Substance UseNCT03735784
Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth
A study testing AWARE in people with Substance Use and Unprotected Sex, run by RAND at 3 sites in United States.
Trial summary
This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Unprotected Sex
- What is being tested?
- AWARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Nov 2018to 23 Mar 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
My Friend's Place
Hollywood, California, 90028
Youth Center on Highland
Los Angeles, California, 90038
Safe Place for Youth
Venice Beach, California, 90291
About this study
Official title: Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth
This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.
- Conditions
- Substance Use, Unprotected Sex
- Being tested
- AWARE
- Medical subject headings
- Substance-Related Disorders, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWAREBehavioural
AWARE consists of four group sessions. The AWARE curriculum involves sharing basic information on sexually transmitted diseases; providing condom use skills training; providing normative feedback on substance use and sexual risk behavior among young adults; discussing unrealistic beliefs about substance use and sexual risk; discussing potential benefits of both cutting down and stopping risky behaviors; and discussing risky situations and coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| AWARE condition | Experimental | AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback. Receives: Behavioral: AWARE |
| Standard Care condition | No intervention | Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
frequency and quantity of alcohol and drug use
Measured: 12 months
Unprotected sex
proportion of condom-unprotected sexual events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start16 Nov 2018
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Tucker, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735784
- Sponsor's protocol ID
- R01AA025641
- Status last verified
- Jun 2021
- First submitted
- 7 Nov 2018
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
DiGuiseppi G, Jose R, D'Amico EJ, Klein DJ, Rodriguez A, Pedersen ER, Tucker JS. Investigating Change in Psychosocial Outcomes for Young Adults Experiencing Homelessness in Los Angeles With and Without Pregnancy Experiences. Perspect Sex Reprod Health. 2025 Sep;57(3):329-339. doi: 10.1111/psrh.70028. Epub 2025 Jul 29.
PubMed 40728251DiGuiseppi G, Pedersen ER, Brown ME, Rodriguez A, Jose R, Klein DJ, D'Amico EJ, Tucker JS. Protective behavioral strategies and alcohol consequences following a group-based motivational intervention for young adults experiencing homelessness. Psychol Addict Behav. 2025 Sep;39(6):516-527. doi: 10.1037/adb0001047. Epub 2025 Jan 9.
PubMed 39786835Tucker JS, D'Amico EJ, Rodriguez A, Garvey R, Pedersen ER, Klein DJ. A randomized controlled trial of a brief motivational interviewing-based group intervention for emerging adults experiencing homelessness: 12-Month effects on substance use and sexual risk behavior. J Subst Use Addict Treat. 2023 Sep;152:209114. doi: 10.1016/j.josat.2023.209114. Epub 2023 Jun 22.
PubMed 37355155Tucker JS, D'Amico EJ, Pedersen ER, Rodriguez A, Garvey R. Study protocol for a group-based motivational interviewing brief intervention to reduce substance use and sexual risk behavior among young adults experiencing homelessness. Addict Sci Clin Pract. 2020 Jul 28;15(1):26. doi: 10.1186/s13722-020-00201-x.
PubMed 32723349
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth
- ClinicalTrials.gov ID
- NCT03735784
- Acronym / sponsor ID
- R01AA025641
- Conditions
- Substance Use, Unprotected Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 8 Nov 2018 (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 study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AWARE condition | Experimental | Behavioral: AWAREAWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback. |
| Standard Care condition | No intervention | –Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| AWAREAWARE consists of four group sessions. The AWARE curriculum involves sharing basic information on sexually transmitted diseases; providing condom use skills training; providing normative feedback on substance use and sexual risk behavior among young adults; discussing unrealistic beliefs about substance use and sexual risk; discussing potential benefits of both cutting down and stopping risky behaviors; and discussing risky situations and coping strategies. | Behavioural | AWARE condition |
Primary outcome
Substance use
Time frame: 12 months
frequency and quantity of alcohol and drug use
Unprotected sex
Time frame: 12 months
proportion of condom-unprotected sexual events
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 21 Jun 2021.
- Derived from this study: PubMed 40728251DiGuiseppi G, Jose R, D'Amico EJ, Klein DJ, Rodriguez A, Pedersen ER, Tucker JS. Investigating Change in Psychosocial Outcomes for Young Adults Experiencing Homelessness in Los Angeles With and Without Pregnancy Experiences. Perspect Sex Reprod Health. 2025 Sep;57(3):329-339. doi: 10.1111/psrh.70028. Epub 2025 Jul 29.
- Derived from this study: PubMed 39786835DiGuiseppi G, Pedersen ER, Brown ME, Rodriguez A, Jose R, Klein DJ, D'Amico EJ, Tucker JS. Protective behavioral strategies and alcohol consequences following a group-based motivational intervention for young adults experiencing homelessness. Psychol Addict Behav. 2025 Sep;39(6):516-527. doi: 10.1037/adb0001047. Epub 2025 Jan 9.
- Derived from this study: PubMed 37355155Tucker JS, D'Amico EJ, Rodriguez A, Garvey R, Pedersen ER, Klein DJ. A randomized controlled trial of a brief motivational interviewing-based group intervention for emerging adults experiencing homelessness: 12-Month effects on substance use and sexual risk behavior. J Subst Use Addict Treat. 2023 Sep;152:209114. doi: 10.1016/j.josat.2023.209114. Epub 2023 Jun 22.
- Derived from this study: PubMed 32723349Tucker JS, D'Amico EJ, Pedersen ER, Rodriguez A, Garvey R. Study protocol for a group-based motivational interviewing brief intervention to reduce substance use and sexual risk behavior among young adults experiencing homelessness. Addict Sci Clin Pract. 2020 Jul 28;15(1):26. doi: 10.1186/s13722-020-00201-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARE in people with Substance Use and Unprotected Sex, run by RAND 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 1 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 21 Jun 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?
Substance use (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT03735784, which also lists 4 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 21 Jun 2021.