Clinical trial NCT02610517: ARCH Research Protocol for Provider Alcohol Pharmacotherapy Training and Assessment
Official title: Integration of Evidence-based Alcohol Interventions Into HIV Care (ARCH-IRA) (Phases 1- Provider Training and 2- Patient Intervention)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Alcoholism
Keywords: Hazardous alcohol use
Computer based intervention (CBI)
Pharmacotherapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Johns Hopkins University
First posted: 2015-11-20
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting.

Detailed description: This study is divided into 2 phases: provider training (Phase 1) and patient level intervention (Phase 2). Phase 1, provider training, is managed through an administrative grant at Johns Hopkins. Providers will be notified of the research project locally but all training and assessments will be through Johns Hopkins.

Phase 1:

Training providers to offer alcohol pharmacotherapy (APT) to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population. However, it is unknown how Infectious Disease providers will feel about treating alcohol use disorders within HIV clinics. Further it is uncertain the specific provider and clinic barriers to implementing this type of program in a primary care setting. A web-based alcohol pharmacotherapy provider training will be provided across the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. At the two intervention sites (University of Alabama at Birmingham and the University of Washington), providers will receive an on-site training in addition to the web-based training on alcohol pharmacotherapy administered at all 8 sites.

The following are the specific aims of this project:

Aim 1: To evaluate provider attitudes before and after alcohol pharmacotherapy training.

Aim 2: To determine barriers and facilitators to alcohol treatment implementation in HIV specialty clinics.

Phase 2:

Determine the effectiveness of computer-delivered brief interventions (CBI) for reducing hazardous drinking in the HIV clinical care setting at two intervention clinics: University of Alabama at Birmingham (UAB) and the University of Washington (UW). The combination of CBI plus alcohol pharmacotherapy (APT) provider training (Phase 1) will be piloted in two clinics in the Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS), a national network of 8 clinical cohorts. Across all 8 CNICS sites, all patients will be screened for hazardous or binge drinking using the AUDIT (Alcohol Use Disorders Identification Test) and MINI (Mini-International Neuropsychiatric Interview) instruments. At UAB and UW, patients who screen eligible (self-report of hazardous or binge drinking using the AUDIT and MINI instruments) will be approached for participation. The data collected through this protocol will be used to compare Standard of Care as noted in Aim 2 below. Standard of Care at UAB includes potential referral to an in-house substance abuse program or an outside agency, both of which are based on the provider's discretion. Providers have the option of offering alcohol pharmacotherapy but this has not been used to date routinely.

Specific aims of this proposal are:

Aim 1: Develop a tailored CBI intervention that addresses alcohol risks specific to HIV-infected patients.

Aim 2: Compare the effectiveness of CBI + APT versus standard care for reducing alcohol use among hazardous drinking HIV infected individuals.

Aim 3: Determine patient-level predictors of CBI and APT engagement and effectiveness.

Aim 4: Determine the facilitators and barriers to successful integration and implementation of these interventions into HIV clinical settings.

Eligibility criteria: Inclusion Criteria:

* At least 18 years or older
* Receiving HIV care at The UAB 1917 Clinic
* Hazardous drinkers as defined by an at-risk alcohol use score on the alcohol related, self-report data collected through the CNICS PRO.
* English speaking
* Willing to participate and provide informed consent

Exclusion Criteria:

* Pregnant or nursing women will be referred to social work for more intensive intervention per standard of care.
* Cognitive impairment such as they cannot provide informed consent
* Non-English speaker
* A visibly intoxicated person will be deferred for consent by the research assistant but will remain eligible for the study
* Patients who previously declined to participate in the project

Primary outcomes:
measure: Drinks per week
timeFrame: up to 1 year after enrollment
measure: Binge drinking episodes
timeFrame: up to 1 year after enrollment
Secondary outcomes:
measure: Number of participants that initiate/request alcohol pharmacotherapy
timeFrame: at enrollment and after visit 2 (3 - 6 months after enrollment)
measure: Number of participants that complete a CNICS Patient Reported Outcome (PRO)
timeFrame: every 3 - 6 months after enrollment and at 12 months after enrollment
measure: Number of participants that initiate antiretroviral therapy (ART)
timeFrame: every 3 - 6 months after enrollment and at 12 months after enrollment
measure: Mean number of participants that adhere to HIV clinic visits
timeFrame: for 1 year after enrollment
measure: Number of subjects with HIV-RNA level (viral loads) < 20 copies/ml
timeFrame: 1 year post enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael S Saag, MD
role: PRINCIPAL_INVESTIGATOR
References: