An interventional study of Safer Sex and Growth Mindsets in HIV and Sexually Transmitted Diseases, sponsored by North Carolina State University. Completed at 1 site in United States. Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by North Carolina State University · Not applicable, Interventional, and Prevention
This study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health Education and Relationship Training). Half of participants will receive Project HEART and half of participants will receive Project 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 girls reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.
This study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health Education and Relationship Training). Half of participants will receive Project HEART and half of participants will receive Project 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 girls 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) communication self-efficacy, and 3) communication intentions.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 222 is below the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →North Carolina State University is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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: Safer Sex
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: Growth Mindsets
Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
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.
6-item Self-report of Program Acceptability
Program acceptability was assessed through a questionnaire that was adapted from prior acceptability surveys. Specifically, six items were included to assess six aspects of acceptability: (i) an intent to return to the website, (ii) whether one would recommend the program to a friend, (iii) whether one would use information from the program in the future, (iv) how much one liked the program, (v) how much one learned from the program and (vi) how much one felt the program kept their attention. The first three questions were coded with dichotomous response options (yes/no-unsure), whereas the last three items used a four point Likert-type scale ranging from 1=not at all to 4=a lot. For analyses, these last 3 items were dichotomized into 1=a lot and 0=not a lot.
Time frame: Immediate post-test at completion of intervention
7-item Self-report of Sexual Communication Self-efficacy
We used the validated Self-Efficacy for HIV Prevention Scale to assess communication self-efficacy. Seven items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Participants responded from 1 for "couldn't do it" to 4 for "very sure." Scores were averaged with higher scores indicating greater confidence in communicating about sex (alpha = 0.82).
Time frame: Immediate post-test at completion of intervention and 3-month follow-up
3-item Self-report of Sexual Communication Intentions Over Next 3 Months
We assessed intentions to communicate about sex with items from the AIDS Risk Behavior Assessment. Three items captured the likelihood of communicating with a partner in the next 3 months about (1) sexual limits and boundaries, (2) STDs and pregnancy, and (3) condom use. Options ranged from 0% to 100% to indicate the likelihood of communicating with a partner. We averaged scores to create a composite (possible range 0-100); higher scores indicated greater likelihood of sexual communication (alpha = 0.84).
Time frame: Immediate post-test at completion of intervention and 3-month follow-up
| Milestone | Project HEART | Control: Project Growing Minds |
|---|---|---|
| Started | 107 | 115 |
| Completed | 105 | 106 |
| Not completed | 2 | 9 |
Program acceptability was assessed through a questionnaire that was adapted from prior acceptability surveys. Specifically, six items were included to assess six aspects of acceptability: (i) an intent to return to the website, (ii) whether one would recommend the program to a friend, (iii) whether one would use information from the program in the future, (iv) how much one liked the program, (v) how much one learned from the program and (vi) how much one felt the program kept their attention. The first three questions were coded with dichotomous response options (yes/no-unsure), whereas the last three items used a four point Likert-type scale ranging from 1=not at all to 4=a lot. For analyses, these last 3 items were dichotomized into 1=a lot and 0=not a lot.
| Participants | Project HEART |
|---|---|
| Would return to site | 84 |
| Recommend to friend | 94 |
| Use Information in Future | 101 |
| Liked program a lot | 60 |
| Learned a lot | 80 |
| Program kept attention a lot | 69 |
We used the validated Self-Efficacy for HIV Prevention Scale to assess communication self-efficacy. Seven items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Participants responded from 1 for "couldn't do it" to 4 for "very sure." Scores were averaged with higher scores indicating greater confidence in communicating about sex (alpha = 0.82).
| units on a scale | Project HEART | Control: Project Growing Minds |
|---|---|---|
| 7-item Self-report of Sexual Communication Self-efficacy | 3.62 ± .47 | 3.51 ± .46 |
We assessed intentions to communicate about sex with items from the AIDS Risk Behavior Assessment. Three items captured the likelihood of communicating with a partner in the next 3 months about (1) sexual limits and boundaries, (2) STDs and pregnancy, and (3) condom use. Options ranged from 0% to 100% to indicate the likelihood of communicating with a partner. We averaged scores to create a composite (possible range 0-100); higher scores indicated greater likelihood of sexual communication (alpha = 0.84).
| units on a scale | Project HEART | Control: Project Growing Minds |
|---|---|---|
| 3-item Self-report of Sexual Communication Intentions Over Next 3 Months | 87.0 ± 22.5 | 78.5 ± 27.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Project HEART | 0/107 (0%) | 0/107 (0%) | 0/107 (0%) |
| Control: Project Growing Minds | 0/115 (0%) | 0/115 (0%) | 0/115 (0%) |
| Age, Continuous(years) | Project HEART | Control: Project Growing Minds | Total |
|---|---|---|---|
| Mean | 15.26 ± .48 | 15.22 ± .47 | 15.24 ± .48 |
| Sex: Female, Male(Participants) | Project HEART | Control: Project Growing Minds | Total |
|---|---|---|---|
| Female | 107 | 115 | 222 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Project HEART | Control: Project Growing Minds | Total |
|---|---|---|---|
| White/Non-Hispanic | 38 | 45 | 83 |
| Black/Non-Hispanic | 29 | 25 | 54 |
| Hispanic | 31 | 34 | 65 |
| Other/Mixed Race-Ethnicity | 9 | 11 | 20 |
| Region of Enrollment(Participants) | Project HEART | Control: Project Growing Minds | Total |
|---|---|---|---|
| United States | 107 | 115 | 222 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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North Carolina State University