Interventions to Improve Reproductive Health Among Adolescents

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

• Status: Completed
• Conditions: Teacher Training
• Intervention / Treatment: Other: E-based virtual facilitator training for Making Proud Choices; Other: In-person facilitator training for Making Proud Choices

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Fidelity	Participants teach an activity that is video recorded and coded for fidelity to the Making Proud Choices curriculum. Participants are scored on completion of curriculum tasks, ability to answer sensitive questions, ability to foster a safe and inclusive environment, and engagement of students. Each of the nine sub-activities from the Making Proud Choices module were rated independently by two coders as 2=done correctly, 1=done partially correct, or 0=not done correctly.	up to 1 hour post teacher training
Pre-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).	30 minutes before teacher training
Post-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).	30 minutes after teacher training
Pre-Training 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.	30 minutes before teacher training
Post-Training 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.	30 minutes after teacher training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of training	19-item measure of perceived acceptability of Making Proud Choices e-based facilitator training. The overall score and the three scales (System Usefulness, Information Quality, and Interface Quality) use a 7-point scale (strongly agree to strongly disagree). Higher scores equal greater acceptability/	30 minutes after teacher training
Applicability of training	10-item measure of perceived applicability and usability of Making Proud Choices e-based facilitator training. Items were rated on a 7-point scale (strongly agree to strongly disagree), with higher scores representing greater perceptions of applicability.	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.	30 minutes after teacher training

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Dfusion Inc.

Study record dates

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): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: health; Sexual
• Other Study ID Numbers: 1R41HD094406 (NIH)

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