NCT03555279

Brief Summary

This application proposes a 2-arm randomized controlled trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS). 100 facilitators will be recruited to deliver the intervention and participate in the research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 13, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

4.1 years

First QC Date

May 18, 2018

Last Update Submit

April 19, 2023

Conditions

Keywords

HIV PreventionJuvenile JusticeSexual HealthEvidence Based Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in HIV/STI Risk Behaviors at 6 months

    AIDS Risk Behavior Assessment (ARBA) A computer-assisted structured interview of self-reported sexual behavior and drug use derived from five well-established measures. The outcomes include ever had sex, condom use, number of partners, sex while using drugs and/or alcohol.

    Baseline and 6-months

Secondary Outcomes (13)

  • Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6

    Baseline and 6-months

  • Change in mental health symptoms at 6 months

    Baseline and 6-months

  • Change in Partner Sexual Communication at 6 months

    Baseline and 6-months

  • Change in Relationship dynamics at 6 months

    Baseline and 6-months

  • Change in trauma symptoms and violence exposure at 6 months

    Baseline and 6-months

  • +8 more secondary outcomes

Study Arms (2)

Probation Staff (PS) Facilitator

EXPERIMENTAL

The PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm intervention is delivered by Probation Staff working at the intervention site. Dosage is 8 2-hour sessions delivered over two weeks.

Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm

Youth Representative (YR) Facilitator

EXPERIMENTAL

The PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm intervention is delivered by young adults who were formally in the juvenile justice system. Dosage is 8 2-hour sessions delivered over two weeks.

Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm

Interventions

HIV Prevention Behavioral Health Intervention delivered by Probation Staff

Probation Staff (PS) Facilitator

HIV Prevention Behavioral Health Intervention delivered by Youth Representatives

Youth Representative (YR) Facilitator

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • a) male or female gender; b) remanded to a probation program; c) 13-17 years old; d) adolescent is fluent in English; e) are not wards of the Department of Child and Family Services (DCFS); and f) they have not already received the PHAT Life intervention.

You may not qualify if:

  • a) are unable to understand the consent/assent process; b) do not speak English, because instruments are normed for English speakers; c) do not assent; d) legal guardians do not consent to teens' participation; e) are not 13 -17 years old; f) are not on probation or remanded to a probation program; g) are wards of the Department of Child and Family Services (DCFS); and h) they have already received the PHAT Life intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • Donenberg GR, Emerson E, Mackesy-Amiti ME, Udell W. HIV-Risk Reduction with Juvenile Offenders on Probation. J Child Fam Stud. 2015 Jun 1;24(6):1672-1684. doi: 10.1007/s10826-014-9970-z.

    PMID: 26097376BACKGROUND
  • Udell W, Donenberg G, Emerson E. Parents matter in HIV-risk among probation youth. J Fam Psychol. 2011 Oct;25(5):785-9. doi: 10.1037/a0024987.

    PMID: 21875199BACKGROUND
  • Wilson HW, Berent E, Donenberg GR, Emerson EM, Rodriguez EM, Sandesara A. Trauma History and PTSD Symptoms in Juvenile Offenders on Probation. Vict Offender. 2013;8(4):10.1080/15564886.2013.835296. doi: 10.1080/15564886.2013.835296.

    PMID: 24273468BACKGROUND
  • Donenberg G, Emerson E, Kendall AD. HIV-risk reduction intervention for juvenile offenders on probation: The PHAT Life group randomized controlled trial. Health Psychol. 2018 Apr;37(4):364-374. doi: 10.1037/hea0000582. Epub 2018 Feb 1.

    PMID: 29389155BACKGROUND
  • Kendall AD, Emerson EM, Hartmann WE, Zinbarg RE, Donenberg GR. A Two-Week Psychosocial Intervention Reduces Future Aggression and Incarceration in Clinically Aggressive Juvenile Offenders. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1053-1061. doi: 10.1016/j.jaac.2017.09.424. Epub 2017 Oct 5.

    PMID: 29173739BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Geri DONENBERG, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Departments of Medicine and Psychology

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 13, 2018

Study Start

March 13, 2017

Primary Completion

April 5, 2021

Study Completion

May 26, 2021

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations