Clinical trial NCT02579135: Reducing HIV Risk Among Adolescents: Evaluating Project HEART
Official title: Reducing HIV Risk Among Adolescents: Evaluating Project HEART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Diseases
Keywords: Condoms
Sexual Abstinence
Sexual Communication
Lead sponsor: North Carolina State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-10-19
Enrollment: 222
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 10th grade girl
* Able to read English

Exclusion Criteria:

* None

Primary outcomes:
measure: 6-item Self-report of Program Acceptability
timeFrame: Immediate post-test at completion of intervention
measure: 7-item Self-report of Sexual Communication Self-efficacy
timeFrame: Immediate post-test at completion of intervention and 3-month follow-up
measure: 3-item Self-report of Sexual Communication Intentions Over Next 3 Months
timeFrame: Immediate post-test at completion of intervention and 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: North Carolina State University
state: North Carolina
Study officials:
affiliation: North Carolina State University
name: Laura Widman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Widman 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.