Evaluation of Are You Ready?

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
The Policy & Research Group
Study ID
NCT06580080
Status
Recruiting
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Conditions

  • Teen Pregnancy Prevention

Eligibility Criteria

Sex
ALL
Age
14 Years - 22 Years
Healthy Volunteers
Accepted

Interventions

  • Are You Ready? (AYR) — BEHAVIORAL
    AYR is a group-based entertainment education (EE) intervention designed for sexually active youth who are at risk for or involved in the juvenile justice and/or child welfare systems. AYR is delivered in one, 2.5-hour (150-minute) session with a group of between 2 to 20 youth. The session includes screening a 40-minute video, "Happy Birthday, Leonard" and group-based discussions led by one to two facilitators. Discussions are guided by a participant workbook with journal prompts and handouts. The session includes two modules; each module involves screening approximately 20 minutes of "Happy Birthday, Leonard" followed by a 40-minute group discussion. Module 1 includes topics related to contraception, condom use (with a condom demonstration), healthy communication, and stress management. Module 2 includes topics related to condom negotiation, communication styles, and intergenerational cycles.
  • Social Media Awareness Shorts (SMAS) — BEHAVIORAL
    SMAS is a virtually delivered, individual-based health program focused on social media use awareness. Participants are directed to a learning management platform that contains a pre-recorded, facilitated program. The program involves watching several short films and independently completing several activities related to social media use. The program does not include information related to the primary outcomes for this study.

Study Details

The goal of this randomized trial is to learn if the Are You Ready? (AYR) intervention has a positive impact on the sexual and mental health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the juvenile justice and/or child welfare systems. The primary research questions it aims to answer are: * Three months after being offered the intervention, does AYR impact youth's receipt of sexually transmitted infection testing in the past three months? * Three months after being offered the intervention, does AYR impact youth's use of coping skills? * Nine months after being offered the intervention, does AYR impact youth's frequency of having vaginal and anal sex without condoms in the past three months? Researchers will compare participants randomized to receive AYR (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 AYR as a virtual or in-person, 2.5 hour group session. Participants randomized to the control group will be offered a virtually delivered control condition.

Key Dates

Start date
Nov 15, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2028
Completion
Sep 14, 2028

Study Design

Enrollment
1,850 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Are You Ready?
  • Sham Comparator: Social Media Awareness Shorts

Primary Outcome Measure

Receipt of sexually transmitted infection (STI) testing in the past three months [ Time Frame: Assessed three months after the intervention period has ended (four 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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