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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04156516
Other study ID # 55597
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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