Wrap It Up Rigorous Evaluation

NCT06574321 | Enrolling By Invitation

• 1 other identifier: TP2AH000084
• Study Type: interventional
• Target: 1,120
• Locations: 1 country
• Sites: 1

Brief 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

Sexually Transmitted Diseases; Pregnancy in Adolescence

Keywords

Pregnancy in Adolescence; Prevention; Sexual Health; Sex Education

Outcome Measures

Primary Outcomes (1)

• No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days

  Vaginal sex: Single-item dichotomous measure assessing any consensual vaginal sex in the past 3 months. If yes, condom and birth control use measured with single-item categorical frequency of (a) condom use with consensual vaginal sex in past 3 months and (b) birth control use, other than condoms, with consensual vaginal sex in past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never. Anal sex: Single-item dichotomous measure assessing any consensual anal sex in the past 3 months. If yes, condom use measured with single-item categorical frequency of condom use with consensual anal sex in the past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never.

  6 months post-baseline

Secondary Outcomes (3)

• Improved self-efficacy for self-advocating with healthcare providers, peers, and partners about sexual health

  6 months post-baseline

• Improved self-efficacy to find and access sexual health services

  6 months post-baseline

• No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days

  12 months post-baseline

Study Arms (2)

WIU Intervention

EXPERIMENTAL

Intervention: Students in schools in this group will receive Wrap It Up, a 4-to-5-session SHE "booster" program

Behavioral: Wrap It Up (WIU)

Comparison

NO INTERVENTION

"Business-as-usual" control: Students in schools in this group will receive their school's normal classroom teaching

Interventions

Wrap It Up (WIU) BEHAVIORAL

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.

WIU Intervention

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• part of the class or group identified by their school
• to 19 years old
• sufficient English language skills (as assessed by data collector) to take part in the TTHSR intervention

You may not qualify if:

• Under 16 years old
• years old or over
• Insufficient English language skills (as assessed by data collector) to take part in the Wrap It Up intervention

Sponsors & Collaborators

• ETR Associates: lead

Study Sites (1)

ETR

Scotts Valley, California, 95066, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pamela J Drake, PhD

  ETR Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This evaluation is a cluster RCT using a "school by year" approach. 16 California schools will participate for 2 years. 8 will be randomly assigned to the "intervention-first" group and 8 to the "comparison-first" group. Each school will serve as its own control and has an equal chance of being in either the intervention-first or the comparison-first group. During their comparison group year, schools will administer their normal sexual health education programming.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)