Substance UseSBIRTNCT01300806
Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting
An observational study of Substance Use, run by University of California, San Francisco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic patients
Who may be able to join
- 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
Who cannot join
- Inability to answer questions with interviewer assistance. Not receiving primary care in clinic.
About this study
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.
Read the 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.
- Conditions
- Substance Use
- Keywords
- HIV, harmful substance use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| myHERO SBIRT | Not described | |
| clinician administered SBIRT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduced substance use among HIV-positive people
Measured: 6 months
Secondary outcomes (1)
technological innovation to improve the quality of medical care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol Dawson Rose, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300806
- Sponsor's protocol ID
- 09035355
- Acronym
- SBIRT
- Status last verified
- May 2013
- First submitted
- 17 Feb 2010
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29229000
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting
- ClinicalTrials.gov ID
- NCT01300806
- Acronym / sponsor ID
- SBIRT / 09035355
- Conditions
- Substance Use
- Keywords
- HIV, harmful substance use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myHERO SBIRT | – | – |
| clinician administered SBIRT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to answer questions with interviewer assistance. Not receiving primary care in clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reduced substance use among HIV-positive people
Time frame: 6 months
1 secondary outcome
technological innovation to improve the quality of medical care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
- Derived from this study: PubMed 29229000Dawson-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Dawson Rose, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduced substance use among HIV-positive people (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01300806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.