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Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEART
Growing Minds
Sponsored by
North Carolina State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • North Carolina State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HEART

Growing Minds

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HIV/STD Knowledge
HIV/STD knowledge was assessed with 9 items (e.g., "STDs usually have noticeable symptoms, like itching or burning"). These were adapted from previous sexual health knowledge questionnaires (Brown, DiClemente, & Park, 1992; Morton, Nelson, Walsh, Zimmerman, & Coe, 1996) and were used in our previous work (Widman, Golin, et al., 2018). Participants rated each item as True, False, or Don't Know. Responses were recoded as 0 (Incorrect or Don't Know) or 1 (Correct). Scores were summed to reflect the total number of correct HIV/STD knowledge questions (possible range=0-9).
Condom Beliefs
Participants' attitudes about condoms were assessed with the 3-item Effect on Sexual Experiences subscale of the Condom Attitudes Scale Adolescent Version (St. Lawrence et al., 1994). An example item includes, "Condoms take away the pleasure of sex." Responses were on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.77). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5).
Sexual Assertiveness
Self-reported sexual assertiveness was assessed with 3-items from the Multidimensional Sexual Self-Concept Scale (Snell, 1998). Items such as, "I'm very assertive about the sexual aspects of my life," were rated on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.75). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5).
Safer Sex Intentions
Intentions to discuss sexual health was assessed with a item developed by our research team based on items from the AIDS Risk Behavior Survey (Donenberg, Emerson, Bryant, Wilson, & Weber-Shifrin, 2001) and our previous work (Widman, Golin, et al., 2018). This item asked how likely teens were to discuss sexual health issues, including pregnancy and STDs, with their partner(s) prior to sexual activity (communication intentions). Response options ranged from 1 (not at all likely) to 5 (very likely). Higher scores indicate better outcomes.
Safer Sex Self-Efficacy
The Self-Efficacy for HIV Prevention Scale (Brown et al., 2014) was used to assess self-efficacy about communication and condom use. Six items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Two items assessed confidence obtaining and using condoms (e.g., "How sure are you that you could have condoms available when you need them?"). Participants responded from 1 (Couldn't do it) to 4 (Very Sure). A mean of all items was computed, such that higher scores indicate better outcomes (possible range 1-4; alpha=.79).

Full Information

First Posted
February 27, 2018
Last Updated
September 8, 2020
Sponsor
North Carolina State University
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1. Study Identification

Unique Protocol Identification Number
NCT03453515
Brief Title
Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Official Title
Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Carolina State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEART
Arm Type
Experimental
Arm Description
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.
Arm Title
Growing Minds
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HEART
Intervention Description
Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
Intervention Type
Behavioral
Intervention Name(s)
Growing Minds
Intervention Description
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 Measure Information:
Title
Acceptability
Description
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
Time Frame
immediate post-test at completion of intervention
Secondary Outcome Measure Information:
Title
HIV/STD Knowledge
Description
HIV/STD knowledge was assessed with 9 items (e.g., "STDs usually have noticeable symptoms, like itching or burning"). These were adapted from previous sexual health knowledge questionnaires (Brown, DiClemente, & Park, 1992; Morton, Nelson, Walsh, Zimmerman, & Coe, 1996) and were used in our previous work (Widman, Golin, et al., 2018). Participants rated each item as True, False, or Don't Know. Responses were recoded as 0 (Incorrect or Don't Know) or 1 (Correct). Scores were summed to reflect the total number of correct HIV/STD knowledge questions (possible range=0-9).
Time Frame
immediate post-test at completion of intervention
Title
Condom Beliefs
Description
Participants' attitudes about condoms were assessed with the 3-item Effect on Sexual Experiences subscale of the Condom Attitudes Scale Adolescent Version (St. Lawrence et al., 1994). An example item includes, "Condoms take away the pleasure of sex." Responses were on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.77). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5).
Time Frame
immediate post-test at completion of intervention
Title
Sexual Assertiveness
Description
Self-reported sexual assertiveness was assessed with 3-items from the Multidimensional Sexual Self-Concept Scale (Snell, 1998). Items such as, "I'm very assertive about the sexual aspects of my life," were rated on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.75). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5).
Time Frame
immediate post-test at completion of intervention
Title
Safer Sex Intentions
Description
Intentions to discuss sexual health was assessed with a item developed by our research team based on items from the AIDS Risk Behavior Survey (Donenberg, Emerson, Bryant, Wilson, & Weber-Shifrin, 2001) and our previous work (Widman, Golin, et al., 2018). This item asked how likely teens were to discuss sexual health issues, including pregnancy and STDs, with their partner(s) prior to sexual activity (communication intentions). Response options ranged from 1 (not at all likely) to 5 (very likely). Higher scores indicate better outcomes.
Time Frame
immediate post-test at completion of intervention
Title
Safer Sex Self-Efficacy
Description
The Self-Efficacy for HIV Prevention Scale (Brown et al., 2014) was used to assess self-efficacy about communication and condom use. Six items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Two items assessed confidence obtaining and using condoms (e.g., "How sure are you that you could have condoms available when you need them?"). Participants responded from 1 (Couldn't do it) to 4 (Very Sure). A mean of all items was computed, such that higher scores indicate better outcomes (possible range 1-4; alpha=.79).
Time Frame
immediate post-test at completion of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 10th or 11th grader Able to read English Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Widman, PhD
Organizational Affiliation
North Carolina State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina State University
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27695
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens

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