Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda

Depression Clinical Trial

— INDEPTH-Uganda  

Official title:

Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056106
• Other study ID #: R01MH098996
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2014
• Last updated: October 2, 2015
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1252
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• antidepressant therapy

Locations

Country	Name	City	State
Uganda	health care facilities receiving technical assistance from Mildmay Uganda	Wakiso, Mpigi, Luwero, Mityana districts

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression diagnostic evaluation	Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression	baseline, Month 6, Month 12	No
Primary	Antidepressant prescription	Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9	baseline, Month 6, Month 12	No
Primary	Depressive symptoms	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	past 2 weeks at Month 6 and Month 12	No
Secondary	Consistent condom use	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	past 6 months prior to baseline, Month 6, Month 12	No
Secondary	ART adherence	single variable to rate adherence to ART over the past month on scale of 0-100	past month prior to baseline, Month 6 and Month 12	No