- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02540304
Teen Pregnancy Prevention Replication Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Teen Pregnancy Prevention Replication Study is being conducted under contract for the U.S. Department of Health and Human Services (DHHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) and Office of Adolescent Health (OAH) by Abt Associates and its subcontractors, Belmont Research Associates, and Decision Information Resources (DIR). The study seeks to add to the knowledge base about effective teen pregnancy prevention programs by examining replications of evidence-based program models currently funded through the Teen Pregnancy Prevention program, administered by OAH.
Through a series of rigorous experimental design evaluations, the study will test multiple replications of three widely-used evidence-based program models to determine their effectiveness across different settings and populations. This strategy of selecting multiple replications of each program model will allow for an examination of variation in impacts across replications for each program model and provide evidence about the generalizability of program effectiveness. A comprehensive implementation study will provide information about the contexts in which evidence-based programs are implemented, the challenges faced in implementing them, and the aspects of program implementation that are associated with program impacts.
The models that will be examined in this study include: ¡Cuidate! (an HIV/STI risk reduction program); Reducing the Risk (a sexuality education curriculum); and Safer Sex (a clinic-based HIV/STI prevention program for high-risk adolescent females). Program impacts will be estimated by using an experimental design in which youth are randomly assigned to treatment and control conditions. The unit of random assignment will be the individual or school class, depending upon the program setting.
Overall, the study will be based on a sample of approximately 8,000 youth in nine locations across the country. The evaluation team will collect baseline information when youth are enrolled in the program, short-term outcome data at a follow-up survey between 6 and 12 months post-random assignment, and longer-term outcome data at a follow-up survey administered between 18 and 24 months post-random assignment. Comparison of outcomes for program and control groups will provide important information about the effectiveness of the programs in reducing teen pregnancy and associated risk behaviors.
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:
- youth at risk active consent parent permission
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TPP program
Reducing the Risk, Safer Sex Intervention, Cuidate!
|
Safer Sex is a clinic-based intervention intended to reduce the incidence of STIs and increase condom use among high-risk sexually active female adolescents and delivered in face-to-face individualized sessions by a female health educator.
Reducing the Risk is a sexuality-education curriculum, most often delivered in a school setting that provides instruction and practice in the social skills needed to put into action what students learn about preventing pregnancy and reducing unsafe behavior in future high-risk situations.
¡Cuidate! is adapted from the Be Proud!
Be Responsible!
curriculum and culturally tailored for Latino youth.
It aims to reduce HIV risk and unintended pregnancies by affecting sexual behaviors such as intercourse, number of partners, and condom use.
Other Names:
|
No Intervention: Business as Usual
Business as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual activity in the last 90 days
Time Frame: 6 months after baseline
|
single dichotomous outcome on self-report questionnaire
|
6 months after baseline
|
Sexual Risk in the last 90 days
Time Frame: 6 months after baseline
|
single dichotomous outcome on self-report questionnaire
|
6 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of Birth Control in the last 90 days
Time Frame: 6 months after baseline
|
single dichotomous outcome on self-report questionnaire
|
6 months after baseline
|
Knowledge of Sexually transmitted infections
Time Frame: 6 months after baseline
|
Average of 12 dichotomous items on self-report questionnaire
|
6 months after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meredith C Kelsey, PhD, Abt Associates Inc
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 (Estimate)
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
- HHSP23320095624WC
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.
Clinical Trials on Teen Pregnancy
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Winter Rose Services, LLCDepartment of Health and Human ServicesUnknown
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Eunice Kennedy Shriver National Institute of Child...CompletedTeen PregnancyUnited States
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The Policy & Research GroupThe Office of Adolescent Health, HHS; Sentient Research; Planned Parenthood Mar...Completed
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Mathematica Policy Research, Inc.Office of Population AffairsCompletedTeen Pregnancy Prevention
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Philliber Research & EvaluationHealthy Futures of Texas; The Office of Adolescent Health, HHSCompletedTeen Pregnancy PreventionUnited States
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Philliber Research & EvaluationThe Office of Adolescent Health, HHSCompletedTeen Pregnancy Prevention
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University of South FloridaUnknown
-
The Policy & Research GroupDepartment of Health and Human ServicesRecruiting
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The Policy & Research GroupDepartment of Health and Human Services; Mathematica Policy Research, Inc.Active, not recruitingTeen Pregnancy PreventionUnited States
-
The Policy & Research GroupThe Office of Adolescent Health, HHSCompletedTeen Pregnancy Prevention
Clinical Trials on Reducing the Risk
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Mathematica Policy Research, Inc.Completed
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-
University of LouisvilleDepartment of Health and Human ServicesCompletedSexually Transmitted Diseases | PregnancyUnited States
-
Children's Hospital of Fudan UniversityCompletedObesity | Overweight | Cardiometabolic RiskChina
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Emory UniversityTerminated
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)CompletedHIV Infections | HIVUnited States
-
Cynthia FontanellaNational Institute of Mental Health (NIMH); Ohio State University; Holzer Gallipolis and other collaboratorsRecruitingSuicidal Ideation | Suicide, Attempted | Suicide PreventionUnited States
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International Islamic Center for Population Studies...Recruiting