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PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice (PHAT Life)

30 april 2018 bijgewerkt door: Geri Donenberg, University of Illinois at Chicago
PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The investigators will test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators.

Studie Overzicht

Gedetailleerde beschrijving

High rates of mental illness, HIV/AIDS/STI, and incarceration among African Americans (AA) reflect significant health disparities, particularly among youth. Teens in juvenile justice are disproportionately AA, and compared to the general population, juvenile offenders (JO) report more risky sexual behavior, drug and alcohol use, and psychiatric disorders, and are more likely to test positive for STIs. Still, few empirically-supported, theoretically-driven programs exist to address their negative health outcomes. This proposal addresses these health disparities by testing an innovative and uniquely tailored HIV/AIDS/STI, mental health, and substance use program designed for and pilot tested with recently arrested 13 - 17 year-old urban males and females (85% African American, 14% Latino/a) released on probation. PHAT Life was derived from a carefully staged process that included an active, diverse, multi-disciplinary advisory board, a youth advisory board, focus groups, two pilot tests, extensive feedback, and a series of curriculum revisions over three years. The R34 established feasibility and acceptability, revealed positive youth and stakeholder feedback, and yielded good preliminary outcomes at 3-month follow-up (e.g., increased condom use) to justify an efficacy trial. This application proposes a 2-arm randomized controlled trial to test PHAT Life versus a health promotion program with recently arrested 13-17 year-old male and female, mostly ethnic minority JO (as representative of Cook County) on probation in Chicago. The investigators will use the procedures and methods established in the developmental study to recruit, enroll, assess, track, and intervene with teens. Investigators will randomly assign youth to PHAT Life (N=150) or a health promotion control group (N=150). The interventions will be delivered in single sex groups of 5 - 7 teens at Evening Reporting Centers. Assessments will occur at baseline, 6-, and 12-months post-treatment, and participants will be screened for three common STIs (Chlamydia, Gonorrhea, Trichamonas) at baseline and 12-month follow-up. All youth who test positive for an STI will receive single dose antibiotic treatment free of charge. An intent-to-treat analysis will be used to test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators. This study answers a compelling need for innovative prevention programs that address the intersecting health disparities of mental illness and HIV/AIDS/STIs among youth in juvenile justice. Without intervention, these teens continue to engage in risk behaviors post-release, amplifying their own and their partner's risk for HIV/AIDS/STIs. The lasting effects on community well-being, individual employment prospects, and neighborhood health are profound, but effective programs can alter the negative developmental trajectories of this very high-risk population and begin to redress existing health disparities.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

349

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • University of Illinois at Chicago

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • male or female gender
  • placed on probation following arrest
  • remanded to a probation program
  • 13-17 years old
  • both adolescent and parent are fluent English speakers
  • not a ward of the state (DCFS Ward).

Exclusion Criteria:

  • are unable to understand the consent/assent process
  • do not speak English, because instruments are normed for English speakers
  • do not assent; d) legal guardians do not consent to teens' participation
  • are not 13 -17 years old
  • are not on probation or remanded to a probation program
  • are Wards of the state (DCFS Ward)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PHAT Life Intervention
PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. PHAT Life draws on social learning theory and a Social-Personal Framework to address individual and social mechanisms related to HIV-risk, including emotion regulation, peer norms, partner communication, relationship characteristics, and HIV/AIDS/STI and substance use knowledge, attitudes, and beliefs.
HIV Prevention behavioral health intervention
Actieve vergelijker: Health Promotion Control
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
Behavioral health intervention control

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in HIV/STI Risk Behaviors at 6 and 12 months
Tijdsspanne: baseline, 6-months, and 12--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, 6-months, and 12--months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-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.
Baseline, 6-months, and 12-months
Change in mental health symptoms at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-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, 6-months, and 12-months
Change in Partner Sexual Communication at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-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, 6-months, and 12-months
Change in Relationship dynamics at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-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, 6-months, and 12-months
Change in trauma symptoms and violence exposure at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-months
The UCLA PTSD Index will measure exposure to trauma and violence.
Baseline, 6-months, and 12-months
Change in peer influences at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-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, 6-months, and 12-months
Change in parental Influences at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-months
The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
Baseline, 6-months, and 12-months
Change in parental communication at 6 and 12 months
Tijdsspanne: Baseline, 6-months, and 12-months
The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.
Baseline, 6-months, and 12-months
Biological Measure of N. Gonorrhoeae Acquisition
Tijdsspanne: 12-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.
12-months
Biological Measure of C. Trachomatis Acquisition
Tijdsspanne: 12-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.
12-months
Biological Measure of T. Vaginalis Acquisition
Tijdsspanne: 12-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-months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Geri DONENBERG, PhD, University of Illinois at Chicago

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juni 2010

Primaire voltooiing (Werkelijk)

15 juli 2016

Studie voltooiing (Werkelijk)

31 december 2017

Studieregistratiedata

Eerst ingediend

29 december 2015

Eerst ingediend dat voldeed aan de QC-criteria

4 januari 2016

Eerst geplaatst (Schatting)

6 januari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 mei 2018

Laatste update ingediend die voldeed aan QC-criteria

30 april 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Hiv

Klinische onderzoeken op PHAT Life Intervention

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