Trial Outcomes & Findings for Reducing HIV Risk Among Adolescents: Evaluating Project HEART (NCT NCT02579135)
NCT ID: NCT02579135
Last Updated: 2018-10-16
Results Overview
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.
COMPLETED
NA
222 participants
Immediate post-test at completion of intervention
2018-10-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
115
|
|
Overall Study
COMPLETED
|
105
|
106
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
Baseline characteristics by cohort
| Measure |
Project 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.
Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
|
Control: Project Growing Minds
n=115 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.
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.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.26 years
STANDARD_DEVIATION .48 • n=5 Participants
|
15.22 years
STANDARD_DEVIATION .47 • n=7 Participants
|
15.24 years
STANDARD_DEVIATION .48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Non-Hispanic
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/Non-Hispanic
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed Race-Ethnicity
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate post-test at completion of interventionPopulation: Data on acceptability only analyzed among girls who completed the Project HEART 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.
Outcome measures
| Measure |
Project 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.
Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
|
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.
|
|---|---|---|
|
6-item Self-report of Program Acceptability
Would return to site
|
84 Participants
|
—
|
|
6-item Self-report of Program Acceptability
Recommend to friend
|
94 Participants
|
—
|
|
6-item Self-report of Program Acceptability
Use Information in Future
|
101 Participants
|
—
|
|
6-item Self-report of Program Acceptability
Liked program a lot
|
60 Participants
|
—
|
|
6-item Self-report of Program Acceptability
Learned a lot
|
80 Participants
|
—
|
|
6-item Self-report of Program Acceptability
Program kept attention a lot
|
69 Participants
|
—
|
PRIMARY outcome
Timeframe: Immediate post-test at completion of intervention and 3-month follow-upWe 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).
Outcome measures
| Measure |
Project 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.
Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
|
Control: Project Growing Minds
n=114 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.
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.
|
|---|---|---|
|
7-item Self-report of Sexual Communication Self-efficacy
|
3.62 units on a scale
Standard Deviation .47
|
3.51 units on a scale
Standard Deviation .46
|
PRIMARY outcome
Timeframe: Immediate post-test at completion of intervention and 3-month follow-upWe 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).
Outcome measures
| Measure |
Project 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.
Safer Sex: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
|
Control: Project Growing Minds
n=114 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.
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.
|
|---|---|---|
|
3-item Self-report of Sexual Communication Intentions Over Next 3 Months
|
87.0 units on a scale
Standard Deviation 22.5
|
78.5 units on a scale
Standard Deviation 27.9
|
Adverse Events
Project HEART
Control: Project 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