HIV InfectionPhatLife-IINCT05339412
Technology-based Training Tool for PHAT Life
A study testing Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life in people with HIV Infection and Sexually Transmitted Infections, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Sexually Transmitted Infections, Implementation
- What is being tested?
- Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Springfield, Oregon, 97477
About this study
Official title: Technology-based Training Tool for an Empirically-Supported Group-Based HIV and STI Prevention Intervention for Juvenile Offenders
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.
Read the 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.
- Being tested
- Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Tool for Preventing HIV/AIDS among Teens (PHAT) LifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-training (6-weeks)
Fidelity
The Investigators will assess treatment fidelity with observer ratings of adherence and competence, as well as demonstration of skills and session flow. Adherence measures will determine whether the program was delivered as planned, and competence ratings will indicate the quality of intervention delivery. After each session, observers will rate each facilitator on a Likert scale from 0 (i.e., worst adherence/competence) to 4 (i.e., best adherence/competence) for each section of the session. Observers will also provide ratings for how well the facilitator demonstrated skills during the session and how well the intervention session flowed. As with adherence and competence, these ratings will range from 0 (i.e., worst demonstration of skills/session flow) to 4 (i.e., best demonstration of skills/session flow). Adherence, competence, demonstration of skills, and session flow were averaged to form one fidelity variable per facilitator.
Measured: Post-training (6-weeks)
Secondary outcomes (10)
Sex Education Confidence Scale
The Sex Education Confidence Scale (SECS) is a 22-item measure and was designed to assess how comfortable one is teaching sex education on a 6-point Likert scale. The minimum item score is "1" and the maximum item score is "6". All items are summed to create total scores. Therefore, the measure ranges from 22 to 132. A higher score indicates more confidence providing sex education.
Measured: Baseline
Sex Education Confidence Scale
The SECS is a 22-item measure and was designed to assess how comfortable one is teaching sex education on a 6-point Likert scale. The minimum item score is "1" and the maximum item score is "6". All items are summed to create total scores. Therefore, the measure ranges from 22 to 132. A higher score indicates more confidence providing sex education.
Measured: Post-training (6-weeks)
Satisfaction With Technology-Based Training
An adapted version of the satisfaction measure currently used for the PHAT Life in-person trainings will be used to measure satisfaction with the technology-based training. This is called the Satisfaction Measure. This is a 21-item measure on a 5-point Likert scale. All items are summed to create a total score, which ranges from 21 to 105. Higher scores indicate greater satisfaction.
Measured: Post-training (6-weeks)
Implementation Outcomes
The implementation outcomes has 5 series of measures adapted based on the RE-AIM framework. All scores are averaged across subscales.
- Adoption, 12-item measure on 5-point Likert scale. Minimum (Min) score is 1 and maximum (Max) score is 5. A higher score indicates greater support for adopting the intervention;
- Implementation, 5-item measure on 10-point scale. Min score is 1 and Max score is 10. A higher score indicates greater support for implementing the intervention;
- Acceptability, 6-item measure on 4-point scale. Min score is 1 and Max score is 4. A higher score indicates greater acceptability of the intervention;
- Appropriateness, 5-item measure on 4-point Likert scale. Min score is 1 and Max score is 4. A higher score indicates greater beliefs that the intervention is appropriate; And
- Maintenance, 6-item measure on 7-point scale. Min score is 1 and Max score is 7. A higher score indicates greater support for maintaining the intervention.
Measured: Post-training (6-weeks)
Utilization: Number of Sessions
The number of sessions logged into the website or app for each user will be evaluated using standard back-end usage data recorded by computer program.
Measured: Post-training (6-weeks)
Utilization: Total Time On-line
The total time spent on the website or app for each user will be evaluated using standard back-end usage data recorded by computer program.
Measured: Post-training (6-weeks)
Utilization: Number of Modules Completed
The number of modules completed on the website or app for each user will be evaluated using standard back-end usage data recorded by computer program.
Measured: Post-training (6-weeks)
Utilization: Number of External Resources Accessed
The number of external resources accessed for each user through the website or app will be evaluated using standard back-end usage data recorded by computer program. External resources referred to the total number of unique resource types accessed. This covered Articles, Consultation Schedule, Multimedia for Sessions, and Facilitator Guide.
Measured: Post-training (6-weeks)
Utilization: Time of Day at Log On
The time of day initial log on to the website or app for each user will be evaluated using standard back-end usage data recorded by computer program.
Measured: Post-training (6-weeks)
Utilization: Length of Time Spent in (a) Information; (b) Support; (c) Video; (d) Assessment Areas of Training Website
The length of time spent in each of the following training areas of the website, (a) information; (b) support; (c) video; (d) assessment, for each user will be evaluated using standard back-end usage data recorded by computer program. These values were summed to create a total average length of time training on the website, which is reported below.
Measured: Post-training (6-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start31 Jan 2024
- Primary completion30 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois at Chicago
- Responsible party
- Sponsor
- Investigators
- David R Smith, PhD, Principal investigator, Oregon Research Behavioral Intervention Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339412
- Sponsor's protocol ID
- MD014113-02
- Acronym
- PhatLife-II
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2022
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-based Training Tool for an Empirically-Supported Group-Based HIV and STI Prevention Intervention for Juvenile Offenders
- ClinicalTrials.gov ID
- NCT05339412
- Acronym / sponsor ID
- PhatLife-II / MD014113-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois at Chicago
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Posted 13 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Technology Based Training Tool Only | Experimental | Behavioral: Training Tool for Preventing HIV/AIDS among Teens (PHAT) LifeThe 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 plus Live Supervision | Experimental | Behavioral: Training Tool for Preventing HIV/AIDS among Teens (PHAT) LifeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to speak English
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 |
|---|---|---|
| Training Tool for Preventing HIV/AIDS among Teens (PHAT) LifeThe 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. | Behavioural | Technology Based Training Tool Only, Technology Based Training Tool plus Live Supervision |
Primary outcome
Change Over Time in HIV Knowledge Needed for HIV Prevention
Time frame: Baseline
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.
Change Over Time in HIV Knowledge Needed for HIV Prevention
Time frame: 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.
Change Over Time in STI Knowledge Needed for HIV Prevention
Time frame: Baseline
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.
Change Over Time in STI Knowledge Needed for HIV Prevention
Time frame: 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.
Fidelity
Time frame: Post-training (6-weeks)
The Investigators will assess treatment fidelity with observer ratings of adherence and competence, as well as demonstration of skills and session flow. Adherence measures will determine whether the program was delivered as planned, and competence ratings will indicate the quality of intervention delivery. After each session, observers will rate each facilitator on a Likert scale from 0 (i.e., worst adherence/competence) to 4 (i.e., best adherence/competence) for each section of the session. Observers will also provide ratings for how well the facilitator demonstrated skills during the session and how well the intervention session flowed. As with adherence and competence, these ratings will range from 0 (i.e., worst demonstration of skills/session flow) to 4 (i.e., best demonstration of skills/session flow). Adherence, competence, demonstration of skills, and session flow were averaged to form one fidelity variable per facilitator.
10 secondary outcomes
Sex Education Confidence Scale
Time frame: Baseline
Sex Education Confidence Scale
Time frame: Post-training (6-weeks)
Satisfaction With Technology-Based Training
Time frame: Post-training (6-weeks)
Implementation Outcomes
Time frame: Post-training (6-weeks)
Utilization: Number of Sessions
Time frame: Post-training (6-weeks)
Utilization: Total Time On-line
Time frame: Post-training (6-weeks)
Utilization: Number of Modules Completed
Time frame: Post-training (6-weeks)
Utilization: Number of External Resources Accessed
Time frame: Post-training (6-weeks)
Utilization: Time of Day at Log On
Time frame: Post-training (6-weeks)
Utilization: Length of Time Spent in (a) Information; (b) Support; (c) Video; (d) Assessment Areas of Training Website
Time frame: Post-training (6-weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David R Smith, PhD principal investigator
Oregon Research Behavioral Intervention Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life in people with HIV Infection and Sexually Transmitted Infections, run by Oregon Research Behavioral Intervention Strategies, Inc. 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 2 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 13 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Over Time in HIV Knowledge Needed for HIV Prevention (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.