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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Next4You for adolescent pregnancy and STI prevention?

The Teen-Tot Clinic study showed that coordinated services for teen mothers improved outcomes like contraceptive use and reduced repeat pregnancies. Similarly, an integrated services program in DC led to sustained contraceptive use and fewer subsequent pregnancies, suggesting that comprehensive care models can effectively prevent teen pregnancies. ^{1 2 3 4 5}

Is the Next4You Program for Adolescent Pregnancy and STI Prevention safe for humans?

The research articles provided do not contain specific safety data for the Next4You Program or similar treatments for adolescent pregnancy and STI prevention. ^{6 7 8 9 10}

How is the Next4You treatment different from other adolescent pregnancy and STI prevention treatments?

The Next4You treatment is unique because it focuses on reaching adolescents before they become sexually active, emphasizing education about the responsibilities of sexuality and parenting, and involving family in prevention efforts. This approach is different from others that primarily focus on providing services after adolescents have already faced the consequences of unprotected sexual activity. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of the study is to rigorously evaluate Next4You, an innovative, fully mobile 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 the foster care system in California.

Research Team

Karin Coyle, PhD

Principal Investigator

ETR

Pamela Anderson, PhD

Principal Investigator

ETR

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The teen-tot clinic: an alternative to traditional care for infants of teenaged mothers. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an integrated services program to prevent subsequent pregnancy and birth among urban teen mothers. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Does a competitive voucher program for adolescents improve the quality of reproductive health care? A simulated patient study in Nicaragua. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Obstetric, neonatal, and psychosocial outcome of pregnant adolescents. [2006]

5. England pubmed.ncbi.nlm.nih.gov

A collaborative outreach clinic for pregnant youth and adolescent mothers: Description of a pilot clinic and its patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Advancing Access to Care through Digital Health: Perspectives from Youth on a Novel Platform to Increase Access to Sexual and Reproductive Health Care and Education for Adolescents and Young Adults. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safer choices 2: rationale, design issues, and baseline results in evaluating school-based health promotion for alternative school students. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Trends in sexual risk behaviors among high school students--United States, 1991-1997. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Advancing HIV Biomedical Prevention Research for At-Risk Adolescents. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The Adolescent Family Life Program as a prevention measure. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Sexually transmitted infections among adolescents: the need for adequate health services. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

A human-centered designed outreach strategy for a youth contraception navigator program. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

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

15. United States pubmed.ncbi.nlm.nih.gov

Strong, smart and bold strategies for improving attendance and retention in an after-school intervention. [2014]