HIV Infections, Sexually Transmitted Diseases
Conditions
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.
Interventions
BEHAVIORALHEART
Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
BEHAVIORALGrowing 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.
Sponsors
North Carolina State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 10th or 11th grader * Able to read English
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 113 |
| 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. | 113 |
| Total | 226 |
Baseline characteristics
| Characteristic | HEART | Growing Minds | Total |
|---|---|---|---|
| Age, Continuous | 16.27 Years STANDARD_DEVIATION 0.79 | 16.24 Years STANDARD_DEVIATION 0.74 | 16.25 Years STANDARD_DEVIATION 0.76 |
| Free/reduced price lunch | 59 Participants | 53 Participants | 112 Participants |
| Race/Ethnicity, Customized Black | 32 Participants | 23 Participants | 55 Participants |
| Race/Ethnicity, Customized Latinx | 28 Participants | 29 Participants | 57 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 46 Participants | 57 Participants | 103 Participants |
| Region of Enrollment United States | 113 Participants | 113 Participants | 226 Participants |
| Sex: Female, Male Female | 69 Participants | 67 Participants | 136 Participants |
| Sex: Female, Male Male | 44 Participants | 46 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 113 |
| other Total, other adverse events | 0 / 113 | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 | 0 / 113 |
Outcome results
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
Time frame: immediate post-test at completion of intervention
Population: 7 participants from HEART and 15 participants from Growing Minds did not complete the acceptability questionnaire.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEART | Acceptability | 88 Participants |
| Growing Minds | Acceptability | 83 Participants |
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).
Time frame: immediate post-test at completion of intervention
Population: 6 participants from HEART and 13 participants from Growing Minds did not complete the condom beliefs scale at post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEART | Condom Beliefs | 3.85 units on a scale | Standard Deviation 0.96 |
| Growing Minds | Condom Beliefs | 3.22 units on a scale | Standard Deviation 0.94 |
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).
Time frame: immediate post-test at completion of intervention
Population: 6 participants from HEART and 13 participants from Growing Minds did not complete the HIV/STD knowledge scale at post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEART | HIV/STD Knowledge | 7.68 units on a scale | Standard Deviation 1.79 |
| Growing Minds | HIV/STD Knowledge | 5.74 units on a scale | Standard Deviation 1.86 |
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.
Time frame: immediate post-test at completion of intervention
Population: 6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex intentions item at post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEART | Safer Sex Intentions | 4.43 units on a scale | Standard Deviation 0.83 |
| Growing Minds | Safer Sex Intentions | 3.97 units on a scale | Standard Deviation 1.15 |
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).
Time frame: immediate post-test at completion of intervention
Population: 6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex self-efficacy scale item at post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEART | Safer Sex Self-Efficacy | 3.30 units on a scale | Standard Deviation 0.66 |
| Growing Minds | Safer Sex Self-Efficacy | 3.21 units on a scale | Standard Deviation 0.56 |
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).
Time frame: immediate post-test at completion of intervention
Population: 6 participants from HEART and 13 participants from Growing Minds did not complete the sexual assertiveness scale at post-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEART | Sexual Assertiveness | 3.88 units on a scale | Standard Deviation 0.98 |
| Growing Minds | Sexual Assertiveness | 3.68 units on a scale | Standard Deviation 0.75 |