Evaluation of Unstained

NCT06574139 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-04-24

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574139 on ClinicalTrials.gov