Clinical trial NCT05121064: Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia
Official title: Common Elements Treatment Approach HIV Alcohol Reduction Trial in Zambia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Alcohol-Related Disorders
Mental Illness
Keywords: HIV
Unhealthy Alcohol Use
Mental Illness
HIV care continuum
sub-Saharan Africa
Alcohol biomarkers
Implementation science
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Centre for Infectious Disease Research in Zambia
First posted: 2021-11-16
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: People meeting criteria will be assigned at random to one of 3 study arms.
Primary purpose: TREATMENT

Brief 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).

Detailed 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; www.cetaglobal.org) 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Living with HIV
* Receiving HIV care at study site
* Hazardous alcohol use plus at least one mental health or other substance use comorbidity or moderate to severe alcohol use disorder regardless of comorbidity
* 6 months since initiation of Antiretroviral Treatment (ART)
* Suboptimal HIV care outcome based on at least 1 of the following occurences in the past year: Late (at least 14 days from scheduled) Antiretroviral Treatment (ART) drug pick up, HIV viral load (VL) above the limit of assay detection, or referral to enhanced adherence

Exclusion Criteria:

* Plan to relocate out of Lusaka in next 6 months
* No access to a telephone
* Actively suicidal or alcohol intoxication and in need of immediate care
* Currently psychotic
* Participating in another interventional study that would interfere with participation

Primary outcomes:
measure: HIV Viral Load Suppression at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in Alcohol Use from enrollment to 6 months
timeFrame: 6 months
measure: Change in Alcohol Use from enrollment to 12 months
timeFrame: 12 months
measure: Change in Alcohol Biomarker from enrollment to 6 months
timeFrame: 6 months
measure: Change in Alcohol Biomarker from enrollment to 12 months
timeFrame: 12 months
measure: Antiretroviral Treatment (ART) Medication Adherence from baseline to 6 months
timeFrame: 6 months
measure: Antiretroviral Treatment (ART) Medication Adherence from enrollment to 12 months
timeFrame: 12 months
measure: Change in HIV Viral Load from enrollment to 6 months
timeFrame: 6 months
measure: Change in HIV Viral Load from enrollment to 12 months
timeFrame: 12 months
measure: Retention in care change from enrollment to 6 months
timeFrame: 6 months
measure: Retention in care change from enrollment to 12 months
timeFrame: 12 months
measure: Changes in Mental Health and Substance Use from enrollment to 6 months
timeFrame: 6 months
measure: Changes in Mental Health and Substance Use from enrollment to 12 months
timeFrame: 12 months
measure: Change in Health Related Quality of Life (QoL) from enrollment to 6 months
timeFrame: 6 months
measure: Change in Health Related Quality of Life (QoL) from enrollment to 12 months
timeFrame: 12 months
Other outcomes:
measure: Analysis of CETA completion
timeFrame: 12 months
measure: Process evaluation
timeFrame: 12 months
measure: Cost effectiveness analysis
timeFrame: 12 months
Locations:
city: Lusaka
country: Zambia
facility: Chilenje Level 1 Hospital
city: Lusaka
country: Zambia
facility: Kalingalinga Health Centre
city: Lusaka
country: Zambia
facility: Kamwala Health Centre
Study officials:
References:
citation: Vinikoor MJ, Sharma A, Murray LK, Figge CJ, Bosomprah S, Chitambi C, Paul R, Kanguya T, Sivile S, Nghiem V, Cropsey K, Kane JC. Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial. Contemp Clin Trials. 2023 Apr;127:107116. doi: 10.1016/j.cct.2023.107116. Epub 2023 Feb 13.
citation: Vinikoor MJ, Sikazwe I, Sharma A, Kanguya T, Chipungu J, Murray LK, Chander G, Cropsey K, Bosomprah S, Mulenga LB, Paul R, Kane J. Intersection of alcohol use, HIV infection, and the HIV care continuum in Zambia: nationally representative survey. AIDS Care. 2023 Oct;35(10):1555-1562. doi: 10.1080/09540121.2022.2092589. Epub 2022 Jun 27.
citation: 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. 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. Trials. 2022 May 19;23(1):417. doi: 10.1186/s13063-022-06319-4.
citation: Kane JC, Glass N, Bolton PA, Mayeya J, Paul R, Mwenge M, Murray LK. Two-year treatment effects of the common elements treatment approach (CETA) for reducing intimate partner violence and unhealthy alcohol use in Zambia. Glob Ment Health (Camb). 2021 Feb 19;8:e4. doi: 10.1017/gmh.2021.2. eCollection 2021.
citation: Murray LK, Dorsey S, Haroz E, Lee C, Alsiary MM, Haydary A, Weiss WM, Bolton P. A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries. Cogn Behav Pract. 2014 May;21(2):111-123. doi: 10.1016/j.cbpra.2013.06.005.