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Recruiting NCT07011563

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

No phase Interventional HIV Prevention Sexual Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention, Control.
Who it may be relevant to
Registry conditions: HIV Prevention, Sexual Health. Basic parameters: 14 years — 17 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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
  • 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.

Primary outcome measures

  • Sexual health communication scale score - youth [Time frame: 4 weeks]
  • Sexual health communication scale score - parent [Time frame: 4 weeks]
Secondary outcome measures (1)
  • PrEP uptake [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Rhode Island Hospital — Providence

Identifiers

NCT: NCT07011563 · 1554023 · K23MH123335

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗