Reducing HIV Risk Among Adolescents: Evaluating Project HEART

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing HIV Risk Among Adolescents: Evaluating Project HEART

Conditions
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HIV, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Safer Sex
* Behavioral: Growth Mindsets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10th grade girl Able to read English Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project HEART<br>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<br>* Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.<br>|
| Other: Control: Project Growing Minds<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | Immediate post-test at completion of intervention and 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Condoms, Sexual Abstinence, Sexual Communication