Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
2 other identifiers
interventional
161
2 countries
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedStudy Start
First participant enrolled
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2020
CompletedJanuary 19, 2021
January 1, 2021
3.2 years
February 18, 2016
January 14, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
HIV viral load
12-month assessment
CD4
12-month assessment
HIV medication adherence over follow-up
Aggregate across 4,8, and 12-month assessment
Depression scores as assessed by an independent (blind assessor) over follow-up
Aggregate across 4,8, and 12-month assessment
Other Outcomes (2)
Depression scores via self-report after intervention
4-month assessment
Depression scores via self-report over follow up
Aggregate across 4,8, and 12-month assessment
Study Arms (2)
CBT-AD
EXPERIMENTALThose 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.
ETAU
NO INTERVENTIONParticipants 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.
Interventions
This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
Eligibility Criteria
You may qualify if:
- HIV-seropositive
- Current diagnosis of depression
- Did not attain viral suppression from first-line ARV per local clinic standard
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Massachusetts General Hospitalcollaborator
- University of Cape Towncollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (3)
University of Miami
Miami, Florida, 33146, United States
The General Hospital Corp dba Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Cape Town
Cape Town, South Africa
Related Publications (2)
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.
PMID: 34708929DERIVEDJoska 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.
PMID: 32012114DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven A Safren, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 18, 2016
First Posted
March 2, 2016
Study Start
July 19, 2016
Primary Completion
October 17, 2019
Study Completion
June 9, 2020
Last Updated
January 19, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share