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

NCT ID: NCT02647710

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-15

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

PHAT Life Intervention

Intervention Type BEHAVIORAL

HIV Prevention behavioral health intervention

Health Promotion Control

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

Group Type ACTIVE_COMPARATOR

Health Promotion Control

Intervention Type BEHAVIORAL

Behavioral health intervention control

Interventions

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PHAT Life Intervention

HIV Prevention behavioral health intervention

Intervention Type BEHAVIORAL

Health Promotion Control

Behavioral health intervention control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Geri Donenberg

Associate Dean of Research, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geri Donenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26097376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21875199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24273468 (View on PubMed)

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.

Reference Type RESULT
PMID: 29389155 (View on PubMed)

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.

Reference Type RESULT
PMID: 29173739 (View on PubMed)

Other Identifiers

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5R01MD005861-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MD005861

Identifier Type: NIH

Identifier Source: org_study_id

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