Development of a Multilevel Intervention to Increase HIV Clinical Trial Participation Among Rural Minorities

Abstract

Minorities are disproportionately affected by HIV/AIDS in the rural Southeast; therefore, it is important to develop targeted, culturally appropriate interventions to support rural minority participation in HIV/AIDS research. Using Intervention Mapping, we developed a comprehensive multilevel intervention for service providers (SPs) and people living with HIV/AIDS (PLWHA). We collected data from both groups through 11 focus groups and 35 individual interviews. Resultant data were used to develop matrices of behavioral outcomes, performance objectives and learning objectives. Each performance objective was mapped with changeable, theory-based determinants to inform components of the intervention. Behavioral outcomes for the intervention included: (a) Eligible PLWHA will enroll in clinical trials; and (b) SPs will refer eligible PLWHA to clinical trials. The ensuing intervention consists of four SPs and six PLWHA educational sessions. Its contents, methods and strategies were grounded in the theory of reasoned action, social cognitive theory, and the concept of social support. All materials were pretested and refined for content appropriateness and effectiveness.

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach

“…After funding, the team spent an additional 1.5 years of work developing the intervention components and pilot testing, excluding the time it took them to carry out the evaluation. This time limitation has been encountered by others [ 45 , 47 ]. We further estimate that implementation of our program by a multi-site coordinating center would require some effort from a coordinating center investigator and at least one recruitment coordinator who would deliver the training of our program to the specialist investigators and coordinators at the participating specialty clinics.…”

“…To our knowledge, this is one of the first theory-informed minority recruitment interventions to be rigorously tested within multi-site clinical trials in various disease areas. Several recruitment interventions that target trial investigators and research staff conducting clinical trials are reported in the literature; however, we only identified two randomized trials [ 17 , 21 ] and a single study that used IM to incorporate theoretical components in their intervention [ 45 ], unlike ours, which uniquely incorporates both.…”

“…Recently, researchers used IM to develop an intervention to increase participation in HIV clinical trials as part of a community-based research study, called Project Education and Access to Services and Testing (EAST) [ 45 ]. The Project EAST intervention helped community physicians locate potential clinical trials and refer their patients to them.…”

African-American and Hispanic Perceptions of HIV Vaccine Clinical Research: A Qualitative Study

“…Implementation of strategies to increase community-level awareness may help mitigate perceptions toward and experiences of social burdens due to study participation. Such tailored strategies would necessitate a multilevel approach, such as one described by Corbie-Smith et al, 34 that includes initiating early communication about upcoming trials, detailed descriptions of the research process, and trialspecific requirements for participation. Collaboration between researchers and trusted local organizations could facilitate this process.…”

ACT2 Peer-Driven Intervention Increases Enrollment into HIV/AIDS Medical Studies Among African Americans/Blacks and Hispanics: A Cluster Randomized Controlled Trial

“…The present study focuses on enrollment into both therapeutic/treatment clinical trials and biomedical observational studies, which evidence similar problematic rates of racial/ethnic under-representation [8]. Although the problem of under-representation of AABH-PLHA is well known, and a number of studies with PLHA have either focused exclusively on or proportionately sampled African American/Black and Latino populations [9–11], no studies have tested intervention strategies to reduce barriers to HAMS for these AABH-PLHA [12, 13]. …”