Trial Outcomes & Findings for Interventions to Improve Reproductive Health Among Adolescents (NCT NCT04227236)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

up to 1 hour post teacher training

Results posted on

2025-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	31	22
Overall Study COMPLETED	31	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interventions to Improve Reproductive Health Among Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E-based Virtual Training n=31 Participants 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.	In-person Training n=22 Participants 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.	Total n=53 Participants Total of all reporting groups
Age, Continuous	36.7 years STANDARD_DEVIATION 13.4 • n=5 Participants	40.8 years STANDARD_DEVIATION 14.1 • n=7 Participants	38.4 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Hispanic	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Non-Hispanic White	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Non-Hispanic Black	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Non-Hispanic Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · Multiple Race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race and ethnicity · unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	22 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training n=22 Participants Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Implementation Fidelity: Conducting Condom Line-up	1.67 score on an item Standard Deviation 0.44	1.26 score on an item Standard Deviation 0.56

PRIMARY outcome

Timeframe: 30 minutes before teacher training and 30 minutes after training

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

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training n=22 Participants Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Training Knowledge of Condom Line-Up Activity Pre-training	63.3 Percent correct Standard Deviation 21.1	66.7 Percent correct Standard Deviation 19.3
Training Knowledge of Condom Line-Up Activity Post-training	96.6 Percent correct Standard Deviation 4.5	100.0 Percent correct Standard Deviation 0.0

PRIMARY outcome

Timeframe: 30 minutes before teacher training and 30 minutes after training

Population: in-person and online training participants

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.

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training n=22 Participants Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Change in Teaching Self-efficacy	.59 score on a scale Standard Deviation .99	.75 score on a scale Standard Deviation .69

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training n=22 Participants Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Implementation Fidelity: Discuss Steps in Condom Use	1.15 score on an item Standard Deviation 0.88	0.79 score on an item Standard Deviation 0.93

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Acceptability of Training	5.80 score on a scale Standard Deviation 1.12	—

SECONDARY outcome

Timeframe: 30 minutes after teacher training

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

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.

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Applicability of Training	5.55 score on a scale Standard Deviation 1.18	—

SECONDARY outcome

Timeframe: 30 minutes after teacher training

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

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.

Outcome measures

Outcome measures
Measure	E-based Virtual Training n=31 Participants Participants in the e-based virtual training (up to 8 participants per session) were placed at one of eight computers (with headphones), which took about 40 minutes. Participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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 Training Participants in-person training participated in a class with 15-20 participants like the usual MPC training environment. The training lasted 1 hour. Like the e-based virtual training, participants completed the condom-line up facilitator training module that corresponds to the Making Proud Choices curriculum. Participants completed 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.
Overall Impression	5.46 score on a scale Standard Deviation 1.15	—

Adverse Events

E-based Virtual Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

In-person Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Regina Firpo-Triplett

dFusion, Inc.

Phone: 831-222-5094

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place