Communication Intervention for Sexual Wellness and HIV Prevention

Overseen By Jack Rusley, MD, MHS

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: Rhode Island Hospital

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young people discuss sexual health more openly with trusted adults, including ways to prevent HIV and other sexually transmitted diseases. It focuses on building communication skills and empowering youth to take control of their health. The trial includes two groups: one will try a new program called "Prepping for The Talk," while the other will continue with their usual health practices. The study seeks males aged 14-17 who have had oral or anal sex with another male, live in the U.S., and speak English. As an unphased trial, this study offers a unique opportunity to contribute to important research on youth sexual health communication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this communication intervention is safe for young people?

Research shows that "Prepping for The Talk" is a program designed to help young people discuss sexual health and HIV prevention. While specific data on the program's safety is not available, it employs teaching and communication methods, which typically carry very low risk.

The program aims to enhance young people's communication skills and increase their knowledge about HIV prevention methods, such as PrEP (pre-exposure prophylaxis). PrEP is a safe and effective method for preventing HIV, and studies have shown it has few side effects.

As "Prepping for The Talk" is an educational program rather than a medical treatment, it presents few safety concerns. Participants are likely to gain better awareness and communication skills, leading to improved health outcomes with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Prepping for The Talk" intervention because it focuses on improving communication for sexual wellness and HIV prevention. Unlike standard care options that primarily focus on medication or barrier methods, this intervention emphasizes open dialogue and education, which can empower individuals to make informed decisions about their health. By enhancing communication skills, it aims to address the root causes of risky behaviors rather than just the symptoms, offering a holistic approach to prevention. This novel strategy could lead to more sustainable and widespread changes in behavior compared to traditional methods.

What evidence suggests that this communication intervention is effective for sexual wellness and HIV prevention?

This trial will compare the "Prepping for The Talk" intervention with standard treatment practices. Research has shown that open discussions about sexual health can increase understanding and reduce risky behaviors. Studies have found that knowledge of preventive tools like PrEP (a medication to prevent HIV) can lower the risk of contracting HIV by over 90% when used correctly. Programs combining HIV prevention with sexual health education have increased interest among young people in these services. Additionally, counseling support has proven effective in reducing risky sexual behaviors. These findings underscore the importance of discussing sexual health to protect against sexually transmitted infections like HIV. ^{1 6 7 8 9}

Who Is on the Research Team?

Jack Rusley, MD, MHS

Principal Investigator

Brown University Health

Are You a Good Fit for This Trial?

This trial is for young individuals seeking to improve communication with trusted adults about sexual health and HIV prevention. It aims to foster open discussions while respecting privacy. Participants must be willing to engage in the study's activities.

Inclusion Criteria

I am between 14 and 17 years old.

English-speaking

I am male.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in activities to improve communication about sexual health with trusted adults

4 weeks

Follow-up

Participants are monitored for changes in sexual health communication and PrEP uptake

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prepping for The Talk

Trial Overview The study tests an intervention designed to facilitate better conversations between youth and trusted adults regarding sexual wellness and HIV prevention, compared against a control group not receiving this specific intervention.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Treatment as usual + Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9118410/

Sexual Communication Self-Efficacy and PrEP Literacy ... According to research, PrEP can reduce the transmission of HIV by more than 90% when used according to instructions. However, PrEP uptake ...

2. researchprotocols.org researchprotocols.org/2025/1/e64186

Protocol for the PrEP Choice Longitudinal Cohort Study Clinical trials of sexual event-driven PrEP regimens or 2-1-1 PrEP using F/TDF have demonstrated it to be highly effective for HIV prevention ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12324821/

A Community-led, Multicomponent HIV Prevention Strategy ... Preliminary data from August 2022 through January 2024 showed promising implementation and effectiveness outcomes. During that time, 113 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S235230182400119X

Effectiveness of integrating HIV prevention within sexual ... This study provides evidence that STI testing and sexual and reproductive health services create demand for serostatus neutral HIV prevention in adolescents ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1600773/pdf

Impact of mHealth on enhancing pre-exposure prophylaxis ... The results showed that after receiving counseling support, 100% of participants exhibited a reduction in sexual risk behavior and approximately ...

6. cdc.gov cdc.gov/hiv/prevention/prep.html

Preventing HIV with PrEP For receptive vaginal sex and injection drug use, PrEP pills reach maximum protection at about 21 days of daily use. No data are available for ...

7. ajmc.com ajmc.com/view/contributor-prep-in-practice-how-to-start-conversations-about-hiv-prevention

How to Start Conversations About HIV Prevention Learning the best type of HIV prevention for those at highest risk can start with conversations about their options, writes Zandraetta ...

8. hivguidelines.org hivguidelines.org/guideline/hiv-prep/

PrEP to Prevent HIV and Promote Sexual Health Its inclusion as a pillar of this initiative emphasizes the safety and effectiveness of PrEP as an HIV prevention method. This guideline was ...

9. jahonline.org jahonline.org/article/S1054-139X(23)00230-6/pdf

Attitudes Toward and Experiences With Discussing ... Because sexual partners of youth living with HIV are at high risk of HIV acquisition, they are a key target population that would benefit from PrEP.