Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens

• Sponsor: North Carolina State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03453515
• Collaborator: (none)
• Enrollment: 226
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 16.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Sexually Transmitted Diseases	Behavioral: HEART; Behavioral: Growing Minds	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 226 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: Mar 1, 2018
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

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.
Other: 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.

Outcome Measures

Primary Outcome Measures

1. Acceptability [immediate post-test at completion of intervention]

   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

1. HIV/STD Knowledge [immediate post-test at completion of intervention]

   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).

2. Condom Beliefs [immediate post-test at completion of intervention]

   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).

3. Sexual Assertiveness [immediate post-test at completion of intervention]

   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).

4. Safer Sex Intentions [immediate post-test at completion of intervention]

   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.

5. Safer Sex Self-Efficacy [immediate post-test at completion of intervention]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 10th or 11th grader

• Able to read English

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Carolina State University	Raleigh	North Carolina	United States	27695

Sponsors and Collaborators

• North Carolina State University

Investigators

• Principal Investigator: Laura Widman, PhD, North Carolina State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2019

More Information

Publications

None provided.

• Responsible Party: Laura Widman, Assistant Professor, North Carolina State University
• ClinicalTrials.gov Identifier: NCT03453515
• Other Study ID Numbers: NCState
• First Posted: Mar 5, 2018
• Last Update Posted: Sep 29, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Sexually Transmitted Diseases

Study Results

Participant Flow

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Period Title: Overall Study
STARTED	113	113
COMPLETED	107	100
NOT COMPLETED	6	13

Baseline Characteristics

Arm/Group Title	HEART	Growing Minds	Total
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.	Total of all reporting groups
Overall Participants	113	113	226
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	16.27 (.79)	16.24 (.74)	16.25 (.76)
Sex: Female, Male (Count of Participants)
Female	69 61.1%	67 59.3%	136 60.2%
Male	44 38.9%	46 40.7%	90 39.8%
Race/Ethnicity, Customized (Count of Participants)
White	46 40.7%	57 50.4%	103 45.6%
Black	32 28.3%	23 20.4%	55 24.3%
Latinx	28 24.8%	29 25.7%	57 25.2%
Other	7 6.2%	4 3.5%	11 4.9%
Region of Enrollment (Count of Participants)
United States	113 100%	113 100%	226 100%
Free/reduced price lunch (Count of Participants)
Count of Participants [Participants]	59 52.2%	53 46.9%	112 49.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

7 participants from HEART and 15 participants from Growing Minds did not complete the acceptability questionnaire.

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Measure Participants	106	98
Count of Participants [Participants]	88 77.9%	83 73.5%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

6 participants from HEART and 13 participants from Growing Minds did not complete the HIV/STD knowledge scale at post-test

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Measure Participants	107	100
Mean (Standard Deviation) [units on a scale]	7.68 (1.79)	5.74 (1.86)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

6 participants from HEART and 13 participants from Growing Minds did not complete the condom beliefs scale at post-test

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Measure Participants	107	100
Mean (Standard Deviation) [units on a scale]	3.85 (.96)	3.22 (.94)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

6 participants from HEART and 13 participants from Growing Minds did not complete the sexual assertiveness scale at post-test

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Measure Participants	107	100
Mean (Standard Deviation) [units on a scale]	3.88 (.98)	3.68 (.75)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex intentions item at post-test

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Measure Participants	107	100
Mean (Standard Deviation) [units on a scale]	4.43 (.83)	3.97 (1.15)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex self-efficacy scale item at post-test

Arm/Group Title	HEART	Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.	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. 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.
Measure Participants	107	100
Mean (Standard Deviation) [units on a scale]	3.30 (.66)	3.21 (.56)

Adverse Events

Time Frame	1 yr
Arm/Group Title	HEART		Growing Minds
Arm/Group 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. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.		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. 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.
All Cause Mortality
	HEART		Growing Minds
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/113 (0%)
Serious Adverse Events
	HEART		Growing Minds
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/113 (0%)
Other (Not Including Serious) Adverse Events
	HEART		Growing Minds
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		0/113 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.