Clinical trial NCT01671501: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
First posted: 2012-08-23
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Impact of motivational interviewing on unhealthy drinking and alcohol related problems
timeFrame: 3 Years
Secondary outcomes:
measure: Impact of e-mail feedback on unhealthy drinking and alcohol related problems
timeFrame: 3 Years
Other outcomes:
measure: Impact of motivational interviewing and emailed feedback interventions on comorbid drug use
timeFrame: 3 years
measure: Impact of motivational interviewing and emailed feedback on interventions on antiretroviral adherence
timeFrame: 3 years
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd
state: California
Study officials:
affiliation: Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California
name: Derek Satre, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Scientist II, Division of Research, Kaiser Permanente, Northern California
name: Michael J Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
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