PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders (PHATLife)

University of Illinois

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm; Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03555279

2015-0936 (Other Identifier)

1R01MD010433 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Probation Staff (PS) Facilitator

Experimental group

Description:

The PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm intervention is delivered by Probation Staff working at the intervention site. Dosage is 8 2-hour sessions delivered over two weeks.

Treatment:

Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm

Youth Representative (YR) Facilitator

Experimental group

Description:

The PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm intervention is delivered by young adults who were formally in the juvenile justice system. Dosage is 8 2-hour sessions delivered over two weeks.

Treatment:

Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm