Next4You Program for Adolescent Pregnancy and STI Prevention

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: ETR Associates

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile program called Next4You, designed to reduce unintended pregnancies and sexually transmitted infections among 16 to 19-year-olds in the California foster care system. Participants will use a web-based platform with short lessons to enhance their knowledge and skills over an intensive 4-week period. A comparison group will access digital resources on general health topics like sleep and exercise. The trial seeks young people in foster care who live in California, speak English, and have access to a digital device. As an unphased trial, this study offers a unique opportunity to contribute to important research that could benefit many young people in foster care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Next4You program is safe for adolescents?

Research shows no specific safety data for the Next4You program or similar treatments aimed at preventing pregnancy and STIs in teenagers. Next4You is an online program for young people aged 16-19, especially those in foster care, offering educational content.

Since the program doesn't involve taking medicine or undergoing medical procedures, it typically presents fewer risks or side effects. As a web-based program, the main safety concern is ensuring the content is suitable and engaging for the audience. Participants can go through the material at their own pace, reducing any pressure or stress.

Overall, even without direct safety data, the program's nature suggests it is likely safe. For questions or concerns about joining, discussing with the study coordinators may provide more details. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Next4You program because it offers a unique, web-based approach to preventing unintended pregnancies and STIs among adolescents in foster care. Unlike traditional in-person education sessions, this program is self-paced and accessible 24/7, making it easier for teens to engage with the content on their own terms. The platform's use of short, diverse microlessons keeps the material engaging and digestible, encouraging consistent participation. This innovative delivery method could potentially reach a wider audience and adapt to the needs of young people more effectively than current options.

What evidence suggests that the Next4You program is effective for preventing adolescent pregnancy and STIs?

This trial will compare the Next4You program with a General Health Mobile Website. Research has shown that digital tools like Next4You can help reduce unplanned pregnancies and sexually transmitted infections (STIs) among teenagers. For example, the Teen-Tot Clinic study found that teens receiving coordinated services used birth control more effectively and had fewer repeat pregnancies. Programs designed for young people, such as those from ETR (creators of Next4You), use engaging educational content to successfully increase knowledge and change behaviors related to sexual health. Early results suggest that digital programs can improve outcomes by making important health information more accessible and engaging for teens. ^{1 6 7 8 9}

Who Is on the Research Team?

Pamela Anderson, PhD

Principal Investigator

ETR

Karin Coyle, PhD

Principal Investigator

ETR

Are You a Good Fit for This Trial?

This trial is for young people aged 16-19 in the foster care system in California who can understand English and have access to a Wi-Fi or cellular-enabled digital device. It's not specified who cannot participate, so it may be open to all eligible youths.

Inclusion Criteria

Foster youth status

County of residence

English proficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screener

Implementation

Participants engage with the Next4You mobile platform or control website for an intensive 4-week period

4 weeks

Online engagement

Follow-up

Participants are monitored for changes in attitudes, knowledge, and behavior through surveys conducted at 3 and 9 months post-intervention

9 months

Surveys at 3 and 9 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Next4You

Trial Overview The study is testing 'Next4You', a mobile program with content modules designed to reduce unintended pregnancies and STIs while boosting knowledge, attitudes, and skills related to adolescent behaviors.

How Is the Trial Designed?

Group I: Next4You Experimental Treatment 1 Intervention

Next4You is a web-based, self-paced program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in foster care in California. Each microlesson is 2-4 minutes with diverse content formats. Youth in the intervention condition will have unlimited access to the platform for an intensive 4-week period. During this period, engagement activities will be deployed twice weekly to draw users back into the platform for further engagement with the microlessons. Content will also be released on a schedule to encourage continued engagement. Following the intensive 4-week period, youth will retain unlimited access to the platform but will not receive reminders to engage with the content. Participants complete online surveys at baseline, as well as 3 months and 9 months after the intervention ends.

Group II: General Health Mobile Website Active Control 1 Intervention

Youth randomized to the attention control condition will have access to a mobile-responsive website that contains digital resources focusing on nutrition, sleep, stress/anxiety, and exercise. Like the intervention group, participants in the attention control group will have unlimited access to the general health digital resources for an intensive 4-week period. Each topic area will have between 1-4 digital pamphlets (for a total of 12 pamphlets) that are downloadable and take between 2-4 minutes to read. Participants complete online surveys related to attitudes, knowledge, and behavior around romantic relationships and sexual behavior at baseline, as well as 3 months and 9 months after the intervention ends.

Who Is Running the Clinical Trial?

ETR Associates

Lead Sponsor

Trials

14

Recruited

12,900+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Published Research Related to This Trial

The VOALA Girls Inc. program is rigorously evaluating its Preventing Adolescent Pregnancy curriculum with 517 participants from urban middle and high schools, aiming to identify effective teen pregnancy prevention strategies.

Innovative changes made during the second cohort of the program successfully increased attendance and reduced attrition rates, addressing common challenges faced in after-school programming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong, smart and bold strategies for improving attendance and retention in an after-school intervention. Markoe Hayes, S., Chapple, S., Ramirez, C.[2014]

The outreach strategy for the youth contraception navigator program, named 'IN Control', was developed using a human-centered design approach, engaging adolescents aged 15-17 to ensure the messages resonate with their needs and experiences.

Key elements of the strategy include normalizing conversations about birth control, acknowledging access challenges, and using diverse imagery to build trust, which are crucial for effectively reaching and influencing young people's behavior regarding contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human-centered designed outreach strategy for a youth contraception navigator program. Wilkinson, TA., Hawryluk, B., Moore, C., et al.[2022]

A review of 73 studies identified four effective program types that can significantly delay sexual initiation and reduce teen pregnancy and sexually transmitted infections among adolescents.

These effective programs include specific sex and HIV education curricula, one-on-one clinician-patient interactions, service learning initiatives, and a comprehensive youth development program, all of which have shown strong evidence in improving sexual health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective approaches to reducing adolescent unprotected sex, pregnancy, and childbearing. Kirby, D.[2014]

The Adolescent Family Life Program aims to prevent adolescent pregnancies by targeting education and outreach before adolescents become sexually active, addressing the rising trends in premarital sexual activity and out-of-wedlock births.

The program also focuses on supporting adolescent parents through services like prenatal care, nutrition counseling, and vocational training, while emphasizing family involvement to create effective prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Adolescent Family Life Program as a prevention measure. Mecklenburg, ME., Thompson, PG.[2021]

The Safer Choices 2 program targets high-risk students in alternative high schools, with a study cohort of 711 out of 940 initially enrolled students, highlighting the need for effective HIV, STI, and pregnancy prevention interventions in this demographic.

Baseline data revealed that a significant portion of students were sexually active, with 55.4% reporting unprotected intercourse, indicating a critical need for targeted educational and preventive measures to address their high-risk behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer choices 2: rationale, design issues, and baseline results in evaluating school-based health promotion for alternative school students. Tortolero, SR., Markham, CM., Addy, RC., et al.[2018]

Citations

1. withpower.com withpower.com/trial/next4you-program-for-adolescent-pregnancy-and-sti-prevention-3ac35

Next4You Program for Adolescent Pregnancy and STI ... The Teen-Tot Clinic study showed that coordinated services for teen mothers improved outcomes like contraceptive use and reduced repeat pregnancies.

2. etr.org etr.org/solutions/research/

Research - ETR Next4You is a digital intervention developed by ETR aimed at reducing unintended pregnancy and STI rates among youth aged 16–19 in California's foster care ...

3. researchgate.net researchgate.net/scientific-contributions/Karin-K-Coyle-2312782345

Karin K. Coyle's research works | ETR Associates and ... Karin K. Coyle's 3 research works with 12 citations, including: Adolescent Sexual Health and Teen Pregnancy Prevention Programs Are Complex and Require Careful

4. medrxiv.org medrxiv.org/content/10.1101/2022.09.13.22279867v1.full-text

Internet Delivered Sexually Transmitted Infection and Teen ... Results Overall, at baseline, reliable contraception was 54.8% and dual protection was 29.4% and the prevalence of STI was 11.1%. Participants ...

5. aspe.hhs.gov aspe.hhs.gov/sites/default/files/migrated_legacy_files//155171/RTRbrief.pdf

Teen Pregnancy Prevention Replication Study This study was designed to address important research and policy questions about the effectiveness of evidence-based teen pregnancy prevention programs, and ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0078039

Sexually Transmitted Disease (STD) (DBCOND0078039) A Parent Child Program to Prevent Adolescent Pregnancy ... Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind ...

7. researchgate.net researchgate.net/publication/391623404_Next4You_Study_Protocol_A_Youth-Centered_Mobile_Intervention_to_Promote_Healthy_Relationships_and_Sexual_Wellness_Among_Adolescents_in_or_Transitioning_from_Foster_Care_Preprint

Next4You Study Protocol: A Youth-Centered Mobile ... The program intends to reduce unintended pregnancies and ... Final data collection is anticipated by March 2026, followed by data analysis.

8. opa.hhs.gov opa.hhs.gov/adolescent-health/adolescent-sexual-and-reproductive-health/data-and-statistics-on-adolescent-sexual-and-reproductive-health

Data and Statistics on Adolescent Sexual and Reproductive ... The 2019 teen pregnancy rate · The teen birth rate in 2022 was 13.6 births for every 1,000 females ages 15-19, down 2% from 2021 (13.9) and down 78% from the ...

9. partnersforfamilyhealth.org partnersforfamilyhealth.org/wp-content/uploads/2021/05/ACT534_PreventionofTeenPregnancyandSexuallyTransmittedDiseases_2020.pdf

Prevention of Teen Pregnancy and Sexually Transmitted ... The program administers three Evidence-Based Teen Pregnancy Prevention program models at five community based organizational sites in four regions of the state.