Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852600
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-05-02
Brief Title:
Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Randomized-controlled Trial of a Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gay and bisexual youth make up 80 of all new HIV infections among adolescents ages 14-19 in the United States yet interventions to improve sexual health outcomes in these youth are extremely limited Our team has developed an intervention -- Parents and Adolescents Talking about Healthy Sexuality PATHS -- to reduce HIV risk for gay and bisexual youth by working with their parents to improve the ways parents communicate with their sons about sexual health The intervention is all completed by parents online and takes 45-60 minutes to complete The goal of this study is to test whether PATHS helps improve sexual health among gay and bisexual male teens ages 14-19
To do this 350 parent-adolescent dyads will be recruited online 50 of those dyads will be racialethnic minority Parents will be randomized to receive either PATHS or a control a film designed to general support parents of gaybisexual youth Parents and sons will then complete surveys every 3 months over a 1-year period Families assigned to PATHS will be compared to families assigned to the film 6 months after the intervention Then the families originally given the control film will receive PATHS and all dyads will be followed for another 6 months This allows us to test the effects of PATHS in the control arm by comparing families experiences in the 6 months before they received the PATHS to their experiences over the next 6 months It also allows us to test whether families who originally received PATHS will continue to benefit 9 and 12-months after the intervention
To assess sexual health adolescents will complete self-report measures of their comfort using condoms their access to condoms their knowledge of the correct way to use a condom their intentions to use condoms their awareness of pre-exposure prophylaxis as an HIV prevention method and their attitudes toward PrEP If they are sexually active they will also report about their history of condom use during sex Adolescents will also complete a video-recorded condom demonstration in which they will demonstrate the appropriate technique for applying a condom using a real condom and a oval-shaped shampoo bottle Finally adolescents will self-report whether they have received an HIV test in the previous year consistent with recommendations for gay and bisexual men by the Centers for Disease Control and Prevention
To do this 350 parent-adolescent dyads will be recruited online 50 of those dyads will be racialethnic minority Parents will be randomized to receive either PATHS or a control a film designed to general support parents of gaybisexual youth Parents and sons will then complete surveys every 3 months over a 1-year period Families assigned to PATHS will be compared to families assigned to the film 6 months after the intervention Then the families originally given the control film will receive PATHS and all dyads will be followed for another 6 months This allows us to test the effects of PATHS in the control arm by comparing families experiences in the 6 months before they received the PATHS to their experiences over the next 6 months It also allows us to test whether families who originally received PATHS will continue to benefit 9 and 12-months after the intervention
To assess sexual health adolescents will complete self-report measures of their comfort using condoms their access to condoms their knowledge of the correct way to use a condom their intentions to use condoms their awareness of pre-exposure prophylaxis as an HIV prevention method and their attitudes toward PrEP If they are sexually active they will also report about their history of condom use during sex Adolescents will also complete a video-recorded condom demonstration in which they will demonstrate the appropriate technique for applying a condom using a real condom and a oval-shaped shampoo bottle Finally adolescents will self-report whether they have received an HIV test in the previous year consistent with recommendations for gay and bisexual men by the Centers for Disease Control and Prevention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None