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Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens

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ClinicalTrials.gov Identifier: NCT03453515
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Widman, North Carolina State University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Sexually Transmitted Diseases Behavioral: HEART Behavioral: Growing Minds Not Applicable

Detailed Description:

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.

Primary outcomes for this study include 1) acceptability of the program, 2) safer sex self-efficacy, and 3) safer sex intentions.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 8, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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

Growing Minds
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
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.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: immediate post-test at completion of intervention ]
    6-item self-report of program acceptability


Secondary Outcome Measures :
  1. HIV/STD knowledge [ Time Frame: immediate post-test at completion of intervention and 6-month follow-up ]
    9-item measure of HIV/STD knowledge

  2. Condom Beliefs [ Time Frame: immediate post-test at completion of intervention and 6-month follow-up ]
    10-item measure of condom beliefs

  3. Sexual Assertiveness [ Time Frame: immediate post-test at completion of intervention and 6-month follow-up ]
    3-item measure of sexual assertiveness

  4. Safer Sex Intentions [ Time Frame: immediate post-test at completion of intervention and 6-month follow-up ]
    2-item measure of intentions to use condoms and talk with partners

  5. Safer Sex Self-Efficacy [ Time Frame: immediate post-test at completion of intervention and 6-month follow-up ]
    8-item self-report of safer sex self-efficacy



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10th or 11th grader
  • Able to read English

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453515


Contacts
Contact: Laura Widman, PhD 919-513-2546 lmwidman@ncsu.edu

Locations
United States, North Carolina
North Carolina State University Recruiting
Raleigh, North Carolina, United States, 27695
Contact: Laura Widman, PhD    919-513-2546    lmwidman@ncsu.edu   
Sponsors and Collaborators
North Carolina State University
Investigators
Principal Investigator: Laura Widman, PhD North Carolina State University

Responsible Party: Laura Widman, Assistant Professor, North Carolina State University
ClinicalTrials.gov Identifier: NCT03453515     History of Changes
Other Study ID Numbers: NCState
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female