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HIV/AIDSPHATLifeNCT03555279

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

A study testing PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm and PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm in people with HIV/AIDS, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm and PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteUnited States
Study dates
13 Mar 2017to 26 May 2021
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; 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

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.

Read the 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.

Conditions
HIV/AIDS
Being tested
PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm, PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm
Keywords
HIV Prevention, Juvenile Justice, Sexual Health, Evidence Based Intervention
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHAT Life: Preventing HIV/AIDS Among Teens--PS ArmBehavioural

    HIV Prevention Behavioral Health Intervention delivered by Probation Staff

  • PHAT Life: Preventing HIV/AIDS Among Teens--YR ArmBehavioural

    HIV Prevention Behavioral Health Intervention delivered by Youth Representatives

Study groups in NCT03555279
Study groupRoleWhat they receive
Probation Staff (PS) FacilitatorExperimentalThe 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.
Receives: Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm
Youth Representative (YR) FacilitatorExperimentalThe 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.
Receives: Behavioral: PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HIV/STI Risk Behaviors at 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.

    Measured: Baseline and 6-months

Secondary outcomes (13)

  1. Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6

    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 and 6-months

  2. Change in mental health symptoms at 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).

    Measured: Baseline and 6-months

  3. Change in Partner Sexual Communication at 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.

    Measured: Baseline and 6-months

  4. Change in Relationship dynamics at 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.

    Measured: Baseline and 6-months

  5. Change in trauma symptoms and violence exposure at 6 months

    The UCLA PTSD Index will measure exposure to trauma and violence.

    Measured: Baseline and 6-months

  6. Change in peer influences at 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.

    Measured: Baseline and 6-months

  7. Change in parental Influences at 6 months

    The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.

    Measured: Baseline and 6-months

  8. Change in parental communication at 6 months

    The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.

    Measured: Baseline and 6-months

  9. 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: Baseline and 6 months

  10. 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: Baseline and 6 months

  11. 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: Baseline and 6 months

  12. Facilitator Characteristics

    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

    Measured: Baseline

  13. Cost Effectiveness

    The costs associated with intervention delivery for each arm will be collected to explore differences across arms.

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start13 Mar 2017
  3. Primary completion5 Apr 2021
  4. Study completion26 May 2021

Resources

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
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555279
Sponsor's protocol ID
2015-0936
Other IDs
1R01MD010433
Acronym
PHATLife
Status last verified
Apr 2023
First submitted
18 May 2018
Last updated
21 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 26097376

  • 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.

    PubMed 21875199

  • 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):10.1080/15564886.2013.835296. doi: 10.1080/15564886.2013.835296.

    PubMed 24273468

  • 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.

    PubMed 29389155

  • 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: 10.1016/j.jaac.2017.09.424. Epub 2017 Oct 5.

    PubMed 29173739

Questions about this trial

What is this clinical trial studying?

A study testing PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm and PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm in people with HIV/AIDS, 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 1 inclusion and 1 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 21 Apr 2023. 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 months (time frame: Baseline and 6-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 NCT03555279, 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 21 Apr 2023.

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