Impact of a Computer-Assisted SBIRT Program in an HIV Car... | NCT01300806

Studies
Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting

NCT01300806

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

210Actual

Phase

Not provided

Conditions

Substance Use

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Feb 17, 2010

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2013

Last Update Posted Date

May 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this research is to assess the impact of the "screening, brief intervention, and referral to treatment" (SBIRT) intervention strategy for harmful substance use among HIV-positive people.

Detailed Description

The specific aims of the study are:

To assess the feasibility of conducting SBIRT using (1) a patient self-administered intervention embedded in a web-based Personal Health Record (PHR) compared to (2) a provider-administered SBIRT intervention guided by the Electronic Medical Record (EMR) during clinic appointments.
To examine the acceptability of web-based PHRs to conduct and communicate SBIRT compared to EMR-activated SBIRT conducted by clinic staff, from the perspective of the patient and the provider.
To assess the impact of SBIRT on risky drug and alcohol use in an HIV/AIDS population and subsequent effects on sexual risk behaviors and antiretroviral therapy (ART) adherence.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduced substance use among HIV-positive people		6 months

Secondary Outcomes

Measure	Description	Time Frame
technological innovation to improve the quality of medical care		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age
confirmed prior HIV+ serostatus
ability to provide informed consent to be a participant over a 6 month period
English or Spanish speaking

Exclusion Criteria:

Inability to answer questions with interviewer assistance. Not receiving primary care in clinic.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care clinic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol Dawson Rose, PhD	University of California, San Francisco	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29229000	Derived	Dawson-Rose C, Draughon JE, Cuca Y, Zepf R, Huang E, Cooper BA, Lum PJ. Changes in Specific Substance Involvement Scores among SBIRT recipients in an HIV primary care setting. Addict Sci Clin Pract. 2017 Dec 12;12(1):34. doi: 10.1186/s13722-017-0101-1.

Label	Type	Description	Intervention Names
myHERO SBIRT
clinician administered SBIRT

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders