Drug UseNCT03079856
Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER
A study testing Brief Intervention in people with Drug Use and Sex Behavior, run by University of Michigan at 1 site in United States.
Trial summary
This project will develop a technology-augmented HIV and substance use risk reduction intervention for delivery in the Emergency Department, a medical setting where at-risk emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Drug Use, Sex Behavior
- What is being tested?
- Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 13 Aug 2018
- Phase
- Interventional
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically stable
- Mentally and physically able to consent
- English-speaking
- Between ages 18-25
- Past-month substance use (including illicit drugs and/or non-medical prescription drug use) and inconsistent condom use in the past month
- Ownership of a smartphone
Who cannot join
- ED presentation suicidality and/or acute psychosis, being in police custody, or present with psychological distress requiring intensive social work (e.g. sexual assault)
- Patients with a significant other that they live with who is currently participating in study
- Actively participating in another study
- Participated in prospective and intervention development phases of the study
- Married
- Do not wish to consent to audio-taping the in-person portion of the ED-based intervention session
Trial locations and contacts
1 site in 1 country.
About this study
This project will develop a technology-augmented HIV and substance use risk reduction intervention for delivery in the Emergency Department, a medical setting where at-risk emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.
Read the detailed description
Research regarding substance use (including illicit drugs and non-medical use of prescription drugs) and HIV-related sexual risk behaviors (HIV SRBs; e.g., inconsistent condom use, multiple partners, sex while intoxicated; and prevention of injection drug use) among emerging adults (EAs; ages 18-25) has generally focused on alcohol use among college students from campus settings; however, substance use and HIV (and other associated Sexually Transmitted Infections) disproportionately occur among young people living in urban, low-resource communities, particularly individuals of racial minorities. The Emergency Department (ED) is a critical venue for accessing at-risk EAs engaging in substance use and HIV risk behaviors. Research shows high rates of substance use and HIV SRBs among EA patients in the ED, yet no intervention exists for EAs in this setting. The ED may be the only opportunity to intervene with these young people because EAs in urban, low-resource settings often lack a primary care provider during the transition from pediatric to adult medicine, may be un-insured or under-insured, and may not be involved in a traditional college campus setting. Further the use of technology (e.g., mobile phones) is relatively ubiquitous among this age group, and most prefer technology-based communication (e.g., text messaging or instant messaging via apps), therefore interventions for EAs may be enhanced by this type of technology. In this phase we will test a tailored intervention for EA patients in the ED focusing on reducing substance use and HIV SRBs, which will be enhanced through the use of mobile app notifications.
- Conditions
- Drug Use, Sex Behavior
- Being tested
- Brief Intervention
- Keywords
- Emerging adults, Drugs, HIV, Risky Sex Behaviors
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
Intervention for emerging adults (EAs) seeking care in the ED. The intervention will be rooted in motivational interviewing (MI) and will be guided by social cognitive, self-determination, and the trans-theoretical theories. The ED visit presents a "teachable moment" for intervening to promote health behavior, therefore eligible EAs will receive a ~30 minute MI-based session in the ED. In order to capitalize on and potentially extend this moment, participants will receive daily booster notifications delivered through a secure mobile app that they will download to their phone at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | ED-based computer-guided intervention for substance use and HIV risk reduction utilizing Motivational Interviewing Receives: Behavioral: Brief Intervention |
| Enhanced Usual Care | No intervention | Substance use and sexual health services information within a brochure provided to participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in days substance use
60-day Timeline Follow-Back (TLFB) will be used to assess total days of any substance use.
Measured: 2-months post baseline
Change in quantity of marijuana use
60-day Timeline Follow-Back (TLFB) will be used to assess quantity of marijuana consumed.
Measured: 2-months post baseline
Change in total alcohol consumption
60-day Timeline Follow-Back (TLFB) will be used to assess quantity of alcohol consumed
Measured: 2-months post baseline
Secondary outcomes (2)
Change in HIV risk behaviors
60-day Timeline Follow-Back (TLFB) will be used to assess frequency of unprotected sex.
Measured: 2-months post baseline
Change in substance use consequences
Modified Rutgers Alcohol Problems Index adapted for alcohol and drugs will assess total substance related consequences experienced.
Measured: 2-months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start9 Oct 2017
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Erin Bonar, University of Michigan
- Investigators
- Erin E Bonar, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079856
- Sponsor's protocol ID
- NIDA036008
- Other IDs
- 4K23DA036008-04
- Status last verified
- Aug 2018
- First submitted
- 27 Feb 2017
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER
- ClinicalTrials.gov ID
- NCT03079856
- Acronym / sponsor ID
- NIDA036008
- Conditions
- Drug Use, Sex Behavior
- Keywords
- Emerging adults, Drugs, HIV, Risky Sex Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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.
This project will develop a technology-augmented HIV and substance use risk reduction intervention for delivery in the Emergency Department, a medical setting where at-risk emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.
Detailed description
Research regarding substance use (including illicit drugs and non-medical use of prescription drugs) and HIV-related sexual risk behaviors (HIV SRBs; e.g., inconsistent condom use, multiple partners, sex while intoxicated; and prevention of injection drug use) among emerging adults (EAs; ages 18-25) has generally focused on alcohol use among college students from campus settings; however, substance use and HIV (and other associated Sexually Transmitted Infections) disproportionately occur among young people living in urban, low-resource communities, particularly individuals of racial minorities. The Emergency Department (ED) is a critical venue for accessing at-risk EAs engaging in substance use and HIV risk behaviors. Research shows high rates of substance use and HIV SRBs among EA patients in the ED, yet no intervention exists for EAs in this setting. The ED may be the only opportunity to intervene with these young people because EAs in urban, low-resource settings often lack a primary care provider during the transition from pediatric to adult medicine, may be un-insured or under-insured, and may not be involved in a traditional college campus setting. Further the use of technology (e.g., mobile phones) is relatively ubiquitous among this age group, and most prefer technology-based communication (e.g., text messaging or instant messaging via apps), therefore interventions for EAs may be enhanced by this type of technology. In this phase we will test a tailored intervention for EA patients in the ED focusing on reducing substance use and HIV SRBs, which will be enhanced through the use of mobile app notifications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Brief InterventionED-based computer-guided intervention for substance use and HIV risk reduction utilizing Motivational Interviewing |
| Enhanced Usual Care | No intervention | –Substance use and sexual health services information within a brochure provided to participants |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Medically stable
- Mentally and physically able to consent
- English-speaking
- Between ages 18-25
- Past-month substance use (including illicit drugs and/or non-medical prescription drug use) and inconsistent condom use in the past month
Key exclusion criteria (6 listed)
- ED presentation suicidality and/or acute psychosis, being in police custody, or present with psychological distress requiring intensive social work (e.g. sexual assault)
- Patients with a significant other that they live with who is currently participating in study
- Actively participating in another study
- Participated in prospective and intervention development phases of the study
- Married
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionIntervention for emerging adults (EAs) seeking care in the ED. The intervention will be rooted in motivational interviewing (MI) and will be guided by social cognitive, self-determination, and the trans-theoretical theories. The ED visit presents a "teachable moment" for intervening to promote health behavior, therefore eligible EAs will receive a ~30 minute MI-based session in the ED. In order to capitalize on and potentially extend this moment, participants will receive daily booster notifications delivered through a secure mobile app that they will download to their phone at enrollment. | Behavioural | Brief Intervention |
Primary outcome
Change in days substance use
Time frame: 2-months post baseline
60-day Timeline Follow-Back (TLFB) will be used to assess total days of any substance use.
Change in quantity of marijuana use
Time frame: 2-months post baseline
60-day Timeline Follow-Back (TLFB) will be used to assess quantity of marijuana consumed.
Change in total alcohol consumption
Time frame: 2-months post baseline
60-day Timeline Follow-Back (TLFB) will be used to assess quantity of alcohol consumed
2 secondary outcomes
Change in HIV risk behaviors
Time frame: 2-months post baseline
Change in substance use consequences
Time frame: 2-months post baseline
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 29 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Erin E Bonar, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention in people with Drug Use and Sex Behavior, run by University of Michigan at 1 site in United States.
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 6 inclusion and 6 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in days substance use (time frame: 2-months post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2018.