Abstract
BackgroundThere 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).ObjectiveThis 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.MethodsThis 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).ResultsThe trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019.ConclusionsResults 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.Trial RegistrationClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824International Registered Report Identifier (IRRID)DERR1-10.2196/14200
Highlights
BackgroundThe global HIV epidemic has disproportionately affected lowand middle-income countries (LMIC) and Southern Africa in particular [1]
Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in low- and middle-income countries (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 antiretroviral therapy (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
Summary
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
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