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

Study Overview
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Brief Summary
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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
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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: 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). 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.

Official Title
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PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm
* Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probation Staff (PS) Facilitator<br>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. | Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm<br>* HIV Prevention Behavioral Health Intervention delivered by Probation Staff<br>|
| Experimental: Youth Representative (YR) Facilitator<br>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. | Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm<br>* HIV Prevention Behavioral Health Intervention delivered by Youth Representatives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV/STI Risk Behaviors at 6 months | AIDS Risk Behavior Assessment (ARBA) A computer-assisted structured interview of self-reported sexual behavior and drug use derived from five well-established measures. The outcomes include ever had sex, condom use, number of partners, sex while using drugs and/or alcohol. | Baseline and 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 | Survey measuring knowledge regarding transmission routes, misconceptions about transmission, and risk-reduction strategies; attitudes and beliefs including peer norms, intentions to prevent HIV/AIDS/STI, attitudes towards preventive actions, and beliefs about condom use; as well as self-efficacy to prevent transmission, apply condoms, and negotiate with a partner. | Baseline and 6-months | 
| Change in mental health symptoms at 6 months | The Youth Self Report (YSR) is a widely-used and validated measure of child behavior problems that generates raw and T-scores for internalizing and externalizing syndromes as well as narrow-band problems (e.g., delinquency, anxiety, depression). | Baseline and 6-months | 
| Change in Partner Sexual Communication at 6 months | Questionnaire in which participants indicate whether they ever talked to their romantic or dating partners and sexual partners about a list of sexual topics, how often they discussed them, and whether they talk was open and comfortable. Items were adapted from the Sexual Risk Behavior Questionnaire. | Baseline and 6-months | 
| Change in Relationship dynamics at 6 months | The Sexual Relationship Power Scale (SRPS) measures perceptions of relationship control and decision-making dominance. It has good internal consistency and predictive and constructed validity. | Baseline and 6-months | 
| Change in trauma symptoms and violence exposure at 6 months | The UCLA PTSD Index will measure exposure to trauma and violence. | Baseline and 6-months | 
| Change in peer influences at 6 months | The Peer Convention Behavior Questionnaire will measure peer support of risky behavior, peer norms, and peer pressure and teens' association with prosocial peers. | Baseline and 6-months | 
| Change in parental Influences at 6 months | The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness. | Baseline and 6-months | 
| Change in parental communication at 6 months | The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents. | Baseline and 6-months | 
| Biological Measure of N. Gonorrhoeae Acquisition | Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for N. gonorrhoeae and treated if necessary at baseline. They will be tested again 12 months later to determine rate of STI acquisition. | Baseline and 6 months | 
| Biological Measure of C. Trachomatis Acquisition | Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for C. Trachomatis and treated if necessary at baseline. They will be tested again 12 months later to determine rate of STI acquisition. | Baseline and 6 months | 
| Biological Measure of T. Vaginalis Acquisition | Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for T. Vaginalis and treated if necessary at baseline. They will be tested again 12 months later to determine rate of STI acquisition. | Baseline and 6 months | 
| Facilitator Characteristics | Probation teens will rate the facilitator team on similarity, credibility, competence, warmth, physical attractiveness, and sense of humor using the 9-item Perception of Peer Educator Rating Scale | Baseline | 
| Cost Effectiveness | The costs associated with intervention delivery for each arm will be collected to explore differences across arms. | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, Juvenile Justice, Sexual Health, Evidence Based Intervention