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NCT Number: NCT03555279

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

HIV Prevention Behavioral Health Intervention delivered by Probation Staff

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

Behavioral

HIV Prevention Behavioral Health Intervention delivered by Youth Representatives

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: PHATLife

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2018
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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