Infant mortality rates, while declining , still remain high for inner city minority communities. While the specific causes are not fully understood, contributory factors have been identified. Phase II of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations is mounting a clinical trial in multiple clinics in Washington, D.C. to determine the efficacy of an integrated health education program delivered within prenatal care settings. The protocol addresses smoking cessation, reduction in environmental tobacco exposure, depression, partner abuse, and reproductive health. The intervention, tailored to a woman's readiness for behavioral change, is provided through a series of individual counseling sessions by trained Health Educators.
Many challenges are presented in implementing clinical trials. The study design, content and delivery will be reported separately. This abstract addresses challenges and potential solutions experienced in operationalizing the protocol in busy clinical settings. It is critically important that clinic management and staff support the project while maintaining separation of clinical care and study protocol. Space and modern equipment are usually at a premium in inner city clinics catering to poor minority patients. While the study provides the latter, the former needs to be negotiated. It is important to leave considerable time for structural implementations. Suggestions are made covering: the agenda and timing of meetings between project and clinic staff; the details of infrastructure required at the clinic sites; the time required for installation; keeping the study logistics consistent across sites; and ways to avoid pitfalls inherent in such a study implementation.
Learning Objectives: 1. Logistics and timing of implementing clinical trials in multiple inner city clinics. 2. Maintaining the integrity of protocol implementation across study sites.
Keywords: Prenatal Interventions, Clinical Trails
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.