NCT02696824|CompletedDMC
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Sponsor study identifier
Secondary identifiers
interventional
161
2 countries
3
Study Start
July 19, 2016
Actual (reported)Primary Completion
October 17, 2019
Actual (reported)Study Completion
June 9, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 9, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2016
Actual (reported)March 2, 2016
Actual (reported)July 19, 2016
Actual (reported)October 17, 2019
Actual (reported)June 9, 2020
Actual (reported)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
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
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.
Steven A Safren, PhD
University of Miami
161 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2016
First Posted
March 2, 2016
Study Start
July 19, 2016
Actual (reported)Cooperative Re-Engagement Controlled Trial (CoRECT)
Contact the study team to confirm eligibility.
Primary Completion
October 17, 2019
Actual (reported)Study Completion
June 9, 2020
Actual (reported)Last Updated
January 19, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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