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

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ClinicalTrials.gov Identifier: NCT02647710
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Geri Donenberg, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: PHAT Life Intervention Behavioral: Health Promotion Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Actual Study Start Date : June 15, 2010
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PHAT Life Intervention
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.
Behavioral: PHAT Life Intervention
HIV Prevention behavioral health intervention

Active Comparator: Health Promotion Control
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
Behavioral: Health Promotion Control
Behavioral health intervention control




Primary Outcome Measures :
  1. Change in HIV/STI Risk Behaviors at 6 and 12 months [ Time Frame: baseline, 6-months, 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 :
  1. Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months [ Time Frame: Baseline, 6-months, 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.

  2. Change in mental health symptoms at 6 and 12 months [ Time Frame: Baseline, 6-months, 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).

  3. Change in Partner Sexual Communication at 6 and 12 months [ Time Frame: Baseline, 6-months, 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.

  4. Change in Relationship dynamics at 6 and 12 months [ Time Frame: Baseline, 6-months, 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.

  5. Change in trauma symptoms and violence exposure at 6 and 12 months [ Time Frame: Baseline, 6-months, and 12-months ]
    The UCLA PTSD Index will measure exposure to trauma and violence.

  6. Change in peer influences at 6 and 12 months [ Time Frame: Baseline, 6-months, 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.

  7. Change in parental Influences at 6 and 12 months [ Time Frame: Baseline, 6-months, and 12-months ]
    The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.

  8. Change in parental communication at 6 and 12 months [ Time Frame: Baseline, 6-months, and 12-months ]
    The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.

  9. Biological Measure of N. Gonorrhoeae Acquisition [ Time Frame: 12-months ]
    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.

  10. Biological Measure of C. Trachomatis Acquisition [ Time Frame: 12-months ]
    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.

  11. Biological Measure of T. Vaginalis Acquisition [ Time Frame: 12-months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647710


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Geri Donenberg, PhD University of Illinois at Chicago

Publications of Results:
Other Publications:
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Responsible Party: Geri Donenberg, Associate Dean of Research, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02647710     History of Changes
Other Study ID Numbers: R01MD005861 ( U.S. NIH Grant/Contract )
5R01MD005861-05 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Keywords provided by Geri Donenberg, University of Illinois at Chicago:
HIV Prevention
Juvenile Justice
Sexual Health
Evidence Based Intervention