Longitudinal Effects of a Sexual Health Intervention: HEART

Adolescent Behavior Clinical Trial

Official title:

Longitudinal Effects of a Sexual Health Intervention: HEART

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04156516
• Other study ID #: 55597
• Status: Terminated
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: June 2022
• Source: North Carolina State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 457
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Current high school student
• Able to read English

Exclusion Criteria:

• Not able to read English

Related Conditions & MeSH terms

• Adolescent Behavior
• STD

Intervention

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

Locations

Country	Name	City	State
United States	North Carolina State University	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
North Carolina State University

Country where clinical trial is conducted

United States, 

Outcome

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