Trial record 1 of 31 for:    " August 19, 2012":" September 18, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
  Purpose

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.


Condition Intervention
HIV
Acquired Immunodeficiency Syndrome
Alcoholism
Alcoholic Intoxication
Substance-Related Disorders
Behavioral: Motivational Interviewing
Behavioral: Email Feedback
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Impact of motivational interviewing on hazardous drinking and alcohol related problems [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of e-mail feedback on hazardous drinking and alcohol related problems [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
Behavioral: Email Feedback
Usual Care
Participants in this arm will receive routine primary care services
Other: Usual Care

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671501

Contacts
Contact: Michael J Silverberg, PhD 510-891-3801 Michael.J.Silverberg@kp.org

Locations
United States, California
Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd Recruiting
San Francisco, California, United States, 94115
Contact: Michael J Silverberg, PhD    510-891-3801    Michael.J.Silverberg@kp.org   
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
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01671501     History of Changes
Other Study ID Numbers: P0048609_Satre
Study First Received: August 20, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
Acquired Immunodeficiency Syndrome
Alcoholism
Alcoholic Intoxication
Substance-Related Disorders
Intervention Studies
Primary Health Care
therapy
prevention & control

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Alcohol Drinking
Alcoholic Intoxication
Alcoholism
Immunologic Deficiency Syndromes
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Drinking Behavior
Alcohol-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014