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| ID | Type | Description | Link |
|---|---|---|---|
| P01AA029544 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| University of Washington | OTHER |
| University of Alabama at Birmingham | OTHER |
| Fenway Community Health |
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Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), The investigators will conduct a Hybrid Type 3 effectiveness-implementation evaluating implementation trial testing whether practice facilitation, an evidence-based multifaceted implementation strategy increases reach, adoption, implementation, and maintenance of stepped care for unhealthy alcohol use in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics located in Boston, San Diego, and Chapel Hill. The investigators will secondarily test whether practice facilitation is associated with decreased unhealthy alcohol use, and improved Antiretroviral Therapy (ART) adherence and viral suppression at the patient level. In practice facilitation, a practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. Stepped care will include brief intervention, cognitive behavioral therapy, and alcohol pharmacotherapy. The practice facilitation intervention will be rolled out sequentially across sites. There will be three phases at each site: pre-implementation planning, implementation with formative evaluation, and post-implementation summative evaluation. Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each site using mixed methods (pre-implementation); (Aim 2a) Determine the effects of practice facilitation on implementation of stepped care (primary) and alcohol use and HIV-related outcomes (secondary) using interrupted time series analysis with synthetic controls (summative evaluation); (Aim 2b) Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods (formative evaluation); and (Aim 3) Describe barriers and facilitators to implementation of alcohol-related interventions at each site to describe maintenance and inform widespread sustainable implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Stepped Care | Experimental | Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Facilitation | Behavioral | A practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation as assessed by the percent of patients receiving an alcohol intervention | Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C) | AUDIT-C Score of <3 in women and <4 in men indicating reduction to lower risk use | Baseline and 12 months |
| Antiretroviral therapy adherence as assessed by a self report on a visual analog scale |
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Inclusion Criteria: Clinic Staff
Exclusion Criteria Clinic Staff
Inclusion Criteria, Patients
Exclusion Criteria, Patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JoAnna Mathena | Contact | 410-955-9534 | jmathen5@jhmi.edu | |
| Geetanjali Chander | Contact | 14432872030 | gchande1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Geetanjali Chander, MD | Johns Hopkins University | Principal Investigator |
| Betsy McCaul, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41918133 | Derived | Chander G, Batey DS, Austin EJ, Bentley MJ, Cachay ER, Crane HM, Farel C, Fleming J, Grelotti DJ, Hutton HE, Idrisov B, Mathena J, McCaul ME, Napravnik S, O'Clerigh C, Lau B, Williams EC. Practice facilitation to implement stepped care for unhealthy alcohol use in HIV clinics: study protocol for a type III hybrid effectiveness-implementation study. Addict Sci Clin Pract. 2026 Mar 31;21(1):34. doi: 10.1186/s13722-026-00662-6. |
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Per NIAAA policy, data will be deposited in the NIAAA Data Archive (NIAAADA), a data repository in the National Institute of Mental Health (NIMH) Data Archive (NDA)
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12 months after study completion
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| OTHER |
| University of North Carolina | OTHER |
| University of California, San Diego | OTHER |
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| Alcohol Stepped Care | Behavioral | Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder |
|
Self report of >90% adherence on visual analog scale with higher scores indicating greater adherence |
| 12 months |
| Viral Suppression as assessed by HIV-RNA copies | Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression. | 12 months |
| Fenway Community Health | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
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| University of North Carolina | Not yet recruiting | Chapel Hill | North Carolina | 27599-7215 | United States |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004327 | Drinking Behavior |
| D001519 | Behavior |