Abstract 17: Social Determinants of Health and Participant Retention in a Disparities Study and Primary Care: Findings From the Hypertension and Values (hyvalue) Trial

Abstract

Background: Clinical research has long suffered from a lack of research participants of diverse backgrounds, such as racial-ethnic minorities and women. How social determinants of health (SDOH) influence retention of research participants in clinical trials has not been well studied. Among a population of patients from three diverse health systems who enrolled in a prospective trial testing a psychosocial intervention, values affirmation, on racial disparities in hypertension medication adherence, we assessed whether SDOH were associated with study retention over 6 months. Methods: Adults who self-identified as non-Hispanic White or Black/African American, had uncontrolled hypertension and enrolled in the Hypertension and Values (HYVALUE) trial from January 2016 through June 2019 were included. Measures of high SDOH burden included: 1) self-reported low-education attainment (high school diploma or equivalent or less than a high school education), 2) difficulty paying for basics (individuals that reported it was hard to pay for the basics like food, housing, medical care, and heating), OR 3) social isolation (unmarried or lived alone). Poor study retention was defined as not completing at least one of the 3- or 6-month follow-up visits. Log binomial regression models adjusting for age, gender, and race-ethnicity were used to estimate the probability of study retention associated with 1 or more SDOH factors. Results: Among 814 study participants, the mean age was 63 years (standard deviation, 11.7 years), 59.1% were women, 51.2% were African-American, and 68.6% had at least one SDOH factor. Overall, 78.1% of participants completed at least one follow-up study visit. African-American participants, women, and individuals with public insurance (i.e., Medicare and/or Medicaid) were more likely to have at least one SDOH factor (72.4% of AAs vs 64.5% of white, 71.1% of women vs 64.5% of men, and 75.2% of those with public insurance vs 53.9% with commercial, respectively). Participants with at least one SDOH factor were less likely to have to have completed a follow-up visit compared to those with no SDOH (75.1% vs 84.8%, p =0.002). When adjusted for age, gender and race-ethnicity, those with at least one SDOH remained significantly less likely to have completed a follow-up visit (adjusted RR 0.91, 95% CI 0.85-0.97). Conclusions: In an ongoing prospective trial evaluating the impact of a Values Affirmation intervention on hypertension medication adherence, we found that a higher burden of SDOH was associated with poorer study retention independent of age, gender or race. Our study suggests that trials with diverse populations should consider retention plans that are attentive to challenges of socially disadvantaged participants.