Longitudinal Effects of a Sexual Health Intervention: HEART

Not Applicable

Terminated

• Conditions: STD; Adolescent Behavior
• Interventions: Behavioral: HealthyMinds; Behavioral: HEART

• Registration Number: NCT04156516
• Lead Sponsor: North Carolina State University

Brief Summary

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 Timeline

• Study First Submitted: 2019-11-02
• Study First Submitted QC: 2019-11-05
• Study Start: 2019-11-06
• Study First Posted: 2019-11-07
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 457

Inclusion Criteria

• Current high school student
• Able to read English

Exclusion Criteria

• Not able to read English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HealthyMinds	HealthyMinds	Attention-matched control: Growth mindset intervention
HEART	HEART	sexual health intervention that focuses on communication skills

Primary Outcome Measures

Name	Time	Method
Condom use at last sex	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	12 months	Percentage of participants who had sexual intercourse in the past 12 months in the treatment group compared to the control group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

North Carolina State University; 🇺🇸 Raleigh, North Carolina, United States