Browsing by Author "Paul R"

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Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial.
(2023-Apr) Vinikoor MJ; Sharma A; Murray LK; Figge CJ; Bosomprah S; Chitambi C; Paul R; Kanguya T; Sivile S; Nghiem V; Cropsey K; Kane JC; Zambian Ministry of Health, Lusaka, Zambia.; Columbia University Mailman School of Public Health, New York, NY, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; School of Medicine, University Teaching Hospital, University of Zambia, Lusaka, Zambia. Electronic address: michael.vinikoor@cidrz.org.; School of Medicine, University Teaching Hospital, University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Public Health, University of Ghana, Accra, Ghana.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.; School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: Clinical and quality of life outcomes in people living with human immunodeficiency virus (PLWH) are undermined by unhealthy alcohol use (UAU), which is highly prevalent in this population and is often complicated by mental health (MH) or other substance use (SU) comorbidity. In sub-Saharan Africa, evidence-based and implementable treatment options for people with HIV and UAU are needed. METHODS: We are conducting a hybrid clinical effectiveness-implementation trial at three public-sector HIV clinics in Lusaka, Zambia. Adults with HIV, who report UAU, and have suboptimal HIV clinical outcomes, will be randomized to one of three arms: an alcohol-focused brief intervention (BI), the BI with additional referral to a transdiagnostic cognitive behavioral therapy (Common Elements Treatment Approach [CETA]), or standard of care. The BI and CETA will be provided by HIV peer counselors, a common cadre of lay health worker in Zambia. Clinical outcomes will include HIV viral suppression, alcohol use, assessed by audio computer-assisted self-interview (ACASI) and direct alcohol biomarkers, Phophatidylethanol and Ethyl glucuronide, and comorbid MH and other SU. A range of implementation outcomes including cost effectiveness will also be analyzed. CONCLUSION: Hybrid and 3-arm trial design features facilitate the integrated evaluation of both brief, highly implementable, and more intensive, less implementable, treatment options for UAU among PLWH in sub-Saharan Africa. Use of ACASI and alcohol biomarkers will strengthen understanding of treatment effects.
Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial.
(2020-Dec) Kane JC; Sharma A; Murray LK; Chander G; Kanguya T; Lasater ME; Skavenski S; Paul R; Mayeya J; Kmett Danielson C; Chipungu J; Chitambi C; Vinikoor MJ; University of Zambia, School of Medicine, University Teaching Hospital, Lusaka, Zambia.; University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.; Columbia University Mailman School of Public Health, New York, NY, USA.; Zambia Ministry of Health, Lusaka, Zambia.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Medical University of South Carolina, Charleston, SC, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
AIMS: Prevalence of unhealthy alcohol use and co-occurring mental health problems is high among persons living with HIV (PLWH) in sub-Saharan Africa (SSA). Yet, there is a dearth of evidence-based treatment options that can address both unhealthy alcohol use and comorbidities in SSA HIV care settings. Recent studies testing single-session alcohol brief interventions (BIs) among PLWH in SSA have suggested that more robust treatments are needed. This paper describes the protocol of a pilot randomized controlled superiority trial that will test the effectiveness of an evidence-based transdiagnostic multi-session psychotherapy, the Common Elements Treatment Approach (CETA), compared to a control condition consisting of a single session brief alcohol intervention (BI) based on CETA, at reducing unhealthy alcohol use, mental health problems, and other substance use among PLWH in urban Zambia. METHODS: The study is a single-blind, parallel, individually randomized trial conducted in HIV treatment centers in Lusaka. 160 PLWH who meet criteria for unhealthy alcohol use + mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible. Participants are randomized 1:1 to receive the single-session BI or CETA. Outcomes are assessed at baseline and a six-month follow-up and include unhealthy alcohol use, depression, trauma symptoms, and other substance use. CONCLUSIONS: The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA. If effectiveness is demonstrated, a larger trial featuring long-term follow-ups and HIV treatment outcomes will be undertaken.
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.
Depression, pregnancy, and HIV: the case to strengthen mental health services for pregnant and post-partum women in sub-Saharan Africa.
(2014-Jul) Stringer EM; Meltzer-Brody S; Kasaro M; Stuebe AM; Wiegand S; Paul R; Stringer JS; Department of Psychiatry, University Teaching Hospital, Lusaka, Zambia.; Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: elizabeth_stringer@med.unc.edu.; Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, NC, USA.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Effectiveness of trauma-focused cognitive behavioral therapy compared to psychosocial counseling in reducing HIV risk behaviors, substance use, and mental health problems among orphans and vulnerable children in Zambia: a community-based randomized controlled trial.
(2024-Jan) Kane JC; Figge C; Paniagua-Avila A; Michaels-Strasser S; Akiba C; Mwenge M; Munthali S; Bolton P; Skavenski S; Paul R; Simenda F; Whetten K; Cohen J; Metz K; Murray LK; School of Medicine, University of Zambia, University Teaching Hospital, Lusaka, Zambia.; Zambia Ministry of Health, Lusaka, Zambia.; Drexel University College of Medicine, Allegheny Health Network/Allegheny General Hospital, Pittsburgh, PA, USA.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Duke Global Health Instittute, Durham, NC, USA.; Department of Health Behavior, University of North Carolina Gillings School of Public Health, Chapel Hill, NC, USA.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. jk4397@cumc.columbia.edu.; Center for Health Policy and Inequalities Research, Durham, NC, USA.; Duke Sanford School of Public Policy, Durham, NC, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA.; ICAP, 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. jk4397@cumc.columbia.edu.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts.Clinical Trials Number: NCT02054780.
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.
Intersection of alcohol use, HIV infection, and the HIV care continuum in Zambia: nationally representative survey.
(2023-Oct) Vinikoor MJ; Sikazwe I; Sharma A; Kanguya T; Chipungu J; Murray LK; Chander G; Cropsey K; Bosomprah S; Mulenga LB; Paul R; Kane J; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; Columbia University Mailman School of Public Health, New York, NY, USA.; School of Medicine, 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.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; University of Zambia, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Through a nationally-representative household survey, we measured the prevalence and correlates of unhealthy alcohol use (UAU) in Zambia and its association with the HIV care continuum. Adolescent and adult (ages 15-59 years) data, including the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), from the 2016 Zambia Population-based HIV Impact Assessment, were analyzed. UAU was defined as AUDIT-C of 3 + points for women and 4 + for men. Among 20,923 participants, 15.3% had UAU; this was 21.6% among people living with HIV (PLWH). Male sex, increasing age, being employed, urban residence, and having HIV were independent correlates of UAU (all
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.
The Role of Violence Acceptance and Inequitable Gender Norms in Intimate Partner Violence Severity Among Couples in Zambia.
(2021-Oct) Fine SL; Kane JC; Murray SM; Skavenski S; Munthali S; Mwenge M; Paul R; Mayeya J; Murray LK; University of Zambia School of Medicine, Lusaka, Zambia.; Zambia Ministry of Health, Lusaka, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Inequitable gender norms, including the acceptance of violence in intimate relationships, have been found to be associated with the occurrence of intimate partner violence (IPV) perpetration and victimization. Despite these findings, few studies have considered whether inequitable gender norms are related to IPV severity. This study uses baseline data from a psychotherapeutic intervention targeting heterosexual couples (
Two-year treatment effects of the common elements treatment approach (CETA) for reducing intimate partner violence and unhealthy alcohol use in Zambia.
(2021) Kane JC; Glass N; Bolton PA; Mayeya J; Paul R; Mwenge M; Murray LK; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Zambia Ministry of Health, Lusaka, Zambia.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; Johns Hopkins University School of Nursing, Baltimore, MD, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of Epidemiology, Columbia University Mailman School of Public Health, New York City, NY, USA.; Department of Psychiatry, University of Zambia School of Medicine, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: Intimate partner violence (IPV) and unhealthy alcohol use are common yet often unaddressed public health problems in low- and middle-income countries. In a randomized trial, we found that the common elements treatment approach (CETA), a multi-problem, flexible, transdiagnostic intervention, was effective in reducing IPV and unhealthy alcohol use among couples in Zambia at a 12-month post-baseline assessment. In this follow-up study, we investigated whether treatment effects were sustained among CETA participants at 24-months post-baseline. METHODS: Participants were heterosexual couples in Zambia in which the woman reported IPV perpetrated by the male partner and in which the male had hazardous alcohol use. Couples were randomized to CETA or treatment as usual plus safety checks. Measures were the Severity of Violence Against Women Scale (SVAWS) and the Alcohol Use Disorders Identification Test (AUDIT). The trial was stopped early upon recommendation by the trial's DSMB due to CETA's effectiveness following the 12-month assessment. Control participants exited the study and were offered CETA. This brief report presents data from an additional follow-up assessment conducted among original CETA participants at a 24-month visit. RESULTS: There were no meaningful changes in SVAWS or AUDIT scores between 12- and 24-months. The within-group treatment effect for SVAWS from baseline to 24-months was CONCLUSIONS: The lack of change in levels of IPV and unhealthy alcohol use between the 12- and 24-month post-baseline timepoints suggests that treatment gains were sustained among participants who received CETA for at least two years from intervention commencement.