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Allan A. Johnson, PhD1, M. Nabil El-Khorazaty, PhD2, Ayman A.E. El-Mohandes, MD, MPH3, Jill G. Joseph, MD, PhD4, Michele Kiely, DrPH5, Haziel Laryea, MS6, Kennan D. Murray, MPH2, and Siva Subramanian, MD7. (1) Department of Nutritional Sciences, Howard University, 2400 Sixth Street, NW, Washington, DC 20059, 202-806-5666, ajohnson@howard.edu, (2) RTI International, 6110 Executive Blvd., Suite 420, Rockville, MD 20852, (3) George Washington University, 2300 I Street, NW, Ross Hall, Room 125, Washington, DC 20037, (4) Center for Health Services and Community Research, Children's National Medical Center, 111 Michigan Ave, NW, Washington, DC 20010, (5) Collaborative Studies Unit, NICHD/NIH/HHS, 6100 Building, Room 7B07H, MSC 7510, Bethesda, MD 20892, (6) NIH-DC Initiative, Howard University, 2018 Georgia Avenue, NW, Washington, DC 20060, (7) Division of Neonatology, Georgetown University, 3800 Reservoir Rd NW, M3400 Main Building, Washington, DC 20007
Researchers have frequently encountered difficulties in the recruitment and retention of minorities resulting in their under-representation in clinical trials. We avoided this problem in a randomized clinical trial to reduce depression, partner abuse and smoking during pregnancy in African Americans and Latinos (Project DC-HOPE). Of 1479 eligible women approached, 1191 (80.5%) agreed to participate in the study. Reasons for refusal to participate included lack of interest or time, did not need help, would think about it, the study was too intrusive, claims of ineligibility, and considering abortion. We delayed randomization until consented participants responded to an initial telephone interview. Of 1191 women who initially consented, 1070 (90%) were reachable by telephone at the numbers they provided and completed the telephone interview. At that point, women were randomized to the intervention and usual care groups. By the end of the expected period of participation, only 52 (5%) had dropped out, and 86 (8%) were considered lost to follow-up. Reasons for dropping out of the study included loss of interest, moving out of the area, denial of risk or need for the intervention, dislike of questions asked, miscarriage, abortion or consideration of abortion, lack of time and illness. The retention rate in our study was 87%, markedly lower than reported in the literature for such a high-risk population. Retention strategies included financial and other incentives, frequent telephone contacts, regular updates of locator information, provision of appointment cards, and tracking hard to find participants.
Funded by NICHD (5 U18 HD031919-10)
Learning Objectives:
Presenting author's disclosure statement:
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.