Evaluation of Unstained

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
The Policy & Research Group
Study ID
NCT06574139
Status
Recruiting
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Conditions

  • Teen Pregnancy Prevention

Eligibility Criteria

Sex
ALL
Age
14 Years - 22 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Nov 2025
Primary completion
Mar 31, 2028
Completion
Sep 14, 2028

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Unstained
  • Sham Comparator: Like

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Policy & Research GroupNew OrleansLouisiana70118
Hilary Demby, MPH
[email protected]
504-865-1545

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