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Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda (INDEPTH-Uganda)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02056106
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : October 5, 2015
Information provided by (Responsible Party):
Glenn Wagner, RAND

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Drug: antidepressant therapy Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Clinical acumen
Depression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care.
Drug: antidepressant therapy
Active Comparator: Protocolized Arm
Structured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment
Drug: antidepressant therapy

Primary Outcome Measures :
  1. Depression diagnostic evaluation [ Time Frame: baseline, Month 6, Month 12 ]
    Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression

  2. Antidepressant prescription [ Time Frame: baseline, Month 6, Month 12 ]
    Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9

  3. Depressive symptoms [ Time Frame: past 2 weeks at Month 6 and Month 12 ]
    depressive symptoms present at Month 6 and Month 12 (in comparison to baseline) to assess treatment response; PHQ-9 will be used to measure depressive symptoms

Secondary Outcome Measures :
  1. Consistent condom use [ Time Frame: past 6 months prior to baseline, Month 6, Month 12 ]
    A single likert scale item will be used to assess condom use in the past month; a single item will also be used to assess whether condom was used during last event of sexual intercourse

  2. ART adherence [ Time Frame: past month prior to baseline, Month 6 and Month 12 ]
    single variable to rate adherence to ART over the past month on scale of 0-100

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18 years or above
  • screens positive for depression (scores > 2 on PHQ-2)
  • medically stable
  • client at the HIV clinic (and hence, HIV positive)

Exclusion Criteria:

  • active acute opportunistic infection
  • about to start HIV antiretroviral therapy or started antiretroviral therapy within past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02056106

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health care facilities receiving technical assistance from Mildmay Uganda
Wakiso, Mpigi, Luwero, Mityana districts, Uganda
Sponsors and Collaborators
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Principal Investigator: Glenn Wagner, PhD RAND
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Glenn Wagner, Senior Behavioral Scientist, RAND Identifier: NCT02056106    
Other Study ID Numbers: R01MH098996 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015
Keywords provided by Glenn Wagner, RAND:
depression, Uganda, HIV, task-shifting, condom use, adherence
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs