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
|Condition or disease||Intervention/treatment||Phase|
|Hiv Adolescent Behavior Family Relations Sexual Orientation||Behavioral: MySTYLE Behavioral: MyHealth||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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.
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.
- 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.
- 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.
- Onset of sexual activity [ Time Frame: 6-months post-baseline ]Participants will be asked to report if they have engaged in sexual activity.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Larry K Brown, MDfirstname.lastname@example.org|
|Principal Investigator:||Larry K Brown, MD||Rhode Island Hospital|