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Enrolling by Invitation

NCT Number: NCT06127277

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

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.

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Key information

Conditions

Pregnancy Related Adolescent Behavior Behavior Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RTI

Berkeley, California, 94704, United States

About this study

Next4You will be tested using a randomized controlled trial (RCT) involving approximately 500-600 young people ages 16-19 with former or current experience in the California foster care system. Participants will complete an online screener that will assess eligibility (age, foster youth status, county of residence, English proficiency, and access to a device that is Wi-Fi or cellular enabled). Participants will be randomly assigned to receive access to the Next4You mobile platform and its microlessons and resources or a control website containing various health promotion materials. Participants in both conditions will have four consecutive weeks to explore the content on the platform (defined as the implementation period). Self-reported survey data related to attitudes, knowledge, and behavior around romantic relationships and sexual behavior are collected at baseline, as well as 3 months and 9 months after the intervention ends.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Age, foster youth status, county of residence, English proficiency, access to a digital device that is Wi-Fi and/or cellular enabled -

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3 months post-intervention

    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).

Secondary outcomes

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

    Time frame: 9 months post-intervention

    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).

  2. Rates of condomless vaginal or anal sex

    Time frame: 3 months post-intervention

    Single measure constructed from number of times having consensual vaginal/anal sex in past 3 months; number of times using a condom during consensual vaginal/anal sex in past 3 months; number of times using birth control during consensual vaginal sex in past 3 months

  3. Rates of condomless vaginal or anal sex

    Time frame: 9 months post-intervention

    Single measure constructed from number of times having consensual vaginal/anal sex in past 3 months; number of times using a condom during consensual vaginal/anal sex in past 3 months; number of times using birth control during consensual vaginal sex in past 3 months

  4. Sexual consent self-efficacy

    Time frame: 3 months post-intervention

    A measure comprised of 35 questions from the Sexual Consent Scale (Humphreys & Brousseau, 2010) that measures perceived self-efficacy related to sexual consent at 3 months after intervention completion.

  5. Sexual consent self-efficacy

    Time frame: 9 months post-intervention

    A measure comprised of 35 questions from the Sexual Consent Scale (Humphreys & Brousseau, 2010) that measures perceived self-efficacy related to sexual consent at 3 months after intervention completion.

  6. Sexual communication self-efficacy

    Time frame: 3 months post-intervention

    A measure comprised of 20 questions from the Sexual Communication Self-Efficacy Scale (Quinn-Nilas et al., 2016) that measures perceived self-efficacy related to sexual communication at 3 months after intervention completion.

  7. Sexual communication self-efficacy

    Time frame: 9 months post-intervention

    A measure comprised of 20 questions from the Sexual Communication Self-Efficacy Scale (Quinn-Nilas et al., 2016) that measures perceived self-efficacy related to sexual communication at 3 months after intervention completion.

  8. Condom use attitudes/beliefs

    Time frame: 3 months post-intervention

    A measure comprised of 10 questions from the Multidimensional Condom Attitudes Scale (Helweg-Larsen & Collins, 1994) that measures attitudes related to condom use at 3 months after intervention completion.

  9. Condom use attitudes/beliefs

    Time frame: 9 months post-intervention

    A measure comprised of 10 questions from the Multidimensional Condom Attitudes Scale (Helweg-Larsen & Collins, 1994) that measures attitudes related to condom use at 3 months after intervention completion.

  10. Contraceptive use attitudes/beliefs

    Time frame: 3 months post-intervention

    A measure comprised of 11 measures from the Contraceptive Attitude Scale (Kyes, 1998) that measure attitudes related to contraceptive use at 3 months after intervention completion.

  11. Contraceptive use attitudes/beliefs

    Time frame: 9 months post-intervention

    A measure comprised of 11 measures from the Contraceptive Attitude Scale (Kyes, 1998) that measure attitudes related to contraceptive use at 3 months after intervention completion.

  12. Experiences with equity and power balance in relationships

    Time frame: 3 months post-intervention

    A measure comprised of the Relationship Control Subscale (15 questions) from the Sexual Relationship Power Scale (Pulerwitz et al., 2000) that measures equity and power balance in relationships at 3 months after intervention completion.

  13. Experiences with equity and power balance in relationships

    Time frame: 9 months post-intervention

    A measure comprised of the Relationship Control Subscale (15 questions) from the Sexual Relationship Power Scale (Pulerwitz et al., 2000) that measures equity and power balance in relationships at 3 months after intervention completion.

  14. Knowledge of health care rights and location of services

    Time frame: 3 months post-intervention

    A measure of the % of correct answers comprised from survey questions on knowledge of health care rights (Anderson et al., 2021; Coyle et al., 2021; Office of Management and Budget, n.d.) at 3 months after intervention completion.

  15. Knowledge of health care rights and location of services

    Time frame: 9 months post-intervention

    A measure of the % of correct answers comprised from survey questions on knowledge of health care rights (Anderson et al., 2021; Coyle et al., 2021; Office of Management and Budget, n.d.) at 3 months after intervention completion.

  16. Experience with condom use

    Time frame: 3 months post-intervention

    A count of condom issues experienced (derived from 8 condom experiences survey questions [Coyle et al., 2021]) at 3 months after intervention completion

  17. Experience with condom use

    Time frame: 9 months post-intervention

    A count of condom issues experienced (derived from 8 condom experiences survey questions [Coyle et al., 2021]) at 3 months after intervention completion

  18. Knowledge of educational rights and programs

    Time frame: 3 months post-intervention

    A measure of the % of correct answers comprised from 3 survey questions on awareness of rights and programs for youth in foster care going to college or trade school at 3 months after intervention completion

  19. Knowledge of educational rights and programs

    Time frame: 9 months post-intervention

    A measure of the % of correct answers comprised from 3 survey questions on awareness of rights and programs for youth in foster care going to college or trade school at 3 months after intervention completion

  20. Financial literacy knowledge

    Time frame: 3 months post-intervention

    A measure of the % of correct answers comprised from 3 survey questions on financial literacy knowledge at 3 months after intervention completion

  21. Financial literacy knowledge

    Time frame: 9 months post-intervention

    A measure of the % of correct answers comprised from 3 survey questions on financial literacy knowledge at 3 months after intervention completion

Sponsors and collaborators

Lead sponsor

ETR Associates

Other

Collaborators

  • RTI International

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Apr 8, 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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