Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT-AD Those assigned to the CBT-AD [cognitive behavioral therapy for adherence and depression) condition, will have up to 8 additional sessions delivered by the study clinic nurse. Additionally, those assigned to CBT-AD will have the procedures available to those assigned to ETAU. |
Behavioral: Cognitive Behavioral Therapy for Adherence and Depression
This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
|
| No Intervention: ETAU Participants in both conditions receive usual care plus the following procedures below. All participant will have the benefit of the psychosocial assessment, and the clinic nurse will provide feedback to the participant and to their clinic doctor about their depression. Additionally, all participants will undergo standard of care "second line treatment" adherence counseling in the clinic . The clinic doctor will not be restricted in terms of referral or treatment of depression for their patient with respect to antidepressant medications or other interventions available. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- HIV viral load [12-month assessment]
Percentage of patients with a detectable viral load at the 12 month assessment
- CD4 [12-month assessment]
Mean CD4 cell counts at the 12 month assessment
- 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
- 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.
Other Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
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Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD.
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Has not received CBT for depression.
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Less than 18 years of age.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33146 |
| 2 | The General Hospital Corp dba Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 3 | University of Cape Town | Cape Town | South Africa |
Sponsors and Collaborators
- University of Miami
- Massachusetts General Hospital
- University of Cape Town
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Steven A Safren, PhD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20150399
- 1R01MH103770-01A1