HIVPHAT LifeNCT02647710
PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
A study testing PHAT Life Intervention in people with HIV, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- PHAT Life Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2010to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- PHAT Life Intervention, Health Promotion Control
- Keywords
- HIV Prevention, Juvenile Justice, Sexual Health, Evidence Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHAT Life InterventionBehavioural
HIV Prevention behavioral health intervention
Health Promotion ControlBehavioural
Behavioral health intervention control
| Study group | Role | What they receive |
|---|---|---|
| PHAT Life Intervention | Experimental | 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. Receives: Behavioral: PHAT Life Intervention |
| Health Promotion Control | Active comparator | A health promotion program focusing on nutrition, physical activity, substance use, and sexual health. Receives: Behavioral: Health Promotion Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6-months, and 12--months
Secondary outcomes (11)
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.
Measured: Baseline, 6-months, and 12-months
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).
Measured: Baseline, 6-months, and 12-months
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.
Measured: Baseline, 6-months, and 12-months
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.
Measured: Baseline, 6-months, and 12-months
Change in trauma symptoms and violence exposure at 6 and 12 months
The UCLA PTSD Index will measure exposure to trauma and violence.
Measured: Baseline, 6-months, and 12-months
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.
Measured: Baseline, 6-months, and 12-months
Change in parental Influences at 6 and 12 months
The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
Measured: Baseline, 6-months, and 12-months
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.
Measured: Baseline, 6-months, and 12-months
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.
Measured: 12-months
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.
Measured: 12-months
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start15 Jun 2010
- Primary completion15 Jul 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Geri Donenberg, University of Illinois Chicago
- Investigators
- Geri Donenberg, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647710
- Sponsor's protocol ID
- R01MD005861
- Other IDs
- 5R01MD005861-05
- Acronym
- PHAT Life
- Status last verified
- Apr 2018
- First submitted
- 29 Dec 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26097376Udell 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.
PubMed 21875199Wilson 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.
PubMed 24273468Donenberg 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.
PubMed 29389155Kendall 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.
PubMed 29173739
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice
- ClinicalTrials.gov ID
- NCT02647710
- Acronym / sponsor ID
- PHAT Life / R01MD005861
- Conditions
- HIV
- Keywords
- HIV Prevention, Juvenile Justice, Sexual Health, Evidence Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Jun 2010 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHAT Life Intervention | Experimental | Behavioral: PHAT Life InterventionPHAT 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. |
| Health Promotion Control | Active comparator | Behavioral: Health Promotion ControlA health promotion program focusing on nutrition, physical activity, substance use, and sexual health. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHAT Life InterventionHIV Prevention behavioral health intervention | Behavioural | PHAT Life Intervention |
| Health Promotion ControlBehavioral health intervention control | Behavioural | Health Promotion Control |
Primary outcome
Change in HIV/STI Risk Behaviors at 6 and 12 months
Time frame: 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.
11 secondary outcomes
Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in mental health symptoms at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in Partner Sexual Communication at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in Relationship dynamics at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in trauma symptoms and violence exposure at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in peer influences at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in parental Influences at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Change in parental communication at 6 and 12 months
Time frame: Baseline, 6-months, and 12-months
Biological Measure of N. Gonorrhoeae Acquisition
Time frame: 12-months
Biological Measure of C. Trachomatis Acquisition
Time frame: 12-months
Biological Measure of T. Vaginalis Acquisition
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 26097376Donenberg 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.
- Background: PubMed 21875199Udell 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.
- Background: PubMed 24273468Wilson 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.
- Results publication: PubMed 29389155Donenberg 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.
- Results publication: PubMed 29173739Kendall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geri Donenberg, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHAT Life Intervention in people with HIV, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV/STI Risk Behaviors at 6 and 12 months (time frame: baseline, 6-months, and 12--months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647710, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.