NCT04863326

Brief Summary

Under contract to the Office of Population Affairs (OPA), Mathematica is conducting an impact study of the Making Proud Choices! (MPC) teen pregnancy prevention program. The impact study is designed to estimate the impact of MPC, compared to the business-as-usual condition, on risk and protective factors, sexual behaviors, and longer term health goals including pregnancy and sexually transmitted infections.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,810

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

April 20, 2021

Last Update Submit

April 28, 2021

Conditions

Outcome Measures

Primary Outcomes (20)

  • Knowledge about HIV

    Proportion of knowledge items about HIV/STDs answered correctly.

    Survey administered 6 months post program

  • Knowledge about pregnancy

    Proportion of knowledge items about pregnancy answered correctly.

    Survey administered 6 months post program

  • Knowledge about condoms

    Proportion of knowledge items about condom use answered correctly.

    Survey administered 6 months post program

  • Knowledge about other forms of contraception

    Proportion of knowledge items about contraceptive use answered correctly.

    Survey administered 6 months post program

  • Belief that sex may adversely affect future goals

    Proportion of statements about how sexual activity will interfere with goals and dreams that the respondent agrees or strongly agrees with.

    Survey administered 6 months post program

  • Belief that condoms can be pleasurable

    Proportion of statements about how condoms can be pleasurable that the respondent agrees or strongly agrees with.

    Survey administered 6 months post program

  • Attitudes about condoms

    Proportion of statements about condom use that the respondent either agrees or strongly agrees with.

    Survey administered 6 months post program

  • Condom self-efficacy

    Proportion of statements about self-efficacy using condoms that the respondent agrees or strongly agrees with.

    Survey administered 6 months post program

  • Condom negotiation

    Proportion of statements about self-efficacy negotiating condom that the respondent agrees or strongly agrees with.

    Survey administered 6 months post program

  • Refusal skills

    Proportion of statements about self-efficacy refusing sex with a partner that the respondent agrees or strongly agrees with.

    Survey administered 6 months post program

  • Ever any sex (vaginal, oral, or anal)

    Binary variable representing if the respondent reported having ever had vaginal, oral, or anal sex.

    Survey administered 6 months post program

  • Any sex (in past 3 months)

    Binary variable representing if the respondent reported having vaginal, oral, or anal sex in the three month period before completing the follow-up survey.

    Survey administered 6 months post program

  • Times having any sex (in past 3 months)

    Count variable representing the total number of times respondent had vaginal, oral and/or anal sex in the three month period before completing the follow-up survey.

    Survey administered 6 months post program

  • Count of vaginal sex partners (in the past 3 months)

    Count variable representing the number of partners for vaginal sex in the three month period before completing the follow-up survey.

    Survey administered 6 months post program

  • Any sex without a condom (in past 3 months)

    Binary variable representing if respondent reported having any risk for STD/STI sex (sex without a condom) in the three month period before completing the follow-up survey.

    Survey administered 6 months post program

  • Times having any sex without a condom in past 3 months

    Count variable representing the total number of times respondent had risky sex in the three months before completing follow-up survey.

    Survey administered 6 months post program

  • Sex without birth control in past 3 months

    Binary variable representing if respondent reported having had unprotected vaginal sex in the three months before completing the follow-up survey.

    Survey administered 6 months post program

  • Times having sex without birth control (in past 3 months)

    Count variable representing the total number of times the respondent had unprotected vaginal sex in the three month period before completing the follow-up survey.

    Survey administered 6 months post program

  • Ever pregnant

    Binary variable representing if the respondent reported a pregnancy or has gotten someone pregnant.

    Survey administered 6 months post program

  • Any sexually transmitted infection (STI)

    Binary variable representing if the respondent indicated having been told they have a sexually transmitted infection.

    Survey administered 6 months post program

Study Arms (2)

Making Proud Choices

EXPERIMENTAL

This evaluation tests the effect of the MPC School Edition, the version of the MPC 5th Edition designed for implementation in school. This edition includes 9.5 hours of content implemented in 14 40-minute modules. Schools assigned to the MPC condition received MPC in a targeted class.

Behavioral: Making Proud Choices

Business as usual

ACTIVE COMPARATOR

The control group continued with their regular programming in the targeted class, which was often a health or Reserve Officer Training Corps (ROTC) class.

Behavioral: Business as usual

Interventions

Making Proud Choices
Business as usual

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in a study school
  • Attending the targeted class (e.g. health class) for the first time

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cole R, Neelan TS, Langan A, Keating B, Walzer J, Asheer S, Zief S. The Impact of Making Proud Choices! on Youth's Sexual Health Attitudes, Knowledge, and Behaviors. J Adolesc Health. 2024 Apr;74(4):787-793. doi: 10.1016/j.jadohealth.2023.10.031. Epub 2023 Dec 13.

MeSH Terms

Interventions

Commerce

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The MPC curriculum aims to provide adolescents with the information and tools they need to reduce their risk of sexually transmitted diseases (STDs), HIV, and pregnancy. The curriculum emphasizes abstinence as the safest choice for avoiding pregnancy and STDs, but also encourages youth to use condoms and other methods of birth control if they do have sex. The curriculum includes video clips, student role-playing activities, and group discussions. It also involves skill-building activities for correct condom use, refusal techniques, and safer-sex negotiation, and opportunities for students to practice these skills.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 28, 2021

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04