Evaluation of Unstained
NCT06574139 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500
Last updated 2026-04-24
Summary
The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the legal system. The primary research questions it aims to answer are:
* Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months?
* Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months?
Researchers will compare participants randomized to receive Unstained (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).
Participants randomized to the treatment group will be offered Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.
Conditions
- Teen Pregnancy Prevention
Interventions
- BEHAVIORAL
-
Like
Like is an hour-long film that discusses the impact of social media on the brain. Participants will receive a link to the film and will be asked to watch it independently. The film does not include information related to the outcomes of interest for the study.
- BEHAVIORAL
-
Unstained
Unstained is an individual-level, virtual intervention that involves three \~60-minute sessions delivered over a 3-6 week period. Each session includes watching two videos (six videos total), followed by a discussion facilitated by study coordinators.
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
Mathematica Policy Research, Inc.
collaborator OTHER -
Reproductive Health National Training Center
collaborator UNKNOWN -
Tsikbal
collaborator UNKNOWN -
The Policy & Research Group
lead OTHER
Principal Investigators
-
Sarah Walsh, PhD · The Policy & Research Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-16
- Primary Completion
- 2028-03-31
- Completion
- 2028-09-14
Countries
- United States
Study Locations
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