Clinical trial NCT02647710: PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Official title: PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV Prevention
Juvenile Justice
Sexual Health
Evidence Based Intervention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-01-06
Enrollment: 349
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change in HIV/STI Risk Behaviors at 6 and 12 months
timeFrame: baseline, 6-months, and 12--months
Secondary outcomes:
measure: Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in mental health symptoms at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Partner Sexual Communication at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in Relationship dynamics at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in trauma symptoms and violence exposure at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in peer influences at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in parental Influences at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Change in parental communication at 6 and 12 months
timeFrame: Baseline, 6-months, and 12-months
measure: Biological Measure of N. Gonorrhoeae Acquisition
timeFrame: 12-months
measure: Biological Measure of C. Trachomatis Acquisition
timeFrame: 12-months
measure: Biological Measure of T. Vaginalis Acquisition
timeFrame: 12-months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Geri Donenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.