Longitudinal Effects of a Sexual Health Intervention: HEART

Study Overview
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Brief Summary
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Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training).

Detailed Description
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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).

Official Title
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Longitudinal Effects of a Sexual Health Intervention: HEART

Conditions
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STD, Adolescent Behavior

Intervention / Treatment
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* Behavioral: HEART
* Behavioral: HealthyMinds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current high school student Able to read English Exclusion Criteria: Not able to read English
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEART<br>sexual health intervention that focuses on communication skills | Behavioral: HEART<br>* sexual health intervention<br>|
| Active Comparator: HealthyMinds<br>Attention-matched control: Growth mindset intervention | Behavioral: HealthyMinds<br>* Growth mindsets of personality and mental health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom use at last sex | Percentage of participants who used condoms at last sexual intercourse in the treatment group compared to the control group | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV/STD Knowledge | 9-item HIV/STD knowledge scale; score range 0-9; higher scores indicate greater HIV/STD knowledge | 12 months | 
| Self-efficacy | 8-item self-efficacy for HIV prevention scale; score range 1-4; higher scores indicate greater self-efficacy | 12 months | 
| Condom Attitudes | 3-item Condom Attitudes scale; score range 1-5; higher scores indicate greater condom attitudes | 12 months | 
| Condom Norms | 3-item condom norms scale; score range 1-5; higher scores indicate greater condom norms | 12 months | 
| Communication intentions | 1-item sexual communication intention; score range 0-4; higher scores indicate greater intentions to communicate with partners about sex | 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 | 12 months | 
| sexual assertiveness | 3-item sexual assertiveness scale score range 1-5; higher scores indicate greater sexual assertiveness | 12 months |