TY - JOUR
T1 - Nurse-delivered cognitive behavioral therapy for adherence and depression among people living with HIV (the ziphamandla study)
T2 - Protocol for a randomized controlled trial
AU - Joska, John A.
AU - Andersen, Lena S.
AU - Smith-Alvarez, Rosana
AU - Magidson, Jessica
AU - Lee, Jasper S.
AU - O'Cleirigh, Conall
AU - Safren, Steven A.
N1 - Funding Information:
The study is supported by award number 5R01MH103770 from the National Institute of Mental Health (NIMH). JM is supported by award number K23DA041901 from the National Institute of Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIMH or the NIH. The authors thank the City of Cape Town Health Department. The authors specifically thank the facility managers and staff at Matthew Goniwe and Town Two clinics as well as Kuyasa, Luvuyo, Zakhele, and Mayenzeke clinics in Khayelitsha, Cape Town, for all their assistance and support. The authors also thank the participants and their families.
Publisher Copyright:
© Joska et al.
PY - 2020/2
Y1 - 2020/2
N2 - Background: There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). Objective: This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. Methods: This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). Results: The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. Conclusions: Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals.
AB - Background: There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). Objective: This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. Methods: This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). Results: The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. Conclusions: Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals.
KW - Cognitive behavioral therapy
KW - HIV
KW - Integrated treatment
KW - Major depressive disorder
KW - Medication adherence
KW - Task shifting
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UR - http://www.scopus.com/inward/citedby.url?scp=85083369611&partnerID=8YFLogxK
U2 - 10.2196/14200
DO - 10.2196/14200
M3 - Article
AN - SCOPUS:85083369611
VL - 9
JO - JMIR Research Protocols
JF - JMIR Research Protocols
SN - 1929-0748
IS - 2
M1 - e14200
ER -