Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, Psychiatric |
Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 10/12/2018 |
Start Date: | March 2013 |
End Date: | August 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
San Francisco, California 94115
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