NCT06574139

Evaluation of Unstained

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: The Policy & Research Group · Academic / Other
• Sex: All
• Age: 14 Years – 22 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Unstained intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).

Conditions

• Teen Pregnancy Prevention

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-09-16
• Primary completion: 2028-03-01
• Completion: 2028-09-14
• First posted: 2024-08-27
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States