NCT05339412

Brief Summary

Youth under age 18 involved in the criminal justice system are disproportionately minorities \& affected by substance abuse, mental illness, \& HIV/STI. Most young offenders are released on community supervision without the STI, mental health, or substance use screening, diagnosis, \& treatment afforded detained youth, despite similar rates of risk behavior. Their long-term trajectory is poor, costs to society are high, \& lasting effects on community well-being \& individual employment prospects are profound. Altering this trajectory is a public health priority. Preventing HIV Among Teens (PHAT) Life is an evidence-based program that meets the need in juvenile justice to address youths' co-morbid health problems. The next step in ensuring that this decade-long line of research produces actual, real-world improvements in the lives of probation youth is to develop a PHAT Life training strategy that is effective, cost-effective, \& sustainable within juvenile justice settings. The private/public collaboration between ORBIS \& UIC will leverage existing resources \& competencies to create a commercially viable technology-based training tool for PHAT Life with great potential for sustainability \& cost-effectiveness. This Phase II uses a formative process to refine, enhance \& complete the technology-based training tool to include: (a) an interactive multimedia web browser \& mobile application, (b) dynamic multimedia presentations \& interactive queries, (c) video examples of mock intervention delivery, (d) audio narration along with scripted language, (e) brief quizzes to ensure comprehension \& knowledge acquisition, (f) opportunities to "learn more" by clicking on tabs for supplemental information, (g) targeted referrals to appendix materials, (h) games to promote engagement, \& (i) other adaptations based on Phase I feedback. The proposed technology-based training tool should be highly sustainable, because it (a) relies on "indigenous" personnel to deliver the intervention, (b) is likely to prove cost-effective since it will utilize a technology that can deliver training at scale, \& (c) will improve fidelity by leveraging technology to provide consistent training experiences to para-professionals. The training tool will be evaluated via a 2-arm RCT with 130 individuals who work with justice-involved youth. Trainees will receive the technology-based training tool.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

February 28, 2022

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change over time in HIV knowledge needed for HIV prevention

    The Human Immunodeficiency Virus Knowledge Questionnaire (HIV-KQ) is an 12-item true/false measure developed to assess knowledge needed for HIV prevention. Total scores are calculated by the number of correct items. The minimum score is "0" and the maximum score is "12". A higher score indicate higher HIV knowledge.

    Baseline

  • Change over time in HIV knowledge needed for HIV prevention

    The Human Immunodeficiency Virus Knowledge Questionnaire (HIV-KQ) is an 12-item true/false measure developed to assess knowledge needed for HIV prevention. Total scores are calculated by the number of correct items. The minimum score is "0" and the maximum score is "12". A higher score indicate higher HIV knowledge.

    Post-training (6-weeks)

  • Change over time in STI knowledge needed for HIV prevention

    The HIV Sexually Transmitted Infections Knowledge Questionnaire (HIV-STI-KQ) is an 12-item true/false measure developed to assess knowledge needed for HIV prevention. Total scores are calculated by the number of correct items. The minimum score is "0" and the maximum score is "12". A higher score indicate higher STI knowledge.

    Baseline

  • Change over time in STI knowledge needed for HIV prevention

    The HIV Sexually Transmitted Infections Knowledge Questionnaire (HIV-STI-KQ) is an 12-item true/false measure developed to assess knowledge needed for HIV prevention. Total scores are calculated by the number of correct items. The minimum score is "0" and the maximum score is "12". A higher score indicate higher STI knowledge.

    Post-training (6-weeks)

  • Fidelity

    The Investigators will assess treatment fidelity with self-report and audio recordings of adherence and competence. Adherence measures will determine whether the program was delivered as planned, and competence ratings will indicate the quality of intervention delivery. After each session, participants will rate whether they delivered each activity (yes/no). On a Likert scale, they will indicate how smoothly the session went, how well they knew and delivered the material, their comfort with participants, and how well the participants interacted. Open-ended questions will offer opportunities to report challenges or barriers encountered during the session. The observers will rate whether each task was completed (yes/no), and using a Likert scale (0=not very well to 5=excellent): (1) facilitator leadership skills (e.g., explained each activity correctly, was open and non-judgmental); and (2) facilitator adherence and competence on delivery of session-specific activities.

    Post-training (6-weeks)

Secondary Outcomes (12)

  • Sex Education Confidence Scale

    Baseline

  • Sex Education Confidence Scale

    Post-training (6-weeks)

  • Satisfaction with Technology-Based Training

    Post-training (6-weeks)

  • Implementation Outcomes

    Post-training (6-weeks)

  • Utilization: Number of Sessions

    Post-training (6-weeks)

  • +7 more secondary outcomes

Study Arms (2)

Technology Based Training Tool Only

EXPERIMENTAL

The technology-based training tool will train facilitators to deliver the behavioral health intervention PHAT Life, which is an innovative HIV/STI, substance use, and mental health intervention for juvenile offenders. The training tool reviews each of PHAT Life's 8 sessions. The curriculum targets broad psychosocial factors implicated in HIV/STI-risk behavior, including promoting positive attitudes toward HIV/STI prevention, self-efficacy to reduce risk, and less substance misuse and sexual risk taking. Content emphasizes the importance of emotion regulation skills to manage strong feelings, uses goal setting and training in positive thought processes to plan ahead, encourages recognition of personal responsibility in future outcomes, and helps youth identify strategies and behaviors to accomplish short- and long-term goals.

Behavioral: Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life

Technology Based Training Tool plus Live Supervision

EXPERIMENTAL

Participants randomized to this condition will receive (in addition to the training tool described above) access to live supervision delivered remotely via commercially available video conferencing software (Zoom). Facilitators-in-training will complete two mock roleplays of curriculum activities, which can be conducted live via Zoom with PHAT Life trainers (either Dr. Floyd or Dr. Snow-Hill) or can be recorded and submitted via the app. Trainers will review for fidelity and provide feedback. During the supervision sessions, participants will have the opportunity to clarify content, ask questions, roleplay group sessions to practice difficult parts of the group sessions, and review feedback on role plays.

Behavioral: Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life

Interventions

The technology-based training tool will train facilitators to deliver the behavioral health intervention PHAT Life, which is an innovative HIV/STI, substance use, and mental health intervention for juvenile offenders. The training tool reviews each of PHAT Life's 8 sessions. The curriculum targets broad psychosocial factors implicated in HIV/STI-risk behavior, including promoting positive attitudes toward HIV/STI prevention, self-efficacy to reduce risk, and less substance misuse and sexual risk taking. Content emphasizes the importance of emotion regulation skills to manage strong feelings, uses goal setting and training in positive thought processes to plan ahead, encourages recognition of personal responsibility in future outcomes, and helps youth identify strategies and behaviors to accomplish short- and long-term goals.

Technology Based Training Tool OnlyTechnology Based Training Tool plus Live Supervision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any staff at the recruitment sites who provides services to justice-involved youth will be eligible for this study

You may not qualify if:

  • Unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David R Smith, PhD

    Oregon Research Behavioral Intervention Strategies, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of two conditions: (1) technology based training tool only; or (2) technology based training tool plus live supervision.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

April 21, 2022

Study Start

January 26, 2024

Primary Completion

November 30, 2024

Study Completion

December 20, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations