STDNCT04156516
Longitudinal Effects of a Sexual Health Intervention: HEART
A study testing HEART and HealthyMinds in people with STD and Adolescent Behavior, run by North Carolina State University at 1 site in United States.
Trial summary
Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STD, Adolescent Behavior
- What is being tested?
- HEART and HealthyMinds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current high school student
- Able to read English
Who cannot join
- Not able to read English
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina State University
Raleigh, North Carolina, 27695
About this study
Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training).
Read the detailed description
Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training). Data collection will occur at pretest, posttest, 12m (primary endpoint) and 18m (to look at stability of effects over time).
- Conditions
- STD, Adolescent Behavior
- Being tested
- HEART, HealthyMinds
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARTBehavioural
sexual health intervention
HealthyMindsBehavioural
Growth mindsets of personality and mental health
| Study group | Role | What they receive |
|---|---|---|
| HEART | Experimental | sexual health intervention that focuses on communication skills Receives: Behavioral: HEART |
| HealthyMinds | Active comparator | Attention-matched control: Growth mindset intervention Receives: Behavioral: HealthyMinds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use at last sex
Percentage of participants who used condoms at last sexual intercourse in the treatment group compared to the control group
Measured: 12 months
Sexual intercourse within the past 12 months
Percentage of participants who had sexual intercourse in the past 12 months in the treatment group compared to the control group
Measured: 12 months
Secondary outcomes (7)
HIV/STD Knowledge
9-item HIV/STD knowledge scale; score range 0-9; higher scores indicate greater HIV/STD knowledge
Measured: 12 months
Self-efficacy
8-item self-efficacy for HIV prevention scale; score range 1-4; higher scores indicate greater self-efficacy
Measured: 12 months
Condom Attitudes
3-item Condom Attitudes scale; score range 1-5; higher scores indicate greater condom attitudes
Measured: 12 months
Condom Norms
3-item condom norms scale; score range 1-5; higher scores indicate greater condom norms
Measured: 12 months
Communication intentions
1-item sexual communication intention; score range 0-4; higher scores indicate greater intentions to communicate with partners about sex
Measured: 12 months
Condom use intention
1-item condom use intention; score range 0-4; higher scores indicate greater intentions to use condoms at next intercourse
Measured: 12 months
sexual assertiveness
3-item sexual assertiveness scale score range 1-5; higher scores indicate greater sexual assertiveness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Nov 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Why it stopped: COVID-19 pandemic interfered with school-based data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STDStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Widman, North Carolina State University
- Investigators
- Laura Widman, PhD, Principal investigator, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156516
- Sponsor's protocol ID
- 55597
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available upon request with proper IRB training and approval
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Effects of a Sexual Health Intervention: HEART
- ClinicalTrials.gov ID
- NCT04156516
- Acronym / sponsor ID
- 55597
- Conditions
- STD, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic interfered with school-based data collection
- Enrolment
- 457 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 7 Nov 2019 (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.
Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training).
Detailed description
Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training). Data collection will occur at pretest, posttest, 12m (primary endpoint) and 18m (to look at stability of effects over time).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEART | Experimental | Behavioral: HEARTsexual health intervention that focuses on communication skills |
| HealthyMinds | Active comparator | Behavioral: HealthyMindsAttention-matched control: Growth mindset intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Current high school student
- Able to read English
Key exclusion criteria (1 listed)
- Not able to read English
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 |
|---|---|---|
| HEARTsexual health intervention | Behavioural | HEART |
| HealthyMindsGrowth mindsets of personality and mental health | Behavioural | HealthyMinds |
Primary outcome
Condom use at last sex
Time frame: 12 months
Percentage of participants who used condoms at last sexual intercourse in the treatment group compared to the control group
Sexual intercourse within the past 12 months
Time frame: 12 months
Percentage of participants who had sexual intercourse in the past 12 months in the treatment group compared to the control group
7 secondary outcomes
HIV/STD Knowledge
Time frame: 12 months
Self-efficacy
Time frame: 12 months
Condom Attitudes
Time frame: 12 months
Condom Norms
Time frame: 12 months
Communication intentions
Time frame: 12 months
Condom use intention
Time frame: 12 months
sexual assertiveness
Time frame: 12 months
Results and safety
The study was stopped early (reason given: COVID-19 pandemic interfered with school-based data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Yes. Deidentified data will be available upon request with proper IRB training and approval
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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. This study is not recruiting at the moment.
Laura Widman, PhD principal investigator
North Carolina State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEART and HealthyMinds in people with STD and Adolescent Behavior, run by North Carolina State University 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 2 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: stopped early, as of the sponsor's last update on 9 Jun 2022. 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?
The study was stopped early (reason given: COVID-19 pandemic interfered with school-based data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condom use at last sex (time frame: 12 months). 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 9 Jun 2022.