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

HIV/AIDS Clinical Trial

— PHATLife  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555279
• Other study ID #: 2015-0936
• Secondary ID: 1R01MD010433
• Status: Completed
• Phase: N/A
• Start date: March 13, 2017
• Est. completion date: May 26, 2021

Study information

• Verified date: April 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: May 26, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm
HIV Prevention Behavioral Health Intervention delivered by Probation Staff
• PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm
HIV Prevention Behavioral Health Intervention delivered by Youth Representatives

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in parental Influences at 6 months	The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.	Baseline and 6-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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