Trial Outcomes & Findings for Enhancing Quality Interventions Promoting Healthy Sexuality (NCT NCT01818791)
NCT ID: NCT01818791
Last Updated: 2026-03-11
Results Overview
attitudes about abstinence - 5-point response scale (5= strongly agree to 1 = strongly disagree), higher score means more prosocial attitudes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
909 participants
Primary outcome timeframe
Baseline, Post (8 weeks later)
Results posted on
2026-03-11
Participant Flow
Participant milestones
| Measure |
Making Proud Choices Alone
These sites will be trained in Making Proud Choices.
Making Proud Choices: Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices. The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
|
Making Proud Choices+Getting To Outcomes
These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.
Making Proud Choices: Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices. The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
Making Proud Choices AND Getting To Outcomes: In addition to MPC, these sites receive the Getting To Outcomes(GTO) intervention, which builds capacity for EBPs by strengthening the knowledge, attitudes, and skills needed to choose, plan, implement, evaluate, sustai
|
|---|---|---|
|
Overall Study
STARTED
|
433
|
476
|
|
Overall Study
COMPLETED
|
275
|
305
|
|
Overall Study
NOT COMPLETED
|
158
|
171
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Quality Interventions Promoting Healthy Sexuality
Baseline characteristics by cohort
| Measure |
Making Proud Choices Alone
n=433 Participants
These sites will be trained in Making Proud Choices.
Making Proud Choices: Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices. The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
|
Making Proud Choices+Getting To Outcomes
n=476 Participants
These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.
Making Proud Choices: Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices. The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use)
Making Proud Choices AND Getting To Outcomes: In addition to MPC, these sites receive the Getting To Outcomes(GTO) intervention, which builds capacity for EBPs by strengthening the knowledge, attitudes, and skills needed to choose, plan, implement, evaluate, and sustai
|
Total
n=909 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
4th-5th grade
|
96 Participants
n=9 Participants
|
91 Participants
n=9 Participants
|
187 Participants
n=18 Participants
|
|
Age, Customized
6th-8th grade
|
320 Participants
n=9 Participants
|
352 Participants
n=9 Participants
|
672 Participants
n=18 Participants
|
|
Age, Customized
9th-12th grade
|
17 Participants
n=9 Participants
|
33 Participants
n=9 Participants
|
50 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=9 Participants
|
242 Participants
n=9 Participants
|
455 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=9 Participants
|
234 Participants
n=9 Participants
|
454 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
433 Participants
n=9 Participants
|
476 Participants
n=9 Participants
|
909 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
433 Participants
n=9 Participants
|
476 Participants
n=9 Participants
|
909 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post (8 weeks later)attitudes about abstinence - 5-point response scale (5= strongly agree to 1 = strongly disagree), higher score means more prosocial attitudes.
Outcome measures
| Measure |
Making Proud Choices Alone
n=275 Participants
These sites will be trained in Making Proud Choices.
Making Proud Choices: Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices. The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
|
Making Proud Choices+Getting To Outcomes
n=305 Participants
These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.
Making Proud Choices: Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
Making Proud Choices AND Getting To Outcomes: In addition to MPC, these sites receive the Getting To Outcomes(GTO) intervention, which builds capacity for EBPs by strengthening the knowledge, attitudes, and skills needed to choose, plan, implement, evaluate, and sustai
|
|---|---|---|
|
Abstinence Attitudes
Baseline
|
4.18 score on a scale
Standard Deviation 1.02
|
4.17 score on a scale
Standard Deviation 1.08
|
|
Abstinence Attitudes
Post
|
4.17 score on a scale
Standard Deviation 1.11
|
4.26 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: At baseline (prior to GTO), midpoint of GTO (after 1 year), post GTO (after 2 years), and after a year of no GTO (for GTO+MPC group) or after a year of GTO after not having it for the previous two years (for MPC only group).Investigators are using the Capacity Interview to assess BGC staff capacity to conduct high-quality teen pregnancy programming. Although programs consist of individual people with varying levels of abilities, capacity ratings are made at the program level since programs operate as a unit. The ratings are made using a structured interview with key program personnel at all 32 BGC sites. The ratings reflect how well each BGC site is carrying out the tasks tied to each of the ten steps of the GTO model, from "highly faithful" to "highly divergent" from ideal practice.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Twice per site in each of the two intervention yearsAdherence -Over the two year intervention period, trained local data collectors are visiting each BGC site and rating how closely BGC staff adhere to each MPC module as designed. Dosage - BGC staff are recording how many of the eight modules each youth receives. Quality of delivery - During site visits, local data collectors are rating BGC staff on their teaching style-communication skills, interactions with participants, enthusiasm, and pacing-using a standardized rating sheet. Participant response - During site visits, local data collectors are rating student participation.
Outcome measures
Outcome data not reported
Adverse Events
Making Proud Choices Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Making Proud Choices+Getting To Outcomes
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place