Reducing HIV Risk Among Adolescents: Evaluating Project HEART

HIV Clinical Trial

Official title:

Reducing HIV Risk Among Adolescents: Evaluating Project HEART

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579135
• Other study ID #: 57033
• Secondary ID: R00HD075654
• Status: Completed
• Phase: N/A
• Start date: September 7, 2015
• Est. completion date: April 6, 2017

Study information

• Verified date: September 2018
• Source: North Carolina State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: April 6, 2017
• Est. primary completion date: May 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• 10th grade girl

• Able to read English

Exclusion Criteria:

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Safer Sex
Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
• 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.

Locations

Country	Name	City	State
United States	North Carolina State University	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
North Carolina State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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