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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by RAND
Sponsor:
Information provided by (Responsible Party):
Glenn Wagner, RAND
ClinicalTrials.gov Identifier:
NCT02056106
First received: February 3, 2014
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Depression
Drug: antidepressant therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Depression diagnostic evaluation [ Time Frame: baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression

  • Antidepressant prescription [ Time Frame: baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9

  • Depressive symptoms [ Time Frame: past 2 weeks at Month 6 and Month 12 ] [ Designated as safety issue: No ]
    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:
  • Consistent condom use [ Time Frame: past 6 months prior to baseline, Month 6, Month 12 ] [ Designated as safety issue: No ]
    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

  • ART adherence [ Time Frame: past month prior to baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    single variable to rate adherence to ART over the past month on scale of 0-100


Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056106

Contacts
Contact: Glenn Wagner, PhD 310-393-0411 ext 7698 gwagner@rand.org

Locations
Uganda
health care facilities receiving technical assistance from Mildmay Uganda Recruiting
Wakiso, Mpigi, Luwero, Mityana districts, Uganda
Sub-Investigator: Dickens Akena, MBChB         
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Glenn Wagner, PhD RAND
  More Information

No publications provided by RAND

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glenn Wagner, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT02056106     History of Changes
Other Study ID Numbers: R01MH098996
Study First Received: February 3, 2014
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
depression, Uganda, HIV, task-shifting, condom use, adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014