Longitudinal Effects of a Sexual Health Intervention: HEART

June 7, 2022 updated by: Laura Widman, North Carolina State University
Randomized Controlled Trial to evaluate the eHealth program, HEART (Health Education and Relationship Training).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27695
        • North Carolina State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current high school student
  • Able to read English

Exclusion Criteria:

  • Not able to read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV/STD Knowledge
Time Frame: 12 months
9-item HIV/STD knowledge scale; score range 0-9; higher scores indicate greater HIV/STD knowledge
12 months
Self-efficacy
Time Frame: 12 months
8-item self-efficacy for HIV prevention scale; score range 1-4; higher scores indicate greater self-efficacy
12 months
Condom Attitudes
Time Frame: 12 months
3-item Condom Attitudes scale; score range 1-5; higher scores indicate greater condom attitudes
12 months
Condom Norms
Time Frame: 12 months
3-item condom norms scale; score range 1-5; higher scores indicate greater condom norms
12 months
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
12 months
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
12 months
sexual assertiveness
Time Frame: 12 months
3-item sexual assertiveness scale score range 1-5; higher scores indicate greater sexual assertiveness
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Carolina State University

Investigators

  • Principal Investigator: Laura Widman, PhD, North Carolina State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

November 2, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 55597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified data will be available upon request with proper IRB training and approval

IPD Sharing Time Frame

Data will be made available within 3 months of study completion.

IPD Sharing Access Criteria

Contact the investigator: lmwidman@ncsu.edu

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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