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

Abstract

African American/Black and Hispanic persons living with HIV/AIDS (“AABH-PLHA”) are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N=540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3% vs. 3.7%; p < .001). Half (55.5%) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7%), almost all into observational studies (95.2%), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions.

Eliminating Racial/Ethnic Disparities in AIDS Clinical Trials in the United States: A Qualitative Exploration of an Efficacious Social/Behavioral Intervention

“…Further, it denies AABH-PLWH equitable access to chances to contribute to and potentially benefit from participation in biomedical research [3,7,8]. Recently we demonstrated that a culturally appropriate, multi-component social/behavioral intervention called the ACT2 Project resulted in substantially higher rates of screening for and enrollment into ACTs compared to a control intervention comprised of health education and treatment as usual [9–11]. We found participants in the intervention arm were 30 times more likely to be screened for ACTs than controls (49.3% vs. 3.7%; p<0.001).…”

“…At the structural level of influence, AABH-PLWH are much less likely to be recruited for or referred to ACTs compared to their White peers [9], including by HIV/AIDS primary care providers, who are typically the main source of such referrals [3,22,23]. The physical location of clinical trials research units (CTRUs), commonly situated in neighborhoods that are distant from patients and located in unfamiliar formal hospital settings, can also serve as an impediment [4].…”

Challenges in Recruiting People Who Use Drugs for HIV-Related Biomedical Research: Perspectives from the Field

“…The evolution of effective treatments for HIV infection has led to the need for other types of studies, for example, how best to engage and retain people in HIV clinical trials and in HIV care. [5][6][7] These efforts are especially needed for drug users who have lower rates of engagement along the HIV continuum of care, including lower retention in care. 8 In addition, as other biomedical advances relevant for PWUD have developed, including PrEP and PEP (pre-and postexposure prophylaxis) and treatment for HCV, there has been an increased need for studies that recruit PWUD to further our knowledge of these treatments and to help ensure equity in their delivery.…”

“…This is particularly important given that many PWUD are racial/ethnic minorities, and although race/ethnic minorities are overrepresented in HIV/AIDS cases, they are underrepresented in HIV/AIDS medical studies. 7,9 Recruitment for biomedical studies has created new challenges for recruiters and for institutions conducting these studies, and guidance to enhance recruitment strategies is needed.…”

Critical race theory as a tool for understanding poor engagement along the HIV care continuum among African American/Black and Hispanic persons living with HIV in the United States: a qualitative exploration

“…Self-Determination Theory is the accepted theoretical underpinning of Motivational Interviewing [68, 69], an approach considered culturally appropriate and highly efficacious for populations of color [70]. Our own intervention research with AABH-PLWH to address health inequity integrates Motivational Interviewing with CRT, and takes the approach of directly uncovering and exploring counter-narratives, medical distrust, and fear in intervention components, while not necessarily seeking to change or influence these understandings, and also acknowledging and fostering autonomy, relatedness, and competence, the core self-determination needs [17, 71, 72]. Similarly, Wagner and Bogart and colleagues [73] have developed a promising culturally appropriate ART adherence intervention for African American PLWH, one which foregrounds counter-narratives [73].…”