Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents

George Washington University (GW)

Status: Enrolling

Conditions: Sexual Health; Hiv

Treatments: Behavioral: Lead with Love (LWL); Behavioral: Parents and Adolescents Talking about Healthy Sexuality (PATHS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05852600

MH129169

Details and patient eligibility

About

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 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

We recruit only parent-adolescent dyads for the study. Both parent and adolescent must agree to participate in order to enroll. Only parents receive the intervention. Adolescents are included in the study only for assessment purposes.

Parent inclusion criteria: Parent or legal guardian of a child with all of the following characteristics:

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

Adolescent 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. parent is willing to enroll in the study and be randomized to one of two intervention conditions.

Exclusion criteria

-- Adolescent with known HIV infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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350 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Parents and Adolescents Talking about Healthy Sexuality (PATHS)

Behavioral: Lead with Love (LWL)

Waitlist Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parents and Adolescents Talking about Healthy Sexuality (PATHS)

Behavioral: Lead with Love (LWL)