Parent-focused Intervention for HIV Prevention

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Lead with Love (LWL) and Parents and Adolescents Talking about Healthy Sexuality (PATHS) for HIV prevention?

Research shows that involving parents in HIV prevention programs can improve communication about sexual health and increase knowledge about safe practices, which helps both parents and adolescents. Programs like Parents Matter! have been effective in enhancing parent-child communication and reducing sexual risk behaviors, suggesting that similar parent-focused interventions like LWL and PATHS could be beneficial. ^{1 2 3 4 5}

Is the parent-focused intervention for HIV prevention safe for humans?

The research on parent-focused interventions like PATHS and similar programs shows that they are generally safe for humans, as they focus on improving communication and education about sexual health without any reported adverse effects. ^{1 6 7 8 9}

How does the PATHS treatment differ from other treatments for HIV prevention?

The PATHS treatment is unique because it focuses on improving communication between parents and adolescents about healthy sexuality, which can lead to better sexual health decisions and increased HIV testing. Unlike other treatments that may target adolescents directly, PATHS involves parents as active participants, enhancing their knowledge and communication skills to effectively guide their children. ^{1 2 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adolescent Sexual Health Education: Parents Benefit Too! [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Pre-risk HIV-prevention paradigm shift: the feasibility and acceptability of the parents matter! Program in HIV risk communities. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

The impact of parent involvement in an effective adolescent risk reduction intervention on sexual risk communication and adolescent outcomes. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancing HIV communication between parents and children: efficacy of the Parents Matter! Program. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Association between parent-adolescent communication about sex-related topics and HIV testing, United States. 2006-2013. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Testing the Efficacy of a Web-Based Parent-Adolescent Sexual Communication Intervention Among Puerto Ricans. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of parental knowledge of adolescent sexual experience: United States, 2012. [2023]

9. United States 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. [2023]