Clinical trial NCT03966885: Zambia Common Elements Treatment Approach Pilot Study
Official title: Zambia Common Elements Treatment Approach Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Use Disorder
Depression
Post-traumatic Stress Disorder
HIV/AIDS
Substance Use Disorders
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: University of Alabama at Birmingham
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-05-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.

Detailed description: Alcohol misuse is a major unaddressed barrier to ending the HIV/AIDS epidemic. Hazardous drinking increases HIV transmission, delays antiretroviral therapy (ART) uptake, reduces adherence and retention, and increases mortality. Comorbid mental health or substance misuse, similar to alcohol use alone, can also significantly undermine HIV treatment. The vast majority of people living with HIV globally live in low- and middle-income countries (LMIC). Similar to most HIV care settings in LMIC, in Zambia, the location of the current study, there are no readily available evidence-based treatments for alcohol misuse or mental health problems.

This study will enroll persons living with HIV (PLWH) who have alcohol misuse in Zambia. Participants will be recruited and screened during regular HIV care visits. Participants will be recruited by their regular care providers (i.e., peer educators, counselors, nurses, physicians) and referred to study staff if they are interested. The investigators anticipate enrolling up to 320 participants, all of whom have hazardous alcohol use. N=160 participants will be high-risk drinkers due to having either a moderate-to-severe alcohol use disorder or mental health comorbidities, or both. These participants will be randomized into the RCT. Participants who have hazardous alcohol use (but not a moderate-to-severe AUD) without mental health comorbidities (a lower risk group of participants) will not be enrolled into the RCT but will be tracked as part of a parallel cohort study. The minimum age of research subjects will be 18. Eligibility will be assessed via audio computer assisted self-interviewing (ACASI).

Participants in the 'cohort study' (i.e., lower risk participants) will receive a brief alcohol intervention. Participants in the RCT (i.e., higher risk participants) will be randomly assigned on a 1:1 basis (stratified by gender) to receive the brief intervention alone or the brief intervention plus CETA.

All participants will be evaluated for outcomes at baseline and at a six month follow-up visit. For RCT participants, the investigators will compare the effectiveness of the brief intervention alone to the brief intervention plus CETA in reducing alcohol misuse and mental health problems. For cohort participants, the investigators will collect preliminary data on whether alcohol misuse reduced at the six month follow-up but there will be no comparison/control group.

The findings from this pilot study will be used to inform future programming and research in Zambia and other LMIC to implement screening, brief intervention, and referral to treatment (SBIRT) programs for alcohol use in HIV care.

Eligibility criteria: Inclusion Criteria:

* Initial inclusion criteria for overall enrollment (into either the Cohort or RCT study) will be:

  * HIV positive
  * Receiving HIV treatment services at one of the two study clinics
  * Current hazardous alcohol use, defined as an AUDIT score of ≥8 for men and ≥ 4 for women
  * Provides informed consent

Secondary inclusion for enrollment into the RCT will be:

* AUDIT scores that indicate a moderate-to-severe AUD (≥12 for women; ≥16 among men)
* AND/OR: meeting validated symptom criteria for depression (≥16 on Center for Epidemiological Studies-Depression (CES-D), trauma/anxiety (≥2.5 on HTQ), and/or substance use (≥27 for any non-tobacco/alcohol substance on ASSIST)

Exclusion Criteria:

* HIV negative
* Not receiving care at one of the study clinics
* Currently psychotic or actively suicidal
* Unable to provide informed consent

Primary outcomes:
measure: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline.
timeFrame: Baseline and 6 months post-baseline
Secondary outcomes:
measure: Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline.
timeFrame: Baseline and 6 months post-baseline
measure: Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline.
timeFrame: Baseline and 6 months post-baseline
measure: Number of Participants With Any Recent Substance Use.
timeFrame: 6 months post-baseline
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for infectious Disease Research in Zambia
Study officials:
affiliation: Columbia University
name: Jeremy C. Kane, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial. Addict Behav Rep. 2020 Apr 29;12:100278. doi: 10.1016/j.abrep.2020.100278. eCollection 2020 Dec.
citation: 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. 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. AIDS Behav. 2022 Feb;26(2):523-536. doi: 10.1007/s10461-021-03408-4. Epub 2021 Jul 30.