Alcohol Exposed PregnancyCARRIINativeNCT06324929
Optimizing a Digital AEP Risk Intervention With Native Women and Communities
A study testing CARRII Native Rapid Pilot Testing in people with Alcohol Exposed Pregnancy and Unplanned Pregnancy, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of Aim 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol. In Aim 2, we will Pilot test 5 new candidate components tailored to Native women at risk of AEP Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Exposed Pregnancy, Unplanned Pregnancy, Alcohol Use, Unspecified
- What is being tested?
- CARRII Native Rapid Pilot Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Native American
- Native American
- Risk for Alcohol Exposed Pregnancy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Fontaine Research Park
Charlottesville, Virginia, 22908
About this study
The purpose of Aim 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol. In Aim 2, we will Pilot test 5 new candidate components tailored to Native women at risk of AEP
Read the detailed description
Alcohol exposed pregnancy (AEP) can result in Fetal Alcohol Spectrum Disorders (FASDs) that cause lifelong costly disabilities from brain, organ, tissue, and neurological damage. While over 3.3 million US women per month are at risk for AEP, risk for AEP among Native American (Native) women is higher, due to low contraception use and high binge drinking rates. For example, 20% of sexually active Native women in the Southwestern US are at risk for AEP, and 52% of pregnancies in the Navajo Nation are unplanned, compared to 45% nationally. Among pregnant women from Great Plains tribes, nearly 30% drink at binge levels and do not use contraception to prevent pregnancy. Among another sample of Native women from Great Plains tribes, 65% were sexually active, not seeking pregnancy, and not using contraception.
For Aim 1 we will implement four study methods to evaluate and tailor CARRII digital intervention components for Native women and prepare them to be used in a subsequent trial. These iterative mixed methods formative studies include:
- Develop an ongoing Native Partners Working Group to review study plans and findings over time with the research team,
- Collect quantitative surveys from Native women to estimate rates of AEP risk, interest/ ability to participate, health literacy, and other factors (n=300),
- Conduct Focus Groups to prototype and tailor new CARRII components (up to n=60), and
- Conduct Think-aloud User Testing (n=20) to finalize a draft of the CARRII Native intervention to prepare for development on a responsive design platform.
After incorporating input from participants (SA 1) and the Native Partners Working Group, we will pilot candidate components (SA2) to assess independent effects on AEP behavioral risk factors (drinking and contraception) while considering practical aspects such as frequency and duration of contact with participants, and costs of each component.
AEP can be prevented by avoiding an unintended pregnancy or reducing alcohol intake by those who may become pregnant. PI Ingersoll was a PI on the seminal CHOICES study that developed the first efficacious theory-based AEP intervention, with 4 Motivational Interviewing (MI) counseling sessions. PI Hanson adapted CHOICES for Native women in tribal communities. The Native-adapted CHOICES reduced AEP risk among Native women, but was too costly to sustain for high-risk women and communities.
In contrast, theory-based digital interventions are highly accessible, more convenient, scalable, and more sustainable, while still efficacious. In R34AA020853, Ingersoll piloted the first automated digital AEP intervention, CARRII. A nationwide pilot randomized controlled trial (RCT) showed that CARRII (but not the education control) significantly reduced AEP risk and pregnancy risk at 3 and 6 months, and drinking risk at 3 months. However, CARRII was studied among general population women, and not Native American women specifically.
Because rates of unintended pregnancy and binge drinking that create AEP risk are inequitable between Native women and the general population, CARRII will be tailored to and optimized for this priority subgroup. Guided by the Multiphase Optimization Strategy (MOST), we will tailor CARRII's existing components for Native women and systematically test proposed novel components (derived from formative work with Native women), to develop an efficient and scalable intervention tailored to Native women at risk of AEP. Optimizing CARRII for Native women will require measuring the efficacy and costs of components to find a balance between impact and affordability for Native communities. The overarching goal of this R61/R33 proposal is to determine the optimal combination of novel intervention strategies to include with CARRII (tailored for Native women) that maximizes digital intervention efficacy at feasible cost for Native communities. Achieving R61 milestones will permit progression to the R33 phase.
- Conditions
- Alcohol Exposed Pregnancy, Unplanned Pregnancy, Alcohol Use, Unspecified, Contraception Use, Sexual Behavior
- Being tested
- CARRII Native Rapid Pilot Testing
- Keywords
- Native American, female, adult, contraception, alcohol, digital intervention, optimization, mHealth (mobile health)
- Medical subject headings
- Alcohol Drinking, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARRII Native Rapid Pilot TestingBehavioural
The candidates that will be tested are: 1) Telephone-administered 30 day timeline follow-back of drinking, sex, and contraception, administered by phone at enrollment and monthly, which should increase awareness of AEP risk and motivation for alcohol and contraception behavior change, 2) Mailed pregnancy tests sent monthly to raise consciousness of pregnancy risk and to detect a new pregnancy early, which should increase motivation for contraception behavior change, 3) Automated, personalized digital safer sex and drink counting/reduction skills training, to improve drinking self-management skills and self-efficacy for drinking reduction and contraception use, 4) Fully automated text messages prompting usage of safer sex and drink reduction skills, which should increase self-efficacy for behavior change, and 5) access to an anonymized Community Message Board of Native women to discuss challenges in behavior change, which should increase perceived social support.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 Survey | No intervention | We will enroll up to 300 Native women ages 18-44 to complete a 35-minute survey to characterize demographics, parity, literacy, AEP risk, drinking levels, knowledge of FASD, location, Tribal affiliation, cultural preferences for tailoring, preferred digital platforms, methods of access to mobile devices/Internet, and interest in a digital women's health study about alcohol and birth control |
| Rapid Pilot Testing | Experimental | Participants will complete a baseline past month TLFB (timeline follow-back) of alcohol use and contraception use during sex and a short online survey evaluating knowledge about AEP risk, intentions to change, self-efficacy for change, and readiness to change alcohol use and contraception behaviors. Each cohort of 10 participants will receive one of the 5 novel components (telephone-administered TLFB 2 weeks after study enrollment, mailed pregnancy test arriving 10-14 days after enrollment, digital safer sex and drink reduction skills training accessible across the 6-week period, automated texting prompting usage of skills across the 6-week period, or anonymized community message board across the 6-week period). Participants will complete a second TLFB for the past 6 weeks, and a short survey to rate the component they experienced, a System Usability Scale on their component, and measures of short-term knowledge, intentions to change, self-efficacy for change, and readiness to change. Receives: Behavioral: CARRII Native Rapid Pilot Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of risky drinking
Defined as binge drinking, and/or drinking over daily risk levels. Unit of measure: Rate of risky drinking Measurement tool: TLFB (timeline follow-back) of alcohol use and contraception use during sex Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.
Measured: 6 weeks
Rate of ineffective/absent contraception use
Defined per method used, or none, when having sex. Unit of measure: Rate of ineffective/absent contraception use Measurement tool: TLFB (timeline follow-back) of alcohol use and contraception use during sex Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.
Measured: 6 weeks
Rate of AEP Risk
Combination of drinking above risk levels and inconsistent or absent use of effective contraception
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start16 May 2024
- Primary completion28 Oct 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Exposed PregnancyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Mixed methods research during Aim 1 will include 4 different components. They are: 1. Convene working group of Native American stakeholders. 2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region 3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women in 10 focus group discussions. 4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women. In Aim 2, we will calculate baseline to 6-week improvements in knowledge about drinking and contraception, intention to change, self-efficacy and readiness for change, differences in drinking and contraception behaviors, and effect sizes of each component. The focus of this aim is to determine the effect size of each novel component.
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Missouri Breaks Industries Research, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lee M Ritterband, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324929
- Sponsor's protocol ID
- SBS6760
- Other IDs
- R61AA030581-01
- Acronym
- CARRIINative
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will comply with NIH data sharing protocols and will upload data to the NIAAA Data archive.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Digital AEP Risk Intervention With Native Women and Communities
- ClinicalTrials.gov ID
- NCT06324929
- Acronym / sponsor ID
- CARRIINative / SBS6760
- Conditions
- Alcohol Exposed Pregnancy, Unplanned Pregnancy, Alcohol Use, Unspecified, Contraception Use, Sexual Behavior
- Keywords
- Native American, female, adult, contraception, alcohol, digital intervention, optimization, mHealth (mobile health)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Minnesota, Missouri Breaks Industries Research, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 16 May 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 22 Mar 2024 (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 Aim 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol. In Aim 2, we will Pilot test 5 new candidate components tailored to Native women at risk of AEP
Detailed description
Alcohol exposed pregnancy (AEP) can result in Fetal Alcohol Spectrum Disorders (FASDs) that cause lifelong costly disabilities from brain, organ, tissue, and neurological damage. While over 3.3 million US women per month are at risk for AEP, risk for AEP among Native American (Native) women is higher, due to low contraception use and high binge drinking rates. For example, 20% of sexually active Native women in the Southwestern US are at risk for AEP, and 52% of pregnancies in the Navajo Nation are unplanned, compared to 45% nationally. Among pregnant women from Great Plains tribes, nearly 30% drink at binge levels and do not use contraception to prevent pregnancy. Among another sample of Native women from Great Plains tribes, 65% were sexually active, not seeking pregnancy, and not using contraception.
For Aim 1 we will implement four study methods to evaluate and tailor CARRII digital intervention components for Native women and prepare them to be used in a subsequent trial. These iterative mixed methods formative studies include:
- Develop an ongoing Native Partners Working Group to review study plans and findings over time with the research team,
- Collect quantitative surveys from Native women to estimate rates of AEP risk, interest/ ability to participate, health literacy, and other factors (n=300),
- Conduct Focus Groups to prototype and tailor new CARRII components (up to n=60), and
- Conduct Think-aloud User Testing (n=20) to finalize a draft of the CARRII Native intervention to prepare for development on a responsive design platform.
After incorporating input from participants (SA 1) and the Native Partners Working Group, we will pilot candidate components (SA2) to assess independent effects on AEP behavioral risk factors (drinking and contraception) while considering practical aspects such as frequency and duration of contact with participants, and costs of each component.
AEP can be prevented by avoiding an unintended pregnancy or reducing alcohol intake by those who may become pregnant. PI Ingersoll was a PI on the seminal CHOICES study that developed the first efficacious theory-based AEP intervention, with 4 Motivational Interviewing (MI) counseling sessions. PI Hanson adapted CHOICES for Native women in tribal communities. The Native-adapted CHOICES reduced AEP risk among Native women, but was too costly to sustain for high-risk women and communities.
In contrast, theory-based digital interventions are highly accessible, more convenient, scalable, and more sustainable, while still efficacious. In R34AA020853, Ingersoll piloted the first automated digital AEP intervention, CARRII. A nationwide pilot randomized controlled trial (RCT) showed that CARRII (but not the education control) significantly reduced AEP risk and pregnancy risk at 3 and 6 months, and drinking risk at 3 months. However, CARRII was studied among general population women, and not Native American women specifically.
Because rates of unintended pregnancy and binge drinking that create AEP risk are inequitable between Native women and the general population, CARRII will be tailored to and optimized for this priority subgroup. Guided by the Multiphase Optimization Strategy (MOST), we will tailor CARRII's existing components for Native women and systematically test proposed novel components (derived from formative work with Native women), to develop an efficient and scalable intervention tailored to Native women at risk of AEP. Optimizing CARRII for Native women will require measuring the efficacy and costs of components to find a balance between impact and affordability for Native communities. The overarching goal of this R61/R33 proposal is to determine the optimal combination of novel intervention strategies to include with CARRII (tailored for Native women) that maximizes digital intervention efficacy at feasible cost for Native communities. Achieving R61 milestones will permit progression to the R33 phase.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods research during Aim 1 will include 4 different components. They are: 1. Convene working group of Native American stakeholders. 2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region 3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women in 10 focus group discussions. 4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women. In Aim 2, we will calculate baseline to 6-week improvements in knowledge about drinking and contraception, intention to change, self-efficacy and readiness for change, differences in drinking and contraception behaviors, and effect sizes of each component. The focus of this aim is to determine the effect size of each novel component.
| Arm | Type | Receives |
|---|---|---|
| Aim 1 Survey | No intervention | –We will enroll up to 300 Native women ages 18-44 to complete a 35-minute survey to characterize demographics, parity, literacy, AEP risk, drinking levels, knowledge of FASD, location, Tribal affiliation, cultural preferences for tailoring, preferred digital platforms, methods of access to mobile devices/Internet, and interest in a digital women's health study about alcohol and birth control |
| Rapid Pilot Testing | Experimental | Behavioral: CARRII Native Rapid Pilot TestingParticipants will complete a baseline past month TLFB (timeline follow-back) of alcohol use and contraception use during sex and a short online survey evaluating knowledge about AEP risk, intentions to change, self-efficacy for change, and readiness to change alcohol use and contraception behaviors. Each cohort of 10 participants will receive one of the 5 novel components (telephone-administered TLFB 2 weeks after study enrollment, mailed pregnancy test arriving 10-14 days after enrollment, digital safer sex and drink reduction skills training accessible across the 6-week period, automated texting prompting usage of skills across the 6-week period, or anonymized community message board across the 6-week period). Participants will complete a second TLFB for the past 6 weeks, and a short survey to rate the component they experienced, a System Usability Scale on their component, and measures of short-term knowledge, intentions to change, self-efficacy for change, and readiness to change. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Native American
- Native American
- Risk for Alcohol Exposed Pregnancy
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 |
|---|---|---|
| CARRII Native Rapid Pilot TestingThe candidates that will be tested are: 1) Telephone-administered 30 day timeline follow-back of drinking, sex, and contraception, administered by phone at enrollment and monthly, which should increase awareness of AEP risk and motivation for alcohol and contraception behavior change, 2) Mailed pregnancy tests sent monthly to raise consciousness of pregnancy risk and to detect a new pregnancy early, which should increase motivation for contraception behavior change, 3) Automated, personalized digital safer sex and drink counting/reduction skills training, to improve drinking self-management skills and self-efficacy for drinking reduction and contraception use, 4) Fully automated text messages prompting usage of safer sex and drink reduction skills, which should increase self-efficacy for behavior change, and 5) access to an anonymized Community Message Board of Native women to discuss challenges in behavior change, which should increase perceived social support. | Behavioural | Rapid Pilot Testing |
Primary outcome
Rate of risky drinking
Time frame: 6 weeks
Defined as binge drinking, and/or drinking over daily risk levels. Unit of measure: Rate of risky drinking Measurement tool: TLFB (timeline follow-back) of alcohol use and contraception use during sex Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.
Rate of ineffective/absent contraception use
Time frame: 6 weeks
Defined per method used, or none, when having sex. Unit of measure: Rate of ineffective/absent contraception use Measurement tool: TLFB (timeline follow-back) of alcohol use and contraception use during sex Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.
Rate of AEP Risk
Time frame: 6 weeks
Combination of drinking above risk levels and inconsistent or absent use of effective contraception
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. We will comply with NIH data sharing protocols and will upload data to the NIAAA Data archive.
Related trials for Alcohol Exposed Pregnancy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Active, not recruiting
CHOICES-TEEN Randomized Controlled Trial
Risk for an Alcohol-Exposed Pregnancy, Risk for Marijuana-Exposed Pregnancy
RecruitingPhase 2
Pilot Study of Prenatal Choline Supplementation
Brain Development, Choline Nutrition
RecruitingPhase 2
RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARRII Native Rapid Pilot Testing in people with Alcohol Exposed Pregnancy and Unplanned Pregnancy, run by University of Virginia 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 3 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: finished, as of the sponsor's last update on 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of risky drinking (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.