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Clinical Trial Summary

This study, which is part of the Zambia Alabama HIV Alcohol Comorbidities Program funded by NIH-NIAAA, is designed to examine the efficacy of brief and in-depth cognitive behavioral therapy-based interventions to address, unhealthy alcohol use, comorbid mental health symptoms, and HIV treatment outcomes among people living with HIV in Zambia. A 3-arm trial will be conducted with participants randomized to a brief intervention alone, the brief intervention plus referral to Common Elements Treatment Approach (CETA), or standard of care (SOC).

Clinical Trial Description

People with HIV are a priority population for alcohol screening and treatment; however, they may be more likely to underreport their alcohol use and may respond less well to alcohol treatments due to untreated comorbidities. Psychological treatments for unhealthy alcohol use should ideally include components to address common mental health and other substance use comorbidities. However, few current treatments can treat both substance use and mental illness with a single protocol. Further, whether integrated treatment of unhealthy alcohol use and its comorbidities is more effective than alcohol-focused treatment alone needs to be established. There are psychological alcohol treatments that are consider brief interventions (BI), which are time limited and require fewer resources to implement. There are also more complex interventions that require multiple sessions with a provider and are more time and resource intensive; however, they may have more potential for short- and long-term effectiveness. In this study we will examine the efficacy of both a brief intervention (BI) alone and a more comprehensive and involving the BI followed by Common Elements Treatment Approach (CETA; among adults with unhealthy alcohol use and HIV in urban Zambia. CETA is a transdiagnostic cognitive behavioral therapy-based intervention that can flexibly treat a range of conditions including substance use, depression, posttraumatic stress, and anxiety. Further, CETA can be delivered by professional and lay providers. There is already evidence that CETA can reduce alcohol use in the general population in Zambia. In pilot study, the BI plus CETA reduced alcohol use and mental health symptoms more at 6 months than the BI alone. Whether the BI is superior to standard of care (SOC), antiretroviral therapy adherence counseling, is not known. This study will build on existing knowledge by looking at longer-term effects (12 months) of the interventions, assess impact on HIV outcomes (adherence to antiretrovirals, retention in HIV care, viral suppression), and to understand whether the BI is superior to current SOC. In the study, we will also evaluate implementation factors related to delivery of the two interventions within public sector HIV clinics. Understanding how to implement interventions for unhealthy alcohol use and mental illness is a major priority in the field. We will have several groups of participants: - 1 Adults with HIV and unhealthy alcohol use- this group will be enrolled and randomly assigned to one of three Arms (A, B or C) of the study. Arm A will receive alcohol brief intervention (BI), Arm B alcohol brief intervention (BI) plus referral to Common Elements Treatment Approach (CETA), or Arm C standard of care (SOC). The participants in Arm A will receive the single session alcohol brief intervention (BI). Participants in Arm B will also receive the BI and then be referred for CETA, which includes 6-12 sessions with a provider. The participants in Arm C will receive standard of care (SOC) only. All participants will be re-assessed at 6 and 12 months post-enrollment. Patients who participate will provide data on alcohol use, mental health and other substance use comorbidities, and HIV outcomes. Data will be generated through surveys and in some cases through laboratory tests (blood and urine). CETA will be provided by HIV peer counselors, a cadre of lay health worker that supports HIV care delivery at facilities in Zambia. - 2 CETA counselors- this group will be enrolled and their competency to provide the intervention will be assessed through role plays. Further, they will be included in focus group discussions to understand experiences delivering CETA at HIV clinics. - 3 Clinic staff- these individuals will be HIV care providers at the study clinics and they will be invited to focus group discussions so we can understand their perspectives on integration of interventions into their clinics. - 4 Key informants- these are high-level policymakers and HIV and mental health/substance use policy makers and experts in Zambia who can guide us on understanding how to scale up study interventions should they be effective. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05121064
Study type Interventional
Source University of Alabama at Birmingham
Contact Michael Vinikoor, M.D.
Phone 265980013335
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date August 2022
Completion date August 2028

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