Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares two models for implementing antidepressant treatment in 10 HIV clinics in
      Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized
      model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine
      depression screening at each clinic visit for all adult patients by trained expert patients
      at triage, (2) training nurses to diagnose depression and prescribe and monitor
      antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and
      monitoring by hired study psychiatrists. The clinical acumen model also includes routine
      depression screening and ongoing supervision, but it relies on the clinical acumen of trained
      primary care providers to further evaluate and treat patients who show signs of depression at
      screening, as opposed to a structured protocol. The primary aim is to test the hypothesis
      that the nurse-driven protocolized model will result in greater uptake of antidepressant
      treatment and better quality of depression care outcomes. The study will also test the
      hypotheses that treatment of depression results in improved HIV treatment adherence, work
      functioning and consistent condom use.
    

Detailed description: 
      The study evaluates a task-shifting approach to depression treatment that uses an
      algorithm-based, nurse-driven model for managing antidepressant treatment in 10 Ugandan HIV
      clinics. The model will include (1) case identification facilitated by routine depression
      screening at each clinic visit for all patients, (2) training nurses to assist primary care
      providers in implementing antidepressant treatment by performing the initial evaluation,
      monitoring symptoms and side effects, and making algorithm-based dose recommendations, and
      (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and
      quality of care. This model will be implemented at 5 randomly selected clinics (protocolized
      arm), while 5 other clinics will be selected to also use routine depression screening but
      will rely on primary care providers to decide whether to further evaluate and treat
      depression (clinical acumen arm). At each site, random samples of 150 patients (total n=1500)
      who have screened positive for possible depression will be followed for 12 months. We will
      compare the two arms on depression evaluation, uptake of antidepressant treatment, and change
      in depression (treatment response). We will also examine the relationship between change in
      depression and key economic and public health outcomes (e.g. work status, condom use, HIV
      treatment adherence).
    

Intervention name(s): antidepressant therapy
Intervention type(s): Drug
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: depression, Uganda, HIV, task-shifting, condom use, adherence