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Parent-focused Intervention for HIV Prevention

N/A

Recruiting

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial tests an online intervention (PATHS) to reduce HIV risk for gay/bisexual male teens by improving parent-son communication about sexual health. 350 parent-adolescent dyads will complete surveys and a condom demonstration over a 1-year period.

Who is the study for?

This trial is for cisgender male teens aged 14-19 who identify as gay or bisexual, live with a parent at least two days per week, and are willing to enroll and complete assessments. It aims to improve sexual health outcomes by enhancing parent-child communication.Check my eligibility

What is being tested?

The study tests the PATHS intervention against a control film (Lead with Love). Parents complete the online program aiming to better communicate about sexual health with their sons. The effectiveness is measured through surveys and condom use demonstrations over one year.See study design

What are the potential side effects?

There are no direct physical side effects from participating in this trial since it involves educational interventions rather than medical treatments. However, discussing sensitive topics might cause emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PrEP attitudes and beliefs

Change in condom access

Change in condom use intentions

+3 more

Secondary outcome measures

Change in competency for sexual health

Demonstrated behavioral skill for using condoms correctly

Parent-report of whether son is "current" on his HIV testing

+1 more

Other outcome measures

Change in parent behaviors supportive of sexual health

Change in parent-adolescent communication about sexual health

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment2 Interventions

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.

Group II: Waitlist ControlActive Control2 Interventions

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor

243 Previous Clinical Trials

453,424 Total Patients Enrolled

Northwestern UniversityOTHER

1,589 Previous Clinical Trials

916,737 Total Patients Enrolled

Duke UniversityOTHER

2,364 Previous Clinical Trials

3,420,292 Total Patients Enrolled

Media Library

Parents and Adolescents Talking about Healthy Sexuality (PATHS) Clinical Trial Eligibility Overview. Trial Name: NCT05852600 — N/A

Sexual Wellness Research Study Groups: Intervention, Waitlist Control

Sexual Wellness Clinical Trial 2023: Parents and Adolescents Talking about Healthy Sexuality (PATHS) Highlights & Side Effects. Trial Name: NCT05852600 — N/A

Parents and Adolescents Talking about Healthy Sexuality (PATHS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852600 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the population engaging in this research project?

"Affirmative, the data hosted on clinicaltrials.gov attests that this medical trial is seeking participants. The study was initially made available to the public on April 24th 2023 and has most recently been updated on May 9th 2023. This research project hopes to enlist 350 individuals at a single site of operation."

Answered by AI

Is participation in this examination still available?

"Affirmative. According to the clinicaltrials.gov records, this research is currently recruiting and was published on April 24th 2023 with its most recent update on May 9th of the same year. The investigators are seeking 350 patients at a single site for inclusion in their study."

Answered by AI

What objectives do researchers hope to achieve through this clinical experiment?

"This clinical trial's main objective is to evaluate the increase in condom access. Assessments will be performed at baseline and then again after 3, 6, 9 and 12 months have passed since randomisation. The primary outcome will take into consideration pre-randomization values as well. Secondary outcomes include photographic evidence of condoms being held by participants; parental confirmation that their child has recently undergone an HIV test; and a 17-item scale measuring sexual health competency (e.g., communicating boundaries during intercourse)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

David Huebner 2023. "Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05852600.