Chicago, Illinois 60612

  • HIV/AIDS

Purpose:

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.


Study summary:

The main objectives of the proposed study are to compare the effectiveness, cost-effectiveness, and sustainability of Youth Representative-led vs. probation staff-led PHAT Life in a real-world juvenile probation setting. The Specific Aims of this study are: 1. To conduct a methodologically-rigorous 2-arm 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). 2. To compare the costs and cost-effectiveness of 100 YR-led vs. PS-led PHAT Life with respect to the acquisition of incident STI. We hypothesize: (a) Compared to teens in PS-led groups, we expect teens in YR-led groups to report less risky sex and substance use at 6-month follow-up, to demonstrate greater improvement on theoretical mediators of risk, and to have fewer incident STI infections; (b) We expect YR-led PHAT Life to cost less and be more cost-effective than PS-led PHAT Life.


Criteria:

Inclusion Criteria: 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. Exclusion Criteria: 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.


Study is Available At:


Original ID:

2015-0936


NCT ID:

NCT03555279


Secondary ID:

1R01MD010433


Study Acronym:

PHAT Life


Brief Title:

PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders


Official Title:

PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

13 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Illinois at Chicago


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

400


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Geri Donenberg, PhD
Principal Investigator
University of Illinois at Chicago
Primary Contact:Erin McCarville, MPH
312-996-1014
emccar2@uic.edu
Backup Contact:Erin Emerson, MA
312-355-3994
eemerson@uic.edu

Study Dates

Start Date:March 13, 2017
Completion Date:August 2021
Completion Type:Anticipated
Primary Completion Date:January 2021
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 24, 2019
First Received Date:May 18, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Cost Effectiveness
Time Frame:Through study completion, an average of 2 years
Safety Issues:False
Description:The costs associated with intervention delivery for each arm will be collected to explore differences across arms.
Outcome Type:Secondary Outcome
Measure:Facilitator Characteristics
Time Frame:Baseline
Safety Issues:False
Description:Probation teens will rate the facilitator team on similarity, credibility, competence, warmth, physical attractiveness, and sense of humor using the 9-item Perception of Peer Educator Rating Scale
Outcome Type:Secondary Outcome
Measure:Biological Measure of T. Vaginalis Acquisition
Time Frame:Baseline and 6 months
Safety Issues:False
Description:Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for T. Vaginalis and treated if necessary at baseline. They will be tested again 12 months later to determi
Outcome Type:Secondary Outcome
Measure:Biological Measure of C. Trachomatis Acquisition
Time Frame:Baseline and 6 months
Safety Issues:False
Description:Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for C. Trachomatis and treated if necessary at baseline. They will be tested again 12 months later to deter
Outcome Type:Secondary Outcome
Measure:Biological Measure of N. Gonorrhoeae Acquisition
Time Frame:Baseline and 6 months
Safety Issues:False
Description:Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for N. gonorrhoeae and treated if necessary at baseline. They will be tested again 12 months later to deter
Outcome Type:Secondary Outcome
Measure:Change in parental communication at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.
Outcome Type:Secondary Outcome
Measure:Change in parental Influences at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
Outcome Type:Secondary Outcome
Measure:Change in peer influences at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:The Peer Convention Behavior Questionnaire will measure peer support of risky behavior, peer norms, and peer pressure and teens' association with prosocial peers.
Outcome Type:Secondary Outcome
Measure:Change in trauma symptoms and violence exposure at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:The UCLA PTSD Index will measure exposure to trauma and violence.
Outcome Type:Secondary Outcome
Measure:Change in Relationship dynamics at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:The Sexual Relationship Power Scale (SRPS) measures perceptions of relationship control and decision-making dominance. It has good internal consistency and predictive and constructed validity.
Outcome Type:Secondary Outcome
Measure:Change in Partner Sexual Communication at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:Questionnaire in which participants indicate whether they ever talked to their romantic or dating partners and sexual partners about a list of sexual topics, how often they discussed them, and whether they talk was open and comfortable. Items were adapted
Outcome Type:Secondary Outcome
Measure:Change in mental health symptoms at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description:The Youth Self Report (YSR) is a widely-used and validated measure of child behavior problems that generates raw and T-scores for internalizing and externalizing syndromes as well as narrow-band problems (e.g., delinquency, anxiety, depression).
Outcome Type:Secondary Outcome
Measure:Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6
Time Frame:Baseline and 6-months
Safety Issues:False
Description:Survey measuring knowledge regarding transmission routes, misconceptions about transmission, and risk-reduction strategies; attitudes and beliefs including peer norms, intentions to prevent HIV/AIDS/STI, attitudes towards preventive actions, and beliefs a
Outcome Type:Primary Outcome
Measure:Change in HIV/STI Risk Behaviors at 6 months
Time Frame:Baseline and 6-months
Safety Issues:False
Description: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 dru

Study Interventions

Intervention Type:Behavioral
Name:PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm
Description:HIV Prevention Behavioral Health Intervention delivered by Probation Staff
Arm Name:Probation Staff (PS) Facilitator
Intervention Type:Behavioral
Name:PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm
Description:HIV Prevention Behavioral Health Intervention delivered by Youth Representatives
Arm Name:Youth Representative (YR) Facilitator

Study Arms

Study Arm Type:Experimental
Arm Name:Youth Representative (YR) Facilitator
Description: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.
Study Arm Type:Experimental
Arm Name:Probation Staff (PS) Facilitator
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Illinois at Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Minority Health and Health Disparities (NIMHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:26097376
Reference Type:Reference
Citation: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:21875199
Reference Type:Reference
Citation: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). doi: 10.1080/15564886.2013.835296.
PMID:24273468
Reference Type:Reference
Citation: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:29389155
Reference Type:Reference
Citation: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:29173739

Data Source: ClinicalTrials.gov

Date Processed: July 28, 2021

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