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

Primary Purpose

HIV, Acquired Immunodeficiency Syndrome, Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Email Feedback
Usual Care
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders, Intervention Studies, Primary Health Care, therapy, prevention & control

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Motivational Interviewing

Email Feedback

Usual Care

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Impact of motivational interviewing on unhealthy drinking and alcohol related problems

Secondary Outcome Measures

Impact of e-mail feedback on unhealthy drinking and alcohol related problems

Full Information

First Posted
August 20, 2012
Last Updated
October 8, 2018
Sponsor
University of California, San Francisco
Collaborators
Kaiser Foundation Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01671501
Brief Title
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Official Title
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Kaiser Foundation Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders
Keywords
HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders, Intervention Studies, Primary Health Care, therapy, prevention & control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Email Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Type
Behavioral
Intervention Name(s)
Email Feedback
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Impact of motivational interviewing on unhealthy drinking and alcohol related problems
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Impact of e-mail feedback on unhealthy drinking and alcohol related problems
Time Frame
3 Years
Other Pre-specified Outcome Measures:
Title
Impact of motivational interviewing and emailed feedback interventions on comorbid drug use
Time Frame
3 years
Title
Impact of motivational interviewing and emailed feedback on interventions on antiretroviral adherence
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Satre, PhD
Organizational Affiliation
Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Silverberg, PhD
Organizational Affiliation
Research Scientist II, Division of Research, Kaiser Permanente, Northern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

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

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