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).

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Immunodeficiency Virus, Human
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Adherence and Depression

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • University of Cape Town
• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • The General Hospital Corp dba Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-AD; 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; This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
No Intervention: 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH); Massachusetts General Hospital; University of Cape Town

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2016
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): June 9, 2020

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Depression; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20150399; 1R01MH103770-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No