MySTYLE: Online Family-based HIV Prevention for Non-heterosexual Black Adolescent Males in the South

NCT03487796 | Completed Results

• 1 other identifier: R34MH113384
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and test the efficacy of an online, family-based intervention (MySTYLE) tailored to the relevant sexual health needs of non-heterosexual adolescent males and their parents/caregivers compared waitlist control group. Adolescent males and their parents will be recruited from community organizations, medical clinics and schools in Jackson, MS. Interviews with youth, parents, and relevant community leaders will inform the development of the interventions. Youth and their parents/caregivers in both intervention arms will complete three assessments in the four months after enrolling. This study will provide a wealth of information about the degree to which this intervention may be disseminated for this highly vulnerable population of young people.

Conditions

Hiv; Adolescent Behavior; Family Relations; Sexual Orientation

Outcome Measures

Primary Outcomes (2)

• Acceptance of an HIV Test at Study Completion

  Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion. This will be assessed via electronic medical chart extraction.

  4 months post-baseline

• Change in Number of Condomless Anal Sex Acts at 4 Months

  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.

  4-months post-baseline

Secondary Outcomes (2)

• HIV Knowledge (Adolescent) at 4 Months

  4-months post-baseline

• Parent Adolescent Sexual Communication Scale

  Baseline, 2- and 4-months post-baseline

Study Arms (2)

MySTYLE

EXPERIMENTAL

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.

Behavioral: MySTYLE

Waitlist Control

OTHER

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.

Other: Waitlist Control

Interventions

MySTYLE BEHAVIORAL

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.

MySTYLE

Waitlist Control OTHER

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.

Waitlist Control

Eligibility Criteria

• Age: 14 Years - 20 Years
• Gender Eligibility Details: Adolescents must identify as biological male. Parent/caregiver may be male or female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Mississippi Medical Center: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39213, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Adolescent Behavior; Sexual Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Results Point of Contact

• Title: Larry K. Brown, MD
• Organization: Rhode Island Hospital

lkbrown@lifespan.org

(401) 793-8808

Study Officials

• Larry K Brown, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 4, 2018
• Study Start: October 28, 2019
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: December 29, 2021
• Results First Posted: December 29, 2021

Record last verified: 2021-11

Locations

US (1)