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| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
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This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol screen; and examines innovative behavioral interventions, and their cost effectiveness, for hazardous drinking within a large HIV primary care clinic. We will compare Motivational Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and outcomes, the proposed study has the potential to make a significant impact in the care of HIV patients.
This application responds to RFA-AA12-009, Interventions to Improve HIV/AIDS and Alcohol-Related Outcomes (U01). The proposed study takes place in a HIV primary care clinic and uses the health plan's electronic medical record (EMR) for screening; it has the potential to provide a significant benefit to HIV-infected individuals by reducing unhealthy drinking and the associated complications. Prior studies have identified high rates of co-occurrence of HIV and unhealthy drinking (defined as drinking over threshold limits, i.e., 4+ daily or 14+ weekly drinks for men and 3+ daily or 7+ weekly drinks for women). Drinking at these levels can compromise antiretroviral (ART) treatment, and increase rates of drug use, depression, unsafe sex, and mortality. The proposed randomized trial examines the comparative effectiveness of two highly implementable behavioral interventions for reducing unhealthy drinking, each with an adaptive, stepped-care component: 1) Motivational Interviewing (MI), consisting of one in-person session with a study clinician and two phone sessions, with three additional phone sessions for those who report unhealthy drinking at 6 months; and 2) Interactive Email Feedback (EF) on alcohol use risks using a secure messaging system integrated into the Electronic Medical Record (EMR), with additional emailed feedback for those who report unhealthy drinking at 6 months. MI and EF are delivered by study staff. A third arm will be usual care only. Participants in all three arms are eligible to receive alcohol screening, brief intervention, and referral to treatment (SBIRT) from usual care clinic staff. We will also evaluate the cost-effectiveness of the two interventions which have the potential for wide adoption in other similar healthcare settings. The two proposed interventions, MI and EF, are promising approaches for reducing unhealthy drinking in the setting of behavioral health and/or primary care. EF also uses secure messaging, an emerging technology that has been tested in other health, behavior change and mental health treatment settings, for problems including alcohol use but not among HIV-infected individuals. In this trial, 600 patients (200 in each arm) will be recruited from Kaiser Permanente Northern California (KPNC) San Francisco. The study population and clinic are ideal to examine such interventions since NIAAA-based screening questions are recorded in the EMR, and comprehensive data are available on health care utilization, ART adherence, and HIV clinical outcomes, including the Veterans Aging Cohort Study (VACS) index, a recently validated prognostic index based on routine clinical laboratory measures. The research team is well-qualified with complementary expertise in clinical psychology, drug and alcohol abuse treatment, HIV epidemiology, and biostatistics. Thus, the team and study setting provide the ideal environment to test MI and EF, two innovative approaches for reducing unhealthy alcohol use in this population, and may provide powerful, and generalizable tools for assisting individuals with HIV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental | The intervention consists of one 45-minute in-person session followed by two 20-minute telephone sessions.The first telephone MI session will occur approximately 10 days after the in-person session. The second call will occur 30 days after the first call. The same research clinician will conduct both the in-person session and phone sessions. The calls will include a review of material covered in the initial session, questions on alcohol use, open-ended questions regarding patients' current motivational level, and a review of the patient's initial goals regarding alcohol consumption and will last about 20 minutes. If after six months hazardous drinking is noted, three more motivational interviewing phone sessions will be delivered by the research clinician. |
|
| Email Feedback | Experimental | Each participant will receive up to three detailed emails, (if participants respond to a first, initial email with information on alcohol use risks). The initial and subsequent emails will be brief in length, and will include specific information on hazardous drinking levels, standard drink size; as well as advice to reduce drinking to non-hazardous levels. Each email will conclude with contact numbers for patients to receive further information and assistance if needed, including information on how to easily access SU treatment; and will encourage participants to respond to the research clinician with questions. If after six months hazardous drinking is detected, up to 3 more detailed emails will be delivered to the participant. |
|
| Usual Care | Other | Participants in this arm will receive routine primary care services only. Usual care in this health care setting may include alcohol screening, brief intervention and referral to treatment (SBIRT) delivered by usual care clinic staff |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral |
| ||
| Email Feedback |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of motivational interviewing on unhealthy drinking and alcohol related problems | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of e-mail feedback on unhealthy drinking and alcohol related problems | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of motivational interviewing and emailed feedback interventions on comorbid drug use | 3 years | |
| Impact of motivational interviewing and emailed feedback on interventions on antiretroviral adherence | 3 years |
Inclusion Criteria:
Exclusion Criteria:
Clinical recommendation from providers that patients are not appropriate due to:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Satre, PhD | Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California | Principal Investigator |
| Michael J Silverberg, PhD | Research Scientist II, Division of Research, Kaiser Permanente, Northern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11251758 | Background | Cook RL, Sereika SM, Hunt SC, Woodward WC, Erlen JA, Conigliaro J. Problem drinking and medication adherence among persons with HIV infection. J Gen Intern Med. 2001 Feb;16(2):83-8. doi: 10.1111/j.1525-1497.2001.00122.x. | |
| 12033694 | Background | Galvan FH, Bing EG, Fleishman JA, London AS, Caetano R, Burnam MA, Longshore D, Morton SC, Orlando M, Shapiro M. The prevalence of alcohol consumption and heavy drinking among people with HIV in the United States: results from the HIV Cost and Services Utilization Study. J Stud Alcohol. 2002 Mar;63(2):179-86. doi: 10.15288/jsa.2002.63.179. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000437 | Alcoholism |
| D000435 | Alcoholic Intoxication |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Behavioral |
|
| Usual Care | Other |
|
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| 21677568 | Background | Silverberg MJ, Ray GT, Saunders K, Rutter CM, Campbell CI, Merrill JO, Sullivan MD, Banta-Green CJ, Von Korff M, Weisner C. Prescription long-term opioid use in HIV-infected patients. Clin J Pain. 2012 Jan;28(1):39-46. doi: 10.1097/AJP.0b013e3182201a0f. |
| 19734820 | Background | Horberg MA, Ranatunga DK, Quesenberry CP, Klein DB, Silverberg MJ. Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California. Sex Transm Dis. 2010 Jan;37(1):53-8. doi: 10.1097/OLQ.0b013e3181b6f0cc. |
| 22209306 | Background | Delucchi KL, Kline Simon AH, Weisner C. Remission from alcohol and other drug problem use in public and private treatment samples over seven years. Drug Alcohol Depend. 2012 Jul 1;124(1-2):57-62. doi: 10.1016/j.drugalcdep.2011.12.006. Epub 2011 Dec 29. |
| 18571875 | Background | Mertens JR, Flisher AJ, Satre DD, Weisner CM. The role of medical conditions and primary care services in 5-year substance use outcomes among chemical dependency treatment patients. Drug Alcohol Depend. 2008 Nov 1;98(1-2):45-53. doi: 10.1016/j.drugalcdep.2008.04.007. Epub 2008 Jun 20. |
| 21050681 | Background | Tsoh JY, Chi FW, Mertens JR, Weisner CM. Stopping smoking during first year of substance use treatment predicted 9-year alcohol and drug treatment outcomes. Drug Alcohol Depend. 2011 Apr 1;114(2-3):110-8. doi: 10.1016/j.drugalcdep.2010.09.008. Epub 2010 Nov 2. |
| 22151625 | Background | Chi FW, Campbell CI, Sterling S, Weisner C. Twelve-Step attendance trajectories over 7 years among adolescents entering substance use treatment in an integrated health plan. Addiction. 2012 May;107(5):933-42. doi: 10.1111/j.1360-0443.2011.03758.x. Epub 2012 Feb 11. |
| 18198170 | Background | Chi FW, Weisner CM. Nine-year psychiatric trajectories and substance use outcomes: an application of the group-based modeling approach. Eval Rev. 2008 Feb;32(1):39-58. doi: 10.1177/0193841X07307317. |
| 31187344 | Derived | Satre DD, Leibowitz AS, Leyden W, Catz SL, Hare CB, Jang H, Lam JO, Bryant KJ, Weisner CM, Sterling SA, Horberg M, Volberding P, Silverberg MJ. Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial. J Gen Intern Med. 2019 Oct;34(10):2054-2061. doi: 10.1007/s11606-019-05065-9. Epub 2019 Jun 11. |
| 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 |
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |