An interventional study of Provider Training and Patient Intervention in HIV and Alcoholism, sponsored by University of Alabama at Birmingham. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 117 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Training providers to offer alcohol pharmacotherapy 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.
Behavioral: Provider Training
Determine the effectiveness of a computer-delivered brief intervention (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).
Behavioral: Patient Intervention
All providers will receive an online survey about alcohol pharmacotherapy, and an on-site training on alcohol pharmacotherapy will be offered at UAB and UW. The training will cover the most commonly prescribed alcohol pharmacotherapy. Some medications (ex: Zofran) have been used clinically for alcohol pharmacotherapy but have not yet received FDA approval for this indication. Research has shown these medications are beneficial as alcohol pharmacotherapy and are more frequently used by doctors due to the more favorable side effects. Providers in this study will use their clinical judgment in prescribing alcohol medications per their normal standard of care and using any new information gained from the alcohol pharmacotherapy training.
Eligible participants will be screened using the Audit and Mini instruments that are routinely asked during regular clinic visits. Once a participant consents, they will be shown 2 computerized brief interventions (CBIs) - one after enrollment (visit 1) and one 3-6 months after enrollment (visit 2). Participants will interact with the touch-screen computer via Peedy the Parrot, a three dimensional animated character. The intervention emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. At the end of both visits, patients will complete a patient satisfaction survey with questions related to ease of use of CBI and satisfaction with program content. Providers will have the opportunity to prescribe pharmacotherapy at visit 1 and 2.
Drinks per week
The Alcohol Use Disorders Identification Test (AUDIT) instrument will be used to assess drinks per week. This is a self-reported instrument.
Time frame: up to 1 year after enrollment
Binge drinking episodes
The Mini-International Neuropsychiatric Interview (MINI) instrument will be used to assess binge drinking episodes. This is a self-reported instrument.
Time frame: up to 1 year after enrollment
Number of participants that initiate/request alcohol pharmacotherapy
Prescription of alcohol pharmacotherapy - number of participants obtaining a prescription at enrollment and/or after visit 2.
Time frame: at enrollment and after visit 2 (3 - 6 months after enrollment)
Number of participants that complete a CNICS Patient Reported Outcome (PRO)
The CNICS PRO is a patient self-reported questionnaire that is asked every 3 - 6 months during a regular clinic visit. The instruments that are used include: Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST); Adult AIDS Clinical Trials Group (AACTG) Adherence; HIV Risk Behaviors; Quality of Life (EuroQOL); Patient Health Questionnaire for Depression and Anxiety (PHQ-9 - Depression; PHQ-5 - Anxiety); Tobacco; Physical Activity
Time frame: every 3 - 6 months after enrollment and at 12 months after enrollment
Number of participants that initiate antiretroviral therapy (ART)
New prescription of ART if they previously were not on therapy
Time frame: every 3 - 6 months after enrollment and at 12 months after enrollment
Mean number of participants that adhere to HIV clinic visits
Medical records data will be used to record the data
Time frame: for 1 year after enrollment
Number of subjects with HIV-RNA level (viral loads) < 20 copies/ml
Virological suppression to \< 20 copies/ml
Time frame: 1 year post enrollment
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham