Enrollment of Spanish-speaking Latinx Adults in Clinical Trials: Five Lessons Learned from a Randomized Study in Substance Use Treatment”

Abstract

Latinx individuals are the largest ethnic minoritized group in the United States (US) at 19% of the population. However, they remain underrepresented in clinical research, accounting for less than 8% of clinical trial participants. Consideration of cultural values could help overcome barriers to inclusion in clinical trials and result in better recruitment and retention of Latinx individuals. In this commentary, we describe general guidance on culturally responsive modifications to facilitate the successful recruitment and retention of Spanish-speaking Latinx participants in Randomized Clinical Trials (RCTs) for substance use. We identify five culturally responsive strategies to help enroll participants in RCTs: 1. Create an ethnically diverse research team, 2. Assess available community partners, 3. Familiarize oneself with the target community, 4. Establish confianza (trust) with participants, and 5. Remain visible to participants and staff from recruitment sites. Representation of Latinx individuals in clinical trials is essential to ensure treatments are responsive to their needs and equitydriven. Some of these strategies can further research in helping to promote the participation of Latinx individuals experiencing substance use concerns, including outreach to those not seeking treatment.

1. Introduction

Latinx individuals represent the largest ethnic minoritized group in the United States (US). Numbers are projected to nearly double by 2060, meaning approximately one in three US residents will identify as Latinx (U.S. Census, 2019). While Latinxs comprise 19% of the population, they account for <8% of clinical trial participants, limiting understanding of treatment needs and preferences (Byrne et al., 2020). Barriers contributing to low participation of Latinx adults in substance use disorder (SUD) treatment and research include stigma, low literacy, psychiatric severity, childcare, loss of wages due to research participation, family responsibilities, high incarceration rate, and unmet SUD treatment needs (Calvo 2016; Espinoza-Kulick & Cerdeña, 2022; George et al., 2014; Lopez et al., 2018). Further, research suggest that the acculturation can represent a risk factor as some Latinx adults may engage in risky drinking to cope with acculturative stressors like discrimination, language barriers, and family-cultural conflicts (Mills & Caetano, 2012).

Although Latinxs are not a monolith, there are shared cultural values (Escobedo et al., 2018; Mercado et al., 2021). Respeto (respect), confianza (trust), familismo (family orientation), personalismo (personal rather than institutional relationships), and simpatia (agreeable interpersonal friendly style) are particularly relevant (Añez et al., 2008; Escobedo et al., 2018; Floríndez et al., 2020). Respeto embodies respect for one’s elders and courtesy to others, including respect for authority (Florindez et al., 2020). Confianza refers to trust between people, including people in healthcare settings (Florindez et al., 2020). Familismo includes prioritizing the collective over the individual and strong identification with family (Arredondo et al., 2014; Campos et al., 2014; Rojas Perez et al., 2022). Finally, personalismo and simpatía refer to personal engagement and friendliness in interpersonal relationships (Arredondo et al., 2014; Campos et al., 2014; Rojas Perez et al., 2022). Attention to these values may enhance research engagement with Latinx individuals (Villalobos., 2016). These values are not necessarily specific to, or limited to Latinx culture, so considering them in clinical research settings could help with engagement of other underrepresented groups.

We offer five lessons learned from a Randomized Clinical Trial (RCT) of SUD treatment for Latinx adults (see Paris et al., 2018 for description). The lessons are primarily anecdotes (sometimes single occurrences) that we are using as examples of why the cultural values and sensitivity to these proved relevant; we are not making any direct links between outcomes and the values.

2. Example RCT

2.1. Overview

The main RCT recruited Spanish-speaking Latinx adults with a SUD (see Paris et al., 2018). All study materials were in Spanish, including our culturally adapted web-based learning intervention program (Computer Based Treatment for Cognitive Behavioral Treatment-CBT4CBT-Spanish) (Jaramillo et al., 2022; Paris et al., 2018; Silva et al., 2022). The study was primarily facilitated by two bilingual/bicultural Spanish-speaking research assistants (RAs). One RA was female, of Latinx background, and a native Spanish speaker. The other RA was also female. of Irish descent, and a primary English speaker with Spanish fluency.

Participants were recruited from community clinics and referrals were primarily provided by clinicians and/or psychiatrists from each participating clinic. RAs participated in weekly clinic staff meetings where new admissions were reviewed. Community advertisements (e.g., highway billboards, advertisements on public transportation) did not prove successful and flyers were also posted in the clinics.

Standard visit reminders were offered over nine weeks (active treatment and follow-up) with appointment cards, face-to-face encounters, phone calls, and letters. Primary contact information and secondary contact phone numbers (e.g., family members) were gathered with the individual’s consent and understanding that participants could rescind permission at any point. Participants’ contact information was updated at follow-up visits when necessary. In some cases, contacts were unreliable as participants lived in shelters or did not have regular phone numbers. Interestingly, many participants informed the RAs of any new contact information without prompting.

2.4. Key Data Sources Informing the Five “Lessons Learned”

Information from consort data, RAs’ records of participant contact, type of referrals received, RAs’ anecdotal stories (both RAs are authors: YJ and KL), participants’ demographic data, self-assessments, and literature search were used to identify the lessons learned. The RAs’ records consisted of referral notes, visit notes, and comments made by RAs in research documents. In addition, the study participants responded to a Cultural Values questionnaire created by the research team. The questionnaire contains four sections (see Table 1). We also used the Short Acculturation Scale for Latinx (SASH; Marin et al., 1987), with results reflecting a low level of acculturation among participants, with 95% having a mean score of 3.0 or less on the SASH. These two instruments were found to be useful to understand cultural backgrounds.

Table 1.

Participants demographics and cultural values survey responds

Categorical Variables	Total n=91 n(%)
Male	62(67)
Never Married	70(76)
Lower than High School	54(59)
Unemployed	60(65)
Client Origin of Birth
Puerto Rico	66(72)
United States	4(4)
South American country	2(2)
Mexico	8(9)
Other Central American country	9(10)
Other area	3(3)
Primary Drug
Alcohol	32(34)
Cocaine	23(25)
Marijuana	33(36)
Opiates	2(2)
Benzodiazepines	1(1)
Other (heroin)	1(1)
Continuous Variables	Mean (SD)
Age	42.9(11.4)
Years living in United States	17.7(13.3)
Age first used primary drug	19.8(9.8)
Years of primary drug use	21.8(12.2)
Days of substance use treatment	6.8(11.2)
Number of previous drug treatments	1.8(3.5)
Number of previous alcohol treatments	1.3(4.6)
Total number of arrests	2.5(6.2)
Cultural Values Survey	n(%)
How much power do you think you have to change your situation at this moment?
none	15(16)
a little	19(20)
more or less	22(24)
a lot	35(38)
How important is destiny?
none	23(25)
a little	9(10)
more or less	15(16)
a lot	44(48)
How important is trust?
none	16(18)
a little	16(18)
more or less	16(18)
a lot	43(47)
When you make a decision, how important is the opinion of someone you trust?
none	12(13)
a little	21(23)
more or less	22(24)
a lot	36(39)
How stressful is it not to be close to family?
none	11(12)
a little	11(12)
more or less	20(18)
a lot	51(55)
How much responsibility do you feel you have in keeping family unity?
none	9(10)
a little	9(10)
more or less	14(15)
a lot	59(64
How much influence does your family have on your treatment decisions?
none	28(30)
a little	13(14)
more or less	12(13)
a lot	38(41)
How important is respect in your relationship with others?
none	4(4)
a little	2(2)
more or less	15(16)
a lot	70(76)
How seriously do you take advice from people you respect?
none	4(4)
a little	5(5)
more or less	15(16)
a lot	67(73)

3. Five Lessons Learned

3.1. Lesson 1: Create a cultural affirming team (confianza, respeto and personalismo/simpatia)

In the Cultural Values questionnaire, 41% of participants responded that respect is “a lot” important in their relationship with others, and 47% said that trust was “a lot” important in their relationship with others. Additionally, in response to the question, “Tell me two ways in which a person can demonstrate respect,” three participants responded: “ayudando, apoyando (helping, supporting)”; “dando confianza (giving trust)”; and “respetando la manera de pensar y mostrar aprecio (respecting the way of thinking and showing appreciation).” These descriptions align with the relationship between RAs and participants.

RAs assisted with scheduling medical appointments, filling out paperwork, and making phone calls on behalf of the participants to address basic needs. Thus, independent of their role in the study, RAs built confianza and showed personalismo/simpatia and respect for the participant as a valued person. In retrospect, having a case manager could be a link to this relationship, since many participants asked the RA for help with issues outside the scope of the study. In addition, Latinx values can be infused into the training, development, and supervision of research staff to enhance culturally responsive care. Creating a culturally affirming team that understands Latinx cultural is paramount.

3.2. Lesson 2: Selecting community partners with credibility in the community (confianza, familismo, and respeto)

Recruitment success seemed influenced by the participants’ confianza and sense of familismo in the clinics. Some participants had a long-standing relationship with their clinic, while others were referred by family, friends, medical providers, and other trusted places. Some participants expressed gratitude for clinicians who invested in their recovery and understood their unique family circumstances (i.e., the isolation associated with the immigrant experience). In addition, when asked, “Tell me how you regularly manage your problems,” some participants noted they would reach out to their clinician: “venir a la clinica (come here to the clinic)” or “llamar a mi terapista (call my therapist).” Additionally, participants would present without an appointment to inform the RA that their contact information had changed or to confirm their upcoming appointments. Participants seemed to feel like the clinic was a safe place that provided support beyond their treatment needs. A thoughtful and intentional process in selecting recruitment sites that had established trust with the community proved essential.

3.3. Lesson 3: Familiarity with the community of potential participants (personalismo/simpatia)

Researchers had conversations with each clinic director to understand the population served. For instance, one site’s participants were mainly Spanish speaking, of Puerto Rican descent, including 32% with serious mental illness (SMI), in comparison to other sites where participants did not have a high rate of SMI or co-occurring SMI and SUD. These factors posed barriers to recruitment. However, recruiting Latinx research participants with literacy concerns and with SMI can be done with accommodations (e.g., reading assessments out loud, repeating as needed). Study visit length was expanded when participants gave lengthy responses or started non-study-related conversations. This observation highlighted the need for orientation of participants to the research process and differentiating meeting with the RA from sessions with their clinicians. In these cases, the research staff maintained an open and compassionate stance—an effort to engage with personalismo and simpatia in a research environment.

3.4. Lesson 4: Establish trust with participants (confianza, personalismo/simpatia, and respeto)

The therapeutic alliance refers to the strength of the bond between the client and clinician, along with their agreement about the treatment goals and activities (Horvath & Luborsky, 1993; Zilcha-Mano & Fisher 2022). Strengthening the alliance is often associated with improvement in outcomes (Horvath & Luborsky, 1993; Zilcha-Mano & Fisher 2022). We recognize the importance of the alliance between research staff and participants and expect that a strong alliance results in improved engagement.

The participant-researcher alliance may have been strengthened when transportation accommodations were made for participants. For example, the RA visited clients at locations convenient to them (e.g., home; inpatient clinic for follow-up, not intervention phase), scheduled transportation (for intervention phase or follow-up visits), and offered bus passes. The developing confianza between RAs and participants facilitated study retention. RAs were viewed as people who wanted to help, but it was also important to remind participants that they were not mental health providers.

3.5. Lesson 5: Remain visible to participants and staff from recruitment sites (confianza and respeto)

Standard recruitment protocol strategies that included having RAs working full-time at two clinic sites and conducting face-to-face recruitment was essential. Flyers posted in the clinics was less effective (few referrals) relative to face-to-face interaction at clinics. Meeting face-to-face at their clinical visits to introduce the study also helped build rapport and study retention, as an already familiar and trusted face was the preferred mode of introduction; this helped build confianza and respeto among clinic staff and prospective participants.

4. Summary

The Latinx population is a fast-growing minoritized ethnic group and needs to be included in research to accurately extrapolate results for this community. Recruiting and retaining Latinx participants in RCTs for SUDs will benefit treatment advances, as it is essential that research studies include people from diverse backgrounds and lived experiences (Chiao et al., 2020; Henrich et al., 2010; Medin et al., 2010). Mental health stigma, unemployment, low acculturation to US culture, and poverty are factors to consider when recruiting Latinxs (OMH, 2021) and other marginalized groups. As such, we recommend recruitment in clinic sites that provide case management services. This assistance offers a valuable service and can reduce barriers to engagement and retention in substance use treatment.

When recruiting underserved populations- including but not limited to immigrant groups or individuals with low acculturation- it is important to consider limited literacy and potential accommodations. Taking into account this factor will increase recruitment by expanding the participation pool (Bernard-Davila et al., 2015). We recommend preparing for lengthier visits when recruiting, as the reading of study materials might be necessary. In addition, participants with less exposure and familiarity with research procedures will benefit from guidance about the differences between the relationship with a research team, guidance as to scope of activities and assistance they can expect, and limits of confidentiality. Research teams should also ensure adequate training on the study population, common psychosocial stressors, and limitations of their roles for RA staff.

The RCT was not designed to test methods for improving the recruitment or retention of Latinx/Spanish-speaking participants. However, our study sample included individuals with several psychosocial stressors that can present barriers to recruitment and retention, and therefore provided a learning opportunity. The relationship participants develop with the research assistants might be viewed as a powerful intervention in itself. However, as long as this is applied equally across treatment conditions it should not undermine the trial’s findings. The described cultural values and the recommended accommodations are not necessarily specific to Latinx populations, and do not apply to all Latinx individuals. Additionally, the intervention needs to be culturally adapted to the targeted population. For instance, our intervention was culturally adapted to include a trauma module which the study team found relevant to the population (Silva et al., 2022).

5. Conclusions

Latinx individuals, as well as other groups who are traditionally underserved in SUD treatment settings and/or underrepresented in SUD clinical research trials, may benefit from these – or other culturally-adapted – accommodations. The ones outlined may not only improve recruitment and retention, but also improve client experience. The goal is to improve clinical outcomes for all in need of SUD treatment.

Highlights.

• Culturally responsive procedures facilitate Latinx recruitment and retention

• Bicultural, bilingual staff could contribute to equity in RCTs

• Consideration of Latinx shared cultural values may improve enrollment and retention.

• Latinx representation in RCTs could improve treatment equity.