Optimizing a Digital AEP Risk Intervention With Native Women and Communities

NCT06324929 | Active Not Recruiting

• 2 other identifiers: SBS6760R61AA030581-01
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief 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

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)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  6 weeks

• Rate of AEP Risk

  Combination of drinking above risk levels and inconsistent or absent use of effective contraception

  6 weeks

Study Arms (2)

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.

Behavioral: CARRII Native Rapid Pilot Testing

Interventions

CARRII Native Rapid Pilot Testing BEHAVIORAL

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.

Rapid Pilot Testing

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Native American
• Native American
• Risk for Alcohol Exposed Pregnancy

Sponsors & Collaborators

• University of Virginia: lead
• University of Minnesota: collaborator
• Missouri Breaks Industries Research, Inc.: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Virginia Fontaine Research Park

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Sexual Behavior

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: May 16, 2024
• Primary Completion: October 28, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after data analysis is completed, we will deposit it in the data archive
• Access Criteria: Other researchers can request data from the NIAAA Data Archive using their procedures.

Locations

US (1)