Department of Surgery, University of Rochester School of Medicine & Dentistry, Rochester, NY, United States.
Department of Public Health Sciences, University of Rochester School of Medicine & Dentistry, Rochester, NY, United States.
J Med Internet Res. 2022 Jun 27;24(6):e34863. doi: 10.2196/34863.
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.
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.
Latino smokers were enrolled into Decídetexto from 4 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 or community-based organizations with whom we partnered, 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 9 different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial.
Of 1112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (457/895, 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 (odds ratio [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 with those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rates 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 with 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 United States (22.4 years vs 32.4 years and 30.3 years, 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%, respectively), 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, respectively; P<.001).
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 fewer acculturated enrollees with lower access to health services-groups who might benefit a great deal from the intervention.
ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-DOI: 10.1016/j.cct.2020.106188.
拉丁裔在临床试验中的代表性仍然严重不足,仅占研究参与者的 2%-3%。为了解决健康差距问题,增加拉丁裔吸烟者参与戒烟试验至关重要。针对这一人群,有效的招募策略研究有限。
本研究旨在比较直接与大众和高努力与低努力招募策略对随机戒烟试验中拉丁裔吸烟者的招募和保留的有效性。我们还研究了招募方式如何影响入组参与者的特征。
从新泽西州、堪萨斯州、密苏里州和纽约州 4 个州招募拉丁裔吸烟者参加 Decídetexto。参与者于 2018 年 8 月至 2021 年 3 月招募。大众招募策略包括通过传单、脸书广告、报纸、电视、广播、教堂公告和我们的 Decídetexto 网站向拉丁裔社区发布英语和西班牙语广告。直接、高努力策略包括与我们合作的诊所或社区组织的转介、社区外展和患者登记电话。直接、低努力策略包括向已吸烟的患者的现有名单发送短信或电子邮件。一个由来自 9 个不同西班牙语裔国家的训练有素的双语(英语和西班牙语)招募人员组成的团队进行招募、评估资格并将参与者纳入试验。
在接受筛查的 1112 人中,895 人(80.5%)符合入选标准,457 人(457/895,51.1%)入组试验。在筛选出的人群中,通过低努力招募策略(包括大众和直接)招募的人更有可能符合入选标准(比值比[OR]1.67,95%CI1.01-2.76 和 OR1.70,95%CI0.98-2.96)并参加试验(OR2.60,95%CI1.81-3.73 和 OR3.02,95%CI2.03-4.51)与通过直接、高努力策略招募的人相比。在入组的参与者中,通过低努力策略(大众和直接)招募的参与者在 3 个月和 6 个月时的保留率与通过直接、高努力方法招募的参与者相似。与通过直接(高和低努力)策略招募的入组参与者相比,通过大众策略招募的参与者更不可能有健康保险(44.0%对 71.2%和 71.7%;P<.001),在美国居住的年限较短(22.4 年对 32.4 年和 30.3 年;P<.001),更有可能是第一代移民(92.7%对 76.5%和 77.5%;P=.007),更有可能主要说西班牙语(89.3%对 65.8%和 66.3%;P<.001),更有可能有酗酒的高风险(5.8 平均分对 3.8 平均分和 3.9 平均分;P<.001)。
虽然大多数参与者是通过直接、高努力策略招募的,但直接、低努力的招募策略产生了一个更有可能符合试验入选标准的筛选池。大众招募策略与较少融入的参与者相关联,他们获得医疗服务的机会较低-这些参与者可能会从干预中受益良多。
ClinicalTrials.gov 标识符:NCT03586596;https://clinicaltrials.gov/ct2/show/NCT03586596。
国际注册报告标识符(IRRID):RR2-DOI:10.1016/j.cct.2020.106188。