HIV Clinical Trial
— PHAT LifeOfficial title:
PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
Verified date | April 2018 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 349 |
Est. completion date | December 31, 2017 |
Est. primary completion date | July 15, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
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. — 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 — 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). doi: 10.1080/15564886.2013.835296. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HIV/STI Risk Behaviors at 6 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 | |
Secondary | Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 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 | |
Secondary | Change in mental health symptoms at 6 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 | |
Secondary | Change in Partner Sexual Communication at 6 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 | |
Secondary | Change in Relationship dynamics at 6 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 | |
Secondary | Change in trauma symptoms and violence exposure at 6 and 12 months | The UCLA PTSD Index will measure exposure to trauma and violence. | Baseline, 6-months, and 12-months | |
Secondary | Change in peer influences at 6 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 | |
Secondary | Change in parental Influences at 6 and 12 months | The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness. | Baseline, 6-months, and 12-months | |
Secondary | Change in parental communication at 6 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 | |
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. | 12-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. | 12-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. | 12-months |
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