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Interventions to Improve Reproductive Health Among Adolescents

Interventions to Improve Reproductive Health Among Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04227236
Enrollment
53
Registered
2020-01-13
Start date
2019-01-07
Completion date
2019-04-17
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teacher Training

Keywords

Sexual, health

Brief 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 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.

Interventions

OTHERE-based virtual facilitator training for Making Proud Choices

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.

OTHERIn-person facilitator training for Making Proud Choices

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.

Sponsors

dfusion Inc
CollaboratorINDUSTRY
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

No masking was done as the assignment was evident based on the type of training offered. However, participants were unaware of the other options.

Intervention model description

Participants were randomly assigned to one of two groups: in-person training or e-based virtual training.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age 21+ and have no prior experience with MPC or providing STI or pregnancy prevention education

Exclusion criteria

* non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Implementation Fidelity: Conducting Condom Line-upup to 1 hour post teacher trainingParticipants 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 Activity30 minutes before teacher training and 30 minutes after training7-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-efficacy30 minutes before teacher training and 30 minutes after training4-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 Use1 hour after trainingParticipants 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.

Secondary

MeasureTime frameDescription
Applicability of Training30 minutes after teacher training10-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.
Overall Impression30 minutes after teacher trainingParticipants 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.
Acceptability of Training30 minutes after teacher training19-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
E-based Virtual Training
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. E-based virtual facilitator training for Making Proud Choices: 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.
31
In-person Training
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. In-person facilitator training for Making Proud Choices: 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.
22
Total53

Baseline characteristics

CharacteristicE-based Virtual TrainingIn-person TrainingTotal
Age, Continuous36.7 years
STANDARD_DEVIATION 13.4
40.8 years
STANDARD_DEVIATION 14.1
38.4 years
STANDARD_DEVIATION 13.7
Race/Ethnicity, Customized
Race and ethnicity
Hispanic
3 Participants4 Participants7 Participants
Race/Ethnicity, Customized
Race and ethnicity
Multiple Race
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Race and ethnicity
Non-Hispanic Asian
6 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Race and ethnicity
Non-Hispanic Black
4 Participants2 Participants6 Participants
Race/Ethnicity, Customized
Race and ethnicity
Non-Hispanic White
17 Participants11 Participants28 Participants
Race/Ethnicity, Customized
Race and ethnicity
unknown
0 Participants1 Participants1 Participants
Region of Enrollment
United States
31 participants22 participants53 participants
Sex: Female, Male
Female
18 Participants11 Participants29 Participants
Sex: Female, Male
Male
13 Participants11 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 22
other
Total, other adverse events
0 / 310 / 22
serious
Total, serious adverse events
0 / 310 / 22

Outcome results

Primary

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.

Time frame: 30 minutes before teacher training and 30 minutes after training

Population: in-person and online training participants

ArmMeasureValue (MEAN)Dispersion
E-based Virtual TrainingChange in Teaching Self-efficacy.59 score on a scaleStandard Deviation 0.99
In-person TrainingChange in Teaching Self-efficacy.75 score on a scaleStandard Deviation 0.69
Primary

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.

Time frame: up to 1 hour post teacher training

ArmMeasureValue (MEAN)Dispersion
E-based Virtual TrainingImplementation Fidelity: Conducting Condom Line-up1.67 score on an itemStandard Deviation 0.44
In-person TrainingImplementation Fidelity: Conducting Condom Line-up1.26 score on an itemStandard Deviation 0.56
Primary

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.

Time frame: 1 hour after training

ArmMeasureValue (MEAN)Dispersion
E-based Virtual TrainingImplementation Fidelity: Discuss Steps in Condom Use1.15 score on an itemStandard Deviation 0.88
In-person TrainingImplementation Fidelity: Discuss Steps in Condom Use0.79 score on an itemStandard Deviation 0.93
Primary

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.

Time frame: 30 minutes before teacher training and 30 minutes after training

Population: Total population separated by e-based and in-person training

ArmMeasureGroupValue (MEAN)Dispersion
E-based Virtual TrainingTraining Knowledge of Condom Line-Up ActivityPre-training63.3 Percent correctStandard Deviation 21.1
E-based Virtual TrainingTraining Knowledge of Condom Line-Up ActivityPost-training96.6 Percent correctStandard Deviation 4.5
In-person TrainingTraining Knowledge of Condom Line-Up ActivityPre-training66.7 Percent correctStandard Deviation 19.3
In-person TrainingTraining Knowledge of Condom Line-Up ActivityPost-training100.0 Percent correctStandard Deviation 0
Secondary

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.

Time frame: 30 minutes after teacher training

Population: Only the participants of the E-based Virtual Training were asked these questions because they only applied to the online training.

ArmMeasureValue (MEAN)Dispersion
E-based Virtual TrainingAcceptability of Training5.80 score on a scaleStandard Deviation 1.12
Secondary

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.

Time frame: 30 minutes after teacher training

Population: Only participants in the E-based Virtual Training group were asked these questions.

ArmMeasureValue (MEAN)Dispersion
E-based Virtual TrainingApplicability of Training5.55 score on a scaleStandard Deviation 1.18
Secondary

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.

Time frame: 30 minutes after teacher training

Population: Only participants of the E-based Virtual Training group answered these questions.

ArmMeasureValue (MEAN)Dispersion
E-based Virtual TrainingOverall Impression5.46 score on a scaleStandard Deviation 1.15

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026