was 85% (785/924) in the intervention and 84% (770/913) in control. The intervention had no effect in PHQ-9 response (risk difference (RD)=-0·08, 95% CI=-0·19; 0·03, p=0·184) or viral load suppression (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.

Interpretation: The trial showed no effect of a district-based intervention to strengthen collaborative care for depression. The linkage of trial participants to the intervention was low. The pragmatic design of the trial revealed the extent of the treatment gap in the context of scaling up mental health services.

Trial Registration: The study protocol has been published26 and registered with ClinicalTrials.gov (NCT02407691), the Pan African Clinical Trials Registry (201504001078347) and the South African National Clinical Trials Register (SANCTR) (DOH-27-0515-5048, NHREC 4048).

Funding: National Institute of Mental Health of the National Institutes of Health

Declaration of Interest: All authors declare no competing interests.

Ethical Approval: Ethical approval was obtained from the University of Cape Town Human Research Ethics Committee (211/2013), King’s College London Research Ethics Office (PNM/12/13-159), and the University of KwaZulu-Natal’s Biomedical Research Ethics Committee (BFC049/15). Permission to conduct the study was granted by the South African National Department of Health and the North West Provincial Department of Health.

Keywords: HIV, depression, collaborative care, antiretroviral therapy, viral load suppression, psychosocial counselling