- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863326
Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrolled in a study school
- Attending the targeted class (e.g. health class) for the first time
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Making Proud Choices
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.
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|
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Active Comparator: Business as usual
The control group continued with their regular programming in the targeted class, which was often a health or Reserve Officer Training Corps (ROTC) class.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge about HIV
Time Frame: Survey administered 6 months post program
|
Proportion of knowledge items about HIV/STDs answered correctly.
|
Survey administered 6 months post program
|
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Knowledge about pregnancy
Time Frame: Survey administered 6 months post program
|
Proportion of knowledge items about pregnancy answered correctly.
|
Survey administered 6 months post program
|
|
Knowledge about condoms
Time Frame: Survey administered 6 months post program
|
Proportion of knowledge items about condom use answered correctly.
|
Survey administered 6 months post program
|
|
Knowledge about other forms of contraception
Time Frame: Survey administered 6 months post program
|
Proportion of knowledge items about contraceptive use answered correctly.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
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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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
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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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
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.
|
Survey administered 6 months post program
|
|
Ever pregnant
Time Frame: Survey administered 6 months post program
|
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)
Time Frame: Survey administered 6 months post program
|
Binary variable representing if the respondent indicated having been told they have a sexually transmitted infection.
|
Survey administered 6 months post program
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HHSP23337014T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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