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

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).

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.

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.

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.

This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device

Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.

Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device

Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.

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.

CES-D scale The CES-D has a total score ranging from 0-60, with higher scores indicated greater depressive symptoms.

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.

Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.

Joska JA, Andersen LS, Smith-Alvarez R, Magidson J, Lee JS, O'Cleirigh C, Safren SA. Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 3;9(2):e14200. doi: 10.2196/14200. Erratum In: JMIR Res Protoc. 2020 Sep 28;9(9):e24074.