NCT02056106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,252

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

February 3, 2014

Last Update Submit

October 2, 2015

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

  • Depression diagnostic evaluation

    Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression

    baseline, Month 6, Month 12

  • 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

  • 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

Secondary Outcomes (2)

  • Consistent condom use

    past 6 months prior to baseline, Month 6, Month 12

  • ART adherence

    past month prior to baseline, Month 6 and Month 12

Study Arms (2)

Clinical acumen

ACTIVE COMPARATOR

Depression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care.

Drug: antidepressant therapy

Protocolized Arm

ACTIVE COMPARATOR

Structured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment

Drug: antidepressant therapy

Interventions

antidepressant therapyDRUG
Clinical acumenProtocolized Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

health care facilities receiving technical assistance from Mildmay Uganda

Wakiso, Mpigi, Luwero, Mityana Districts, Uganda

Location

Related Publications (2)

  • Wagner GJ, Ngo V, Goutam P, Glick P, Musisi S, Akena D. A Structured Protocol Model of Depression Care versus Clinical Acumen: A Cluster Randomized Trial of the Effects on Depression Screening, Diagnostic Evaluation, and Treatment Uptake in Ugandan HIV Clinics. PLoS One. 2016 May 11;11(5):e0153132. doi: 10.1371/journal.pone.0153132. eCollection 2016.

    PMID: 27167852DERIVED

  • Wagner GJ, Ngo V, Glick P, Obuku EA, Musisi S, Akena D. INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial. Trials. 2014 Jun 25;15:248. doi: 10.1186/1745-6215-15-248.

    PMID: 24962086DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Glenn Wagner, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Behavioral Scientist

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations

UG(1)