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

Not Applicable

Completed

• Conditions: Immunodeficiency Virus, Human; Depressive Symptoms
• Interventions: Behavioral: Cognitive Behavioral Therapy for Adherence and Depression

• Registration Number: NCT02696824
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Study Start: 2016-07-19
• Primary Completion: 2019-10-17
• Study Completion: 2020-06-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• HIV-seropositive
• Current diagnosis of depression
• Did not attain viral suppression from first-line ARV per local clinic standard

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-AD	Cognitive Behavioral Therapy for Adherence and Depression	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.
HIV viral load	12-month assessment	Percentage of patients with a detectable viral load at the 12 month assessment

Trial Locations

Locations (3)

University of Cape Town; 🇿🇦 Cape Town, South Africa

The General Hospital Corp dba Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Miami; 🇺🇸 Miami, Florida, United States