Sexual Health EducationNCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
A study testing iCHAMPSS 2.0 in people with Sexual Health Education, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sexual Health Education
- What is being tested?
- iCHAMPSS 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Belinda Hernandez, PhD, MPH, (210) 276-9009, Belinda.Hernandez@uth.tmc.edu
Laura Thormaehlen, (713) 500-9000, Laura.C.Thormaehlen@uth.tmc.edu
About this study
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.
- Conditions
- Sexual Health Education
- Being tested
- iCHAMPSS 2.0
- Keywords
- iCHAMPSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCHAMPSS 2.0Behavioural
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:
- the CHAMPSS Model tutorial, which familiarizes Champions with the iCHAMPSS 2.0 system
- 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
- a tools library, which includes a suite of over 60 decision support tools
- an interactive linkage system, which is an online platform to help Champions connect with others and to receive technical assistance (TA)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 1 semester of implementation then 7 semesters of intervention | Experimental | Not described Receives: Behavioral: iCHAMPSS 2.0 |
| Arm 2: 1 semester of control, 1 semester of implementation then 7 semesters of intervention | Experimental | Not described Receives: Behavioral: iCHAMPSS 2.0 |
| Arm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention | Experimental | Not described Receives: Behavioral: iCHAMPSS 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of schools within a district implementing an EBP
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Rate of implementation of the EBP
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Percentage of schools that have implemented the evidence-based program for more than one academic year as assessed by the implementation survey
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in perceived complexity as assessed by the staff survey
This is a 3 item questionnaire and each is scored form (1) Strongly disagree to (5) Strongly agree, maximum score of 15, higher score indicating worse outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in compatibility as assessed by the staff survey
This is a 5 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree maximum score 25, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in relative advantage as assessed by the staff survey
This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score of 20, higher score indicating better better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in perceived social systems support in parent community as assessed by the staff survey
This is a 8 item questionnaire and each is scored from (1) not at all supportive to (4) very supportive , maximum score of 32 , higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in presence of school policy as assessed by the staff survey
This is a 2 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 10, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in adequate resources as assessed by the staff survey
This is a 5 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 25, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in presence of a program champion as assessed by the staff survey
This is a 4 item questionnaire and each is scored 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in implementation climate as assessed by the staff survey
This is a 6 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 30, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in inter organizational relationships as assessed by the staff survey
This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in intra organizational relationships as assessed by the staff survey
This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in perceived need as assessed by the staff survey
This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score range of 20, higher score indicating worse outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in self-efficacy as assessed by the staff survey
This is a 19 item questionnaire and each is scored from 1(not at all confident)-4(very confident) , maximum score range of 76, higher score indicating better outcome
Measured: From baseline to end of intervention period (about 20 to 30 months from baseline)
Frequency of use of iCHAMPSS 2.0 as assessed by the website analytics
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Time spent using iCHAMPSS 2.0 as assessed by the district coordinator survey
This will be reported categorically as less than one hour, 1-2 hours, 3-4 hours, 5-6 hours and 7 hours or more
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Number of recurring users of iCHAMPSS 2.0 as assessed by the website analytics
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Number of unique users of iCHAMPSS 2.0 as assessed by the website analytics
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Mean number of users per school district of iCHAMPSS 2.0 as assessed by the website analytics
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Percentage of school districts/schools using iCHAMPSS 2.0 as assessed by the website analytics
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
This will be reported as a percentage
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Perceived facilitators to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
This will be reported as a percentage
Measured: From baseline to end of school year (about 7 to 12 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start2 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Health EducationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Belinda Hernandez, The University of Texas Health Science Center, Houston
- Investigators
- Belinda Hernandez, PhD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679620
- Sponsor's protocol ID
- HSC-SPH-24-0672
- Other IDs
- R01HD111699
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
- ClinicalTrials.gov ID
- NCT07679620
- Acronym / sponsor ID
- HSC-SPH-24-0672
- Conditions
- Sexual Health Education
- Keywords
- iCHAMPSS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCHAMPSS 2.0iCHAMPSS 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) | Behavioural | Arm 1: 1 semester of implementation then 7 semesters of intervention, Arm 2: 1 semester of control, 1 semester of implementation then 7 semesters of intervention, Arm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention |
Primary outcome
Change in percentage of schools within a district implementing an EBP
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Rate of implementation of the EBP
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
27 secondary outcomes
Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Percentage of schools that have implemented the evidence-based program for more than one academic year as assessed by the implementation survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in perceived complexity as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in compatibility as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in relative advantage as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in perceived social systems support in parent community as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in presence of school policy as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in adequate resources as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in presence of a program champion as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in implementation climate as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in inter organizational relationships as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in intra organizational relationships as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in perceived need as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Change in self-efficacy as assessed by the staff survey
Time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)
Frequency of use of iCHAMPSS 2.0 as assessed by the website analytics
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Time spent using iCHAMPSS 2.0 as assessed by the district coordinator survey
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Number of recurring users of iCHAMPSS 2.0 as assessed by the website analytics
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Number of unique users of iCHAMPSS 2.0 as assessed by the website analytics
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Mean number of users per school district of iCHAMPSS 2.0 as assessed by the website analytics
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Percentage of school districts/schools using iCHAMPSS 2.0 as assessed by the website analytics
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Perceived facilitators to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Time frame: From baseline to end of school year (about 7 to 12 months from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Belinda Hernandez, PhD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCHAMPSS 2.0 in people with Sexual Health Education, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belinda Hernandez, PhD, MPH ((210) 276-9009, Belinda.Hernandez@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of schools within a district implementing an EBP (time frame: From baseline to end of intervention period (about 20 to 30 months from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.