Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01671501
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2012-08-20
Brief Title:
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized clinical trial uses a health plans 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 HIVAIDS and Alcohol-Related Outcomes U01 The proposed study takes place in a HIV primary care clinic and uses the health plans 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 ie 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None