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NCT Number: NCT06574139

Evaluation of Unstained

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.

Recruiting

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Key information

Conditions

Teen Pregnancy Prevention

Age range

14 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

Location status: Recruiting

Location contact

Hilary Demby, MPH

CONTACT

[email protected]

504-865-1545

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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:

    • 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.

  2. 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:

    • In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom?
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elyse Mason, MPH

CONTACT

[email protected]

504.865.1545

Hilary Demby, MPH

CONTACT

[email protected]

504.865.1545

Sponsors and collaborators

Lead sponsor

The Policy & Research Group

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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