Wrap It Up Rigorous Evaluation
NCT06574321 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1120
Last updated 2026-01-23
Summary
Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. Wrap It Up (WIU) is a sexual health education "booster" program for older high school students attending school in rural communities that was designed to help address this situation. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated with a randomized controlled trial.
WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE.
The study's primary research question is:
What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?
The study's secondary research questions are:
* What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers, peers, and partners about their sexual health?
* What is the impact at 6-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services?
* What is the impact at 12-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?
Conditions
- Pregnancy in Adolescence
- Sexually Transmitted Diseases
Interventions
- BEHAVIORAL
-
Wrap It Up (WIU)
WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered in five 1-hour sessions during late high school, intended to enhance the effectiveness of previous SHE.
Sponsors & Collaborators
-
ETR Associates
lead OTHER
Principal Investigators
-
Pamela J Drake, PhD · ETR Associates
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-29
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- United States
Study Locations
More Related Trials
-
Trial of the Teens and Toddlers Intervention
NCT01310543 ·Status: COMPLETED ·Phase: PHASE3
-
Replication of the Teen Outreach Program in Kansas City
NCT02514759 ·Status: COMPLETED ·Phase: NA
-
LeadHer, a Gender-specific Teen Pregnancy Prevention Curriculum for Girls 15-19
NCT03265314 ·Status: COMPLETED ·Phase: NA
-
A Parent Child Program to Prevent Adolescent Pregnancy
NCT02333019 ·Status: COMPLETED ·Phase: NA
-
Replication of the Teen Outreach Program in the Pacific Northwest
NCT02514811 ·Status: COMPLETED ·Phase: NA
-
A Pre and Post Test Intervention Design to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya
NCT03065842 ·Status: COMPLETED ·Phase: NA
-
An Intervention to Reduce Risk Factors for Adolescent Pregnancy
NCT04222959 ·Status: COMPLETED ·Phase: NA
-
Taking Responsible Actions in Life Evaluation
NCT05182736 ·Status: COMPLETED ·Phase: NA
-
Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings
NCT05796687 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Using Social Media to Enhance the Impact of the Teen Outreach Program
NCT01535651 ·Status: COMPLETED ·Phase: NA
-
Planned Parenthood Teen Council Program Study
NCT05087004 ·Status: COMPLETED ·Phase: NA
-
Louisville Teen Pregnancy Prevention Project
NCT01411878 ·Status: COMPLETED ·Phase: NA
-
Reducing Teen Pregnancy in the Emergency Department
NCT03866811 ·Status: COMPLETED ·Phase: NA
-
Rigorous Evaluation of Let's Talk Birth Control
NCT06670066 ·Status: RECRUITING ·Phase: NA
-
Contraceptive Awareness and Reproductive Education
NCT01627574 ·Status: COMPLETED ·Phase: NA
-
Latino Teen Pregnancy Prevention K23
NCT06105905 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success
NCT03311061 ·Status: UNKNOWN ·Phase: NA
-
Contraceptive Awareness and Reproductive Education
NCT01132950 ·Status: UNKNOWN ·Phase: NA
-
The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
NCT03253783 ·Status: COMPLETED ·Phase: NA
-
Reducing Adolescent Pregnancy in the Emergency Department
NCT04744155 ·Status: COMPLETED ·Phase: NA
-
Study on Mhealth and Reproductive Health in Teens
NCT02031575 ·Status: COMPLETED ·Phase: NA
-
Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls
NCT03029962 ·Status: COMPLETED ·Phase: NA
-
Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
NCT04578093 ·Status: WITHDRAWN ·Phase: NA
-
Girl2Girl: A Web-based Trial
NCT04809155 ·Status: UNKNOWN ·Phase: NA
-
Heart to Heart: Testing a Sexual Health Training for Foster and Kinship Caregivers
NCT03331016 ·Status: COMPLETED ·Phase: NA