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NCT Number: NCT06580080

Evaluation of Are You Ready?

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.

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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 Are You Ready? (AYR) 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 (four months after baseline); and nine months post-intervention (ten months after baseline).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At risk for or involved in the juvenile justice and/or child welfare systems
  • Has had vaginal or anal sex in the last 6 months or has ever had vaginal or anal sex and self-report likelihood of having sex in the next 6 months
  • Comfortable reading, speaking, and writing in English
  • United States resident

Exclusion criteria

  • Has received other known sexual and reproductive health evidence-based interventions implemented in their local area.
  • Enrolled in an ongoing PRG-run TPP study
  • Identified as fraudulent

Treatment and study plan

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.

Primary outcomes

  1. 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)

    Participants are asked the following item:

    • Have you been tested for sexually transmitted infections (STIs) in the past 3 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 three months and 1 indicates a person who has received STI testing in the past three months.

  2. Use of coping skills

    Time frame: Assessed three months after the intervention period has ended (four months post-baseline)

    Participants are asked on a 4-point scale ranging from "I did not use" (1) to "I used almost all the time" (4) how often they used the following strategies:

    • I talked to someone to find out more about the situation.
    • I let people know what I needed.
    • I talked to someone who could act in some way to change the situation.
    • I asked for ideas from a friend who I could trust.
    • I made a great effort to make things work.
    • I spent time with someone I wanted to be with.
    • I tried to look after my health by eating food that was good for me.
    • I tried to eat regularly.
    • I made a plan of action and followed it through.
    • I tried to release my anger by exercising.
    • I tried to look after myself by getting plenty of sleep.
    • I tried to be physically fit. The measure is calculated as the average response to all 12 items in the scale.

  3. Times having vaginal and anal sex without condoms in the past three months

    Time frame: Assessed nine months after the intervention period has ended (ten months post-baseline)

    Participants are asked the following two items:

    • In the past 3 months, how many times have you had vaginal sex without you or your sexual partner using a condom?
    • In the past 3 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 three months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past three 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
  • Institute of Women & Ethnic Studies
  • Mathematica Policy Research, Inc.
  • Reproductive Health National Training Center

Registry information

Acronym: AYR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 30, 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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