NCT03735784

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

November 7, 2018

Last Update Submit

June 17, 2021

Conditions

Substance UseUnprotected Sex

Outcome Measures

Primary Outcomes (2)

  • Substance use

    frequency and quantity of alcohol and drug use

    12 months

  • Unprotected sex

    proportion of condom-unprotected sexual events

    12 months

Study Arms (2)

AWARE condition

EXPERIMENTAL

AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback.

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.

Interventions

AWAREBEHAVIORAL

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.

AWARE condition

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

My Friend's Place

Hollywood, California, 90028, United States

Location

Youth Center on Highland

Los Angeles, California, 90038, United States

Location

Safe Place for Youth

Venice Beach, California, 90291, United States

Location

Related Publications (4)

  • 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.

    PMID: 40728251DERIVED

  • DiGuiseppi 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.

    PMID: 39786835DERIVED

  • Tucker 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.

    PMID: 37355155DERIVED

  • Tucker 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.

    PMID: 32723349DERIVED

MeSH Terms

Conditions

Substance-Related DisordersUnsafe Sex

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Behavioral Scientist

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

November 16, 2018

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations

US(3)