N/A N=72 Randomized Single-blind Prevention

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

Hiv · Adolescent Behavior · Family Relations · Sexual Orientation

Bottom Line

View on ClinicalTrials.gov: NCT03487796 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Acceptance of an HIV Test at Study Completion — 8; 8; 9; 10 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MySTYLE (Behavioral); Waitlist Control (Other)
Age: Pediatric, Adult · 14+ yrs
Sex: All
Sponsor: Rhode Island Hospital
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Acceptance of an HIV Test at Study Completion	8; 8; 9; 10	—
PRIMARY Change in Number of Condomless Anal Sex Acts at 4 Months	0.7; 0.5	—
SECONDARY HIV Knowledge (Adolescent) at 4 Months	3.4; 3.5	—
SECONDARY Parent Adolescent Sexual Communication Scale	20.1; 23.6	—

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.

Eligibility Criteria

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03487796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.