Supplemental Material for Cognitive Behavioral Therapy for Body Image and Self-Care (CBT-BISC) in Sexual Minority Men Living With HIV: A Randomized Controlled Trial

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. CLINICALTRIAL ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14200

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Optimizing enrollment methods: Lessons learned from an mHealth, pilot HIV prevention randomized controlled trial with sexual minority men

International Journal of STD & AIDS ◽

10.1177/0956462419831854 ◽

2019 ◽

Vol 30 (7) ◽

pp. 703-706 ◽

Cited By ~ 3

Author(s):

Jason W Mitchell ◽

Sara Lammert ◽

Thu Danh ◽

Keith J Horvath

Keyword(s):

Randomized Controlled Trial ◽

Sexual Minority ◽

Controlled Trial ◽

Decision Rules ◽

Lessons Learned ◽

Sexual Minority Men ◽

Randomized Controlled ◽

Minority Men ◽

Using Data ◽

Enrollment Process

Using data from eligible participants, we evaluated procedures of a multi-step enrollment process for an mHealth, pilot randomized controlled trial aimed to promote regular HIV testing among at-risk, diverse sexual minority men. Completion rates of eligible participants were calculated and characterized for these enrollment procedures. Among 3058 men who screened, 183 were eligible and 113 enrolled. Two groups emerged: “As planned” (n = 98) followed enrollment directions as designed; “Laggers” (n = 15) did not follow these directions and required additional efforts resulting in mixed results for improving enrollment. Findings suggest the need for pre-determined enrollment decision rules based on available resources.

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Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/14200 ◽

2020 ◽

Vol 9 (2) ◽

pp. e14200 ◽

Cited By ~ 2

Author(s):

John A Joska ◽

Lena S Andersen ◽

Rosana Smith-Alvarez ◽

Jessica Magidson ◽

Jasper S Lee ◽

...

Keyword(s):

South Africa ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Art Adherence ◽

First Line ◽

Randomized Controlled ◽

Persons Living With Hiv ◽

Living With Hiv

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. Trial Registration ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824 International Registered Report Identifier (IRRID) DERR1-10.2196/14200

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