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

Study Overview
=================
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.

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

Conditions
-----------------
Immunodeficiency Virus, Human, Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy for Adherence and Depression


Participation Criteria
=================
Eligibility 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-AD<br>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<br>* This treatment involves integrating CBT for depression with CBT for adherence following our Life-Steps approach.<br>|
| No Intervention: ETAU<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load | Percentage of patients with a detectable viral load at the 12 month assessment | 12-month assessment | 
| CD4 | Mean CD4 cell counts at the 12 month assessment | 12-month assessment | 
| 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 | 
| 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 |