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Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02056106
Acronym
INDEPTH-Uganda
Enrollment
1252
Registered
2014-02-05
Start date
2013-01-31
Completion date
2014-12-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, Uganda, HIV, task-shifting, condom use, adherence

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.

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).

Interventions

Sponsors

RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Depression diagnostic evaluationbaseline, Month 6, Month 12Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression
Antidepressant prescriptionbaseline, Month 6, Month 12Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 \> 9
Depressive symptomspast 2 weeks at Month 6 and Month 12depressive 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

MeasureTime frameDescription
Consistent condom usepast 6 months prior to baseline, Month 6, Month 12A 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 adherencepast month prior to baseline, Month 6 and Month 12single variable to rate adherence to ART over the past month on scale of 0-100

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026