Clinical trial NCT02938377: Alcohol Research Consortium in HIV-Intervention Research Arm
Official title: Alcohol Research Consortium in HIV-Intervention Research Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Positive
Alcohol Use
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 4985
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were given varying levels of treatment depending on their alcohol use.
Primary purpose: TREATMENT

Brief summary: Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms.

Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes.

Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions

Detailed description: Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease drinking quantity and or frequency compared to pre-algorithm levels. Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD symptoms compared to pre-algorithm symptoms levels.

Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits and HIV medications compared to pre-algorithm levels. Hypothesis 2B. Patients who receive algorithm-guided treatment will have improved HIV biomarkers (e.g., CD4 and VL). Hypothesis 3B. There will be a positive relationship between VL and alcohol consumption measured by self-report and PEth level.

Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, HCV, other drug use disorders). Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving algorithm-guided treatment will have better alcohol, mental health and HIV treatment outcomes compared to similar individuals in SC. Hypothesis 3B: PLWH with comorbid HCV receiving algorithm-guided treatment will have improved FIB4 results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug use will decrease among those receiving algorithm-guided treatment vs SC.

Eligibility criteria: Inclusion Criteria:

* At least 18 years or older;
* Receiving HIV care at the UAB, UW or UCSD clinics and not anticipating changing clinics over the next 12 months;
* AUDIT-C score \> 3 women or \> 4 men at time of PRO.

Exclusion Criteria:

* Non-English speaking;
* Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.

Primary outcomes:
measure: Audit-C Score on a Scale
timeFrame: 18 month window
Secondary outcomes:
measure: PEth Levels
timeFrame: Between baseline and 6 month follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Seattle
country: United States
facility: Harborview Medical Center; 2 West Clinic; UW Center for AIDS
state: Washington
Study officials:
References: