Clinical trial NCT04863326: Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program
Official title: Evaluation of the Making Proud Choices! Teen Pregnancy Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: Office of Population Affairs
First posted: 2021-04-28
Enrollment: 2810
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Knowledge about HIV
timeFrame: Survey administered 6 months post program
measure: Knowledge about pregnancy
timeFrame: Survey administered 6 months post program
measure: Knowledge about condoms
timeFrame: Survey administered 6 months post program
measure: Knowledge about other forms of contraception
timeFrame: Survey administered 6 months post program
measure: Belief that sex may adversely affect future goals
timeFrame: Survey administered 6 months post program
measure: Belief that condoms can be pleasurable
timeFrame: Survey administered 6 months post program
measure: Attitudes about condoms
timeFrame: Survey administered 6 months post program
measure: Condom self-efficacy
timeFrame: Survey administered 6 months post program
measure: Condom negotiation
timeFrame: Survey administered 6 months post program
measure: Refusal skills
timeFrame: Survey administered 6 months post program
measure: Ever any sex (vaginal, oral, or anal)
timeFrame: Survey administered 6 months post program
measure: Any sex (in past 3 months)
timeFrame: Survey administered 6 months post program
measure: Times having any sex (in past 3 months)
timeFrame: Survey administered 6 months post program
measure: Count of vaginal sex partners (in the past 3 months)
timeFrame: Survey administered 6 months post program
measure: Any sex without a condom (in past 3 months)
timeFrame: Survey administered 6 months post program
measure: Times having any sex without a condom in past 3 months
timeFrame: Survey administered 6 months post program
measure: Sex without birth control in past 3 months
timeFrame: Survey administered 6 months post program
measure: Times having sex without birth control (in past 3 months)
timeFrame: Survey administered 6 months post program
measure: Ever pregnant
timeFrame: Survey administered 6 months post program
measure: Any sexually transmitted infection (STI)
timeFrame: Survey administered 6 months post program
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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