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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06127277
Other study ID # Next4You
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 25, 2023
Est. completion date September 29, 2026

Study information

Verified date November 2023
Source ETR Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date September 29, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 19 Years
Eligibility 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: -

Study Design


Intervention

Behavioral:
Next4You
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.

Locations

Country Name City State
United States RTI Berkeley California

Sponsors (2)

Lead Sponsor Collaborator
ETR Associates RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of choosing abstinence or the use of other contraception and/or 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 vaginal sex with birth control other than condoms in the past 3 months (main and casual sex partners); consensual anal sex in the past 3 months (main and casual sex partners); and consensual anal sex with a condom in past 3 months (main and casual sex partners). 3 months post-intervention
Secondary Prevalence of choosing abstinence or the use of other contraception and/or 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 vaginal sex with birth control other than condoms in the past 3 months (main and casual sex partners); consensual anal sex in the past 3 months (main and casual sex partners); and consensual anal sex with a condom in past 3 months (main and casual sex partners). 9 months post-intervention
Secondary Rates of condomless vaginal or anal sex 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 months post-intervention
Secondary Rates of condomless vaginal or anal sex 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 9 months post-intervention
Secondary Sexual consent self-efficacy 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. 3 months post-intervention
Secondary Sexual consent self-efficacy 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. 9 months post-intervention
Secondary Sexual communication self-efficacy 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. 3 months post-intervention
Secondary Sexual communication self-efficacy 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. 9 months post-intervention
Secondary Condom use attitudes/beliefs 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. 3 months post-intervention
Secondary Condom use attitudes/beliefs 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 months post-intervention
Secondary Contraceptive use attitudes/beliefs 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. 3 months post-intervention
Secondary Contraceptive use attitudes/beliefs 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. 9 months post-intervention
Secondary Experiences with equity and power balance in relationships 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. 3 months post-intervention
Secondary Experiences with equity and power balance in relationships 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. 9 months post-intervention
Secondary Knowledge of health care rights and location of services 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. 3 months post-intervention
Secondary Knowledge of health care rights and location of services 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. 9 months post-intervention
Secondary Experience with condom use A count of condom issues experienced (derived from 8 condom experiences survey questions [Coyle et al., 2021]) at 3 months after intervention completion 3 months post-intervention
Secondary Experience with condom use A count of condom issues experienced (derived from 8 condom experiences survey questions [Coyle et al., 2021]) at 3 months after intervention completion 9 months post-intervention
Secondary Knowledge of educational rights and programs 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 3 months post-intervention
Secondary Knowledge of educational rights and programs 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 9 months post-intervention
Secondary Financial literacy knowledge A measure of the % of correct answers comprised from 3 survey questions on financial literacy knowledge at 3 months after intervention completion 3 months post-intervention
Secondary Financial literacy knowledge A measure of the % of correct answers comprised from 3 survey questions on financial literacy knowledge at 3 months after intervention completion 9 months post-intervention
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