NCT04156516

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

November 2, 2019

Last Update Submit

June 7, 2022

Conditions

STDAdolescent Behavior

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • HIV/STD Knowledge

    12 months

  • Self-efficacy

    12 months

  • Condom Attitudes

    12 months

  • Condom Norms

    12 months

  • Communication intentions

    12 months

  • +2 more secondary outcomes

Study Arms (2)

HEART

EXPERIMENTAL

sexual health intervention that focuses on communication skills

Behavioral: HEART

HealthyMinds

ACTIVE COMPARATOR

Attention-matched control: Growth mindset intervention

Behavioral: HealthyMinds

Interventions

HEARTBEHAVIORAL

sexual health intervention

HEART
HealthyMindsBEHAVIORAL

Growth mindsets of personality and mental health

HealthyMinds

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Current high school student
  • Able to read English

You may not qualify if:

  • Not able to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina State University

Raleigh, North Carolina, 27695, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Laura Widman, PhD

    North Carolina State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 7, 2019

Study Start

November 6, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be made available within 3 months of study completion.
Access Criteria
Contact the investigator: lmwidman@ncsu.edu

Locations

US(1)