Interventions to Improve Reproductive Health Among Adolescents

NCT04227236 | Completed Results

• 1 other identifier: 1R41HD094406
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Teacher Training

Keywords

Sexual; health

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 hour after training

Secondary Outcomes (3)

• Acceptability of Training

  30 minutes after teacher training

• Applicability of Training

  30 minutes after teacher training

• Overall Impression

  30 minutes after teacher training

Study Arms (2)

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.

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.

Other: In-person facilitator training for Making Proud Choices

Interventions

E-based virtual facilitator training for Making Proud Choices OTHER

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.

E-based virtual training

In-person facilitator training for Making Proud Choices OTHER

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.

In-person training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non-English speaking

Sponsors & Collaborators

• RAND: lead
• dfusion Inc: collaborator

Study Sites (1)

Dfusion, Inc

Scotts Valley, California, 95066, United States

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Limitations and Caveats

Our findings are limited by a small sample size, which is typical for a Phase I SBIR grant meant to be a "proof of concept" study. Recruitment included adults (18 years or older) with interest in the study and no prior experience with MPC rather than teachers or community-based youth leaders who are likely the target audience for this training.

Results Point of Contact

• Title: Regina Firpo-Triplett
• Organization: dFusion, Inc.

regina.firpo@dfusioninc.com

831-222-5094

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was done as the assignment was evident based on the type of training offered. However, participants were unaware of the other options.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: January 13, 2020
• Study Start: January 7, 2019
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• 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.
• 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.

Locations

US (1)