Study

Study Description

CARRII Native is an interactive, online program designed to help women and others who can become pregnant, to reduce the risk of having an alcohol exposed pregnancy. It was developed at the University of Virginia with funding from the National Institutes of Health. The purpose of this study is to find out if an Internet intervention tailored for Native American women is an effective way to reduce the risk of alcohol exposed pregnancy.

Participation Steps

Interested and motivated individuals are needed to help evaluate CARRII. Participation in this study will involve the following steps:

1. Give your consent to provide information over the Internet and electronically sign the screening consent form, then complete the interest form on this website.
2. Research staff will determine if you meet initial eligibility criteria.
3. If you meet initial eligibility criteria, we will contact you by email and schedule a phone or Zoom interview.
4. During the phone or Zoom interview, we will explain the study and discuss the criteria for enrollment. We will have time to answer any questions or concerns you may have during the phone call. If you choose to participate, you will electronically sign a study consent form.    
5. We will then continue the phone screen and ask you questions about your drinking, sexual history, and contraception history.
6. If you are still eligible after the phone screen is complete, we will email you a link to set your password.
7. Next, you will complete an online Questionnaire. These questions will take about 1½ hours to complete. The questions ask about your drinking, sexual history, ob/gyn history, general health, mental health, habits, and daily life activities.
8. Once you complete the Questionnaire, you will be asked to enter online CARRII Diaries for 14 days. The CARRII Diaries only take 2-3 minutes to enter and ask about what you drank, whether you had sex, and if so, what kind of contraception, if any, was used.
9. We will send you a $25 electronic gift card after completing the online Questionnaire and 14 diaries.
10. After completing the online Questionnaire and 14 online CARRII Diaries, you will be randomly assigned (like the flip of a coin) to 1 of 8 study groups. You have an equal chance of being assigned to any of the 8 groups. 
    • Each group will use an interactive online program for 8 weeks with tailored instructions about how to reduce your risks, plus a combination of zero, one, two, or three new intervention components. 
    • The online program includes weekly assignments and personalized feedback. 
      The components may include monthly pregnancy tests by mail; access to digital training in safer sex and reduced drinking; or daily text messages about safer sex and drinking reduction.
11. Post Assessments: At 10 weeks, you will be asked to complete another online Questionnaire and 14 more online CARRII Diaries. 
12. We will send you a $125 electronic gift card after completing the post-assessment (questionnaire and 14 diaries).  

More details can be found in the 

Privacy

We are committed to protecting your privacy. Here is how we will ensure your privacy is protected:

1. The information you submit is stored on a secure server. Our servers meet HIPAA Privacy Rule protections (Health Insurance Portability and Accountability Act).
2. Our servers are maintained by the Center for Behavioral Health and Technology staff at UVA. The staff assesses the network structure to make sure the latest security technology software is being used. 
3. Only a limited number of authorized research staff members have access to these servers. All research staff have completed our Institutional Review Board (IRB) trainings including training on protecting your rights.
4. All studies in which our Internet interventions are involved have been reviewed and approved by the University of Virginia IRB as required by federal regulations regarding human research studies. The primary role of the IRB is to protect the safety and welfare of human participants.
5. We have a Certificate of Confidentiality from the federal government that provides additional protections for you. The Certificate helps us to refuse to share your study records without your consent.

You will find more information about privacy protections in the 

Documents

• Click here to print out a copy of the Study Consent Form. The consent form provides details about the study. You will go through this with a staff member if you appear eligible to participate in the study.
• The drink card and contraception cards will be useful for the phone interview and throughout the study. Click the Drink Card and the Contraception Card to see each.