Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health

NCT07011563 | Recruiting

• 2 other identifiers: 1554023K23MH123335
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy. If youth don't have a parent they can talk to about sexual health, we want to help them find a trusted adult to talk to. We also want to help youth take control of their own health by learning about different ways to protect their health.

Conditions

HIV Prevention; Sexual Health

Outcome Measures

Primary Outcomes (2)

• Sexual health communication scale score - youth

  We will administer the SHC scale to youth as a survey

  4 weeks

• Sexual health communication scale score - parent

  We will administer the SHC scale to parent as a survey

  4 weeks

Secondary Outcomes (1)

• PrEP uptake

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Intervention

Treatment as usual +

ACTIVE COMPARATOR

Behavioral: Control

Interventions

Intervention BEHAVIORAL

Youth: interventionist-facilitated 1:1 conversation with the youth via videoconference that includes a) brief sexual health assessment, b) individualized information about HIV risk reduction including PrEP, and c) use of motivational interviewing strategies to discuss barriers to PrEP. Parents: brief (\~20-30 min) web-based, interactive learning module ("module") designed to provide information about sexual health communication (SHC) best practices, HIV prevention strategies (e.g., condoms, STI testing, PrEP), as well as build practical skills around SHC using evidence-based behavior change methods (e.g., building confidence, aligning values with actions).

Intervention

Control BEHAVIORAL

Youth: interventionist-facilitated 1:1 conversation with the youth via videoconference that includes a) brief sexual health assessment, and b) didactic information about condom use, STI testing (including HIV), and PrEP (but not motivational interviewing or individualized information on HIV risk reduction). Parent: brief written information on a digital platform (i.e., website) with advice about talking to youth about sexual health with web-links to resources about STI/HIV prevention and PrEP. This information will not be interactive or use behavior change methods.

Treatment as usual +

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 14-17
• Assigned male
• Oral OR anal sex with an assigned male
• Live in the United States
• English-speaking

You may not qualify if:

• None

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jack Rusley, MD, MHS

  Brown University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Rusley, MD, MHS

CONTACT

401-444-5980; jack.rusley@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 9, 2025
• Study Start: May 16, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 9, 2025

Record last verified: 2025-06

Locations

US (1)