Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01671501

Collaborator

Kaiser Foundation Research Institute (Other)

614

Enrollment

Location

Arms

Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Acquired Immunodeficiency Syndrome Alcoholism Alcoholic Intoxication Substance-Related Disorders	Behavioral: Motivational Interviewing Behavioral: Email Feedback Other: Usual Care	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

614 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interviewing 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.	Behavioral: Motivational Interviewing
Experimental: Email Feedback 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.	Behavioral: Email Feedback
Other: Usual Care 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	Other: Usual Care

Arm

Intervention/Treatment

Experimental: Motivational Interviewing

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.

Behavioral: Motivational Interviewing

Experimental: Email Feedback

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.

Behavioral: Email Feedback

Other: Usual Care

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

Other: Usual Care

Outcome Measures

Primary Outcome Measures

Impact of motivational interviewing on unhealthy drinking and alcohol related problems [3 Years]

Secondary Outcome Measures

Impact of e-mail feedback on unhealthy drinking and alcohol related problems [3 Years]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults ages 18 and over seeking HIV services at the KPNC San Francisco medical center
Report of any unhealthy drinking in the previous year (≥ 3 drinks in a day or 7+ per week for women and ≥ 4 drinks in a day or 14+ per week for men) and,
Report of web access at time of recruitment

Exclusion Criteria:

Clinical recommendation from providers that patients are not appropriate due to:

Acute psychiatric problems; OR
Inability to understand consent procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd	San Francisco	California	United States	94115

Sponsors and Collaborators

University of California, San Francisco
Kaiser Foundation Research Institute

Investigators

Principal Investigator: 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