Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care

NCT06127277 | Enrolling By Invitation

• 1 other identifier: Next4You
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Behavior; Sexually Transmitted Diseases; Pregnancy Related

Keywords

Pregnancy; Adolescence; Sexually Transmitted Infections; Decision Making; Prevention Education

Outcome Measures

Primary Outcomes (1)

• Prevalence of choosing abstinence or the use of condoms if having vaginal or anal sex in the past 3 months

  Measured with single-item dichotomous measure of behavior analyzed individually to assess: any consensual vaginal sex in the past 3 months (main and casual sex partners); any consensual vaginal sex with a condom in the past 3 months (main and casual sex partners); any consensual anal sex in the past 3 months (main and casual sex partners); and any consensual anal sex with a condom in past 3 months (main and casual sex partners).

  3 months post-intervention

Secondary Outcomes (21)

• Prevalence of choosing abstinence or the use of condoms if having vaginal or anal sex in the past 3 months

  9 months post-intervention

• Rates of condomless vaginal or anal sex

  3 months post-intervention

• Rates of condomless vaginal or anal sex

  9 months post-intervention

• Sexual consent self-efficacy

  3 months post-intervention

• Sexual consent self-efficacy

  9 months post-intervention

Study Arms (2)

Next4You

EXPERIMENTAL

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.

Behavioral: Next4You

General Health Mobile Website

ACTIVE COMPARATOR

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.

Behavioral: Next4You

Interventions

Next4You BEHAVIORAL

Youth in the intervention arm will have access for four continuous weeks to a mobile intervention that covers topics related to communication, relationships, sexual wellness, contraception, respecting self and partners, and building wealth and wellness.

General Health Mobile Website; Next4You

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• ETR Associates: lead
• RTI International: collaborator

Study Sites (1)

RTI

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pamela Anderson, PhD

  ETR

  PRINCIPAL INVESTIGATOR

• Karin Coyle, PhD

  ETR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: September 25, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)