INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial

BACKGROUND: Despite 10 to% of persons living with HIV in sub-Saharan Africa having clinical depression, and the consequences of depression for key public health outcomes (HIV treatment adherence and condom use), depression treatment is rarely integrated into HIV care programs. Task-shifting, protocolized approaches to depression care have been used to overcome severe shortages of mental health specialists in developing countries, but not in sub-Saharan Africa and not with HIV clients. The aims of this trial are to evaluate the implementation outcomes and cost-effectiveness of a task-shifting, protocolized model of antidepressant care for HIV clinics in Uganda. METHODS/DESIGN: INDEPTH-Uganda is a cluster randomized controlled trial that compares two task-shifting models of depression care - a protocolized model versus a model that relies on the clinical acumen of trained providers to provide depression care in ten public health HIV clinics in Uganda. In addition to data abstracted from routine data collection mechanisms and supervision logs, survey data will be collected from patient and provider longitudinal cohorts; at each site, a random sample of 150 medically stable patients who are depressed according to the PHQ-2 screening will be followed for 12 months, and providers involved in depression care implementation will be followed over 24 months. These data will be used to assess whether the two models differ on implementation outcomes (proportion screened, diagnosed, treated; provider fidelity to model of care), provider adoption of treatment care knowledge and practices, and depression alleviation. A cost-effectiveness analysis will be conducted to compare the relative use of resources by each model. DISCUSSION: If effective and resource-efficient, the task-shifting, protocolized model will provide an approach to building the capacity for sustainable integration of depression treatment in HIV care settings across sub-Saharan Africa and improving key public health outcomes. TRIAL REGISTRATION: INDEPTH-Uganda has been registered with the National Institutes of Health sponsored clinical trials registry (3 February 2013) and has been assigned the identifier NCT02056106.