Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | March 2016 |
| End Date: | January 2022 |
| Contact: | Steven A Safren, PhD |
| Email: | ssafren@miami.edu |
| Phone: | 305-243-3471 |
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).
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).
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.
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.
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.
We found this trial at
3
sites
Boston, Massachusetts 02114
Phone: 617-643-0385
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Steven A Safren, PhD
Phone: 305-243-3471
University of Miami A private research university with more than 15,000 students from around the...
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