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

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ClinicalTrials.gov Identifier: NCT03487796
Recruitment Status : Not yet recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
University of Mississippi Medical Center
Information provided by (Responsible Party):
Dr. Larry K. Brown, Rhode Island Hospital

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 to an online family-based intervention that addresses general health topics. 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 interventions will complete three assessments in the six 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.

Condition or disease Intervention/treatment Phase
Hiv Adolescent Behavior Family Relations Sexual Orientation Behavioral: MySTYLE Behavioral: MyHealth Not Applicable

Detailed Description:
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 an attention-equivalent control group receiving general health information, 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: MySTYLE: Online Family-based HIV Prevention for Non-heterosexual Black Adolescent Males in the South
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: MySTYLE
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.

Active Comparator: MyHealth
MyHEALTH is an attention-equivalent comparison condition with the same format as MySTYLE. 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 general health behavior.
Behavioral: MyHealth
Youth and parents 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 general health behavior. Topics will include nutrition, exercise, sleep, tobacco, caffeine, and HIV facts.




Primary Outcome Measures :
  1. Acceptance of an HIV test at study completion [ Time Frame: 6 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 sex acts at 6 months [ Time Frame: 6-months post-baseline ]
    Participants will be asked to report the number of condomless sex acts they have engaged in, in the past 90 days at baseline and at the 6 month follow-up. The change in number of condomless sex acts will be assessed.

  3. Onset of sexual activity [ Time Frame: 6-months post-baseline ]
    Participants will be asked to report if they have engaged in sexual activity.


Secondary Outcome Measures :
  1. HIV Knowledge (Adolescent) [ Time Frame: Baseline, 3- and 6-months post-baseline ]
    The measure of HIV knowledge that will be used comes from work conducted by Dr. Brown. Dr. Brown's brief HIV-related knowledge and attitudes scales have demonstrated adequate test-retest reliability (r =0.67 to 0.83) in a delayed education control group, and good internal consistency (α = 0.62 to 0.79).

  2. Condom Attitudes Scale-Adolescent [ Time Frame: Baseline, 3- and 6-months post baseline ]
    The Condoms Attitudes Scale was developed to measure adolescents' attitudes about condom use. Responses to this 23-item scale are on a 7-point Likert-style scale ranging from strongly disagree to strongly agree. The CAS-A has an internal consistency of .8.

  3. Condom Use Self-Efficacy [ Time Frame: Baseline, 3- and 6-months post-baseline ]
    The Condom Use Self-Efficacy scale included in this study will be that which was previously tested by Dr. Richard Crosby with young Black males (Cronbach's alpha was .83). This 9-item scale assesses participants' confidence in their ability to properly use condoms. Scale items are rated on a Likert scale that ranges from 1 (very sure I could not) to 4 (very sure I could). Scale scores range from 9-36 with higher scores indicating greater perceived ability to properly use condoms.

  4. Self-efficacy for HIV Prevention (Adolescent) [ Time Frame: Baseline, 3- and 6-months post-baseline ]
    The Self-Efficacy for HIV Prevention scale was developed to assess adolescents' perceived self-efficacy to engage in behavior that prevents the acquisition of HIV. It uses 12 items that use assess prevention and risk-reduction behaviors such as the ability to obtain, carry, and use condoms; limit the number of sexual partners; talk with partners about safer sex and recognize dangerous drug use. The items have four response options from "very sure" to "couldn't do it." It has been frequently used in adolescents and in Project STYLE, with 721 youth in three different cities, it demonstrated an internal consistency alpha of 0.89.

  5. Adolescent Risk Behavior Assessment [ Time Frame: Baseline, 3- and 6-months post-baseline ]
    The ARBA, currently used in Dr. Brown's other federally-funded projects is a reliable and valid structured interview assessing self-reported sexual behaviors. It assesses type of sexual behavior (i.e., anal, oral, vaginal) in the past 3 months, frequency of sex, age of sexual debut, and number and gender of partners. Additional questions cover use of barrier method contraception, sex with high-risk partners, exchanging sex for drugs, reasons for condom nonuse, frequency and quantity of substance use and having sex while using alcohol/drugs.

  6. Parent Adolescent Sexual Communication Scale [ Time Frame: Baseline, 3- and 6-months post-baseline ]
    The Miller Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents. Youth and parents complete separate versions. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adolescents must identify as biological male. Parent/caregiver may be male or female.
Accepts Healthy Volunteers:   Yes
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 18; 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487796


Contacts
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Contact: Larry K Brown, MD 401-793-8808 lkbrown@lifespan.org

Sponsors and Collaborators
Rhode Island Hospital
University of Mississippi Medical Center
Investigators
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Principal Investigator: Larry K Brown, MD Rhode Island Hospital

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Responsible Party: Dr. Larry K. Brown, Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03487796     History of Changes
Other Study ID Numbers: R34MH113384 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No