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

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696824
• Other study ID #: 20150399
• Secondary ID: 1R01MH103770-01A
• Status: Completed
• Phase: N/A
• Start date: July 19, 2016
• Est. completion date: June 9, 2020

Study information

• Verified date: January 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 9, 2020
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression
• Depressive Symptoms
• HIV Infections
• Immunodeficiency Virus, Human

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Adherence and Depression
This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town
United States	The General Hospital Corp dba Massachusetts General Hospital	Boston	Massachusetts
United States	University of Miami	Miami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	Massachusetts General Hospital, National Institute of Mental Health (NIMH), University of Cape Town

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression scores via self-report after intervention	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.	4-month assessment
Other	Depression scores via self-report over follow up	CES-D scale; The CES-D has a total score ranging from 0-60, with higher scores indicated greater depressive symptoms.	Aggregate across 4,8, and 12-month assessment
Primary	Changes in HIV medication adherence throughout intervention phase	Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device	Assessed between baseline and the 4 month assessment
Primary	Depression scores as assessed by an independent (blind assessor) after intervention.	Hamilton Depression Rating Scale; The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.	4 month assessment
Secondary	HIV viral load	Percentage of patients with a detectable viral load at the 12 month assessment	12-month assessment
Secondary	CD4	Mean CD4 cell counts at the 12 month assessment	12-month assessment
Secondary	HIV medication adherence over follow-up	Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device	Aggregate across 4,8, and 12-month assessment
Secondary	Depression scores as assessed by an independent (blind assessor) over follow-up	Hamilton Depression Rating Scale; The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.	Aggregate across 4,8, and 12-month assessment