- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03487796
MySTYLE: Online Family-based HIV Prevention for Non-heterosexual Black Adolescent Males in the South
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39213
- University of Mississippi Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Eligibility criteria for adolescents in all phases of the project will be: 1) at least 14 years of age but no more than 20; 2) stably-housed (have resided with the same adult caregiver for the past 6 months and no plans to leave the city or caregiver in the next 6 months). We understand that this will preclude homeless youth who may be at risk for HIV but MySTYLE will not be designed to address the numerous structural need of chronically homeless youth; 3) the ability to read and speak English; 4) identify as a biological male; 5) and identify racially as Black African American.
Eligibility criteria for Parents/caregivers for all phases of the project will be: 1) parent/caregiver or trusted adult of an adolescent who is potentially eligible for enrollment into the study; and 2) English speaking.
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Exclusion Criteria: Exclusion criteria will be: a) not able to provide meaningful assent as determined by research staff, b) known HIV-infection (staff will facilitate entry into care if needed). Although we expect that most enrolled youth with be non-heterosexual Black adolescent males, heterosexual youth who enroll will be able to complete all intervention activities.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MySTYLE
MySTYLE is online, brief and encourages parent-adolescent communication about sex and HIV prevention.
Participants (non-heterosexual Black adolescent males and parents/caregivers) will receive two texts per week (for eight weeks) with links to intervention content that includes video, games and graphics to improve knowledge, motivation and skills for HIV prevention.
Topics include assertive communication, sexual safety, goal setting, and resilience.
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Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks).
Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
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Other: Waitlist Control
Participants randomized to the waitlist control will be eligible to receive the eight-week MySTYLE intervention after the completion of the 4-month follow-up assessment.
During their first four months of participation, waitlist control participants will not receive any intervention materials.
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Youth and parents will not receive intervention materials for the first four months of participation.
At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks).
Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Acceptance of an HIV Test at Study Completion
Time Frame: 4 months post-baseline
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Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion.
This will be assessed via electronic medical chart extraction.
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4 months post-baseline
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Change in Number of Condomless Anal Sex Acts at 4 Months
Time Frame: 4-months post-baseline
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Participants will be asked to report the number of condomless anal sex acts they have engaged in, in the past 90 days at baseline and at the 4 month follow-up.
The change in number of condomless sex acts will be assessed.
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4-months post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Knowledge (Adolescent) at 4 Months
Time Frame: 4-months post-baseline
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The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with "true," "false," or "do not know" response options.
Total scores range from 0 to 5. Higher scores indicate greater knowledge.
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4-months post-baseline
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Parent Adolescent Sexual Communication Scale
Time Frame: Baseline, 2- and 4-months post-baseline
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The Miller Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents.
Only adolescent participants, not parent/caregivers, were asked to complete this scale.
Evidence supports internal consistencies between .65 and .86.
Each item is rated on a Likert scale 1 (not true) to 7 (very true) with scale scores ranging from 6-42.
Higher scores indicate better communication about sexual behaviors.
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Baseline, 2- and 4-months post-baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Larry K Brown, MD, Rhode Island Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R34MH113384 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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