Pregnancy RelatedNCT06127277
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
A study testing Next4You in people with Pregnancy Related and Adolescent Behavior, run by ETR Associates at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Adolescent Behavior, Sexually Transmitted Diseases
- What is being tested?
- Next4You
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed 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.
- Being tested
- Next4You
- Keywords
- Pregnancy, Adolescence, Sexually Transmitted Infections, Decision Making, Prevention Education
- Medical subject headings
- Adolescent Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next4YouBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Next4You |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 9 months post-intervention
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
Measured: 3 months post-intervention
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
Measured: 9 months post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 9 months post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 9 months post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 9 months post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 9 months post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 9 months post-intervention
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.
Measured: 3 months post-intervention
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.
Measured: 9 months post-intervention
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
Measured: 3 months post-intervention
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
Measured: 9 months post-intervention
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
Measured: 3 months post-intervention
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
Measured: 9 months post-intervention
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
Measured: 3 months post-intervention
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
Measured: 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Sep 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETR Associates
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International
- Responsible party
- Sponsor
- Investigators
- Pamela Anderson, PhD, Principal investigator, ETRKarin Coyle, PhD, Principal investigator, ETR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127277
- Sponsor's protocol ID
- Next4You
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson PM, Ong SL, Elgin D, Laird J, Starr D, Daniels S, Rogers J, Coyle KK. Youth-Centered Mobile Intervention (Next4You) to Promote Healthy Relationships and Sexual Wellness Among Adolescents in or Transitioning From Foster Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 3;15:e77185. doi: 10.2196/77185.
PubMed 41632960
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next4You: : A Fully Mobile Relationships Based Program for Youth in Foster Care
- ClinicalTrials.gov ID
- NCT06127277
- Acronym / sponsor ID
- Next4You
- Keywords
- Pregnancy, Adolescence, Sexually Transmitted Infections, Decision Making, Prevention Education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ETR AssociatesUniversity, hospital or other
- Collaborators
- RTI International
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Next4You | Experimental | Behavioral: Next4YouNext4You 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. |
| General Health Mobile Website | Active comparator | Behavioral: Next4YouYouth 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 may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next4YouYouth 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. | Behavioural | General Health Mobile Website, Next4You |
Primary outcome
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).
21 secondary outcomes
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
Rates of condomless vaginal or anal sex
Time frame: 3 months post-intervention
Rates of condomless vaginal or anal sex
Time frame: 9 months post-intervention
Sexual consent self-efficacy
Time frame: 3 months post-intervention
Sexual consent self-efficacy
Time frame: 9 months post-intervention
Sexual communication self-efficacy
Time frame: 3 months post-intervention
Sexual communication self-efficacy
Time frame: 9 months post-intervention
Condom use attitudes/beliefs
Time frame: 3 months post-intervention
Condom use attitudes/beliefs
Time frame: 9 months post-intervention
Contraceptive use attitudes/beliefs
Time frame: 3 months post-intervention
Contraceptive use attitudes/beliefs
Time frame: 9 months post-intervention
Experiences with equity and power balance in relationships
Time frame: 3 months post-intervention
Experiences with equity and power balance in relationships
Time frame: 9 months post-intervention
Knowledge of health care rights and location of services
Time frame: 3 months post-intervention
Knowledge of health care rights and location of services
Time frame: 9 months post-intervention
Experience with condom use
Time frame: 3 months post-intervention
Experience with condom use
Time frame: 9 months post-intervention
Knowledge of educational rights and programs
Time frame: 3 months post-intervention
Knowledge of educational rights and programs
Time frame: 9 months post-intervention
Financial literacy knowledge
Time frame: 3 months post-intervention
Financial literacy knowledge
Time frame: 9 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 41632960Anderson PM, Ong SL, Elgin D, Laird J, Starr D, Daniels S, Rogers J, Coyle KK. Youth-Centered Mobile Intervention (Next4You) to Promote Healthy Relationships and Sexual Wellness Among Adolescents in or Transitioning From Foster Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 3;15:e77185. doi: 10.2196/77185.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Anderson, PhD principal investigator
ETR
Karin Coyle, PhD principal investigator
ETR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next4You in people with Pregnancy Related and Adolescent Behavior, run by ETR Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.