Depressive Symptoms, Immunodeficiency Virus, Human
Conditions
Brief summary
The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).
Detailed description
Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.
Interventions
This treatment involves integrating CBT for depression with CBT for adherence following our Life-Steps approach.
Sponsors
Massachusetts General Hospital
University of Cape Town
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-seropositive * Current diagnosis of depression * Did not attain viral suppression from first-line ARV per local clinic standard
Exclusion criteria
* Unable or unwilling to provide informed consent. * Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD. * Has not received CBT for depression. * Less than 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HIV medication adherence throughout intervention phase | Assessed between baseline and the 4 month assessment | Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device |
| Depression scores as assessed by an independent (blind assessor) after intervention. | 4 month assessment | Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4 | 12-month assessment | Mean CD4 cell counts at the 12 month assessment |
| Depression scores as assessed by an independent (blind assessor) over follow-up | Aggregate across 4,8, and 12-month assessment | Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms. |
| HIV medication adherence over follow-up | Aggregate across 4,8, and 12-month assessment | Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device |
| HIV viral load | 12-month assessment | Percentage of patients with a detectable viral load at the 12 month assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression scores via self-report after intervention | 4-month assessment | Center for Epidemiological Studies-Depression (CES-D) scale The CES-D has a total score ranging from 0-60, with higher scores indicated greater depressive symptoms. |
| Depression scores via self-report over follow up | Aggregate across 4,8, and 12-month assessment | CES-D scale The CES-D has a total score ranging from 0-60, with higher scores indicated greater depressive symptoms. |
Countries
South Africa, United States
Outcome results
None listed