Clinical trial NCT03555279: PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders
Official title: PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
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: 2018-06-13
Enrollment: 218
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: This application proposes a 2-arm randomized controlled trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS). 100 facilitators will be recruited to deliver the intervention and participate in the research.

Detailed description: The main objectives of the proposed study are to compare the effectiveness, cost-effectiveness, and sustainability of Youth Representative-led vs. probation staff-led PHAT Life in a real-world juvenile probation setting. The Specific Aims of this study are:

1. To conduct a methodologically-rigorous 2-arm trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS).
2. To compare the costs and cost-effectiveness of 100 YR-led vs. PS-led PHAT Life with respect to the acquisition of incident STI.

We hypothesize: (a) Compared to teens in PS-led groups, we expect teens in YR-led groups to report less risky sex and substance use at 6-month follow-up, to demonstrate greater improvement on theoretical mediators of risk, and to have fewer incident STI infections; (b) We expect YR-led PHAT Life to cost less and be more cost-effective than PS-led PHAT Life.

Eligibility criteria: Inclusion Criteria:

a) male or female gender; b) remanded to a probation program; c) 13-17 years old; d) adolescent is fluent in English; e) are not wards of the Department of Child and Family Services (DCFS); and f) they have not already received the PHAT Life intervention.

Exclusion Criteria:

a) are unable to understand the consent/assent process; b) do not speak English, because instruments are normed for English speakers; c) do not assent; d) legal guardians do not consent to teens' participation; e) are not 13 -17 years old; f) are not on probation or remanded to a probation program; g) are wards of the Department of Child and Family Services (DCFS); and h) they have already received the PHAT Life intervention.

Primary outcomes:
measure: Change in HIV/STI Risk Behaviors at 6 months
timeFrame: Baseline and 6-months
Secondary outcomes:
measure: Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6
timeFrame: Baseline and 6-months
measure: Change in mental health symptoms at 6 months
timeFrame: Baseline and 6-months
measure: Change in Partner Sexual Communication at 6 months
timeFrame: Baseline and 6-months
measure: Change in Relationship dynamics at 6 months
timeFrame: Baseline and 6-months
measure: Change in trauma symptoms and violence exposure at 6 months
timeFrame: Baseline and 6-months
measure: Change in peer influences at 6 months
timeFrame: Baseline and 6-months
measure: Change in parental Influences at 6 months
timeFrame: Baseline and 6-months
measure: Change in parental communication at 6 months
timeFrame: Baseline and 6-months
measure: Biological Measure of N. Gonorrhoeae Acquisition
timeFrame: Baseline and 6 months
measure: Biological Measure of C. Trachomatis Acquisition
timeFrame: Baseline and 6 months
measure: Biological Measure of T. Vaginalis Acquisition
timeFrame: Baseline and 6 months
measure: Facilitator Characteristics
timeFrame: Baseline
measure: Cost Effectiveness
timeFrame: Through study completion, an average of 2 years
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.