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

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ClinicalTrials.gov Identifier: NCT03555279
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Geri Donenberg, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Probation Staff (PS) Facilitator
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
HIV Prevention Behavioral Health Intervention delivered by Probation Staff

Experimental: Youth Representative (YR) Facilitator
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
HIV Prevention Behavioral Health Intervention delivered by Youth Representatives




Primary Outcome Measures :
  1. Change in HIV/STI Risk Behaviors at 6 months [ Time Frame: Baseline and 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.


Secondary Outcome Measures :
  1. Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 [ Time Frame: Baseline and 6-months ]
    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.

  2. Change in mental health symptoms at 6 months [ Time Frame: Baseline and 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).

  3. Change in Partner Sexual Communication at 6 months [ Time Frame: Baseline and 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.

  4. Change in Relationship dynamics at 6 months [ Time Frame: Baseline and 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.

  5. Change in trauma symptoms and violence exposure at 6 months [ Time Frame: Baseline and 6-months ]
    The UCLA PTSD Index will measure exposure to trauma and violence.

  6. Change in peer influences at 6 months [ Time Frame: Baseline and 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.

  7. Change in parental Influences at 6 months [ Time Frame: Baseline and 6-months ]
    The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.

  8. Change in parental communication at 6 months [ Time Frame: Baseline and 6-months ]
    The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.

  9. Biological Measure of N. Gonorrhoeae Acquisition [ Time Frame: Baseline and 6 months ]
    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.

  10. Biological Measure of C. Trachomatis Acquisition [ Time Frame: Baseline and 6 months ]
    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.

  11. Biological Measure of T. Vaginalis Acquisition [ Time Frame: Baseline and 6 months ]
    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.

  12. Facilitator Characteristics [ Time Frame: Baseline ]
    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

  13. Cost Effectiveness [ Time Frame: Through study completion, an average of 2 years ]
    The costs associated with intervention delivery for each arm will be collected to explore differences across arms.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555279


Contacts
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Contact: Erin McCarville, MPH 312-996-1014 emccar2@uic.edu
Contact: Erin Emerson, MA 312-355-3994 eemerson@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Erin McCarville, MPH    312-996-1014    emccar2@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Geri Donenberg, PhD University of Illinois at Chicago

Publications:
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Responsible Party: Geri Donenberg, Professor, Departments of Medicine and Psychology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03555279     History of Changes
Other Study ID Numbers: 1R01MD010433 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Geri Donenberg, University of Illinois at Chicago:
HIV Prevention
Juvenile Justice
Sexual Health
Evidence Based Intervention