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

There is a long standing concern that minorities, in particular African Americans and Hispanics, are less willing to participate in clinical research than non-minorities. This belief exists not only among researchers [1] but among the minority populations as well. Many individuals believe that the Tuskegee Syphilis Study has negatively influenced the relationship between African Americans and the biomedical research community [2, 3]. However, Gamble [4] suggested that this distrust predated the public revelations about the Tuskegee study. When the federal government mandated in the 1993 Revitalization Act the proportional inclusion of all racial/ethnic minorities in human subject research, factors affecting recruitment and retention of minorities became a topic of more intense discussion. The scientific community increasingly recognizes the motivation behind federally mandated inclusion criteria: insuring that the results of research benefit all groups. To achieve this, it is necessary to guarantee that the results of medical and behavioral research are applicable and available to all members of the population. Also, it is important to determine whether the results differ for a specific race and/or ethnic group, so that generalization from one race/ethnic group to another is valid.

There is a broad literature exploring reasons for differential minority participation in clinical trials. In addition to the memory of the Tuskegee Study [2, 5], there is a more generalized distrust among minorities of the medical community [6‐9] and a history of negative experiences with health facilities [6]. Other reasons cited include those related to the organization and communication of research and those related to circumstances in minority communities. Issues related to the organization and communication include the paucity of clinical trials occurring at institutions where minorities seek medical care [2, 7], ineffective communication by research staff [7, 8], complex study medicine regimens, difficulty in rescheduling appointments due to lack of flexibility on the part of study personnel [3, 10], complicated and cumbersome record-keeping requirements [11, 12], lack of feedback, and ineffective informed consent procedures [6, 10]. On the other hand, issues related to the circumstances of minority populations include fear of being used as guinea pigs [8, 13], lack of awareness of medical trials [8, 10], the influences of relatives and friends, working multiple jobs, conflicting work schedules [6, 10], barriers to transportation [7, 10] and child care, poor incentives, inability to complete self-administered forms (i.e., low literacy), language barriers [8, 14], personal reasons, lack of time, and other priorities which take precedence over study obligations [11, 12]. Other problems mentioned more often by ethnically diverse subjects who withdrew from a multicenter randomized controlled research trial were lack of time, negative side effects, and dissatisfaction with the overall research process [3, 10].

Beliefs that minorities are less willing to participate in research, when compared to non-minority populations, stem mainly from their under-representation in various surveys due to higher non-response rates and/or lack of access to health research. An accurate validation of these beliefs to evaluate minority recruitment into many clinical and behavioral intervention studies is not possible at all times. Unlike response rates in surveys, lack of reporting of the numbers of screened/potential/eligible subjects in clinical and behavioral research necessary for the calculation of recruitment rates by race and ethnicity makes it impossible to assess the success/failure of minority recruitment [11]. A recent report by Wendler, et al. [15] suggests, contrary to popular belief, that the differences in the rates at which non-Hispanic whites and minorities agree to participate in health research are small. This conclusion is based on a review of 20 health research studies (3 interview studies, 10 clinical intervention studies, and 7 surgery trials) that included sufficient data to determine consent rates by race or ethnicity. Where differences (although non-significant) did occur, minority groups tended to be more, not less, willing to participate in research. This review suggests that the primary reasons for lack of participation by minority groups is the failure to invite them to participate, to provide accessible sites for participation, and failure to overcome barriers such as childcare arrangements and transportation costs. Because this analysis focused on clinical intervention trials and did not include behavioral or prevention trials or natural history studies, it is possible that the study characteristics may more strongly affect participation than race or ethnicity. For example, in a behavioral and counseling educational intervention, it is possible that the inability to foresee immediate and/or personal benefit for the time commitment that is required may discourage participation. This would suggest that successful recruitment and retention of minorities may depend also on the type of research that is being conducted.

This paper focuses on the recruitment and retention of participants in a behavioral and counseling intervention trial entitled "Interventions for Risk Factors in Pregnant Women in Washington, DC: An Integrated Approach" or DC-Healthy Outcomes of Pregnancy Education (hereinafter referred to as Project DC-HOPE). In an attempt to understand why our recruitment and retention strategies were so successful, the socio-demographic characteristics and risk profiles of women who were retained are compared to those who were not retained. Since outcome measures regarding risk factors may be evaluated at two time points (at delivery and at 8–10 weeks postpartum), retention can be measured at these two distinct points. Retention rates, as estimated on the basis of completed interviews, are compared for follow-up interviewing prior to delivery and at the postpartum period by socio-demographic and risk characteristics. Comparisons of those who completed these interviews with those who did not complete these interviews are also presented.

Project DC-HOPE was one project within the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia, a collaborative effort involving the Children's National Medical Center, George Washington University, Georgetown University, Howard University, the National Institute of Child Health and Human Development (NICHD)/NIH/DHHS, and RTI International. Project DC-HOPE was a randomized clinical trial targeting smoking (including environmental tobacco smoke exposure), depression, and intimate partner violence (IPV). The primary goal was to estimate whether a multi-modal, integrated counseling and educational intervention reduces smoking and environmental tobacco smoke exposure (ETSE), depression, and IPV (defined as being victimized) among pregnant African American and Latina women. A secondary goal was to estimate whether a clinic-based intervention reducing smoking, ETSE, depression, and IPV in pregnancy would reduce adverse pregnancy outcomes (e.g., prematurity and low birth weight) and lower infant morbidity and mortality.

Outcome measures were selected to address both sets of goals. Medical records of infants and mothers were abstracted to obtain data on pregnancy outcome measures. In addition, an assessment battery of standardized and validated self-report measures of the targeted risks and cotinine levels based on saliva specimens were collected. These assessments were obtained at baseline, 22–26 weeks and 34–38 weeks of gestation, and 8–10 weeks postpartum. Subjects were recruited at six prenatal care clinics in Washington, DC. Women were eligible to participate if they were Washington, D.C. residents, African American or Latino, at least 18 years of age, at 28 weeks gestation or less, and English speaking. These eligibility criteria were verified from clinic records. Institutional review boards at Howard University, RTI International, and NIH approved the study.

To ensure adequate statistical power for testing the hypotheses that multidisciplinary integrated intervention will result in reductions in targeted risk factors and improvements in pregnancy outcomes, determination of sample size requirements was essential. Based on the number of births to African American women in Washington, DC, estimates of the number of women appearing at participating clinics in their first two trimesters of pregnancy, the prevalence of the risk factors estimated from previous studies, the estimated refusal rate, and the 2-year recruitment period, a total of 1,750 pregnant women were expected to enroll. Because of the study design and eligibility criteria, participants identified would have a 100% prevalence of a specific risk factor. Assuming a 20% drop-out rate, and 20% loss to follow-up, 1,050 women were expected to be retained at the end of the follow-up period (525 in each of the care groups). This number, assuming a 5% level of significance, 80% power, would allow the detection of 10–20% reductions in risk-specific factors among those in the intervention group from a 100% prevalence at recruitment time. This number was also sufficient to detect a 25% reduction in prematurity and low birthweight combined in the intervention group as compared to that for the usual care (estimated at 20%).

Project DC-HOPE staff members were grouped into four functional teams: Recruitment Specialists (RSs) conducted participant recruitment and retention of study subjects and collected saliva specimens; Pregnancy Advisors (PAs) delivered the intervention; telephone interviewers administered the evaluation interviews; and abstractors obtained information from medical records.

Recruitment took place between July 9, 2001 and October 31, 2003, four months beyond the original planned 2-year period. Follow-up activities of participants continued until July 31, 2004. The project started at four clinic sites. Because one site closed ten months after the start of the study, a fifth site was added in February 2002, and an additional sixth site was added in May 2003. These steps were taken to ensure the recruitment of the required sample size.

RSs approached women presenting for prenatal care while waiting for their appointments. Clinic logs were monitored closely on a daily basis for both returned participants and new clients. The RSs briefly explained the objectives of the study to the women and provided them with a brochure describing the study and answers to common questions. Interested women gave written consent for screening. Women were screened for socio-demographic eligibility and the presence of one or more of the four targeted risks using an Audio-Computer-Assisted Self Interview (A-CASI). A-CASI methodology allows subjects to listen to digitally recorded questions on headphones that are connected to a laptop computer while the question is simultaneously displayed on the computer screen. As a response choice is heard, it is highlighted on the screen. The subject answers by touching the chosen response option on the screen. A-CASI offers an environment in which sensitive information is easily and privately reported without the need for special computer skills or reading ability. Consequently, risky behaviors are reported more frequently than in more conventional interviewing or self-administered paper and pencil forms [16‐19].

The recruitment process was flexible in order to enhance participation. If a woman were reluctant to start the screening process due to time constraints, the RSs would suggest that she complete the screening and recruitment process when she returned to the clinic at a later date.

Women found to be eligible based on A-CASI responses were invited to participate in the study and provided with all information necessary to make an informed and knowledgeable decision. Those interested signed a second form consenting to participate in the randomized trial once they completed the baseline interview.

These consenting participants were asked to provide contact information, including the best phone number for reaching them and the names and telephone numbers of two relatives or friends who did not live with them. Efforts were taken to develop contact procedures from the research staff who maintained confidentiality when communicating with participants outside the clinic setting. Addresses were collected to facilitate tracing efforts, but the women were informed that they would not receive mail from Project DC-HOPE. Since one of the screened risk factors was IPV, staff did not want to raise women's risk for abuse by receiving mail from the study that might be negatively regarded by an abusive partner, or would expose her pregnancy. For similar reasons, women were asked whether or not telephone messages from Project DC-HOPE staff could be left on their telephone answering machines. If not, this was noted in her computerized record accessible by all project teams.

After completing the baseline interview, women were randomly assigned to usual care or intervention group. Site- and risk-specific block randomization of participants was conducted. Women randomized to the intervention group met with trained PAs (in addition to seeing their physician) either immediately before or after a routine prenatal visit and at two postpartum sessions during which they received individualized counseling targeting their area(s) of risk. Women in the intervention group attended on average 3.9 ± 2.8 prenatal sessions, and 53.6% attended at least 4 prenatal sessions. Participants spent an average of 35.3 ± 14.8 minutes per session. Women assigned to the usual care group met with their primary care providers as per standard clinic practice.

The successful recruitment and retention of low-income minority women in Project DC-HOPE is in marked contrast to previous reports for similar ethnic minorities in clinical research [3, 11, 12, 31‐33]. It has been reported that recruitment rates of ethnic minorities in clinical trials are small when compared to non-minorities [31, 34, 35]. Our results can, to some degree, be attributed to the resources expended. As Powe and Gary [12] have suggested, incentives play an important role in the initial recruitment and subsequent retention of this ethnic minority population. The project supported a clinic site administrator to ensure the integration of the project into the clinic's everyday activities. In addition, the project design contributed to our recruitment and retention success. This included enrolling participants after they completed the baseline interview and scheduling intervention sessions to coincide with prenatal care visits. Also, the subject matter and timing of this study likely contributed to the successful recruitment and retention of participants. Pregnancy is a finite time interval during which the health of the baby is of heightened concern. Additionally, mothers may be more motivated to make behavior changes to improve their own health as well as that of their unborn infant.

These strategies alone were not likely sufficient, however. A great contribution to our success was the conscientious and dedicated efforts of the project teams. They effectively used the DMS and skillfully applied the strategies taught in training. Matching the RSs and PAs to our study population in terms of gender and ethnicity was also critical, as has been demonstrated in other research efforts. Moreno-John, et al. [36] report that the Resource Centers on Minority Aging Research employ staff and researchers that are ethnically and culturally matched to community participants, since it has been found that employment of researchers and staff reflective of the community improves subject satisfaction and adherence. Similarly, using interviewers of the same ethnic backgrounds as their subjects [3] and employing project staff who pay attention to cultural sensitivity [37‐39] enhance recruitment and retention of minority populations. The collection of multiple telephone numbers, sharing updated contact information, and effective tracing techniques also led to high retention. Monitoring study progress to identify troubleshooting strategies, close supervision by the project management team, and convening meetings to discuss issues and resolve problems provided a research environment that was cohesive and goal-oriented.

Of all eligible minority women, 85% agreed to participate. Of those agreeing, 90% completed the baseline interview and were enrolled. This finding is counter to the assertion that African-American and minority women are unwilling to participate in research. In Project DC-HOPE, over 60% of those who refused to participate did so because they denied the need for help or lacked interest, which is conceptually similar to reasons reported in the literature [12] but contrary to the themes of lack of trust or fear. We speculate that the significant differences in enrollment rates by clinic site were a function of the recruitment skills of the RSs and the predisposition of the potential participants.

The lack of substantial differences in the socio-demographic characteristics and risk profiles of women retained and not retained in the study indicates similarity between the two groups, and suggests that this factor did not bias the findings of the study. Randomization into the intervention or the usual care group did not impact significantly on women's retention rates. Thus, reasons for non-retention were not intervention-specific. However, the differences between women who were lost to follow-up and women who dropped out of the study are interesting to note. Women who dropped out were more educated, more likely to be married and employed, older, and less likely to be receiving Medicaid.

In addition, women not receiving WIC were less likely to complete the postpartum interview compared to women who were receiving WIC. A profile of the WIC children [40] shows them to be economically needier than the non-WIC children, and the average age of their mothers at the time of birth was 25 years, with 8% under the age of 18. Our results show that the WIC women were significantly less educated, not working, and more likely to be receiving Medicaid than the non-WIC women. The WIC women were younger than the non-WIC women (24.4 vs. 25.2 years). It is possible that women who dropped out of the study had more stable lives and viewed the study as less beneficial to them. For these women, the benefits of the study must consistently be reinforced throughout the duration of the study to prevent them from losing interest and dropping out. Interestingly, women with only IPV risk had the lowest non-completion rates of any risk group, perhaps finding the study beneficial to them.

On the other hand, women who were lost to follow-up were less educated, not married, unemployed, younger and receiving Medicaid. In our prediction models, being single, separated, widowed, or divorced was a significant predictor for not completing the postpartum interview. Although not significant, prediction results indicated a trend for women with less than high school education being more likely not to complete the postpartum interview. Even though the WIC recipients had higher interview completion rates than the non-WIC recipients, among women who were lost to follow-up, 65% were receiving WIC as compared to 38% among women who dropped out. In addition, women in the usual care group, with whom there was less contact throughout the study, were also more likely to be lost to follow-up as compared to the intervention group. We conclude that the women lost to follow-up were likely less stable and more difficult to contact and retain. Those women are young, less educated, less likely to be married or employed, and more likely to be on Medicaid. For such women, investigators should emphasize the need for obtaining accurate and complete contact information in order to be able to minimize non-retention as much as possible.

The success of the recruitment and retention efforts in Project DC-HOPE indicates that difficulties in recruiting and retaining minorities for clinical and behavioral research are not insurmountable. With targeted recruitment and retention strategies, minorities will participate at high rates in these trials. It is important that they be included in these trials because the prevalence of many health problems is higher in ethnic minorities, and health outcomes are often poorer. Consequently, the reduction of racial and ethnic health disparities has become an important public health objective, requiring concerted and innovative efforts. In addition, the inclusion of ethnic minorities in clinical and behavioral research provides better access to new and high-quality health care often not available to them, and permits the study of potential ethnic differences in the pathology of disease. Finally, increased participation of ethnic minorities will result in improved generalizability of research results.