JMIR Publications

ABSTRACT

There is an unmet need to develop effective, feasible and scale-able interventions for poor adherence and depression in persons living with HIV (PLWH) in low- and middle-income countries (LAMIC). This study aims to investigate the effectiveness of a nurse-delivered cognitive-behavioural therapy intervention for adherence and depression (CBT-AD) among PLWH who are failing first line anti-retroviral therapy (ART) in Cape Town, South Africa. This study is a two-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in S. Africa. One hundred-sixty 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 eight sessions of CBT-AD or enhanced treatment as usual (ETAU). Participants will be assessed for depression using the Mini International Neuropsychiatric Interview (MINI) at baseline, 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, 12-month assessments). Results of this study will inform whether an existing intervention (CBT-AD), can be effectively administered in LAMIC by nurses, with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioural intervention to enhance ART adherence among PLWH with depression in a high-prevalence setting, in order to move towards achieving the UNAIDS 90-90-90 goals.