Evaluation of Unstained

April 21, 2026 updated by: The Policy & Research Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Like
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.
Experimental: Unstained
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of sexually transmitted infection (STI) testing in the past four months
Time Frame: Assessed three months after the intervention period has ended (five months post-baseline)

Participants are asked the following item:

1) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months.
Assessed three months after the intervention period has ended (five months post-baseline)
Times having vaginal and anal sex without condoms in the past four months
Time Frame: Assessed nine months after the intervention period has ended (11 months post-baseline)

Participants are asked the following two items:

  1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom?
  2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
Assessed nine months after the intervention period has ended (11 months post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Policy & Research Group

Collaborators

Department of Health and Human Services
Mathematica Policy Research, Inc.
Reproductive Health National Training Center
Tsikbal

Investigators

  • Principal Investigator: Sarah Walsh, PhD, The Policy & Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 14, 2028

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1 TP2AH000085-01-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.

IPD Sharing Time Frame

The individual participant dataset will become available twelve months after the study has concluded.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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