The role of functional, social, and mobility dynamics in facilitating older African Americans participation in clinical research.

PURPOSE: Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans. METHODS: Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation. RESULTS: Logistic regression models demonstrated that greater transportation mobility (odds ratio [OR]=2.10; p=0.007) and social ability (OR=1.77; p=0.02) were associated with increased intentions of joining a clinical trial, as was greater basic daily living ability (OR=3.25; p=0.03), though only among single participants. Among adults age ≥65 years, those with lower levels of support during personal crises were more likely to join clinical trials (OR=0.57; p=0.04). CONCLUSION: To facilitate clinical trial entry, recruitment efforts need to consider the physical limitations of their potential participants, particularly basic physical abilities and disabilities. Crisis support measures may be acting as a proxy for personal health issues among those aged >65 years, who would then be more likely to seek clinical trials for the personal health benefits. Outreach to assisted living homes, hospitals, and other communities is a promising avenue for improved clinical trial recruitment of older African Americans.

Enrollment in YFV Vaccine Trial: An Evaluation of Recruitment Outcomes Associated with a Randomized Controlled Double-Blind Trial of a Live Attenuated Yellow Fever Vaccine.

This investigation evaluated several factors associated with diverse participant enrollment of a clinical trial assessing safety, immunogenicity, and comparative viremia associated with administration of 17-D live, attenuated yellow fever vaccine given alone or in combination with human immune globulin. We obtained baseline participant information (e.g., sociodemographic, medical) and followed recruitment outcomes from 2005 to 2007. Of 355 potential Yellow Fever vaccine study participants, 231 cases were analyzed. Strong interest in study participation was observed among racial and ethnically diverse persons with 36.34% eligible following initial study screening, resulting in 18.75% enrollment. The percentage of white participants increased from 63.66% (prescreened sample) to 81.25% (enrollment group). The regression model was significant with white race as a predictor of enrollment (OR=2.744, 95% CI=1.415-5.320, p=0.003).In addition, persons were more likely to enroll via direct outreach and referral mechanisms compared to mass advertising (OR=2.433, 95% CI=1.102-5.369). The findings indicate that racially diverse populations can be recruited to vaccine clinical trials, yet actual enrollment may not reflect that diversity.

From (Un)Willingness to InvolveMENt: Development of a Successful Study Brand for Recruitment of Diverse MSM to a Longitudinal HIV Research.

BACKGROUND: HIV continues to be a major concern among MSM, yet Black MSM have not been enrolled in HIV research studies in proportionate numbers to White MSM. We developed an HIV prevention research brand strategy for MSM. METHODS: Questionnaires and focus groups were conducted with 54 participants. Descriptive statistics and chi-square analyses were performed and qualitative data were transcribed and content analyzed to identify common themes. RESULTS: Formative research results indicated that younger Black MSM (18-29 years) were less likely to think about joining prevention studies compared to older (≥30 years) Black MSM (x2 = 5.92, P = 0.015). Qualitative and quantitative results indicate four prominent themes related to brand development: (1) communication sources (message deliverer), (2) message (impact of public health messaging on perceptions of HIV research), (3) intended audience (underlying issues that influence personal relevance of HIV research), and (4) communication channels (reaching intended audiences). CONCLUSION: The findings highlight the importance of behavioral communication translational research to effectively engage hard-to-reach populations. Despite reservations, MSM in our formative study expressed a need for active involvement and greater education to facilitate their engagement in HIV prevention research. Thus, the brand concept of "InvolveMENt" emerged.