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

NCT ID: NCT07011563

Last Updated: 2025-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Prevention Sexual Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Group Type EXPERIMENTAL

Intervention

Intervention Type 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).

Treatment as usual +

Group Type ACTIVE_COMPARATOR

Control

Intervention Type 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.

Interventions

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Intervention

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 Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jack Rusley

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jack Rusley, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Brown University Health

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jack Rusley, MD, MHS

Role: CONTACT

401-444-5980

Facility Contacts

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Jack Rusley, MD, MHS

Role: primary

401-444-5980

Other Identifiers

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K23MH123335

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1554023

Identifier Type: -

Identifier Source: org_study_id

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