SBIR Phase II New Risk Assessment/Intervention For Pregnant Woman

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DA016045-02A1
Agency Tracking Number: DA016045
Amount: $667,396.00
Phase: Phase II
Program: SBIR
Awards Year: 2006
Solicitation Year: 2006
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Small Business Information
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 () -
Business Contact
Phone: (505) 244-3099
Research Institution
DESCRIPTION (provided by applicant): Drug use is common among pregnant women, yet only an estimated 32 percent to 42 percent of prenatal care providers routinely ask patients about their use of drugs. Prenatal visits afford a unique opportunity for providers to educate women about prevention, and to detect drug use during pregnancy. To facilitate efficient use of provider resources, we developed a computerized interactive survey interview, the Pregnancy Information Program (PIP) that has been extensively tested in non-Hispanic white, Hispanic, and American Indian populations. Earlier studies demonstrated that the PIP was well received in multiple ethnic/racial pregnant populations. More importantly, the PIP evoked more honest responses regarding drug use and other socially stigmatized behaviors than paper-and-pencil questionnaires. In Phase I we updated the program, integrated current diagnostic standards, added a tailored motivational intervention, and incorporated audio and video elements to the program. For this Phase II project, we propose to further enhance the software capabilities, expand the domains of use to clinicians, and develop a commercial quality CD ROM prototype of the entire instrument. We will beta test the completed instrument in 6 community women's clinics, to determine its acceptability and ease of use, through anonymous clinician surveys and rates of completion. We will also conduct a randomized, controlled clinical trial of 346 pregnant women to determine PIP's ability to promote behavior change from the initial to the third trimesters of pregnancy. Primary outcomes evaluated in this trial include self-reported changes in nutrition, drug use, alcohol use, cigarette smoking, HIV risk behavior, and partner abuse avoidance. We will also assess stages of readiness to change, where change is not yet manifest. Subjects in their first trimester will be randomized to complete the PIP or a computer questionnaire minus the educational and customized motivational feedback. Both groups also will receive printed educational information. In their third trimesters, subjects will complete a second computer-based questionnaire to determine current behaviors, and will participate in a personal interview regarding their reaction to PIP. Paired data will be analyzed using generalized linear mixed models to estimate differences between and within groups over time. This study will reveal the potential of the PIP to enhance prenatal healthy behaviors, and improve birth outcomes, while saving providers time.

* information listed above is at the time of submission.

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