Recruitment and retention of low-income minority women in a behavioral intervention to reduce smoking, depression, and intimate partner violence during pregnancy.

BACKGROUND: Researchers have frequently encountered difficulties in the recruitment and retention of minorities resulting in their under-representation in clinical trials. This report describes the successful strategies of recruitment and retention of African Americans and Latinos in a randomized clinical trial to reduce smoking, depression and intimate partner violence during pregnancy. Socio-demographic characteristics and risk profiles of retained vs. non-retained women and lost to follow-up vs. dropped-out women are presented. In addition, subgroups of pregnant women who are less (more) likely to be retained are identified. METHODS: Pregnant African American women and Latinas who were Washington, DC residents, aged 18 years or more, and of 28 weeks gestational age or less were recruited at six prenatal care clinics. Potentially eligible women were screened for socio-demographic eligibility and the presence of the selected behavioral and psychological risks using an Audio Computer-Assisted Self-Interview. Eligible women who consented to participate completed a baseline telephone evaluation after which they were enrolled in the study and randomly assigned to either the intervention or the usual care group. RESULTS: Of the 1,398 eligible women, 1,191 (85%) agreed to participate in the study. Of the 1,191 women agreeing to participate, 1,070 completed the baseline evaluation and were enrolled in the study and randomized, for a recruitment rate of 90%. Of those enrolled, 1,044 were African American women. A total of 849 women completed the study, for a retention rate of 79%. Five percent dropped out and 12% were lost-to-follow up. Women retained in the study and those not retained were not statistically different with regard to socio-demographic characteristics and the targeted risks. Retention strategies included financial and other incentives, regular updates of contact information which was tracked and monitored by a computerized data management system available to all project staff, and attention to cultural competence with implementation of study procedures by appropriately selected, trained, and supervised staff. Single, less educated, alcohol and drug users, non-working, and non-WIC women represent minority women with expected low retention rates. CONCLUSION: We conclude that with targeted recruitment and retention strategies, minority women will participate at high rates in behavioral clinical trials. We also found that women who drop out are different from women who are lost to follow-up, and require different strategies to optimize their completion of the study

Hematologic and Vitamin Status of African American Women and Their Relationships to Pregnancy Outcome

A prospective observational study was conducted to investigate the effects of nutrition and related factors on the outcome of pregnancy in nulliparous African American women 16-35 years of age. Blood samples from a subset of these subjects were taken during the first (1st), second (2nd) and third (3rd) trimesters of pregnancy and at delivery. Cord blood samples were also collected at delivery. Levels of selected biochemical variables including serum ferritin, vitamin B12 and folate as well as whole blood folate, and selected hematologic indices were determined and correlated with pregnancy outcome variables. During the second trimester of pregnancy, values for hematocrit and hemoglobin were less than 30% and 11 g/dL, respectively, in 16% and 30% of the participants, respectively. Serum and whole blood (WB) folate increased sequentially during pregnancy. Cord concentrations of serum folate were significantly higher than maternal concentrations at delivery (P\u3c0.05). Serum ferritin declined significantly from 36±5.6 ng/ml in the first trimester to 17±1.5 ng/ml during the 3rd trimester (P\u3c0.05), and returned to the 2nd trimester level (26±2.0 ng/ml) at delivery. Second trimester WB folate was positively related to birth weight (R2=0.21), while gestational age was inversely correlated with 3rd trimester vitamin B12 (R2=0.34). These data suggest that vitamin B12 and folate play an important role in the outcome of pregnancy in this population