Parent-focused Intervention for HIV Prevention

Recruiting at 1 trial location

Overseen By Stephanie Micicco, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: HIV infection

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called PATHS, designed to help parents discuss sexual health with their gay or bisexual sons to reduce HIV risk. The study compares families using PATHS with those watching a supportive film for parents of gay/bisexual youth. It seeks parent-son pairs where the son is a gay or bisexual male, aged 14-19, living with the parent at least two days a week. Parents complete the online program, while sons help assess its impact on their sexual health knowledge and practices. The goal is to determine if PATHS improves sexual health outcomes by enhancing communication between parents and their sons. As an unphased trial, this study provides a unique opportunity for families to contribute to important research that could enhance communication and health outcomes for gay and bisexual youth.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems unlikely that medication changes are required since the study focuses on parent-adolescent communication rather than medical treatment.

What prior data suggests that the PATHS intervention is safe for improving sexual health communication?

Research has shown that the PATHS (Parents and Adolescents Talking about Healthy Sexuality) program helps parents discuss sexual health and HIV prevention with their children. This entirely online program aims to improve communication skills. Without involving physical or medical treatments, it presents fewer safety concerns than programs using medications.

Studies have found that parents using PATHS are nearly four times more likely to discuss HIV with their children, indicating the program's effectiveness and positive reception. No reports of harm or negative effects have emerged from using PATHS, as it serves as an educational tool rather than a medical treatment.

Overall, PATHS facilitates important health conversations between parents and children. As an online program, it is generally considered safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PATHS intervention for HIV prevention because it focuses on enhancing communication between parents and adolescents about healthy sexuality, a unique approach compared to standard informational methods. Unlike traditional programs that might only target adolescents, PATHS involves parents directly, encouraging open dialogue and ongoing education. This method not only aims to provide immediate knowledge but also strengthens the parent-child relationship, potentially leading to longer-lasting preventative behaviors. By including a "refresher" module, PATHS ensures that the information and skills are reinforced over time, which could lead to more sustained behavioral changes.

What evidence suggests that the PATHS intervention could be effective for improving sexual health among gay and bisexual male teens?

Research has shown that the PATHS program, which participants in this trial may receive, can help reduce HIV risk among gay and bisexual youth by improving communication between parents and children about sexual health. Studies have found that open discussions about topics like sexuality and HIV can lead to better sexual health outcomes. These outcomes include increased comfort and knowledge about using condoms and understanding pre-exposure prophylaxis (PrEP), a method to prevent HIV. The PATHS program aims to equip parents with the tools needed for these important conversations. Early results suggest that this approach may enhance teens' confidence and skills in practicing safe sex. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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.

I am a 14-19 year old cisgender male, identify as gay or bisexual, live with my parent at least 2 days a week, and my parent agrees to join the study.

I am the parent or guardian of a 14-19 year old cisgender male who identifies as gay or bisexual, lives with me at least 2 days a week, and is willing to join the study.

Exclusion Criteria

I am a teenager and I have HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents complete the PATHS toolkit online, which takes 45-60 minutes. A refresher module is completed one month later.

1 month

Online completion

Control

Parents in the control group view a supportive film and complete a refresher module one month later. After 6 months, they receive the PATHS toolkit.

6 months

Online completion

Follow-up

Participants are monitored for changes in sexual health outcomes through surveys every 3 months over a 1-year period.

12 months

Surveys every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Lead with Love (LWL)
• Parents and Adolescents Talking about Healthy Sexuality (PATHS)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 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 Control Active Control 2 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.

Parents and Adolescents Talking about Healthy Sexuality (PATHS) is already approved in United States for the following indications:

Approved in United States as Parents and Adolescents Talking about Healthy Sexuality (PATHS) for:

• Educational intervention to reduce HIV risk in gay and bisexual adolescents

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A study of 942 parent-child pairs found that 87% of parents were aware of their adolescents' sexual experiences, highlighting the importance of communication in understanding and addressing sexual health.

Parents who had previously discussed sexual health with their children were more likely to have accurate knowledge of their child's sexual experiences, suggesting that fostering open conversations can lead to better awareness and potentially safer sexual practices among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of parental knowledge of adolescent sexual experience: United States, 2012. Potter, J., Soren, K., Santelli, J.[2023]

The PATHS online intervention significantly improved communication about HIV between parents and their sons, with parents reporting increased discussions about HIV, condom use, and facilitating HIV testing in the three months following the program.

Parents showed notable improvements in their attitudes, skills, and intentions regarding sexual health conversations with their sons, highlighting their potential role in HIV prevention among young men who have sex with men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Parent-Focused HIV Prevention Intervention for Young Men Who have Sex with Men: A Pilot Randomized Clinical Trial. Huebner, DM., Barnett, AP., Baucom, BRW., et al.[2023]

Adolescents who communicated with their parents about HIV prevention and condom use before age 18 were more likely to get tested for HIV, based on a study of 7,252 young adults aged 18-24.

For young women specifically, discussions about birth control methods and STDs also correlated with higher rates of HIV testing, highlighting the importance of comprehensive sex education from parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between parent-adolescent communication about sex-related topics and HIV testing, United States. 2006-2013. Balaji, AB., Oraka, E., Fasula, AM., et al.[2022]

A brief parent-adolescent sexual risk communication intervention was effective in improving communication about sex-related issues and enhancing adolescents' condom use skills and self-efficacy among 2,564 grade 10 students and their parents in the Bahamas.

The study suggests that incorporating a brief parent-adolescent communication intervention into HIV prevention programs can significantly enhance their effectiveness, especially when reinforced with periodic follow-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of parent involvement in an effective adolescent risk reduction intervention on sexual risk communication and adolescent outcomes. Wang, B., Stanton, B., Deveaux, L., et al.[2018]

In a study involving 1,833 Bahamian parent-youth dyads, parents who participated in the Caribbean Informed Parents and Children Together program reported significant improvements in their knowledge of condom use and perceived competence in discussing sexual health with their children.

The program not only aimed to benefit adolescents but also resulted in parents feeling more equipped to communicate about sex-related topics, enhancing their ability to guide their children and protect themselves from sexual risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent Sexual Health Education: Parents Benefit Too! Dinaj-Koci, V., Deveaux, L., Wang, B., et al.[2018]

The Cuídalos Web-based intervention significantly improved sexual communication between parents and adolescents, as reported by 660 parent/adolescent pairs over a 12-month period.

Parents in the experimental group discussed topics like peer pressure and sexual risk more frequently than those in the control group, demonstrating the effectiveness of this online program for enhancing sexual health communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Efficacy of a Web-Based Parent-Adolescent Sexual Communication Intervention Among Puerto Ricans. Varas-Díaz, N., Betancourt-Díaz, E., Lozano, AJ., et al.[2021]

The Parents Matter! Program (PMP) was successfully implemented in 13 out of 15 community sites across the U.S. and Puerto Rico, demonstrating its feasibility and acceptability in promoting parent-child communication about sexual risk reduction.

With 76% of parents attending at least four out of five sessions, the program showed high satisfaction levels, indicating that engaging parents in HIV prevention efforts is a promising strategy for addressing sexual risk behaviors in preadolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-risk HIV-prevention paradigm shift: the feasibility and acceptability of the parents matter! Program in HIV risk communities. Miller, KS., Maxwell, KD., Fasula, AM., et al.[2022]

The Parents Matter! Program (PMP) significantly improved African-American parents' perceptions of their children's readiness to learn about sexual issues, with a 29% increase in the enhanced group compared to 16% in the control group (p < .001).

Parents in the enhanced PMP group reported better communication with their children about HIV/AIDS, abstinence, and condom use, with significant increases in concordant responses between parent-child dyads (up to 15% improvement, p < .001), indicating the program's effectiveness in promoting sexual health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing HIV communication between parents and children: efficacy of the Parents Matter! Program. Miller, KS., Lin, CY., Poulsen, MN., et al.[2022]

The study evaluated a parent-based program called Moms Stopping It Now! (Ms. Now) designed to prevent HIV infection in adolescents of mothers living with HIV, involving 12 African American mother-adolescent pairs in a pilot program.

Participants reported high satisfaction and engagement with the program, and significant improvements were noted in protective parenting outcomes, such as parent-child relationship quality and parental monitoring, indicating the program's potential efficacy in strengthening families affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parent-Based Intervention to Prevent HIV Among Adolescent Children of Mothers Living with HIV: The Ms. Now! Program. Tarantino, N., Armistead, LP.[2020]

Citations

1. parentwithlove.northwestern.edu parentwithlove.northwestern.edu/paths/

PATHS PATHS is a toolkit we developed to help parents communicate more effectively with their children about sexuality and HIV.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836779/

Effects of a Parent-focused HIV Prevention Intervention for ... This study presents the results of a pilot RCT of Parents and Adolescents Talking about Health Sexuality (PATHS)—an online intervention ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1054139X25004501

Parent-Adolescent Relationship Quality, Sexual Health ... HIV pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention method recommended for sexually active adolescents aged 14–17 years ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05852600

Parent-focused Intervention to Reduce HIV Risk in Gay and ... Our team has developed an intervention -- Parents and Adolescents Talking about Healthy Sexuality (PATHS) -- to reduce HIV risk for gay and bisexual youth by ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12406781/

Family-based sexual health interventions for adolescents in low Family-based sexual health interventions (FBSHI) have proven to be a successful approach to promoting adolescent sexual and reproductive health ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36352294/

Effects of a Parent-Focused HIV Prevention Intervention for ... Parents and Adolescents Talking about Healthy Sexuality (PATHS) is an online intervention for parents designed to improve communication about ...

7. aidsmap.com aidsmap.com/news/dec-2022/educating-parents-sexual-health-increases-hiv-testing-among-young-gay-and-bisexual

Educating parents on sexual health increases HIV testing ... According to the reports of the adolescents, parents who used the application were almost four times more likely to share information on HIV ...