HIV, Sexually Transmitted Diseases
Conditions
Keywords
Condoms, Sexual Abstinence, Sexual Communication
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSafer Sex
Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
BEHAVIORALGrowth Mindsets
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
North Carolina State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 10th grade girl * Able to read English
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-item Self-report of Program Acceptability | Immediate post-test at completion of intervention | 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. |
| 7-item Self-report of Sexual Communication Self-efficacy | Immediate post-test at completion of intervention and 3-month follow-up | 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). |
| 3-item Self-report of Sexual Communication Intentions Over Next 3 Months | Immediate post-test at completion of intervention and 3-month follow-up | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Project 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.
Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. | 107 |
| Control: Project 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.
Growth Mindsets: 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. | 115 |
| Total | 222 |
Baseline characteristics
| Characteristic | Project HEART | Control: Project Growing Minds | Total |
|---|---|---|---|
| Age, Continuous | 15.26 years STANDARD_DEVIATION 0.48 | 15.22 years STANDARD_DEVIATION 0.47 | 15.24 years STANDARD_DEVIATION 0.48 |
| Race/Ethnicity, Customized Black/Non-Hispanic | 29 Participants | 25 Participants | 54 Participants |
| Race/Ethnicity, Customized Hispanic | 31 Participants | 34 Participants | 65 Participants |
| Race/Ethnicity, Customized Other/Mixed Race-Ethnicity | 9 Participants | 11 Participants | 20 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic | 38 Participants | 45 Participants | 83 Participants |
| Region of Enrollment United States | 107 Participants | 115 Participants | 222 Participants |
| Sex: Female, Male Female | 107 Participants | 115 Participants | 222 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 115 |
| other Total, other adverse events | 0 / 107 | 0 / 115 |
| serious Total, serious adverse events | 0 / 107 | 0 / 115 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Project HEART | 3-item Self-report of Sexual Communication Intentions Over Next 3 Months | 87.0 units on a scale | Standard Deviation 22.5 |
| Control: Project Growing Minds | 3-item Self-report of Sexual Communication Intentions Over Next 3 Months | 78.5 units on a scale | Standard Deviation 27.9 |
Comparison: We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.p-value: <0.001Regression, Linear
Primary
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
Population: Data on acceptability only analyzed among girls who completed the Project HEART intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Project HEART | 6-item Self-report of Program Acceptability | Would return to site | 84 Participants |
| Project HEART | 6-item Self-report of Program Acceptability | Recommend to friend | 94 Participants |
| Project HEART | 6-item Self-report of Program Acceptability | Use Information in Future | 101 Participants |
| Project HEART | 6-item Self-report of Program Acceptability | Liked program a lot | 60 Participants |
| Project HEART | 6-item Self-report of Program Acceptability | Learned a lot | 80 Participants |
| Project HEART | 6-item Self-report of Program Acceptability | Program kept attention a lot | 69 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Project HEART | 7-item Self-report of Sexual Communication Self-efficacy | 3.62 units on a scale | Standard Deviation 0.47 |
| Control: Project Growing Minds | 7-item Self-report of Sexual Communication Self-efficacy | 3.51 units on a scale | Standard Deviation 0.46 |
Comparison: Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.p-value: 0.32Regression, Linear