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Reducing HIV Risk Among Adolescents: Evaluating Project HEART

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ClinicalTrials.gov Identifier: NCT02579135
Recruitment Status : Completed
First Posted : October 19, 2015
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Laura Widman, North Carolina State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV
Sexually Transmitted Diseases
Interventions Behavioral: Safer Sex
Behavioral: Growth Mindsets
Enrollment 222
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Project HEART Control: Project Growing Minds
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 107 115
Completed 105 106
Not Completed 2 9
Arm/Group Title Project HEART Control: Project Growing Minds Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 107 115 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 115 participants 222 participants
15.26  (.48) 15.22  (.47) 15.24  (.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 115 participants 222 participants
Female
107
 100.0%
115
 100.0%
222
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 115 participants 222 participants
White/Non-Hispanic
38
  35.5%
45
  39.1%
83
  37.4%
Black/Non-Hispanic
29
  27.1%
25
  21.7%
54
  24.3%
Hispanic
31
  29.0%
34
  29.6%
65
  29.3%
Other/Mixed Race-Ethnicity
9
   8.4%
11
   9.6%
20
   9.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 107 participants 115 participants 222 participants
107
 100.0%
115
 100.0%
222
 100.0%
1.Primary Outcome
Title 6-item Self-report of Program Acceptability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data on acceptability only analyzed among girls who completed the Project HEART intervention
Arm/Group Title Project HEART
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
Would return to site
84
  78.5%
Recommend to friend
94
  87.9%
Use Information in Future
101
  94.4%
Liked program a lot
60
  56.1%
Learned a lot
80
  74.8%
Program kept attention a lot
69
  64.5%
2.Primary Outcome
Title 7-item Self-report of Sexual Communication Self-efficacy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Project HEART Control: Project Growing Minds
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 107 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.62  (.47) 3.51  (.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Project HEART, Control: Project Growing Minds
Comments 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.
Type of Statistical Test Superiority
Comments Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).
Statistical Test of Hypothesis P-Value .32
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter beta
Estimated Value 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
3.Primary Outcome
Title 3-item Self-report of Sexual Communication Intentions Over Next 3 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Project HEART Control: Project Growing Minds
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 107 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
87.0  (22.5) 78.5  (27.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Project HEART, Control: Project Growing Minds
Comments 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.
Type of Statistical Test Superiority
Comments Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter beta
Estimated Value 8.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Project HEART Control: Project Growing Minds
Hide Arm/Group Description

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.

No adverse events.

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.

No adverse events.

All-Cause Mortality
Project HEART Control: Project Growing Minds
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/115 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Project HEART Control: Project Growing Minds
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/115 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Project HEART Control: Project Growing Minds
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/115 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Laura Widman
Organization: North Carolina State University
Phone: 919-513-2546
Responsible Party: Laura Widman, North Carolina State University
ClinicalTrials.gov Identifier: NCT02579135     History of Changes
Other Study ID Numbers: 57033
R00HD075654 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2015
First Posted: October 19, 2015
Results First Submitted: April 27, 2018
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018