Over 25 million people living with HIV (PLWHIV) reside in sub-Saharan Africa (SSA), including over 1 million in Uganda . Scaled-up access to HIV antiretroviral therapy (ART) has led to nearly 10 million in SSA and just under 300,000 Ugandans receiving treatment by the end of 2012 , resulting in dramatic declines in mortality [2, 3] and HIV becoming a chronic, manageable disease . ART also contributes to HIV prevention by reducing infectiousness [5, 6], and being associated with increased condom use [7, 8]. However, depression has emerged as a major threat to the success and benefits of ART, as it impedes ART adherence [9–11] and condom use [12–14], and has been associated with a greater likelihood of mortality [15–17] and worse immunologic and virologic response to treatment [18–21]. Clinical depression, as diagnosed by structured clinical interviews, generally ranges from 10 to 20% among PLWHIV in SSA [22–24], while an additional 20 to 30% have elevated depressive symptoms [23–27]. A wide range of interventions are effective in treating depression in PLWHIV , including antidepressants [29, 30], and depression treatment improves ART use, adherence and outcomes [31–34]. Yet despite the prevalence of depression and its consequences for the fight against HIV, depression treatment is rarely integrated into HIV care programs in SSA .
A severe shortage of mental health professionals is a key barrier to depression care in Uganda and the larger region . There are just over thirty psychiatrists in Uganda or one for every one million citizens, and most are in or near the capital city Kampala. Given the lack of psychiatrists, it is generally left to primary care providers to diagnose and treat depression. However, whether it is due to lack of psychiatric training, lack of appreciation of the value of mental health care, or lack of time and resources, providers have shown a reluctance to engage in mental health treatment in Uganda, even though antidepressants are on the national formulary and free of charge. Perhaps in part because depressed patients often present first with somatic symptoms, providers prefer to first rule out possible physical and medical causes rather than evaluating mental illness . Often it is only when mental illness is so advanced that it is causing obvious disruption and dysfunction, do providers consider mental illness and then attempt to refer out to psychiatric specialists . Even if depression care training were provided and primary care providers had a greater appreciation for mental health care, most HIV clinics in Uganda have only 1 clinical or medical officer for seeing 50 to 100 patients daily; so the concern is that many depressed patients would still go undetected, and bottlenecks of patients waiting for providers would worsen.
Understanding how to effectively implement evidence-based treatment in HIV settings, where need is high and mental health capacity is virtually non-existent is essential. With the emphasis on developing feasible, sustainable models of health care delivery in resource-poor settings, task-shifting models have presented a solution to scarce highly trained health professionals [37, 38]. Task-shifting involves training lower cadres to take on many of the duties traditionally performed by more highly trained providers who are less available. Task-shifting, nurse-driven care has been shown to result in equivalent levels of quality of care in the context of HIV care and ART scale-up in SSA [39, 40]. As a result, task-shifting is an approach widely used to facilitate HIV care in Uganda, with nurses often assuming the role of primary care provider, and a clinical or medical officer being present for oversight and to handle more complicated cases. This task-shifting approach has not been adapted for management of depression treatment for HIV patients, but ‘collaborative care’ models of depression treatment have been implemented with non-HIV patients in the US [41–44] as well as resource constrained settings [45–47]. These models use a team-based approach, typically consisting of a depression care manager (often a nurse), primary care provider and supervising psychiatric specialist in medical settings, and a structured, algorithm-based protocol that enables the care manager to take over many of the responsibilities of antidepressant therapy management. Controlled studies have demonstrated the effectiveness of collaborative care models [48–51]; furthermore, algorithm-based, protocol-driven care has been associated with better quality of care and treatment outcomes [43, 46, 48, 49], as the structured approach results in greater likelihood of adequate treatment dosage and duration .
INDEPTH (INtegration of DEPression Treatment in HIV care)-Uganda is a cluster randomized trial that attempts to identify an effective, resource-efficient model for integrating depression treatment into HIV care in low resources settings such as Uganda. In the HIV clinics of ten health care facilities, the trial is comparing two active task-shifting implementation models of depression care: a protocolized model in which care is provided largely by trained nurses who act as depression care managers, and a model that relies on the clinical acumen of trained primary care providers (most, but not all, of whom are also nurses). An alternative approach to the use of a structured protocol to guide depression care by non-mental health professionals, the clinical acumen model (like the protocolized model) takes an active approach to depression care by integrating a brief routine depression screening process for all patients at each clinic visit, but what the primary care provider does with this screening information is left to their discretion as opposed to following a structured protocol. So, both of these models are active task-shifting models of depression care, as the clinical acumen model goes beyond current usual care, which relies solely on primary care provider to assess and treat, or refer to external specialists - which has resulted in depression being severely under-diagnosed and treated.
According to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) implementation framework, to have an impact on health at the population level, an intervention must be adopted by providers, reach a large proportion of the patient population, be implemented with fidelity, effectively improve outcomes, and be maintained post study [53, 54]. Accordingly, the objectives of INDEPTH-Uganda are to compare the two task-shifting models on (1) reach (screening and follow-up rates), adoption (treatment uptake), fidelity (quality of depression care implementation by the providers), and effectiveness (alleviation of depression symptoms) implementation parameters, and (2) cost-effectiveness. A secondary objective is to assess the impact of depression treatment on key economic (work) and public health (ART adherence, condom use) outcomes. Our hypothesis is that the protocolized model will result in better implementation of depression care, better overall alleviation of depression, and better cost-effectiveness, compared to clinical acumen. If effective and resource-efficient, the protocolized model will provide an approach to building the capacity for sustainable provision of depression treatment across SSA and improving key public health outcomes of HIV care.