Site-Randomized Controlled Trial of a Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living with HIV in the United States

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Larry K. Brown ◽  
Miriam Chernoff ◽  
Betsy D. Kennard ◽  
Graham J. Emslie ◽  
Kathryn Lypen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Medication Management ◽  
The United States ◽  
Randomized Controlled ◽  
Management Algorithm ◽  
Treatment Of Depression ◽  
Youth Living With Hiv ◽  
Living With Hiv

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

BACKGROUND Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. CLINICALTRIAL ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10791

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial

10.2196/10791 ◽  
2019 ◽  
Vol 8 (2) ◽  
pp. e10791 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

scholarly journals Experiences with a violence and mental health safety protocol for a randomized controlled trial to support youth living with HIV

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Katherine G. Merrill ◽  
Jonathan K. Mwansa ◽  
Sam Miti ◽  
Virginia M. Burke ◽  
Elizabeth A. Abrams ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Resource Constraints ◽  
Controlled Trial ◽  
Sub Saharan Africa ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Adherence Support ◽  
Youth Living With Hiv ◽  
Living With Hiv

Abstract Background Safety protocols are an essential component of studies addressing violence and mental health but are rarely described in the published literature from Sub-Saharan Africa. We designed and implemented a safety protocol within Project YES! (Youth Engaging for Success), which enrolled 276 youth living with HIV (ages 15–24 years) in a randomized controlled trial of a peer-mentoring intervention across four HIV clinics in Ndola, Zambia. Methods Youth who reported severe violence and/or suicidal thoughts on research surveys or during meetings with youth peer mentors (YPM) were referred to designated healthcare providers (HCP). We explored experiences with the safety protocol using: a) monitoring data of referrals, and b) in-depth interviews with youth (n = 82), HCP (n = 10), YPM (n = 8), and staff (n = 6). Descriptive statistics were generated and thematic analysis of coded transcripts and written memos performed. Results Nearly half of youth enrolled (48% of females, 41% of males) were referred to a HCP at least once. The first referral was most often for sexual violence (35%) and/or suicidal ideation/depression (29%). All referred youth aged 15–17 years and over 80% of referred youth aged 18 + agreed to see a HCP. HCP referred 15% for additional services outside the clinic. Twenty-nine youth, all HCP, all YPM, and all staff interviewed discussed the safety protocol. Most youth felt “encouraged,” “helped,” “unburdened,” and “relieved” by their meetings with HCP; some expressed concerns about meeting with HCP. The safety protocol helped HCP recognize the need to integrate care for violence and mental health with medication adherence support. HCP, YPM, and study staff raised implementation challenges, including youth choosing not to open up to HCP, time and resource constraints, deficiencies in HCP training, and stigma and cultural norms inhibiting referrals outside the clinic for emotional trauma and mental health. Conclusions Implementing a safety protocol within an HIV clinic-based research study is possible and beneficial for youth and HCP alike. Implementation challenges underscore that HCP in Zambia work in over-stretched healthcare systems. Innovative strategies must address deficiencies in training and resources within HIV clinics and gaps in coordination across services to meet the overwhelming need for violence and mental health services among youth living with HIV.

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

2019 ◽  
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. CLINICALTRIAL ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14200

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