Objective-We developed the Clinical Research Involvement Scales (CRIS) to assess clinical trial willingness-to-participate.Study Design and Setting-Diverse populations (N=919) aged ≥ 18 years from Atlanta, Georgia were included in comprehensive testing of the 41-item CRIS instrument. The formative phase focused on item content for the new measures (n=54). Questionnaires from potential vaccine trial participants (n=865) collected at multiple timepoints resulted in evaluation of scale reliability and validity (i.e., attitudes, behavioral and normative beliefs, perceived social support for clinical research participation, social norm compliance, perceptions of the clinical research organization, and perceived relevance of the research endeavor).Results-Qualitative testing revealed adequate comprehension and content validity of the initial item set. The subjective norms domain (n=3) initially exhibited poor internal consistency in pilot testing (Cronbach's α = 0.525), yet rewording of the items resulted in consistently stable measurement improvement (Cronbach's α = 0.850). Each of the CRIS subscales demonstrated extremely high reliability, ranging from 0.734 -0.918. Confirmatory factor analysis verified itemfactor relationships and determined construct and convergent validity (RMSEA=.068; CFI=0.835).Conclusions-CRIS is a reliable instrument for measuring community attitudes toward participation in biomedical research studies. Results of this study support the use of these scales to recruit diverse populations to clinical trials.

In the United States, the number and proportion of HIV/AIDS cases among black/African Americans continue to highlight the need for new biomedical prevention interventions, including an HIV vaccine, microbicide, or new antiretroviral (ARV) prevention strategies such as pre-exposure prophylaxis (PrEP) to complement existing condom usage, harm reduction methods, and behavioral change strategies to stem the HIV epidemic. Although black/African Americans are disproportionately impacted by HIV/AIDS, their participation in HIV clinical research continues to have unique challenges. We theorize that interaction among multilevel factors creates ideal alignment for minority participation in HIV clinical studies. Thus, we initially set out to test an extended model of reasoned action with 362 participants to understand the interplay of sociopsychological and network-level considerations influencing minority participation in HIV prevention research efforts. In this study, we linked the intrapersonal dimensions of attitudes, beliefs, and normative concerns to community-level components, appraisal of involvement with the clinical research organization, an entity which operates within a networked structure of community partner agencies, and identification with coalition advocacy aims. Various participatory outcomes were explored including involvement in future HIV vaccine community functions, participation in community promotion of HIV vaccine research, and community mobilization. Three-stage least squares estimates indicated similar findings across three models. Significant effects demonstrate the importance of positive attitudes toward HIV vaccine research, favorable health research beliefs, perceived social support for participation, HIV/AIDS issue engagement, and perceived relevance of the clinical research site’s mission and values. Identification of these nuanced pathway effects provides implications for tailored community program development.

BackgroundUnderrepresentation of older-age racial and ethnic minorities in clinical research is a significant barrier to health in the United States, as it impedes medical research advancement of effective preventive and therapeutic strategies.ObjectiveThe objective of the study was to develop and test the feasibility of a community-developed faith-based intervention and evaluate its potential to increase the number of older African Americans in clinical research.MethodsUsing a cluster-randomized design, we worked with six matched churches to enroll at least 210 persons. We provided those in the intervention group churches with three educational sessions on the role of clinical trials in addressing health disparity topics, and those in the comparison group completed surveys at the same timepoints. All persons enrolled in the study received ongoing information via newsletters and direct outreach on an array of clinical studies seeking participants. We evaluated the short-, mid-, and longer-term effects of the interventional program on clinical trial-related outcomes (ie, screening and enrollment).ResultsFrom 2012 to 2013, we enrolled a balanced cohort of 221 persons in the program. At a 3-month follow-up, mean intention to seek information about clinical trials was higher than baseline in both treatment (mu=7.5/10; sigma=3.1) and control arms (mu=6.6/10; sigma=3.3), with the difference more pronounced in the treatment arm. The program demonstrated strong retention at 3-month (95.4%, 211/221) and 6-month timepoints (94.1%, 208/221).ConclusionsThe “Dose of Hope” program addressed an unmet need to reach an often overlooked audience of older African Americans who are members of churches and stimulate their interest in clinical trial participation. The program demonstrated its appeal in the delivery of effective messages and information about health disparities, and the role of clinical research in addressing these challenges.

Background This mixed methods study reports on product acceptance from a Phase I clinical trial of a candidate non-nucleoside reverse transcriptase inhibitor (NNRTI) vaginal microbicide product (UC781). The product was evaluated in the context of a Phase I clinical trial in an area characterized by high HIV prevalence among minority women. The findings will inform the development of an acceptable microbicide that will address the needs of diverse women and their partners. Methods This is a mixed methods study of 34 racially and ethnically diverse female participants and 10 male partners in Atlanta, Georgia. Chi-square tests for marginal homogeneity and kappa statistics were calculated to analyze differences between groups on product attributes and use intention. ANOVA was used to examine difference between the treatment groups. Qualitative data were analyzed via constant comparative methodology. Results Thirty-four out of the original female cohort of 36 completed the questionnaire. Approval of future microbicide development was high at 91.2% (n=31) despite a lack of enthusiasm for the placebo and UC781 formulations. Overall female acceptability was correlated with personal protection motivation (r=1.00, p<0.001). African American women indicated greater likelihood of post-licensure microbicide use (X2(3)=7.9, p=0.048) and ascribed greater importance to its potential protection against HIV (X2(4)=18.7, p=0.001) and its potential for dual protection (protective against STIs and/or pregnancy) compared to white women (X2(4)=11.3, p=0.024). Men and women supported development in the form of an intravaginal ring or suppository. Men were more likely to encourage female adoption of the method if it afforded HIV protection (r=0.935, p=0.001). Conclusions Although most women agreed that the development of a microbicide was an important endeavor, quantitative and qualitative data indicated they would not use placebo or UC781 due to the objectionable viscosity, odor, and color. Male partners felt the potential protective benefit of a future microbicide product was its most important feature.