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临床试验/NCT05339412
NCT05339412已完成不适用

Technology-based Training Tool for an Empirically-Supported Group-Based HIV and STI Prevention Intervention for Juvenile Offenders

Oregon Research Behavioral Intervention Strategies, Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change over time in HIV knowledge needed for HIV prevention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to speak English

结局指标

主要结局

Change over time in HIV knowledge needed for HIV prevention

时间窗: Post-training (6-weeks)

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.

Fidelity

时间窗: Post-training (6-weeks)

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.

Change over time in STI knowledge needed for HIV prevention

时间窗: Post-training (6-weeks)

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.

次要结局

  • Sex Education Confidence Scale(Post-training (6-weeks))
  • Utilization: Total Time On-line(Post-training (6-weeks))
  • Utilization: Number of External Resources Accessed(Post-training (6-weeks))
  • Utilization: Number of Times Logged on Each Week(Post-training (6-weeks))
  • Utilization: Length of time spent in (a) information; (b) support; (c) video; (d) assessment areas of training website(Post-training (6-weeks))
  • Implementation Outcomes(Post-training (6-weeks))
  • Utilization: Number of Homework Modules Completed(Post-training (6-weeks))
  • Training Tool Cost Data(Post-training (6-weeks))
  • Satisfaction with Technology-Based Training(Post-training (6-weeks))
  • Utilization: Number of Sessions(Post-training (6-weeks))
  • Utilization: Time of Day at Log On(Post-training (6-weeks))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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