Recruiting

Sexual Health Education

Sponsor:

Rhode Island Hospital

Code:

NCT07011563

Conditions

HIV Prevention

Sexual Health

Eligibility Criteria

Sex: Male

Age: 14 - 17

Healthy Volunteers: Accepted

Interventions

Intervention

Control

Study Details

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

Study ID

NCT07011563

Start date

May 16, 2025

Status verified date

Jun, 2025

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 14 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

active comparator: Treatment as usual +

Interventions

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).

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.

Primary outcome measure

  • Sexual health communication scale score - youth [ Time Frame: 4 weeks ]
  • Sexual health communication scale score - parent [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Jack Rusley, MD, MHS

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

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Jack Rusley, MD, MHS

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

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jun 9, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-06-09.