Longitudinal Effects of a Sexual Health Intervention: HEART

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

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).

Interventions

  • Behavioral: HEART
    • sexual health intervention
  • Behavioral: HealthyMinds
    • Growth mindsets of personality and mental health

Arms, Groups and Cohorts

  • Experimental: HEART
    • sexual health intervention that focuses on communication skills
  • Active Comparator: HealthyMinds
    • Attention-matched control: Growth mindset intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Current high school student
  • Able to read English

Exclusion Criteria

  • Not able to read English

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • North Carolina State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura Widman, Associate Professor of Psychology – North Carolina State University
  • Overall Official(s)
    • Laura Widman, PhD, Principal Investigator, North Carolina State University
  • Overall Contact(s)
    • Laura Widman, PhD, 919-513-2546, lmwidman@ncsu.edu

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