Evaluation of Unstained

NCT ID: NCT06574139

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2028-09-14

Brief Summary

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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

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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

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Teen Pregnancy Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Unstained

Group Type EXPERIMENTAL

Unstained

Intervention Type BEHAVIORAL

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.

Like

Group Type SHAM_COMPARATOR

Like

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* United States resident
* Owns or has regular access to a personal device with internet access
* Comfortable reading, speaking, and writing in English
* Has had vaginal or anal sex in the past 3 months
* At risk for or involved in the legal system

Exclusion Criteria

* Currently trying to start a pregnancy
* Currently in jail or being detained in a facility
* Enrolled in an ongoing PRG-run TPP study
* Identified as fraudulent
* Participating in another known OPA-funded research study
Minimum Eligible Age

14 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Mathematica Policy Research, Inc.

OTHER

Sponsor Role collaborator

Reproductive Health National Training Center

UNKNOWN

Sponsor Role collaborator

PCI Media

UNKNOWN

Sponsor Role collaborator

The Policy & Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Walsh, PhD

Role: PRINCIPAL_INVESTIGATOR

The Policy & Research Group

Locations

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The Policy & Research Group

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hilary Demby, MPH

Role: CONTACT

Phone: 504.865.1545

Email: [email protected]

Elyse Mason, MPH

Role: CONTACT

Phone: 504.865.1545

Email: [email protected]

Facility Contacts

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Hilary Demby, MPH

Role: primary

Other Identifiers

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1 TP2AH000085-01-00

Identifier Type: -

Identifier Source: org_study_id