NCT02696824

Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immunodeficiency Virus, Human
• Depressive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Adherence and Depression	This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Timeline

• Start date: 2016-07-19
• Primary completion: 2019-10-17
• Completion: 2020-06-09
• First posted: 2016-03-02
• Last updated: 2021-01-19

Locations

3 sites across 2 countries: United States, South Africa