Hiv Clinical Trial
Official title:
MySTYLE: Online Family-based HIV Prevention for Non-heterosexual Black Adolescent Males in the South
Verified date | November 2021 |
Source | Rhode Island Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | April 22, 2021 |
Est. primary completion date | April 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 20 Years |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
United States | University of Mississippi Medical Center | Jackson | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital | University of Mississippi Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 months post-baseline | |
Primary | 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. | 4-months post-baseline | |
Secondary | 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. | 4-months post-baseline | |
Secondary | 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. | Baseline, 2- and 4-months post-baseline |
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