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PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice (PHAT Life)

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PHAT Life Intervention
Health Promotion Control
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV Prevention, Juvenile Justice, Sexual Health, Evidence Based Intervention

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • male or female gender
  • placed on probation following arrest
  • remanded to a probation program
  • 13-17 years old
  • both adolescent and parent are fluent English speakers
  • not a ward of the state (DCFS Ward).

Exclusion Criteria:

  • are unable to understand the consent/assent process
  • do not speak English, because instruments are normed for English speakers
  • do not assent; d) legal guardians do not consent to teens' participation
  • are not 13 -17 years old
  • are not on probation or remanded to a probation program
  • are Wards of the state (DCFS Ward)

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PHAT Life Intervention

Health Promotion Control

Arm Description

PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. PHAT Life draws on social learning theory and a Social-Personal Framework to address individual and social mechanisms related to HIV-risk, including emotion regulation, peer norms, partner communication, relationship characteristics, and HIV/AIDS/STI and substance use knowledge, attitudes, and beliefs.

A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.

Outcomes

Primary Outcome Measures

Change in HIV/STI Risk Behaviors at 6 and 12 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.

Secondary Outcome Measures

Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
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 about condom use; as well as self-efficacy to prevent transmission, apply condoms, and negotiate with a partner.
Change in mental health symptoms at 6 and 12 months
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).
Change in Partner Sexual Communication at 6 and 12 months
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 from the Sexual Risk Behavior Questionnaire.
Change in Relationship dynamics at 6 and 12 months
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.
Change in trauma symptoms and violence exposure at 6 and 12 months
The UCLA PTSD Index will measure exposure to trauma and violence.
Change in peer influences at 6 and 12 months
The Peer Convention Behavior Questionnaire will measure peer support of risky behavior, peer norms, and peer pressure and teens' association with prosocial peers.
Change in parental Influences at 6 and 12 months
The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
Change in parental communication at 6 and 12 months
The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.
Biological Measure of N. Gonorrhoeae Acquisition
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 determine rate of STI acquisition.
Biological Measure of C. Trachomatis Acquisition
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 determine rate of STI acquisition.
Biological Measure of T. Vaginalis Acquisition
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 determine rate of STI acquisition.

Full Information

First Posted
December 29, 2015
Last Updated
April 30, 2018
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02647710
Brief Title
PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Acronym
PHAT Life
Official Title
PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2010 (Actual)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The investigators will test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators.
Detailed Description
High rates of mental illness, HIV/AIDS/STI, and incarceration among African Americans (AA) reflect significant health disparities, particularly among youth. Teens in juvenile justice are disproportionately AA, and compared to the general population, juvenile offenders (JO) report more risky sexual behavior, drug and alcohol use, and psychiatric disorders, and are more likely to test positive for STIs. Still, few empirically-supported, theoretically-driven programs exist to address their negative health outcomes. This proposal addresses these health disparities by testing an innovative and uniquely tailored HIV/AIDS/STI, mental health, and substance use program designed for and pilot tested with recently arrested 13 - 17 year-old urban males and females (85% African American, 14% Latino/a) released on probation. PHAT Life was derived from a carefully staged process that included an active, diverse, multi-disciplinary advisory board, a youth advisory board, focus groups, two pilot tests, extensive feedback, and a series of curriculum revisions over three years. The R34 established feasibility and acceptability, revealed positive youth and stakeholder feedback, and yielded good preliminary outcomes at 3-month follow-up (e.g., increased condom use) to justify an efficacy trial. This application proposes a 2-arm randomized controlled trial to test PHAT Life versus a health promotion program with recently arrested 13-17 year-old male and female, mostly ethnic minority JO (as representative of Cook County) on probation in Chicago. The investigators will use the procedures and methods established in the developmental study to recruit, enroll, assess, track, and intervene with teens. Investigators will randomly assign youth to PHAT Life (N=150) or a health promotion control group (N=150). The interventions will be delivered in single sex groups of 5 - 7 teens at Evening Reporting Centers. Assessments will occur at baseline, 6-, and 12-months post-treatment, and participants will be screened for three common STIs (Chlamydia, Gonorrhea, Trichamonas) at baseline and 12-month follow-up. All youth who test positive for an STI will receive single dose antibiotic treatment free of charge. An intent-to-treat analysis will be used to test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators. This study answers a compelling need for innovative prevention programs that address the intersecting health disparities of mental illness and HIV/AIDS/STIs among youth in juvenile justice. Without intervention, these teens continue to engage in risk behaviors post-release, amplifying their own and their partner's risk for HIV/AIDS/STIs. The lasting effects on community well-being, individual employment prospects, and neighborhood health are profound, but effective programs can alter the negative developmental trajectories of this very high-risk population and begin to redress existing health disparities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV Prevention, Juvenile Justice, Sexual Health, Evidence Based Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PHAT Life Intervention
Arm Type
Experimental
Arm Description
PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. PHAT Life draws on social learning theory and a Social-Personal Framework to address individual and social mechanisms related to HIV-risk, including emotion regulation, peer norms, partner communication, relationship characteristics, and HIV/AIDS/STI and substance use knowledge, attitudes, and beliefs.
Arm Title
Health Promotion Control
Arm Type
Active Comparator
Arm Description
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
Intervention Type
Behavioral
Intervention Name(s)
PHAT Life Intervention
Intervention Description
HIV Prevention behavioral health intervention
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion Control
Intervention Description
Behavioral health intervention control
Primary Outcome Measure Information:
Title
Change in HIV/STI Risk Behaviors at 6 and 12 months
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 drugs and/or alcohol.
Time Frame
baseline, 6-months, and 12--months
Secondary Outcome Measure Information:
Title
Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
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 about condom use; as well as self-efficacy to prevent transmission, apply condoms, and negotiate with a partner.
Time Frame
Baseline, 6-months, and 12-months
Title
Change in mental health symptoms at 6 and 12 months
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).
Time Frame
Baseline, 6-months, and 12-months
Title
Change in Partner Sexual Communication at 6 and 12 months
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 from the Sexual Risk Behavior Questionnaire.
Time Frame
Baseline, 6-months, and 12-months
Title
Change in Relationship dynamics at 6 and 12 months
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.
Time Frame
Baseline, 6-months, and 12-months
Title
Change in trauma symptoms and violence exposure at 6 and 12 months
Description
The UCLA PTSD Index will measure exposure to trauma and violence.
Time Frame
Baseline, 6-months, and 12-months
Title
Change in peer influences at 6 and 12 months
Description
The Peer Convention Behavior Questionnaire will measure peer support of risky behavior, peer norms, and peer pressure and teens' association with prosocial peers.
Time Frame
Baseline, 6-months, and 12-months
Title
Change in parental Influences at 6 and 12 months
Description
The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
Time Frame
Baseline, 6-months, and 12-months
Title
Change in parental communication at 6 and 12 months
Description
The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.
Time Frame
Baseline, 6-months, and 12-months
Title
Biological Measure of N. Gonorrhoeae Acquisition
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 determine rate of STI acquisition.
Time Frame
12-months
Title
Biological Measure of C. Trachomatis Acquisition
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 determine rate of STI acquisition.
Time Frame
12-months
Title
Biological Measure of T. Vaginalis Acquisition
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 determine rate of STI acquisition.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: male or female gender placed on probation following arrest remanded to a probation program 13-17 years old both adolescent and parent are fluent English speakers not a ward of the state (DCFS Ward). Exclusion Criteria: are unable to understand the consent/assent process do not speak English, because instruments are normed for English speakers do not assent; d) legal guardians do not consent to teens' participation are not 13 -17 years old are not on probation or remanded to a probation program are Wards of the state (DCFS Ward)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geri Donenberg, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26097376
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. doi: 10.1007/s10826-014-9970-z.
Results Reference
background
PubMed Identifier
21875199
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.
Results Reference
background
PubMed Identifier
24273468
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):10.1080/15564886.2013.835296. doi: 10.1080/15564886.2013.835296.
Results Reference
background
PubMed Identifier
29389155
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.
Results Reference
result
PubMed Identifier
29173739
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.
Results Reference
result

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PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice

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