Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
NCT ID: NCT05852600
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2023-04-24
2026-08-02
Brief Summary
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To do this 350 parent-adolescent dyads will be recruited online (50% of those dyads will be racial/ethnic minority). Parents will be randomized to receive either PATHS or a control (a film designed to general support parents of gay/bisexual 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Intervention
Participants assigned to the intervention arm are immediately given the opportunity to view Lead with Love, and then to complete the PATHS toolkit. One month after completing PATHS, they complete a "refresher" module that is designed to boost the initial effects of PATHS.
Parents and Adolescents Talking about Healthy Sexuality (PATHS)
PATHS is an intervention delivered to parents of AMSM that aims to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. PATHS can all be accessed online, is self-paced, and typically takes parents 40-60 minutes to complete. The toolkit is comprised of 7 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy, and intention for communicating about sex. Material is presented in a variety of modalities (e.g., text, videos of experts, videos of other parents describing their experiences). Parents set personalized goals for themselves regarding activities and conversations they want to have with their sons, selecting from a menu of options provided by the intervention. One month later parents complete a "refresher" module that queries them about whether they have achieved their goals, and provides customized content to support the behaviors parents have yet to enact.
Lead with Love (LWL)
Lead with Love is a 35-minute "education entertainment" film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and reactions to their child's health, and accepting their child's sexual orientation, and engaging in behaviors that are more supportive and less rejecting. This is achieved by telling the true stories of four families and how they responded to the news that their child was LGB, and by having experts (psychologists, teachers, clergy) provide information and guidance. One month after watching LWL, parents return to the website to review "refresher" materials that summarize the most important lessons from the film.
Waitlist Control
Participants assigned to the waitlist control arm are immediately given the opportunity to view Lead with Love. One month after viewing the film, they complete a "refresher" module that reviews the most important lessons from the film. Six months after being randomized, participants are then given access to the PATHS toolkit. One month after completing the PATHS toolkit, they complete a "refresher" module that is designed to boost the initial effects of PATHS.
Parents and Adolescents Talking about Healthy Sexuality (PATHS)
PATHS is an intervention delivered to parents of AMSM that aims to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. PATHS can all be accessed online, is self-paced, and typically takes parents 40-60 minutes to complete. The toolkit is comprised of 7 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy, and intention for communicating about sex. Material is presented in a variety of modalities (e.g., text, videos of experts, videos of other parents describing their experiences). Parents set personalized goals for themselves regarding activities and conversations they want to have with their sons, selecting from a menu of options provided by the intervention. One month later parents complete a "refresher" module that queries them about whether they have achieved their goals, and provides customized content to support the behaviors parents have yet to enact.
Lead with Love (LWL)
Lead with Love is a 35-minute "education entertainment" film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and reactions to their child's health, and accepting their child's sexual orientation, and engaging in behaviors that are more supportive and less rejecting. This is achieved by telling the true stories of four families and how they responded to the news that their child was LGB, and by having experts (psychologists, teachers, clergy) provide information and guidance. One month after watching LWL, parents return to the website to review "refresher" materials that summarize the most important lessons from the film.
Interventions
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Parents and Adolescents Talking about Healthy Sexuality (PATHS)
PATHS is an intervention delivered to parents of AMSM that aims to increase parent communication about sexuality and HIV, as well as other parent behaviors supportive of sexual risk reduction. PATHS can all be accessed online, is self-paced, and typically takes parents 40-60 minutes to complete. The toolkit is comprised of 7 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy, and intention for communicating about sex. Material is presented in a variety of modalities (e.g., text, videos of experts, videos of other parents describing their experiences). Parents set personalized goals for themselves regarding activities and conversations they want to have with their sons, selecting from a menu of options provided by the intervention. One month later parents complete a "refresher" module that queries them about whether they have achieved their goals, and provides customized content to support the behaviors parents have yet to enact.
Lead with Love (LWL)
Lead with Love is a 35-minute "education entertainment" film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and reactions to their child's health, and accepting their child's sexual orientation, and engaging in behaviors that are more supportive and less rejecting. This is achieved by telling the true stories of four families and how they responded to the news that their child was LGB, and by having experts (psychologists, teachers, clergy) provide information and guidance. One month after watching LWL, parents return to the website to review "refresher" materials that summarize the most important lessons from the film.
Eligibility Criteria
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Inclusion Criteria
1. cisgender male
2. age 14-19
3. self-identifies as gay or bisexual
4. lives in the same house with parent at least 2 days per week
5. child is willing to enroll in the study and complete assessments
1. cisgender male
2. age 14-19
3. self-identifies as gay or bisexual
4. lives in the same house with parent at least 2 days per week
5. parent is willing to enroll in the study and be randomized to one of two intervention conditions.
Exclusion Criteria
14 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Duke University
OTHER
University of Utah
OTHER
George Washington University
OTHER
Responsible Party
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David Huebner
Professor
Locations
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George Washington University
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MH129169
Identifier Type: -
Identifier Source: org_study_id
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