NCT03453515

Brief Summary

This study evaluates an educational web-based intervention designed to increase adolescent boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health Education and Relationship Training). Half of participants will receive HEART and half of participants will receive Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

February 27, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

February 27, 2018

Results QC Date

October 16, 2019

Last Update Submit

September 8, 2020

Conditions

HIV InfectionsSexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    6-item self-report of program acceptability. Each item analyzed separately for the percentage endorsement. Items were as follows: Liked the program Learned new things Program kept attention Will use information in the future Useful for girls my age Useful for boys my age Below we report results for the first item: number of participants who agree that they like the program

    immediate post-test at completion of intervention

Secondary Outcomes (5)

  • HIV/STD Knowledge

    immediate post-test at completion of intervention

  • Condom Beliefs

    immediate post-test at completion of intervention

  • Sexual Assertiveness

    immediate post-test at completion of intervention

  • Safer Sex Intentions

    immediate post-test at completion of intervention

  • Safer Sex Self-Efficacy

    immediate post-test at completion of intervention

Study Arms (2)

HEART

EXPERIMENTAL

Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete.

Behavioral: HEART

Growing Minds

OTHER

Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete.

Behavioral: Growing Minds

Interventions

HEARTBEHAVIORAL

Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.

HEART
Growing MindsBEHAVIORAL

Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.

Growing Minds

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • th or 11th grader
  • Able to read English

You may not qualify if:

  • None

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

HIV InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Laura Widman
Organization
North Carolina State University
lmwidman@ncsu.edu
919-513-2546

Study Officials

  • Laura Widman, PhD

    North Carolina State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Assistant Professor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

March 1, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2019

Last Updated

September 29, 2020

Results First Posted

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)