Evaluation of Unstained

NCT06574139 | Recruiting

• 1 other identifier: 1 TP2AH000085-01-00
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Receipt of sexually transmitted infection (STI) testing in the past four months

  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

  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)

Study Arms (2)

Unstained

EXPERIMENTAL

Behavioral: Unstained

Like

SHAM COMPARATOR

Behavioral: Like

Interventions

Unstained 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.

Unstained

Like 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.

Like

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Policy & Research Group: lead
• Department of Health and Human Services: collaborator
• Mathematica Policy Research, Inc.: collaborator
• Reproductive Health National Training Center: collaborator
• Tsikbal: collaborator

Study Sites (1)

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

RECRUITING

Study Officials

• Sarah Walsh, PhD

  The Policy & Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilary Demby, MPH

CONTACT

504.865.1545; hilary@policyandresearch.com

Elyse Mason, MPH

CONTACT

504.865.1545; elyse@policyandresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 14, 2028
• Last Updated: April 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The individual participant dataset will become available twelve months after the study has concluded.

Locations

US (1)