Skip to main content
OpenTrials
Completed

NCT Number: NCT03487796

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

In recent years, the highest rates of HIV in the U.S. have been concentrated among young men who have sex with men (MSM), especially those of color. Unfortunately, evidenced-based intervention programs for non-heterosexual Black adolescent males (nHBAM) do not exist. Drs. Brown and Crosby have each designed, tested (in the context of NIH-funded RCTs) behavioral interventions targeting young people at-risk of HIV acquisition. Also, their previous work demonstrates that parental involvement prevents sexual risk behavior by adolescents. They will adapt key elements of STYLE, an efficacious HIV prevention program for adolescents and their parents/caregivers, to be relevant for nHBAM. A formative phase will use in-depth interviews to assess and identify the needs of nHBAM and their parents/caregivers. Work groups, composed of youth, parents/caregivers, stakeholders, and investigators, will tailor and refine the content in an iterative process with a sophisticated media company (MEE studios). MySTYLE is proposed to be a series of eight online novella episodes designed to increase relevant knowledge, attitudes, and sexual protective behaviors of nHBAM. The project will take place in Jackson MS, which has the highest prevalence of HIV among urban MSM in the U.S. and the third highest rate among Black MSM under the age of 25. Adolescents and parents will be recruited from community organizations, medical clinics and schools. The feasibility and effect sizes of MySTYLE, compared to a waitlist control group, will be tested with a cohort of 72 nHBAM and their parents. Interventions effect sizes will be determined for sexual behaviors, HIV testing, and psychosocial mediators (e.g., knowledge, attitudes, communication between adolescents and their parents/caregivers relative to sex, safer sex, and sexuality).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptance of an HIV Test at Study Completion

    Time frame: 4 months post-baseline

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

  2. Change in Number of Condomless Anal Sex Acts at 4 Months

    Time frame: 4-months post-baseline

    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.

Secondary outcomes

  1. HIV Knowledge (Adolescent) at 4 Months

    Time frame: 4-months post-baseline

    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.

  2. Parent Adolescent Sexual Communication Scale

    Time frame: Baseline, 2- and 4-months post-baseline

    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.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • University of Mississippi Medical Center

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2018
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.