Teen Pregnancy PreventionNCT04863326
Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program
A study testing Making Proud Choices and Business as usual in people with Teen Pregnancy Prevention, run by Mathematica Policy Research, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Making Proud Choices and Business as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,810 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in a study school
- Attending the targeted class (e.g. health class) for the first time
Who cannot join
- None
About this study
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.
Read the 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.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Making Proud Choices, Business as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Proud ChoicesBehavioural
Business as usualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about HIV
Proportion of knowledge items about HIV/STDs answered correctly.
Measured: Survey administered 6 months post program
Knowledge about pregnancy
Proportion of knowledge items about pregnancy answered correctly.
Measured: Survey administered 6 months post program
Knowledge about condoms
Proportion of knowledge items about condom use answered correctly.
Measured: Survey administered 6 months post program
Knowledge about other forms of contraception
Proportion of knowledge items about contraceptive use answered correctly.
Measured: 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.
Measured: 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.
Measured: Survey administered 6 months post program
Attitudes about condoms
Proportion of statements about condom use that the respondent either agrees or strongly agrees with.
Measured: 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.
Measured: Survey administered 6 months post program
Condom negotiation
Proportion of statements about self-efficacy negotiating condom that the respondent agrees or strongly agrees with.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Survey administered 6 months post program
Ever pregnant
Binary variable representing if the respondent reported a pregnancy or has gotten someone pregnant.
Measured: 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.
Measured: Survey administered 6 months post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Population Affairs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863326
- Sponsor's protocol ID
- HHSP23337014T
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38099897
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program
- ClinicalTrials.gov ID
- NCT04863326
- Acronym / sponsor ID
- HHSP23337014T
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,810 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Office of Population Affairs
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Making Proud Choices | Experimental | Behavioral: Making Proud ChoicesThis 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. |
| Business as usual | Active comparator | Behavioral: Business as usualThe control group continued with their regular programming in the targeted class, which was often a health or Reserve Officer Training Corps (ROTC) class. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrolled in a study school
- Attending the targeted class (e.g. health class) for the first time
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Making Proud Choices | Behavioural | Making Proud Choices |
| Business as usual | Behavioural | Business as usual |
Primary outcome
Knowledge about HIV
Time frame: Survey administered 6 months post program
Proportion of knowledge items about HIV/STDs answered correctly.
Knowledge about pregnancy
Time frame: Survey administered 6 months post program
Proportion of knowledge items about pregnancy answered correctly.
Knowledge about condoms
Time frame: Survey administered 6 months post program
Proportion of knowledge items about condom use answered correctly.
Knowledge about other forms of contraception
Time frame: Survey administered 6 months post program
Proportion of knowledge items about contraceptive use answered correctly.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Ever pregnant
Time frame: Survey administered 6 months post program
Binary variable representing if the respondent reported a pregnancy or has gotten someone pregnant.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 38099897Cole 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Making Proud Choices and Business as usual in people with Teen Pregnancy Prevention, run by Mathematica Policy Research, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about HIV (time frame: Survey administered 6 months post program). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.