HIVNCT02703116
Employing eSBI in HIV Testing for At-risk Youth
A study testing Alcohol Use BI and Nutrition Intervention in people with HIV and Substance Use, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites in United States.
Trial summary
The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender… Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Use
- What is being tested?
- Alcohol Use BI and Nutrition Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2016to Oct 2020
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged 16 to 25 years
- seeking testing for HIV infection
- HIV-negative or HIV status unknown (per self-report)
- Male who has had sex with men OR transgender woman who has had sex with men (i.e., born male, identify as female/transgender, and at any point in the gender transition process)
- English-speaking.
Who cannot join
- volunteer seems distraught or emotionally unstable (i.e. suicidal, manic, exhibiting violent behavior)
- volunteer seems intoxicated or under the influence of psychoactive agents
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
Howard Brown Health Center
Chicago, Illinois, 60613
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth
The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis) care continuum.
Read the detailed description
The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV and PrEP (pre-exposure prophylaxis) care continuum. We will do this with the following aims:
Aim 1: Assess the feasibility, acceptability and initial efficacy of electronic Screening \& Brief Intervention + Seek, Test, Treat and Retain (eSBI+ STTR) compared to STTR-only to reduce alcohol and other substance use among 450 YMSM and YTW in Chicago, ages 16-25, at 1, 3, 6, and 12 months post-intervention.
Aim 2: To explore the initial efficacy of eSBI+STTR in comparison to STTR-only on secondary exploratory outcomes within the HIV and PrEP care continuum among YMSM and YTW.
Aim 3: Determine the degree to which sub-groups of youth are differentially impacted by eSBI+STTR based on socio-demographic characteristics and co-morbid mental health problems to inform future targeting and/or tailoring of the intervention.
- Conditions
- HIV, Substance Use
- Being tested
- Alcohol Use BI, Nutrition Intervention
- Keywords
- HIV, 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.
Alcohol Use BIBehavioural
Those who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach.
Nutrition InterventionBehavioural
Those randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition).
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Use BI | Experimental | Those who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach. Receives: Behavioral: Alcohol Use BI |
| Nutrition Intervention | Active comparator | Those randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition). Receives: Behavioral: Nutrition Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Alcohol Use
Self-reported frequency of alcohol use in the previous 1 and 12 months assessed via computer-assisted self-interviewing.
Measured: 1, 3, 6 and 12 months post-intervention
Secondary outcomes (1)
PrEP and HIV-related Care Engagement
PrEP and HIV-related medical care engagement (completed clinical visits) will be abstracted from medical records.
Measured: 1, 3, 6 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Garofalo, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Robert Garofalo, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoNiranjan Karnik, MD, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703116
- Sponsor's protocol ID
- R01DA041071
- Other IDs
- R01DA041071
- Status last verified
- Nov 2021
- First submitted
- 2 Mar 2016
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share de-identified study data upon request to study contacts and with approval from the principal investigator(s).
Publications
Karnik NS, Kuhns LM, Hotton AL, Del Vecchio N, McNulty M, Schneider J, Donenberg G, Keglovitz Baker K, Diskin R, Muldoon A, Rivera J, Summersett Williams F, Garofalo R. Findings From the Step Up, Test Up Study of an Electronic Screening and Brief Intervention for Alcohol Misuse in Adolescents and Young Adults Presenting for HIV Testing: Randomized Controlled Efficacy Trial. JMIR Ment Health. 2023 Mar 29;10:e43653. doi: 10.2196/43653.
PubMed 36989027Kuhns LM, Karnik N, Hotton A, Muldoon A, Donenberg G, Keglovitz K, McNulty M, Schneider J, Summersett-Williams F, Garofalo R. A randomized controlled efficacy trial of an electronic screening and brief intervention for alcohol misuse in adolescents and young adults vulnerable to HIV infection: step up, test up study protocol. BMC Public Health. 2020 Jan 8;20(1):30. doi: 10.1186/s12889-020-8154-6.
PubMed 31914971
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth
- ClinicalTrials.gov ID
- NCT02703116
- Acronym / sponsor ID
- R01DA041071
- Conditions
- HIV, Substance Use
- Keywords
- HIV, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 9 Mar 2016 (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 purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis) care continuum.
Detailed description
The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV and PrEP (pre-exposure prophylaxis) care continuum. We will do this with the following aims:
Aim 1: Assess the feasibility, acceptability and initial efficacy of electronic Screening \& Brief Intervention + Seek, Test, Treat and Retain (eSBI+ STTR) compared to STTR-only to reduce alcohol and other substance use among 450 YMSM and YTW in Chicago, ages 16-25, at 1, 3, 6, and 12 months post-intervention.
Aim 2: To explore the initial efficacy of eSBI+STTR in comparison to STTR-only on secondary exploratory outcomes within the HIV and PrEP care continuum among YMSM and YTW.
Aim 3: Determine the degree to which sub-groups of youth are differentially impacted by eSBI+STTR based on socio-demographic characteristics and co-morbid mental health problems to inform future targeting and/or tailoring of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Use BI | Experimental | Behavioral: Alcohol Use BIThose who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach. |
| Nutrition Intervention | Active comparator | Behavioral: Nutrition InterventionThose randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition). |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged 16 to 25 years
- seeking testing for HIV infection
- HIV-negative or HIV status unknown (per self-report)
- Male who has had sex with men OR transgender woman who has had sex with men (i.e., born male, identify as female/transgender, and at any point in the gender transition process)
- English-speaking.
Key exclusion criteria (2 listed)
- volunteer seems distraught or emotionally unstable (i.e. suicidal, manic, exhibiting violent behavior)
- volunteer seems intoxicated or under the influence of psychoactive agents
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 |
|---|---|---|
| Alcohol Use BIThose who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach. | Behavioural | Alcohol Use BI |
| Nutrition InterventionThose randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition). | Behavioural | Nutrition Intervention |
Primary outcome
Change in Frequency of Alcohol Use
Time frame: 1, 3, 6 and 12 months post-intervention
Self-reported frequency of alcohol use in the previous 1 and 12 months assessed via computer-assisted self-interviewing.
1 secondary outcome
PrEP and HIV-related Care Engagement
Time frame: 1, 3, 6 and 12 months post-intervention
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 15 Nov 2021.
- Derived from this study: PubMed 36989027Karnik NS, Kuhns LM, Hotton AL, Del Vecchio N, McNulty M, Schneider J, Donenberg G, Keglovitz Baker K, Diskin R, Muldoon A, Rivera J, Summersett Williams F, Garofalo R. Findings From the Step Up, Test Up Study of an Electronic Screening and Brief Intervention for Alcohol Misuse in Adolescents and Young Adults Presenting for HIV Testing: Randomized Controlled Efficacy Trial. JMIR Ment Health. 2023 Mar 29;10:e43653. doi: 10.2196/43653.
- Derived from this study: PubMed 31914971Kuhns LM, Karnik N, Hotton A, Muldoon A, Donenberg G, Keglovitz K, McNulty M, Schneider J, Summersett-Williams F, Garofalo R. A randomized controlled efficacy trial of an electronic screening and brief intervention for alcohol misuse in adolescents and young adults vulnerable to HIV infection: step up, test up study protocol. BMC Public Health. 2020 Jan 8;20(1):30. doi: 10.1186/s12889-020-8154-6.
- Individual participant dataSharing planned: Yes. Share de-identified study data upon request to study contacts and with approval from the principal investigator(s).
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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.
Robert Garofalo, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Niranjan Karnik, MD, PhD principal investigator
Rush University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Use BI and Nutrition Intervention in people with HIV and Substance Use, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites 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 5 inclusion and 2 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Frequency of Alcohol Use (time frame: 1, 3, 6 and 12 months post-intervention). 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 NCT02703116, which also lists 2 linked publications.
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 15 Nov 2021.