Overview

This trial is active, not recruiting.

Condition hiv
Treatments phat life intervention, health promotion control
Sponsor University of Illinois at Chicago
Collaborator National Institute on Minority Health and Health Disparities (NIMHD)
Start date June 2010
End date July 2015
Trial size 349 participants
Trial identifier NCT02647710, 5R01MD005861-05, R01MD005861

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
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.
phat life intervention
HIV Prevention behavioral health intervention
(Active Comparator)
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
health promotion control
Behavioral health intervention control

Primary Outcomes

Measure
Change in HIV/STI Risk Behaviors at 6 and 12 months
time frame: 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
time frame: Baseline, 6-months, and 12-months
Change in mental health symptoms at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Change in Partner Sexual Communication at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Change in Relationship dynamics at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Change in trauma symptoms and violence exposure at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Change in peer influences at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Change in parental Influences at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Change in parental communication at 6 and 12 months
time frame: Baseline, 6-months, and 12-months
Biological Measure of N. Gonorrhoeae Acquisition
time frame: 12-months
Biological Measure of C. Trachomatis Acquisition
time frame: 12-months
Biological Measure of T. Vaginalis Acquisition
time frame: 12-months

Eligibility Criteria

Male or female participants from 13 years up to 17 years old.

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)

Additional Information

Official title PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Principal investigator Geri Donenberg, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.