Browsing by Author "Inoue S"

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Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial.
(2022-May-19) Figge CJ; Kane JC; Skavenski S; Haroz E; Mwenge M; Mulemba S; Aldridge LR; Vinikoor MJ; Sharma A; Inoue S; Paul R; Simenda F; Metz K; Bolton C; Kemp C; Bosomprah S; Sikazwe I; Murray LK; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 655 Huntington Ave, Boston, MA, 02115, USA.; Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.; Department of Medicine, University of Alabama at Birmingham, 845 19th Street South, Birmingham, AL, 35294, USA.; Department of Medicine, University of Zambia, PO Box 50110, Lusaka, Zambia.; Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA. cfigge1@jh.edu.; Ministry of Health Zambia, Haille Selassie Avenue, Ndeke House, P.O. Box 30205, Lusaka, Zambia.; Department of Psychiatry, University of Zambia, PO Box 50110, Lusaka, Zambia.; Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W 168th St., New York City, NY, 10032, USA.; Department of Global Health, Hans Rosling Center, University of Washington School of Public Health, 3980 15th Ave. NE, Seattle, WA, 98105, USA.; The Centre for Infectious Disease Research (CIDRZ) Zambia, Plot 34620, Lusaka, Zambia.
BACKGROUND: In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Common Elements Treatment Approach (CETA) is an evidence-based, flexible, transdiagnostic intervention delivered by lay counselors to address comorbid mental and behavioral health conditions, though its effectiveness has not yet been tested among AYA. This paper describes the protocol for a randomized controlled trial that will test the effectiveness of traditional in-person delivered CETA and a telehealth-adapted version of CETA (T-CETA) in reducing mental and behavioral health problems among AYA in Zambia. Non-inferiority of T-CETA will also be assessed. METHODS: This study is a hybrid type 1 three-arm randomized trial to be conducted in Lusaka, Zambia. Following an apprenticeship model, experienced non-professional counselors in Zambia will be trained as CETA trainers using a remote, technology-delivered training method. The new CETA trainers will subsequently facilitate technology-delivered trainings for a new cohort of counselors recruited from community-based partner organizations throughout Lusaka. AYA with mental and behavioral health problems seeking services at these same organizations will then be identified and randomized to (1) in-person CETA delivery, (2) telehealth-delivered CETA (T-CETA), or (3) treatment as usual (TAU). In the superiority design, CETA and T-CETA will be compared to TAU, and using a non-inferiority design, T-CETA will be compared to CETA, which is already evidence-based in other populations. At baseline, post-treatment (approximately 3-4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline), we will assess the primary outcomes such as client trauma symptoms, internalizing symptoms, and externalizing behaviors and secondary outcomes such as client substance use, aggression, violence, and health utility. CETA trainer and counselor competency and cost-effectiveness will also be measured as secondary outcomes. Mixed methods interviews will be conducted with trainers, counselors, and AYA participants to explore the feasibility, acceptability, and sustainability of technology-delivered training and T-CETA provision in the Zambian context. DISCUSSION: Adolescents and young adults in LMIC are a priority population for the treatment of mental and behavioral health problems. Technology-delivered approaches to training and intervention delivery can expand the reach of evidence-based interventions. If found effective, CETA and T-CETA would help address a major barrier to the scale-up and sustainability of mental and behavioral treatments among AYA in LMIC. TRIAL REGISTRATION: ClinicalTrials.gov NCT03458039 . Prospectively registered on May 10, 2021.
Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial.
(2022-Feb) Kane JC; Sharma A; Murray LK; Chander G; Kanguya T; Skavenski S; Chitambi C; Lasater ME; Paul R; Cropsey K; Inoue S; Bosomprah S; Danielson CK; Chipungu J; Simenda F; Vinikoor MJ; Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W. 168th Street, Room 519, New York, NY, 10032, USA.; School of Medicine, University of Zambia, University Teaching Hospital, Lusaka, Zambia.; University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.; Zambia Ministry of Health, Lusaka, Zambia.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. jk4397@cumc.columbia.edu.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W. 168th Street, Room 519, New York, NY, 10032, USA. jk4397@cumc.columbia.edu.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
This randomized controlled trial tested the efficacy of a multi-session, evidence-based, lay counselor-delivered transdiagnostic therapy, the Common Elements Treatment Approach (CETA), in reducing unhealthy alcohol use and comorbidities among persons living with HIV (PLWH) in Zambia. Adult PLWH with (a) unhealthy alcohol use plus mental health or substance use comorbidities, or (b) severe unhealthy alcohol use were randomized to receive a single-session alcohol brief intervention (BI) alone or BI plus referral to CETA. Outcomes were measured at baseline and a 6-month follow-up and included Alcohol Use Disorders Identification Test (AUDIT) score (primary), depression and trauma symptoms, and other substance use (secondary). We enrolled 160 participants; 78 were randomized to BI alone and 82 to BI plus CETA. Due to COVID-19, the trial ended early before 36 participants completed. Statistically and clinically significant reductions in mean AUDIT score from baseline to 6-month follow-up were observed in both groups, however, participants assigned to BI plus CETA had significantly greater reductions compared to BI alone (- 3.2, 95% CI - 6.2 to - 0.1; Cohen's d: 0.48). The CETA effect size for AUDIT score increased in line with increasing mental health/substance use comorbidity (0 comorbidities d = 0.25; 1-2 comorbidities d = 0.36; 3+ comorbidities d = 1.6). Significant CETA treatment effects were observed for depression, trauma, and several other substances. BI plus referral to CETA was feasible and superior to BI alone for unhealthy alcohol use among adults with HIV, particularly among those with comorbidities. Findings support future effectiveness testing of CETA for HIV outcomes among PLWH with unhealthy alcohol use.Clinical Trials Number: NCT03966885.
Testing the validity of the AUDIT-C and AUDIT-3 to detect unhealthy alcohol use among high-risk populations in Zambia: A secondary analysis from two randomized trials.
(2021-Dec-01) Inoue S; Chitambi C; Vinikoor MJ; Kanguya T; Murray LK; Sharma A; Chander G; Paul R; Mwenge MM; Munthali S; Kane JC; University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; University of Zambia School of Medicine, Lusaka, Zambia.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA.; Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA. Electronic address: sachi_inoue@hsph.harvard.edu.
BACKGROUND: This study evaluated the test characteristics of brief versions of the Alcohol Use Disorders Identification Test (AUDIT), the AUDIT-C and AUDIT-3, compared to the full AUDIT in populations with heavy drinking living in Zambia and compared differences in effect size estimates when using brief versions in clinical trials. METHODS: Data were obtained from two randomized trials of the Common Elements Treatment Approach (CETA) for reducing unhealthy alcohol use among adult couples and people living with HIV (PLWH) in Zambia. The full AUDIT was administered to participants at baseline and at 6- or 12-month follow-up. Sensitivity and specificity of the brief versions were calculated in comparison to the full AUDIT. Mixed effects regression models were estimated to calculate the effect sizes from the trials using the brief versions and these were compared to the originally calculated effect sizes using the full version. RESULTS: The AUDIT-C performed well at cut-off ≥ 3 for both men (sensitivity: >80%; specificity: >76%) and women (sensitivity: >84%; specificity: >88%). The AUDIT-3 performed best at cut-off ≥ 1, but with comparatively reduced validity for men (sensitivity: >77%; specificity: ≥60%) and women (sensitivity: ≥72%; specificity: >62%). Effect sizes were different by up to 52% using the AUDIT-C and up to 60% for the AUDIT-3 compared to the AUDIT. CONCLUSIONS: The AUDIT-C is recommended as a brief screening tool for community-based and clinic-based screening in Zambia among populations with high prevalence of unhealthy alcohol use. For research studies, the full AUDIT is recommended to calculate treatment effect.