Clinical trial NCT05852600: Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
Official title: Randomized-controlled Trial of a Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Sexual Health
Keywords: randomized controlled trial
parenting
sexual minority youth
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Duke University
name: University of Utah
First posted: 2023-05-10
Enrollment: 350
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in condom use self-efficacy
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values.
measure: Change in condom access
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values.
measure: Change in condom use intentions
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values.
measure: Change in PrEP attitudes and beliefs
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values.
measure: Frequency of condomless anal intercourse (CAS) without protection by PrEP
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the total frequency of CAS reported across both the 3- and 6-month assessments.
measure: Youth self-report of being "current" on HIV testing
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will whether youth are "current" on HIV testing at the 6-month assessment.
Secondary outcomes:
measure: Demonstrated behavioral skill for using condoms correctly
timeFrame: Youth will complete this activity twice: (1) between the 3 and 6-month assessment, and (2) between the 9 and 12-month assessment. The activity conducted between 3 and 6-month assessments will be the primary outcome for this measure.
measure: Photo of condom in youth's possession
timeFrame: Photo uploads at the 6-month assessment will be compared across the study arms
measure: Parent-report of whether son is "current" on his HIV testing
timeFrame: Parents will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be whether youth are "current" at the 6-month assessment.
measure: Change in competency for sexual health
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values.
Other outcomes:
measure: Change in parent-adolescent communication about sexual health
timeFrame: Youth will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be the 6-month post-randomization assessment, adjusted for baseline values.
measure: Change in parent behaviors supportive of sexual health
timeFrame: Parents and sons will complete this measure at baseline (pre-randomization) and at 3, 6, 9, and 12-months post randomization. The primary outcome will be aggregate of behaviors reported at the 3 and 6-month assessments, adjusted for baseline.
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
References: