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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01671501
First received: August 20, 2012
Last updated: April 10, 2014
Last verified: April 2014

August 20, 2012
April 10, 2014
March 2013
August 2016   (final data collection date for primary outcome measure)
Impact of motivational interviewing on hazardous drinking and alcohol related problems [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01671501 on ClinicalTrials.gov Archive Site
Impact of e-mail feedback on hazardous drinking and alcohol related problems [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients

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 hazardous drinking, 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 hazardous 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 hazardous drinking and the associated complications. Prior studies have identified high rates of co-occurrence of HIV and hazardous drinking (defined as drinking over threshold limits, i.e., 5+ daily or 14+ weekly drinks for men and 4+ daily or 7+ weekly drinks for women). Drinking at these levels can compromise antiretroviral (ART) treatment, and increase rates of depression, unsafe sex, and mortality. The proposed randomized trial examines the comparative effectiveness of two highly implementable behavioral interventions for reducing hazardous 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 hazardous drinking at 6 months; and 2) Interactive Email Feedback (EF) on hazardous drinking risks using a secure messaging system integrated into the Electronic Medical Record (EMR), with additional emailed feedback for those who report hazardous drinking at 6 months. A third arm will be usual care. 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 hazardous 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 hazardous alcohol use in this population, and may provide powerful, and generalizable tools for assisting individuals with HIV infection.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • HIV
  • Acquired Immunodeficiency Syndrome
  • Alcoholism
  • Alcoholic Intoxication
  • Substance-Related Disorders
  • Behavioral: Motivational Interviewing
  • Behavioral: Email Feedback
  • Other: Usual Care
  • 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.
    Intervention: Behavioral: Motivational Interviewing
  • Experimental: Email Feedback
    Each participant will receive three detailed emails. 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, 3 more detailed emails will be delivered to the participant.
    Intervention: Behavioral: Email Feedback
  • Usual Care
    Participants in this arm will receive routine primary care services
    Intervention: Other: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
August 2017
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults ages 18 and over seeking HIV services at the KPNC San Francisco medical center
  • Report at clinical intake of any hazardous drinking (≥ 4 drinks in a day or 7+ per week for women and ≥ 5 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
Both
18 Years and older
No
Contact: Michael J Silverberg, PhD 510-891-3801 Michael.J.Silverberg@kp.org
United States
 
NCT01671501
P0048609_Satre
Yes
University of California, San Francisco
University of California, San Francisco
Kaiser Foundation Research Institute
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
University of California, San Francisco
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP