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Completed

NCT Number: NCT04863326

Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program

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.

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Key information

Conditions

Teen Pregnancy Prevention

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This evaluation used a cluster randomized controlled trial (RCT) design to assess the effectiveness of MPC, with schools within districts randomly assigned to one of two conditions: (1) MPC implemented by health educators, or (2) business as usual. In total, 31 school clusters were randomly assigned to condition, including roughly 2800 students, in four geographic areas across the U.S.

The study was implemented over the course of three school years (2016-17, 2017-18 and 2018-19), with youth in each year considered a separate evaluation cohort, and with participating schools (and new cohorts of eligible youth) randomized to condition each year.

There are two main sources of data for this study: outcome and implementation data. Youth in the study completed two waves of self-report surveys: (1) a baseline survey administered before programming began, and (2) a follow-up outcome survey administered approximately six months after the end of programming (approximately 9 months after baseline, on average). The surveys measured antecedents to sexual behavior (risk and protective factors), sexual behaviors, and ultimately, MPC's health goals of reducing sexually transmitted infections and teen pregnancies. Program implementation data included fidelity and attendance logs, observations, interviews, study youth focus groups, staff surveys, and technical assistance logs.

The benchmark analytic approach for estimating program impacts focuses on individuals with observed (non-missing) outcome data, and will statistically adjust for several baseline and location variables to produce credible and precise estimates of program effectiveness. Several sensitivity analyses will be conducted to understand the robustness of the findings across alternative specifications, and to understand the effect of MPC across a variety of subgroups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Making Proud Choices

Behavioral

Business as usual

Behavioral

Primary outcomes

  1. Knowledge about HIV

    Time frame: Survey administered 6 months post program

    Proportion of knowledge items about HIV/STDs answered correctly.

  2. Knowledge about pregnancy

    Time frame: Survey administered 6 months post program

    Proportion of knowledge items about pregnancy answered correctly.

  3. Knowledge about condoms

    Time frame: Survey administered 6 months post program

    Proportion of knowledge items about condom use answered correctly.

  4. Knowledge about other forms of contraception

    Time frame: Survey administered 6 months post program

    Proportion of knowledge items about contraceptive use answered correctly.

  5. Belief that sex may adversely affect future goals

    Time frame: Survey administered 6 months post program

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

  6. Belief that condoms can be pleasurable

    Time frame: Survey administered 6 months post program

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

  7. Attitudes about condoms

    Time frame: Survey administered 6 months post program

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

  8. Condom self-efficacy

    Time frame: Survey administered 6 months post program

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

  9. Condom negotiation

    Time frame: Survey administered 6 months post program

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

  10. Refusal skills

    Time frame: Survey administered 6 months post program

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

  11. Ever any sex (vaginal, oral, or anal)

    Time frame: Survey administered 6 months post program

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

  12. Any sex (in past 3 months)

    Time frame: Survey administered 6 months post program

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

  13. Times having any sex (in past 3 months)

    Time frame: Survey administered 6 months post program

    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.

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

    Time frame: Survey administered 6 months post program

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

  15. Any sex without a condom (in past 3 months)

    Time frame: Survey administered 6 months post program

    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.

  16. Times having any sex without a condom in past 3 months

    Time frame: Survey administered 6 months post program

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

  17. Sex without birth control in past 3 months

    Time frame: Survey administered 6 months post program

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

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

    Time frame: Survey administered 6 months post program

    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.

  19. Ever pregnant

    Time frame: Survey administered 6 months post program

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

  20. Any sexually transmitted infection (STI)

    Time frame: Survey administered 6 months post program

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

Sponsors and collaborators

Lead sponsor

Mathematica Policy Research, Inc.

Other

Collaborators

  • Office of Population Affairs

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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