NCT07679620

Brief Summary

The purpose of this study is to assess the efficacy of iCHAMPSS 2.0 in impacting Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) implementation outcomes, with implementation of a sexual health evidence-based program (EBP) assess iCHAMPSS 2.0's efficacy in impacting determinants of sexual health EBP implementation and to conduct a process evaluation to monitor iCHAMPSS 2.0 implementation, reach, dosage, and barriers and facilitators to implementing iCHAMPSS 2.0 during the study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Apr 2028

Study Start

First participant enrolled

April 2, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

July 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 9, 2026

Last Update Submit

June 29, 2026

Conditions

Keywords

iCHAMPSS

Outcome Measures

Primary Outcomes (2)

  • Change in percentage of schools within a district implementing an EBP

    From baseline to end of intervention period (about 20 to 30 months from baseline)

  • Rate of implementation of the EBP

    From baseline to end of intervention period (about 20 to 30 months from baseline)

Secondary Outcomes (27)

  • Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board

    From baseline to end of intervention period (about 20 to 30 months from baseline)

  • Percentage of School Health Advisory Councils (SHACs) that have adopted a sexual health EBP to their school board

    From baseline to end of intervention period (about 20 to 30 months from baseline)

  • Percentage of schools with the school board's approval of an Evidence Based Program (EBP)

    From baseline to end of intervention period (about 20 to 30 months from baseline)

  • Percentage of schools with the principal's approval of an EBP

    From baseline to end of intervention period (about 20 to 30 months from baseline)

  • Percentage of students receiving majority (over 50%) of a sexual health EBP

    From baseline to end of intervention period (about 20 to 30 months from baseline)

  • +22 more secondary outcomes

Study Arms (3)

Arm 1: 1 semester of implementation then 7 semesters of intervention

EXPERIMENTAL
Behavioral: iCHAMPSS 2.0

Arm 2: 1 semester of control, 1 semester of implementation then 7 semesters of intervention

EXPERIMENTAL
Behavioral: iCHAMPSS 2.0

Arm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention

EXPERIMENTAL
Behavioral: iCHAMPSS 2.0

Interventions

iCHAMPSS 2.0BEHAVIORAL

iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features: 1. the CHAMPSS Model tutorial, which familiarizes Champions with the iCHAMPSS 2.0 system 2. a Staging Tool, which helps Champions understand their school's level of readiness to adopt, implement, and maintain a sexual health EBP, and can tailor their experience 3. a tools library, which includes a suite of over 60 decision support tools 4. an interactive linkage system, which is an online platform to help Champions connect with others and to receive technical assistance (TA)

Arm 1: 1 semester of implementation then 7 semesters of interventionArm 2: 1 semester of control, 1 semester of implementation then 7 semesters of interventionArm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Licensed educator or administrator who holds one of the following positions: 1) district or school administrator (e.g., health coordinators, instructional specialists, and curriculum coordinators), 2) health and physical education teachers, and 3) social and health service staff (e.g., nurses and counselors) in a Texas school district participating in the iCHAMPSS 2.0 study

You may not qualify if:

  • not holding a job in a Texas school district as a school stakeholder, OR holding a job in a Texas school district as a school stakeholder but not in a school district participating in the iCHAMPSS 2.0 study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

  • Belinda Hernandez, PhD, MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is a stepwise cluster randomized control design study.There will be 3 clusters of school districts and each cluster will have five school districts with an average of five schools within each district.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

July 1, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

July 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations