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
|Condition or disease||Intervention/treatment||Phase|
|HIV Sexually Transmitted Diseases||Behavioral: Safer Sex Behavioral: Growth Mindsets||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing HIV Risk Among Adolescents: Evaluating Project HEART|
|Actual Study Start Date :||September 7, 2015|
|Actual Primary Completion Date :||May 4, 2016|
|Actual Study Completion Date :||April 6, 2017|
Experimental: 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.
Behavioral: 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.
Behavioral: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579135
|United States, North Carolina|
|North Carolina State University|
|Raleigh, North Carolina, United States, 27695|
|Principal Investigator:||Laura Widman, PhD||North Carolina State University|