Reducing HIV Risk Among Adolescents: Evaluating Project HEART
2 other identifiers
interventional
222
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2015
CompletedFirst Submitted
Initial submission to the registry
October 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2017
CompletedResults Posted
Study results publicly available
October 16, 2018
CompletedOctober 16, 2018
September 1, 2018
8 months
October 10, 2015
April 27, 2018
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Project HEART
EXPERIMENTALInteractive 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.
Control: Project Growing Minds
OTHERAttention-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.
Interventions
Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
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.
Eligibility Criteria
You may qualify if:
- th grade girl
- Able to read English
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Carolina State University
Raleigh, North Carolina, 27695, United States
Related Publications (2)
Widman L, Golin CE, Kamke K, Burnette JL, Prinstein MJ. Sexual Assertiveness Skills and Sexual Decision-Making in Adolescent Girls: Randomized Controlled Trial of an Online Program. Am J Public Health. 2018 Jan;108(1):96-102. doi: 10.2105/AJPH.2017.304106. Epub 2017 Nov 21.
PMID: 29161072DERIVEDWidman L, Golin CE, Noar SM, Massey J, Prinstein MJ. ProjectHeartforGirls.com: Development of a Web-Based HIV/STD Prevention Program for Adolescent Girls Emphasizing Sexual Communication Skills. AIDS Educ Prev. 2016 Oct;28(5):365-377. doi: 10.1521/aeap.2016.28.5.365.
PMID: 27710087DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Laura Widman
- Organization
- North Carolina State University
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Widman, PhD
North Carolina State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 10, 2015
First Posted
October 19, 2015
Study Start
September 7, 2015
Primary Completion
May 4, 2016
Study Completion
April 6, 2017
Last Updated
October 16, 2018
Results First Posted
October 16, 2018
Record last verified: 2018-09