JMIR Publications

ABSTRACT

Background:

Latinos remain disproportionately underrepresented in clinical trials, comprising only 2-3% of research participants. In order to address health disparities it is critically important to increase enrollment of Latino smokers in smoking cessation trials. There is limited research examining effective recruitment strategies for this population.

Objective:

The purpose of this study was to compare the effectiveness of direct versus mass and high- versus low-effort recruitment strategies on recruitment and retention of Latino smokers to a randomized smoking cessation trial. We also examine how the type of recruitment might have influenced the characteristics of enrolled participants.

Methods:

Latino smokers were enrolled into Decídetexto from four states – New Jersey, Kansas, Missouri, and New York. Participants were recruited from August 2018 until March 2021. Mass recruitment strategies included English and Spanish advertisements to the Latino community via flyers, Facebook ads, newspapers, television, radio, church bulletins, and our Decídetexto website. Direct, high-effort strategies included referrals from clinics and/or CBOs we partnered with, in-person community outreach, and patient registry calls. Direct, low-effort strategies included texting or emailing pre-existing lists of patients who smoked. A team of trained bilingual (English and Spanish) recruiters from nine different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial.

Results:

Of 1,112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (51.1%) enrolled in the trial. Within the pool of screened individuals, those recruited by low-effort recruitment strategies (both mass and direct) were significantly more likely to be eligible (OR=1.67, 95% CI=1.01-2.76 and OR=1.70, 95% CI=0.98-2.96, respectively) and enrolled in the trial (OR=2.60, 95% CI-1.81-3.73 and OR=3.02, 95% CI=2.03-4.51, respectively) compared to those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rate at 3 months and 6 months among participants recruited via low-effort strategies (both mass and direct) were similar to participants recruited via direct, high-effort methods. Compared to enrolled participants recruited via direct (high- and low-effort strategies) participants recruited via mass strategies were less likely to have health insurance (44.0% vs 71.2% and 71.7%, respectively; P<.001), lived fewer years in the U.S. (22.4 yrs vs 32.4 yrs and 30.3 yrs, respectively; P<.001), more likely to be 1st generation (92.7% vs 76.5% and 77.5%, respectively; P<.007), more likely to primarily speak Spanish (89.3% vs 65.8% and 66.3%), and more likely to be at high risk for alcohol abuse (5.8 mean score vs 3.8 mean score and 3.9 mean score; P<.001).

Conclusions:

Although most participants were recruited via direct, high-effort strategies, direct low-effort recruitment strategies yielded a screening pool more likely to be eligible for the trial. Mass recruitment strategies were associated with less acculturated enrollees with lower access to health services—groups that might benefit a great deal from the intervention. Clinical Trial: ClinicalTrials.gov Identifier: NCT03586596