Trial Outcomes & Findings for Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens (NCT NCT03453515)
NCT ID: NCT03453515
Last Updated: 2020-09-29
Results Overview
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
COMPLETED
NA
226 participants
immediate post-test at completion of intervention
2020-09-29
Participant Flow
Participant milestones
| Measure |
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.
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
|
Overall Study
COMPLETED
|
107
|
100
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Baseline characteristics by cohort
| Measure |
HEART
n=113 Participants
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.
|
Growing Minds
n=113 Participants
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
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.27 Years
STANDARD_DEVIATION .79 • n=5 Participants
|
16.24 Years
STANDARD_DEVIATION .74 • n=7 Participants
|
16.25 Years
STANDARD_DEVIATION .76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latinx
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
113 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Free/reduced price lunch
|
59 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediate post-test at completion of interventionPopulation: 7 participants from HEART and 15 participants from Growing Minds did not complete the acceptability questionnaire.
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
Outcome measures
| Measure |
HEART
n=106 Participants
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.
|
Growing Minds
n=98 Participants
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.
|
|---|---|---|
|
Acceptability
|
88 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: immediate post-test at completion of interventionPopulation: 6 participants from HEART and 13 participants from Growing Minds did not complete the HIV/STD knowledge scale at post-test
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).
Outcome measures
| Measure |
HEART
n=107 Participants
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.
|
Growing Minds
n=100 Participants
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.
|
|---|---|---|
|
HIV/STD Knowledge
|
7.68 units on a scale
Standard Deviation 1.79
|
5.74 units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: immediate post-test at completion of interventionPopulation: 6 participants from HEART and 13 participants from Growing Minds did not complete the condom beliefs scale at post-test
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).
Outcome measures
| Measure |
HEART
n=107 Participants
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.
|
Growing Minds
n=100 Participants
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.
|
|---|---|---|
|
Condom Beliefs
|
3.85 units on a scale
Standard Deviation .96
|
3.22 units on a scale
Standard Deviation .94
|
SECONDARY outcome
Timeframe: immediate post-test at completion of interventionPopulation: 6 participants from HEART and 13 participants from Growing Minds did not complete the sexual assertiveness scale at post-test
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).
Outcome measures
| Measure |
HEART
n=107 Participants
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.
|
Growing Minds
n=100 Participants
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.
|
|---|---|---|
|
Sexual Assertiveness
|
3.88 units on a scale
Standard Deviation .98
|
3.68 units on a scale
Standard Deviation .75
|
SECONDARY outcome
Timeframe: immediate post-test at completion of interventionPopulation: 6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex intentions item at post-test
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.
Outcome measures
| Measure |
HEART
n=107 Participants
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.
|
Growing Minds
n=100 Participants
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.
|
|---|---|---|
|
Safer Sex Intentions
|
4.43 units on a scale
Standard Deviation .83
|
3.97 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: immediate post-test at completion of interventionPopulation: 6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex self-efficacy scale item at post-test
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).
Outcome measures
| Measure |
HEART
n=107 Participants
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.
|
Growing Minds
n=100 Participants
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.
|
|---|---|---|
|
Safer Sex Self-Efficacy
|
3.30 units on a scale
Standard Deviation .66
|
3.21 units on a scale
Standard Deviation .56
|
Adverse Events
HEART
Growing Minds
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place