Description of an efficacious behavioral peer-driven intervention to reduce racial/ethnic disparities in AIDS clinical trials.

AIDS clinical trials (ACTs) are critical to the development of new treatments for HIV infection. However, people of color living with HIV/AIDS are involved in ACTs at disproportionally low rates, with African-Americans experiencing the greatest under-representation. In this article, we describe the core elements and key characteristics of a highly efficacious multi-component peer-driven intervention (PDI) designed to increase rates of screening for and enrollment into ACTs among African-American and Latino/Hispanic individuals, by addressing the main complex, multi-level barriers they experience to ACTs. We discuss the process of developing the intervention, the theoretical models guiding its delivery format and content, and provide an overview of the intervention's components. We then use brief case studies to illustrate a number of key issues that may arise during intervention implementation. Finally, we describe lessons learned and provide recommendations for the PDI's uptake in clinical and clinical trials settings.

Gender differences in attitudes toward AIDS clinical trials among urban HIV-infected individuals from racial and ethnic minority backgrounds.

Racial/ethnic minorities and women are under-represented in AIDS clinical trials (ACTs). We examined gender differences in willingness to participate in ACTs among urban HIV-infected individuals (N = 286). Sixty percent of participants were male, and most were from racial/ethnic minority backgrounds (55% African-American, 34% Latino/Hispanic, 11% White/other). Knowledge of ACTs was poor. Males and females did not differ substantially in their distrust of AIDS scientists, or in barriers to ACTs. Almost all (87%) were somewhat or very willing to join ACTs. Females were less willing than males to join, including trials testing new medications or new medication combinations. Males and females differed in correlates of willingness to participate in ACTs. Despite long-standing barriers to medical research among minorities and women, willingness to participate was substantial, particularly for men, although the factors that might motivate them to join differed by gender. Women appeared more averse to trials involving new anti-retroviral regimens than men. Gender-specific outreach, behavioural intervention, and social marketing efforts are needed.

From science to application: the development of an intervention package.

Many community-based organizations and health departments want to implement HIV prevention interventions with scientifically demonstrated effectiveness. The Replicating Effective Programs (REP) project supported researchers in developing intervention packages designed to help prevention partners replicate effective programs in their settings. Intervention packages convey the intervention's foundation, components, and methods and are one part of a larger system needed to transfer research-based HIV prevention technology to service providers. Implementation packages were developed using a multistage process. The original researchers drafted the materials, advisory groups reviewed the packages, and adopting agencies used the materials in trial runs. The advisory groups and adopting agencies recommended extensive use of examples, thorough explanations about the rationale for each intervention component, explicit representation of people of color in the materials, clear statements about the intended audience(s), and an easy-to-use and visually appealing format. Packages were revised based on these recommendations and the outcomes of the trial runs.

Orientation and training: preparing agency administrators and staff to replicate an HIV prevention intervention.

Effective orientation and training are fundamental to the successful implementation of any intervention because they communicate the critical first impressions of the intervention and the skills needed to conduct it. When research-based HIV prevention interventions are translated into practice, issues arise that require adaptation and expansion of the basic functions of orientation and training. This article identifies some of these issues by drawing on the experience of researchers in the Replicating Effective Programs (REP) project. The purpose, structure, and instructional approach of the orientation and training for administrators, staff, and volunteers are described in depth for one project, with comparisons and additional examples from others. Based on these descriptions, critical issues for orientation and training for replication are presented. These include extending orientation and training to a broad audience within the adopting agency, allocating sufficient time to ensure understanding of the intervention, and planning for staff turnover.

Transfer of research-based HIV prevention interventions to community service providers: fidelity and adaptation.

HIV prevention research interventions usually follow protocols with specific procedures. If a community-delivered intervention uses the same procedures with the same populations as those in the original research, the behavior change effects should be similar. However, community-based providers may not replicate an intervention exactly as it was conducted in the effectiveness study. Adaptation may be needed to better meet the needs of the clients, community, or organization. We propose that interventions can be defined in terms of core elements likely to be responsible for effectiveness. These core elements cannot be changed without fundamentally changing the intervention, whereas other characteristics may be modified without altering effectiveness. HIV prevention researchers and service providers can collaborate to develop interventions that not only are effective but can also be successfully implemented by service organizations. If researchers actively involve service providers and community members in intervention planning, technology transfer goals can be better achieved.