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

University of Miami

Status: Completed

Conditions: Depressive Symptoms; Immunodeficiency Virus, Human

Treatments: Behavioral: Cognitive Behavioral Therapy for Adherence and Depression

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02696824

20150399

1R01MH103770-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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161 participants in 2 patient groups

CBT-AD

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Adherence and Depression

ETAU

No Intervention group

Description:

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.