Abstract
BackgroundIn low- and middle-income countries (LMIC), it is uncertain whether a “dedicated” approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a “designated” approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes.Methods/DesignThis is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios.DiscussionStudy findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting.Trial registrationPan African Clinical Trials Registry, Trial registration number: ACTR201610001825403. Registered 17 October 2016.
Highlights
In low- and middle-income countries (LMIC), it is uncertain whether a “dedicated” approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a “designated” approach is most effective and cost-effective
Funded mental health treatment focuses on managing severe mental disorders within specialist psychiatric hospitals, with limited services being available in primary health care (PHC) services [8]
Chronic disease services in the Western Cape are similar to chronic disease services in other parts of South Africa: they are busy, under-resourced, and a significant proportion of patients have co-occurring mental disorders [25]
Summary
In low- and middle-income countries (LMIC), it is uncertain whether a “dedicated” approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a “designated” approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. Like many low- and middle- income countries (LMICs) [1, 2], South Africa has a high burden of mental disorders, with an estimated 30% of the adult population meeting diagnostic criteria for a mental disorder at some point in their life [3]. In South Africa, a substantial treatment gap exists for adults with common mental disorders (CMDs), that includes mood, anxiety and alcohol use disorders: approximately 75% of those affected never access mental health treatment [4]. As untreated depression and alcohol use disorders are associated with sub-optimal adherence to chronic disease treatment, and increased risk of treatment failure and negative treatment outcomes [18, 19], ensuring access to treatment for these CMDs is an essential component of an effective health system response to chronic disease
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