Teen Pregnancy PreventionAYRNCT06580080
Evaluation of Are You Ready?
A study testing Are You Ready? (AYR) and Social Media Awareness Shorts (SMAS) in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Are You Ready? (AYR) and Social Media Awareness Shorts (SMAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,850 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 14 Sep 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Policy & Research Group
New Orleans, Louisiana, 70118
About this study
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?
Read more
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.
Read the detailed description
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).
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Are You Ready? (AYR), Social Media Awareness Shorts (SMAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Are You Ready? (AYR)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Are You Ready? | Experimental | Not described Receives: Behavioral: Are You Ready? (AYR) |
| Social Media Awareness Shorts | Sham comparator | Not described Receives: Behavioral: Social Media Awareness Shorts (SMAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of sexually transmitted infection (STI) testing in the past three months
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.
Measured: Assessed three months after the intervention period has ended (four months post-baseline)
Use of coping skills
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.
Measured: Assessed three months after the intervention period has ended (four months post-baseline)
Times having vaginal and anal sex without condoms in the past three months
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.
Measured: Assessed nine months after the intervention period has ended (ten months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Nov 2024
- Primary completionAug 2028 (estimated)
- Study completion14 Sep 2028 (estimated)
Why it stopped: Grant funding was unexpectedly suspended by the U.S. Department of Health \& Human Services.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc., Reproductive Health National Training Center, Institute of Women & Ethnic Studies
- Responsible party
- Sponsor
- Investigators
- Sarah Walsh, PhD, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580080
- Sponsor's protocol ID
- 1 TP2AH000094-01-00
- Acronym
- AYR
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Are You Ready?
- ClinicalTrials.gov ID
- NCT06580080
- Acronym / sponsor ID
- AYR / 1 TP2AH000094-01-00
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Grant funding was unexpectedly suspended by the U.S. Department of Health \& Human Services.
- Enrolment
- 1,850 participants (estimated)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc., Reproductive Health National Training Center, Institute of Women & Ethnic Studies
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Are You Ready? | Experimental | Behavioral: Are You Ready? (AYR) |
| Social Media Awareness Shorts | Sham comparator | Behavioral: Social Media Awareness Shorts (SMAS) |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Are You Ready? (AYR)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. | Behavioural | Are You Ready? |
| Social Media Awareness Shorts (SMAS)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. | Behavioural | Social Media Awareness Shorts |
Primary outcome
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: 1) 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.
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: 1. I talked to someone to find out more about the situation. 2. I let people know what I needed. 3. I talked to someone who could act in some way to change the situation. 4. I asked for ideas from a friend who I could trust. 5. I made a great effort to make things work. 6. I spent time with someone I wanted to be with. 7. I tried to look after my health by eating food that was good for me. 8. I tried to eat regularly. 9. I made a plan of action and followed it through. 10. I tried to release my anger by exercising. 11. I tried to look after myself by getting plenty of sleep. 12. I tried to be physically fit. The measure is calculated as the average response to all 12 items in the scale.
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: 1. In the past 3 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Walsh, PhD principal investigator
The Policy & Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Are You Ready? (AYR) and Social Media Awareness Shorts (SMAS) in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.