N/A
N=304
Trial of Collaborative Depression Care Management for HIV Patients
Depression · HIV
Bottom Line
View on ClinicalTrials.gov: NCT01372605 ↗Enrolled (actual)
304
Serious AEs
1.0%
Results posted
Oct 2016
Primary outcome: Primary: Antiretroviral Medication Adherence — 89.2; 87.6 observed pills taken as % of expected
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Measurement-Based Care collaborative depression management (Other); Enhanced Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antiretroviral Medication Adherence |
86.3; 94.5 | — |
| SECONDARY Depressive Symptoms |
13.5; 17.2 | — |
| SECONDARY Antiretroviral Medication Adherence |
86.3; 94.5 | — |
| SECONDARY Health Care Costs |
4611; 4535 | — |
| SECONDARY Appointment Adherence |
81.3; 80.1 | — |
| SECONDARY Number of Participants With Viral Load Below Detection |
68; 75 | — |
| SECONDARY Quality of Life |
41.6; 37.6 | — |
| SECONDARY Self Reported Adherence |
92.7; 93.9 | — |
| SECONDARY Self-reported Adherence |
91.6; 94.1 | — |
| SECONDARY Safety Endpoint |
2; 4 | — |
| SECONDARY Depression-free Days |
160; 136 | — |
Summary
This project will integrate a depression treatment and brief medication adherence counseling intervention into clinical care at three HIV clinics and will use a randomized controlled trial to assess whether, relative to usual care, the intervention leads to improved HIV medication adherence. The depression treatment intervention uses a model known as Measurement-Based Care which equips Depression Care Managers with systematic measurement tools, a decision algorithm, and psychiatric backup and trains them to provide decision support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.
Eligibility Criteria
Inclusion Criteria
- Age 18-65
- HIV-positive
- Patient Health Questionnaire-9 (PHQ-9) total score >= 10
- Confirmed current major depressive episode
- English-speaking
Exclusion Criteria
- History of bipolar disorder
- History of psychotic disorder
- Failure of adequate trials of two different antidepressants at effective doses in the current depressive episode
- Current substance dependence requiring inpatient hospitalization
- Not mentally competent
- Acute suicidality or other psychiatric presentation requiring immediate hospitalization
Data sourced from ClinicalTrials.gov (NCT01372605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.