Interventions to Improve Reproductive Health Among Adolescents

July 21, 2025 updated by: RAND
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Scotts Valley, California, United States, 95066
        • Dfusion, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 hour post teacher training
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.
30 minutes before teacher training and 30 minutes after training
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.
30 minutes before teacher training and 30 minutes after 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.
1 hour after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Training
Time Frame: 30 minutes after teacher 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.

30 minutes after teacher training
Applicability of Training
Time Frame: 30 minutes after teacher 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.

30 minutes after teacher training
Overall Impression
Time Frame: 30 minutes after teacher training

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.

30 minutes after teacher training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

April 17, 2019

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R41HD094406 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

We will make the data and supporting information available within one year of the final year of funding of the project. No end date is determined.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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