An interventional study of MySTYLE and Waitlist Control in Hiv, Adolescent Behavior and Family Relations, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 14 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-29.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
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.
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).
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's enrollment of 72 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Compared within Adolescent Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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 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.
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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.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: 4-months post-baseline
HIV Knowledge (Adolescent) at 4 Months
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.
Time frame: 4-months post-baseline
Parent Adolescent Sexual Communication Scale
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.
Time frame: Baseline, 2- and 4-months post-baseline
| Milestone | MySTYLE | Waitlist Control |
|---|---|---|
| Started | 41 | 31 |
| 2 month follow-up | 24 | 26 |
| Completed | 23 | 25 |
| Not completed | 18 | 6 |
| Withdrew: Lost to follow-up | 18 | 6 |
Behavioral outcome: acceptance of a rapid, point of care HIV test at study completion. This will be assessed via electronic medical chart extraction.
| Participants | MySTYLE | Waitlist Control |
|---|---|---|
| No | 8 | 8 |
| Yes | 9 | 10 |
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.
| condomless anal sex acts | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults |
|---|---|---|---|---|
| Change in Number of Condomless Anal Sex Acts at 4 Months | 0.7 ± 0.5 | 0.5 ± 0.8 | — | — |
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.
| score on a scale | MySTYLE | Waitlist Control |
|---|---|---|
| HIV Knowledge (Adolescent) at 4 Months | 3.4 ± 0.8 | 3.5 ± 1.1 |
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.
| score on a scale | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults |
|---|---|---|---|---|
| Parent Adolescent Sexual Communication Scale | 20.1 ± 8.8 | 23.6 ± 9.5 | — | — |
Collected over Data on adverse effects was collection from time of enrollment to end of follow-up, 4-months post-baseline.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MySTYLE Adolescents | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Waitlist Control Adolescents | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| MySTYLE Trusted Adults | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Waitlist Control Trusted Adults | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
Notes: Baseline data is missing for one Waitlist Control Trusted Adult.
| Age, Continuous(years) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| Mean | 18.1 ± 1.7 | 18.4 ± 1.5 | 38.0 ± 12.6 | 44.0 ± NA | 18.2 ± 1.6 |
| Sex/Gender, Customized(Participants) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| Male | 38 | 31 | 1 | 0 | 70 |
| Female | 1 | 0 | 4 | 0 | 5 |
| Trans male/trans man | 1 | 0 | 0 | 1 | 2 |
| Genderqueer/non-comforming | 1 | 0 | 0 | 0 | 1 |
| Sex: Female, Male(Participants) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| Female | 1 | 0 | 4 | 1 | 6 |
| Male | 40 | 31 | 1 | 0 | 72 |
| Ethnicity (NIH/OMB)(Participants) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 41 | 30 | 5 | 1 | 77 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 39 | 28 | 4 | 1 | 72 |
| White | 0 | 0 | 1 | 0 | 1 |
| More than one race | 2 | 2 | 0 | 0 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Most Recent Grade Completed(Participants) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| 8th grade | 0 | 1 | — | — | 1 |
| 9th grade | 1 | 1 | — | — | 2 |
| 10th grade | 6 | 2 | — | — | 8 |
| 11th grade | 3 | 1 | — | — | 4 |
| 12th grade | 4 | 3 | — | — | 7 |
| Other | 27 | 22 | — | — | 49 |
| Sexual Orientation(Participants) | MySTYLE Adolescents | Waitlist Control Adolescents | MySTYLE Trusted Adults | Waitlist Control Trusted Adults | Total |
|---|---|---|---|---|---|
| Exploring | 3 | 2 | — | — | 5 |
| Undecided | 1 | 1 | — | — | 2 |
| Questioning | 2 | 0 | — | — | 2 |
| Other | 1 | 0 | — | — | 1 |
| Gay | 16 | 16 | — | — | 32 |
| Bisexual | 6 | 4 | — | — | 10 |
| More than one endorsement | 12 | 8 | — | — | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2019 to primary completion in Apr 2021, 17 months.
Results were first posted in Dec 2021, 8 months after primary completion.
Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 17 months is below that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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