Clinical trial NCT05339412: Technology-based Training Tool for PHAT Life
Official title: Technology-based Training Tool for an Empirically-Supported Group-Based HIV and STI Prevention Intervention for Juvenile Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Sexually Transmitted Infections
Implementation
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Illinois at Chicago
First posted: 2022-04-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of two conditions: (1) technology based training tool only; or (2) technology based training tool plus live supervision.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study will comply with the NIH Policy on the Use of sIRB for Multi-Site Research. The University of Illinois Chicago (UIC) has been selected to serve as the single IRB of record (sIRB) for the research described in this proposal. Once the PHAT Life Training Tool is complete, Investigators will enroll 6 paraprofessionals to conduct a brief usability test to ensure the tool is working properly. After edits are made based on the feedback from the usability test, 10 paraprofessionals who work with justice-involved youth will pilot test the study materials and protocol to ensure that Investigators are ready for scale in a randomized trial. To meet the proposed study's aims, the research team has commitment from three sites who serve justice-involved youth (see Letters of Support): (a) Cook County Juvenile Temporary Detention Center, (b) Cook County Department of Probation and Court Services, and (c) Heartland Alliance. Together, there are about 445 eligible staff across settings. The proposed sample (N=130) represents 29% of eligible participants. Investigators, thus, expect minimal difficulty reaching the proposed sample size. Researchers will present the project at agency staff meetings and invite people to indicate interest. Flyers will be posted in relevant spaces with researcher contact information. Researchers will offer to present information about the project at agency events. Agency staff will distribute recruitment materials to eligible personnel (e.g., probation staff or public health educators) and invite them to contact the researchers. The agency staff will also invite individuals to consent to release their contact information for the research team to contact them directly. The recruitment coordinator will contact interested individuals by phone, email, text, and instant messenger. Recruitment will continue in this manner until enrollment goals are met for each condition.

Once enrolled in the study, participants will be assigned a unique, de-identifiable project ID number, which will be affiliated with their baseline survey, Training Tool, and post-training survey. Research staff will fully explain the study and ask for their consent to participate. Participants will indicate their consent via project webpage just prior to the baseline assessment. Participants will be randomized to condition after completing their baseline measures via Qualtrics. A table will be created based on a computer-generated random numbers list that will be used by research staff to assign condition. Participants will then be provided with their login information and instructions for accessing the PHAT Life Training Tool. For those in the Training Tool Plus Supervision condition, participants will receive individualized supervision and participate in two mock role-plays of PHAT Life activities after completing the training tool. All participants will be sent the post-training assessments via Qualtrics. Finally, participants will be instructed to lead one PHAT Life group where they will audio record sessions 1 and 4 of the PHAT Life curriculum.

Eligibility criteria: Inclusion Criteria:

* Any staff at the recruitment sites who provides services to justice-involved youth will be eligible for this study
* Given that the training and curriculum are only offered in English, English-speaking will be an inclusion criterion

Exclusion Criteria:

• Unable to speak English

Primary outcomes:
measure: Change over time in HIV knowledge needed for HIV prevention
timeFrame: Baseline
measure: Change over time in HIV knowledge needed for HIV prevention
timeFrame: Post-training (6-weeks)
measure: Change over time in STI knowledge needed for HIV prevention
timeFrame: Baseline
measure: Change over time in STI knowledge needed for HIV prevention
timeFrame: Post-training (6-weeks)
measure: Fidelity
timeFrame: Post-training (6-weeks)
Secondary outcomes:
measure: Sex Education Confidence Scale
timeFrame: Baseline
measure: Sex Education Confidence Scale
timeFrame: Post-training (6-weeks)
measure: Satisfaction with Technology-Based Training
timeFrame: Post-training (6-weeks)
measure: Implementation Outcomes
timeFrame: Post-training (6-weeks)
measure: Utilization: Number of Sessions
timeFrame: Post-training (6-weeks)
measure: Utilization: Total Time On-line
timeFrame: Post-training (6-weeks)
measure: Utilization: Number of Homework Modules Completed
timeFrame: Post-training (6-weeks)
measure: Utilization: Number of External Resources Accessed
timeFrame: Post-training (6-weeks)
measure: Utilization: Time of Day at Log On
timeFrame: Post-training (6-weeks)
measure: Utilization: Number of Times Logged on Each Week
timeFrame: Post-training (6-weeks)
measure: Utilization: Length of time spent in (a) information; (b) support; (c) video; (d) assessment areas of training website
timeFrame: Post-training (6-weeks)
measure: Training Tool Cost Data
timeFrame: Post-training (6-weeks)
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
name: David R Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: