Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens

HIV Infections Clinical Trial

Official title:

Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453515
• Other study ID #: NCState
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2020
• Source: North Carolina State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• 10th or 11th grader

• Able to read English

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

Intervention

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

Locations

Country	Name	City	State
United States	North Carolina State University	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
North Carolina State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	immediate post-test at completion of intervention
Secondary	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).	immediate post-test at completion of intervention
Secondary	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).	immediate post-test at completion of intervention
Secondary	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.	immediate post-test at completion of intervention
Secondary	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).	immediate post-test at completion of intervention