Teacher TrainingNCT04227236
Interventions to Improve Reproductive Health Among Adolescents
A study testing E-based virtual facilitator training for Making Proud Choices and In-person facilitator training for Making Proud Choices in people with Teacher Training, run by RAND at 1 site in United States.
Trial summary
The proposed virtual training prototype will provide Making Proud Choices (MPC) facilitator trainees the opportunity to make decisions, build facilitator skills, practice core concepts and enhance self-efficacy with a virtual audience programmed to display a range of behaviors and emotions, simulating a true-to-life… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Teacher Training
- What is being tested?
- E-based virtual facilitator training for Making Proud Choices and In-person facilitator training for Making Proud Choices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 17 Apr 2019
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21+ and have no prior experience with MPC or providing STI or pregnancy prevention education
Who cannot join
- non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
The proposed virtual training prototype will provide Making Proud Choices (MPC) facilitator trainees the opportunity to make decisions, build facilitator skills, practice core concepts and enhance self-efficacy with a virtual audience programmed to display a range of behaviors and emotions, simulating a true-to-life experience with immediate feedback. Seventy-two adults who have experience working with adolescents but not with MPC, STI, or pregnancy prevention education will receive MPC training. Participants will be randomly assigned to either: 1) virtual training in the MPC module on condom use n=36), or 2) dfusion/ETR's traditional in-person training in the same module (n=36). Using mixed methods (survey, focus groups, observations), the project will evaluate the virtual training's impact on STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills and its usability, feasibility, and acceptability.
Read the detailed description
Dfusion, in partnership with the RAND Corporation, Allen Interactions and Dr. Loretta Jemmott (MPC developer), proposes to develop an online avatar-based virtual training that can make MPC training more accessible while still being as effective as in-person. In this Phase I STTR, we will develop and test a prototype of the online, avatar-based virtual training for activities of MPC and test it with 72 adults who have experience working with adolescents (but not with MPC or any HIV/STI/teen pregnancy risk-reduction program). At random, 36 will receive traditional in-person MPC training, and 36 will receive avatar-based MPC training. The avatar group (n=36) will be compared to the in-person group (n=36) on their STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills.
The scientific premise is that avatar-based virtual training will prepare educators to implement the popular evidence-based MPC as effectively as traditional (and expensive) face-to-face trainings. The specific aims are:
- Aim 1: Develop a prototype for a novel, online avatar-based virtual training for select components of the evidence-based STI/pregnancy risk reduction program Making Proud Choices.
- Aim 2: Using mixed methods (survey, focus groups, observations), evaluate the avatar-based training's preliminary impact on facilitator STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills compared to in-person training, as well as its usability and acceptability.
By developing novel tools/platforms to improve the dissemination and implementation of evidence-based behavioral interventions to prevent STIs/teen pregnancy, this application is in line with the priorities of the NICHD Population Dynamics Branch, which supports reproductive health research on STIs and family planning. If successful, not only will dfusion proceed to Phase II, but the findings could inform other nascent efforts to develop avatar facilitator trainings that could make a range of evidence-based programs more accessible to community-based organizations.
- Conditions
- Teacher Training
- Being tested
- E-based virtual facilitator training for Making Proud Choices, In-person facilitator training for Making Proud Choices
- Keywords
- Sexual, health
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-based virtual facilitator training for Making Proud ChoicesOther
Participants complete the Making Proud Choices (MPC) facilitator training using an e-based virtual trainer on a computer. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum.
In-person facilitator training for Making Proud ChoicesOther
Participants complete the Making Proud Choices (MPC) facilitator training using the standard in-person training method. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum.
| Study group | Role | What they receive |
|---|---|---|
| E-based virtual training | Experimental | Participants in the e-based virtual training (up to 8 participants per session) will be placed at one of eight computers (with headphones), which we estimate will take less time (about 40 minutes), due to the individualized learning and 1:1 nature of the training instead of 1:15. Participants will complete the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Receives: Other: E-based virtual facilitator training for Making Proud Choices |
| In-person training | Active comparator | Participants in-person training will participate in a class with 15-20 participants like the usual MPC training environment. The training will last 1 hour. Like the e-based virtual training, participants will complete the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Receives: Other: In-person facilitator training for Making Proud Choices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Fidelity: Conducting Condom Line-up
Participants teach an activity that is video recorded and coded for fidelity to the Making Proud Choices curriculum. Participants are scored on the completion of multiple curriculum tasks by two coders as 2=done correctly, 1=done partially correct, or 0=not done correctly. This particular measure was a single item about the degree to which the teacher correctly conducted the condom line up activity.
Measured: up to 1 hour post teacher training
Training Knowledge of Condom Line-Up Activity
7-item survey measure of knowledge related to condom safety and objectives of the condom line-up module of Making Proud Choices. Responses were coded as correct (1) and incorrect (0). Averaging together the 0s and 1, we calculated a percentage correct for the whole 7 item survey, with 100% being all correct, and 0% being all incorrect.
Measured: 30 minutes before teacher training and 30 minutes after training
Change in Teaching Self-efficacy
4-item self-efficacy measure assessing confidence in teaching condom safety, rated from 1 (not at all) to 7(extremely). Scores were averaged to create a self-efficacy scale score. Change scores were calculated by subtracting scores Post-Pre Training.
Measured: 30 minutes before teacher training and 30 minutes after training
Implementation Fidelity: Discuss Steps in Condom Use
Participants teach an activity that is video recorded and coded for fidelity to the Making Proud Choices curriculum. Participants are scored on the completion of multiple curriculum tasks by two coders as 2=done correctly, 1=done partially correct, or 0=not done correctly. This particular measure was a single item about the degree to which the teacher correctly discussed the steps in the activity on how to use a condom properly.
Measured: 1 hour after training
Secondary outcomes (3)
Acceptability of Training
19-item measure of perceived acceptability of Making Proud Choices e-based facilitator training. The overall score, which is an average of all 19 items, uses a 7-point scale (strongly agree to strongly disagree). Higher scores equal greater acceptability. Thus, the high score is 7 (training perceived as most acceptable). The low score is 1 (training perceived as the least acceptable).
Only the participants of the E-based Virtual Training group were asked these questions.
Measured: 30 minutes after teacher training
Applicability of Training
10-item measure of perceived applicability of Making Proud Choices e-based facilitator training. Items were rated on a 7-point scale (strongly agree to strongly disagree). All items were averaged together to create a total score, with higher scores representing greater perceptions of applicability. Thus, the high score is 7 (training perceived as most applicable). The low score is 1 (training perceived as the least applicable).
Only participants in the E-based Virtual Training group were asked these questions.
Measured: 30 minutes after teacher training
Overall Impression
Participants overall impressions of the training were assessed using 4 item measure, rated on a 7-point Likert scale ("very difficult to use" to "very easy to use", "very boring" to "very interesting", "very amateurish" to "very professional", and "very basic" to "very informative"). Items were average to create an overall impression score, with higher scores reflecting greater overall impression. Thus, the high score is 7 (training perceived with the highest favorable impression). The low score is 1 (training perceived with the least favorable impression).
Only participants of the E-based Virtual Training group answered these questions.
Measured: 30 minutes after teacher training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start7 Jan 2019
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
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 Teacher TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two groups: in-person training or e-based virtual training.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- dfusion Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227236
- Sponsor's protocol ID
- 1R41HD094406
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2019
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the raw data files and codebooks available for public use within one year of the final year of funding. We will make the dataset and associated documentation available outside our team under a data-sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology and (3) a commitment to destroying or returning the data after analyses are completed. Identifiers will never be included in these shared files. Individual researchers can contact the PIs for data and through filling out a data request and use form that we will create for the purposes of data sharing. Researchers can access the data through RAND's restricted-access server with password protection after their request is reviewed and approved by our institution officials.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Improve Reproductive Health Among Adolescents
- ClinicalTrials.gov ID
- NCT04227236
- Acronym / sponsor ID
- 1R41HD094406
- Conditions
- Teacher Training
- Keywords
- Sexual, health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- dfusion Inc
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed virtual training prototype will provide Making Proud Choices (MPC) facilitator trainees the opportunity to make decisions, build facilitator skills, practice core concepts and enhance self-efficacy with a virtual audience programmed to display a range of behaviors and emotions, simulating a true-to-life experience with immediate feedback. Seventy-two adults who have experience working with adolescents but not with MPC, STI, or pregnancy prevention education will receive MPC training. Participants will be randomly assigned to either: 1) virtual training in the MPC module on condom use n=36), or 2) dfusion/ETR's traditional in-person training in the same module (n=36). Using mixed methods (survey, focus groups, observations), the project will evaluate the virtual training's impact on STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills and its usability, feasibility, and acceptability.
Detailed description
Dfusion, in partnership with the RAND Corporation, Allen Interactions and Dr. Loretta Jemmott (MPC developer), proposes to develop an online avatar-based virtual training that can make MPC training more accessible while still being as effective as in-person. In this Phase I STTR, we will develop and test a prototype of the online, avatar-based virtual training for activities of MPC and test it with 72 adults who have experience working with adolescents (but not with MPC or any HIV/STI/teen pregnancy risk-reduction program). At random, 36 will receive traditional in-person MPC training, and 36 will receive avatar-based MPC training. The avatar group (n=36) will be compared to the in-person group (n=36) on their STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills.
The scientific premise is that avatar-based virtual training will prepare educators to implement the popular evidence-based MPC as effectively as traditional (and expensive) face-to-face trainings. The specific aims are:
- Aim 1: Develop a prototype for a novel, online avatar-based virtual training for select components of the evidence-based STI/pregnancy risk reduction program Making Proud Choices.
- Aim 2: Using mixed methods (survey, focus groups, observations), evaluate the avatar-based training's preliminary impact on facilitator STI/pregnancy prevention knowledge, teaching efficacy, and teaching skills compared to in-person training, as well as its usability and acceptability.
By developing novel tools/platforms to improve the dissemination and implementation of evidence-based behavioral interventions to prevent STIs/teen pregnancy, this application is in line with the priorities of the NICHD Population Dynamics Branch, which supports reproductive health research on STIs and family planning. If successful, not only will dfusion proceed to Phase II, but the findings could inform other nascent efforts to develop avatar facilitator trainings that could make a range of evidence-based programs more accessible to community-based organizations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two groups: in-person training or e-based virtual training.
| Arm | Type | Receives |
|---|---|---|
| E-based virtual training | Experimental | Other: E-based virtual facilitator training for Making Proud ChoicesParticipants in the e-based virtual training (up to 8 participants per session) will be placed at one of eight computers (with headphones), which we estimate will take less time (about 40 minutes), due to the individualized learning and 1:1 nature of the training instead of 1:15. Participants will complete the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. |
| In-person training | Active comparator | Other: In-person facilitator training for Making Proud ChoicesParticipants in-person training will participate in a class with 15-20 participants like the usual MPC training environment. The training will last 1 hour. Like the e-based virtual training, participants will complete the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 21+ and have no prior experience with MPC or providing STI or pregnancy prevention education
Key exclusion criteria (1 listed)
- non-English speaking
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 |
|---|---|---|
| E-based virtual facilitator training for Making Proud ChoicesParticipants complete the Making Proud Choices (MPC) facilitator training using an e-based virtual trainer on a computer. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum. | Other | E-based virtual training |
| In-person facilitator training for Making Proud ChoicesParticipants complete the Making Proud Choices (MPC) facilitator training using the standard in-person training method. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum. | Other | In-person training |
Primary outcome
Implementation Fidelity: Conducting Condom Line-up
Time frame: up to 1 hour post teacher training
Participants teach an activity that is video recorded and coded for fidelity to the Making Proud Choices curriculum. Participants are scored on the completion of multiple curriculum tasks by two coders as 2=done correctly, 1=done partially correct, or 0=not done correctly. This particular measure was a single item about the degree to which the teacher correctly conducted the condom line up activity.
Training Knowledge of Condom Line-Up Activity
Time frame: 30 minutes before teacher training and 30 minutes after training
7-item survey measure of knowledge related to condom safety and objectives of the condom line-up module of Making Proud Choices. Responses were coded as correct (1) and incorrect (0). Averaging together the 0s and 1, we calculated a percentage correct for the whole 7 item survey, with 100% being all correct, and 0% being all incorrect.
Change in Teaching Self-efficacy
Time frame: 30 minutes before teacher training and 30 minutes after training
4-item self-efficacy measure assessing confidence in teaching condom safety, rated from 1 (not at all) to 7(extremely). Scores were averaged to create a self-efficacy scale score. Change scores were calculated by subtracting scores Post-Pre Training.
Implementation Fidelity: Discuss Steps in Condom Use
Time frame: 1 hour after training
Participants teach an activity that is video recorded and coded for fidelity to the Making Proud Choices curriculum. Participants are scored on the completion of multiple curriculum tasks by two coders as 2=done correctly, 1=done partially correct, or 0=not done correctly. This particular measure was a single item about the degree to which the teacher correctly discussed the steps in the activity on how to use a condom properly.
3 secondary outcomes
Acceptability of Training
Time frame: 30 minutes after teacher training
Applicability of Training
Time frame: 30 minutes after teacher training
Overall Impression
Time frame: 30 minutes after teacher training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will make the raw data files and codebooks available for public use within one year of the final year of funding. We will make the dataset and associated documentation available outside our team under a data-sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology and (3) a commitment to destroying or returning the data after analyses are completed. Identifiers will never be included in these shared files. Individual researchers can contact the PIs for data and through filling out a data request and use form that we will create for the purposes of data sharing. Researchers can access the data through RAND's restricted-access server with password protection after their request is reviewed and approved by our institution officials.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-based virtual facilitator training for Making Proud Choices and In-person facilitator training for Making Proud Choices in people with Teacher Training, run by RAND 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 7 Aug 2025. 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 7 Aug 2025). 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?
Implementation Fidelity: Conducting Condom Line-up (time frame: up to 1 hour post teacher training). The study lists 4 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 7 Aug 2025.