BRIEF REPORT

Lessons learned in clinical research recruitment of midlife Latinas
during COVID-19

Yamnia I. Cortés, PhD, MPH,FNP-BC, FAHA,1 Mayra Duran, MD,1 Valentina Marginean, BSN, RN,2

Latesha K. Harris, BSN, RN,1 Andrea Cazales, BSN, RN,1 Lymari Santiago, MRC, OTL, PCAT,1

Margarita Diaz Mislan, MRC,1 and Krista M. Perreira, PhD3

Abstract
Objective: The purpose of this brief report is to describe lessons learned in recruitingand enrollingmidlifeLatinas in a

pilot study to reduce cardiovascular disease (CVD) risk during the menopause transition. We also discuss strategies
implemented to overcome the challenges presented by the novel coronavirus (COVID-19) pandemic.

Methods: Menopausia, Salud y Corazón is a two-group (intervention, waitlist control), repeated measures study.
The intervention consists of CVD risk education, coping skills training, physical activity, and stress management.
Eligible participants are peri- and early postmenopausal Latinas age 40 to 60 years, free of CVD. From August 2020
to October 2021, we screened 110 women recruited from cultural events and health fairs (n¼ 56), local businesses
(n¼ 24), and snowball sampling (n¼ 30). Of these, 60 were eligible for inclusion and 41 enrolled.

Results: Strategies that contributed to successful recruitment included: a primarily Latina bilingual (English,
Spanish) research team; flexibility with location and scheduling of data collection; and multiple modes of
communication (ie, mailings, phone calls, and text messages). Additionally, we addressed Latino cultural values
such as respeto (respect), familismo (loyalty to family), and confianza (trust). In response to COVID-19, we included
virtual recruitment strategies, limited in-person visits, and distributed community resources for COVID-19.

Conclusion: We have found that despite the challenges presented by COVID-19, midlife Latinas are receptive to
clinical research engagement. Researcher flexibility, multiple recruitment modalities, a bilingual research team, and
communication strategies that address cultural values are essential elements for the representation of midlife Latinas
in research.

Key Words: Clinical trial – COVID-19 – Latinas – Middle aged – Research design.

Video Summary: http://links.lww.com/MENO/A943.

I
n 2019, the number of Latinas age 45 to 54 years in the
United States (US) reached over 3.5 million, accounting
for 17% of US women in this age group.1 Despite the

National Institutes of Health mandating the inclusion of
historically marginalized populations in clinical research,
Latinas continue to be underrepresented in studies of midlife
women, particularly during the menopause transition.2,3 For
example, only 4% of participants in the Women’s Health

Initiative and 8% of participants in the Study of Women’s
Health Across the Nation are Latina.4,5 Thus, our current
understanding of the menopause transition, its impact on
health, and symptom management is mostly from data with
non-Latina White women. Common barriers to the inclusion
of Latinas in clinical research are: a lack of knowledge about
research opportunities; culture and language discordance with
the research team; logistical concerns such as transportation

Received October 16, 2021; revised and accepted January 17, 2022.
From the 1School of Nursing, The University of North Carolina at Chapel
Hill, Chapel Hill, NC; 2Brody School of Medicine, East Carolina
University, Greenville, NC; and 3Department of Social Medicine, The
University of North Carolina at Chapel Hill School of Medicine, Chapel
Hill, NC.

Disclaimer: The content of this manuscript is solely the responsibility of
the authors and does not necessarily represent the official views of the
NIMHD or NIH.
Funding/support: This study is funded by the National Institutes of
Health and the National Institute of Minority Health and Health
Disparities (K23MD014767, PI: Cortés). Additional support was

provided by the NC TraCS Inclusive Science Program (ISP)
ULITR002489 (Perreira).

Clinical trial registration: Prospectively registered, NCT04313751 (03/
19/2020), Protocol version 1.0.
Financial disclosure/conflicts of interest: None reported.

Supplemental digital content is available for this article. Direct URL
citations are provided in the HTML and PDF versions of this article on the
journal’s Website (www.menopause.org).

Address correspondence to: Yamnia I. Cortés, PhD, MPH, FNP-BC,
FAHA, School of Nursing, The University of North Carolina at Chapel
Hill, Campus Box 7460, Chapel Hill, NC 27599-7460. E-mail: yicorte-
s@email.unc.edu

Menopause, Vol. 29, No. 7, 2022

Menopause: The Journal of The North American Menopause Society
Vol. 29, No. 7, pp. 883-888
DOI: 10.1097/GME.0000000000001983

2022 by The North American Menopause Society

883

�

Copyright © 2022 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.

http://links.lww.com/MENO/A943
http://www.menopause.org/
mailto:yicortes@email.unc.edu
mailto:yicortes@email.unc.edu


and time commitment; institutional mistrust; and fear of
deportation.6,7 Motivating factors for Latinas to participate
in clinical research have included contributing to society,
gaining knowledge that may benefit their families, and being
recruited by a trusted individual.7

This brief report describes lessonswe have learned in recruit-
ing and enrolling midlife Latinas (age 40-60 y) in a multi-
component intervention to reduce cardiovascular disease
(CVD) risk during the menopause transition. This is an impor-
tant group to study given that CVD risk increases during the
menopause transition and Latinas have a more adverse CVD
risk factor profile than non-Latina White women.8,9 Since the
studywas implemented during the novel coronavirus (COVID-
19) pandemic, we also discuss the challenges COVID-19
introduced for recruitment and enrollment in the clinical trial,
and strategies we implemented to overcome these challenges.
The approaches described in this report may enhance the
participation of midlife Latinas in future clinical research.

STUDY OVERVIEW
Menopausia, Salud, Corazón (Menopause, Health, Heart) is

a two-group, repeated measures pilot study examining the
feasibility and initial efficacy of a multi-component interven-
tion to reduce CVD risk in peri-and early postmenopausal
Latinas aged 40 to 60 years. The study rationale and protocol
have been described elsewhere.10 Briefly, after baseline assess-
ment, twogroupswere randomly assigned to an intervention led
by community health workers or a wait-list control. The inter-
vention group received 12 weekly 2-hour sessions, including
cardiovascular health education, coping skills training, physical
activity, and stress management (eg, breathing techniques,
mindfulness exercises). Educational messages included infor-
mation about menopause and CVD risk during the menopause
transition. During Phase II of the intervention, participants
received three monthly sessions of continued support to prob-
lem-solve issues related to nutrition, exercise, sleep, anxiety,
and depressive symptoms. Next, participants were expected to
maintain skills on their own for 6months. Body mass index,
waist circumference, blood pressure, psychosocial factors,
menopause symptoms, pregnancy history, and health behaviors
were assessed at three time points: baseline, 6months (comple-
tion of the intervention), and 12months (after 6mo with no
contact from the study staff).Measures of arterial stiffness, lipid
profile, glucose, high-sensitivity C-reactive protein, and hair
cortisol were collected at baseline and at 12-month follow-up.

Participant eligibility and enrollment
Inclusion criteria for women in this study were age 40 to

60 years; self-identification as Hispanic/Latina; ability to
understand spoken English or Spanish; perimenopausal or
early postmenopausal (change in length of bleeding or inter-
bleeding interval, or no menstrual bleeding in the past 3-
24mo); intact uterus and at least one ovary; not currently
pregnant; no hormone therapy or birth control pills in the past
3 months. Exclusion criteria for this study were: a history of
CVD (heart attack, stroke, coronary heart disease), heart

murmur, congenital heart disease, family history of sudden
death, or difficulty exercising. Women on anti-hypertensive,
lipid-lowering, or diabetes medications were not excluded.

Between July 1, 2020, and October 15, 2021, we screened
110 women recruited from cultural events and health fairs
(n¼ 56), community organizations and local businesses
(n¼ 24), and snowball sampling (n¼ 30). Of these, 60
(54.5%) were eligible for inclusion, and 41 have been
enrolled. Table 1 presents sociodemographic factors for par-
ticipants screened and enrolled.

LESSONS LEARNED

Strategies for recruitment and enrollment
Bilingual research team

Mistrust and lack of accurate Spanish-language informa-
tion about the research process are common barriers for
Latino participation in clinical research.11 To address these
potential barriers and build trust, the Principal Investigator
(bilingual Latina) assembled a primarily Latina bilingual
(English, Spanish) research team that lives in the communities
we targeted for recruitment. In addition, the Principal Inves-
tigator actively participated in recruitment events. Prior stud-
ies have found that Latinos may be more likely to participate
in research when they feel understood and can communicate
directly with bilingual research team members.11 Having
more diversity among researchers can enhance the recruit-
ment of midlife Latinas because researchers with cultural and
linguistic similarities to potential participants can better
understand participant concerns and build rapport when inter-
acting with them. Having a relatable research team that
provided accurate information about COVID-19 in Spanish
was particularly important. Nearly two-thirds (65%) of Latino
adults say the COVID-19 outbreak is a significant threat to the
health of the US population as a whole, and nearly half (49%)
say that COVID-19 is a threat to day-to-day life in their local
community.12 Providing up-to-date information about the
pandemic was essential to build trust and rapport with the
community and facilitated recruitment.

Community engagement
Another strategy to build trust and reach potential partic-

ipants is collaborating with community-based organizations
(CBOs) that serve Latino communities. As in prior studies we
worked with CBOs to attend public cultural events and health
fairs, recruited from waiting rooms at community health
clinics, and disseminated information in-person at parishes
with a Latino ministry and/or Spanish-language services.13

Understandably, we cutback this recruitment approach in
response to the COVID-19 pandemic and shelter-in-place
policies. We received Institutional Review Board approval
for limited in-person recruitment at drive-thru health fairs,
food distribution efforts, and local Latino-owned businesses.
Additionally, we leveraged our existing community partner-
ships to recruit remotely by attending virtual town halls
and health fairs, presenting online health workshops, and
distributing recruitment materials electronically (eg, social

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Copyright © 2022 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.



media, email, newsletters, parish bulletins). At all in-person
recruitment sites, we distributed personal protective equip-
ment, hand sanitizers, COVID-19 education materials, and
local resources for testing and support (Table 2).

Screening and informed consent processes
Screening for eligibility was completed via phone. During

the phone screening, research personnel assessed the partic-
ipant’s level of comfort with technology (ie, text messaging,
mobile applications, use of a computer or tablet, navigating
the internet) and, if eligible, scheduled a time to complete the
informed consent process and baseline visit. Participants had
the option of completing the informed consent using a
Research Electronic Data Capture e-consent, on the phone,
via video conference (eg, Zoom, Facetime, WhatsApp), or
during a limited in-person visit. As of today, none of the
participants have opted to complete an e-consent. Most
participants have preferred to receive the consent form in
the mail and review it with research personnel via video
conferencing (n¼ 6) or in person (n¼ 33). Two participants
preferred reviewing and giving consent over the phone with
the opportunity to ask additional questions during the limited
in-person visit. This preferred method has worked well for us
since participants have ample time to review the consent and

ask questions during this one-on-one time with the research
staff. An important takeaway from this approach is that
researchers must be flexible and adjust research protocols
to meet participants’ level of comfort, understanding, and
need. Our current observations suggest that we would not
have met the enrollment goal thus far if we did not offer
multiple options to complete screening and informed consent.

Strategies for data collection
Flexibility and collecting data remotely

To protect research participants and personnel from
COVID-19 exposure, we used alternative data collection
methods such as phone, mail, and video conferencing. We
received permission for limited in-person interactions to
collect biological/physiological data. While collecting data
on an online platform such as Research Electronic Data
Capture can facilitate the data collection process, many of
our participants prefer paper documents and may not
have consistent access to the internet.14 We mailed baseline
questionnaires to eligible participants and scheduled a time
to review them with research personnel via phone or video
conferencing along with the consent forms. We shortened
the in-person biological/physiological data collection visit
to 60 to 75 minutes by first remotely completing the

TABLE 1. Characteristics of women screened for inclusion between July 2020 and October 2021

Characteristics Total screened (n¼ 110) Eligible (n¼ 60) Enrolled (n¼ 41)

Age, mean�SD 48.0� 5.5 47.2� 4.6 47.5� 4.8
Recruitment site, n (%)

Cultural events and health fairs 56 (50.9) 16 (26.7) 10 (24.4)
Church, Latino CBO or businesses 24 (21.8) 30 (50.0) 18 (43.9)
Referral/Snowball sampling 30 (27.3) 14 (23.3) 13 (31.7)

Hispanic/Latina, n (%) 110 (100) 60 (100) 41 (100)
Screened in Spanish, n (%) 110 (100) 60 (100) 41 (100)
Self-reported overall health, n (%)

Poor 12 (10.9) 2 (3.3) 1 (2.4)
Good 65 (59.0) 38 (63.3) 25 (61.0)
Very good 24 (21.8) 14 (23.3) 11 (26.8)
Excellent 6 (5.5) 3 (5.0) 3 (7.3)
Don’t know 3 (2.7) 3 (5.0) 1 (2.4)

Months since LMP, median [IQR] 1.4 [0.6,19.9] 0.9 [0.4, 3.4] 0.9 [0.2, 3.3]
Would you describe your menstrual cycle as..

Very regular 8 (7.3) 4 (6.7) 1 (2.4)
Mostly regular with occasional irregularity 48 (43.6) 36 (60.0) 27 (65.9)
Most or always irregular, or absent 54 (49.1) 20 (33.3) 13 (31.7)

During the last year, did your menstrual flow usually start within 4 d of the day you expected it to start? n (%)
No 82 (74.5) 45 (75.0) 29 (70.7)
Yes 15 (13.6) 2 (3.3) 2 (4.9)
Don’t know 13 (11.8) 10 (16.7) 10 (24.4)

Have you EVER used birth control pills, menstrual hormone therapy, or hormonal patches, rings, injections, sprays, or topical cream? N (%)
No, never 45 (40.9) 28 (46.7) 14 (34.1)
Yes, but not in last 3 mo 46 (41.8) 30 (50.0) 25 (61.0)
Yes, have used in last 3 mo 16 (14.5) 0 0
Don’t know 3 (2.7) 2 (3.3) 2 (4.9)

Have you had a hysterectomy or oophorectomy? n (%)
No 96 (87.3) 57 (95.0) 38 (92.7)
Hysterectomy only 7 (6.4) 1 (1.7) 1 (2.4)
Yes, one ovary removed 4 (3.6) 2 (3.3) 2 (4.9)
Yes, bilateral oophorectomy 3 (2.7) 0 0

Any history of CVD, n (%)
No 107 (97.3) 60 (100) 41 (100)
Yes 2 (1.8) 0 0
Don’t know 1 (0.9) 0 0

CBO, community based organization; CVD, cardiovascular disease (angina, angioplasty, coronary artery disease, heart attack, heart failure, heart murmur
or arrhythmia, kidney failure, stroke); LMP, last menstrual period; SD, standard deviation.

CLINICAL RESEARCH RECRUITMENT DURING COVID-19

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interviewer-administered baseline questionnaire, which was
critical to success. Participants who decided to self-administer
the questionnaire could still clarify any uncertainties during
in-person biological/physiological data collection with
research personnel. Data were not collected until the comple-
tion of the informed consent process.

Prior studies have shown that it is feasible and acceptable to
collect data at community sites such as parishes and CBOs.15

After these spaces closed in response to COVID-19, we gave
participants the option of an in-person data collection visit at
the Biobehavioral Laboratory at the University or during a
home visit. We implemented stringent safety precautions for
biological/physiological data collection such as a symptom
checklist, temperature assessment, use of personal protective
equipment (ie, mask, goggles, gown, shoe covers), hand
hygiene, and equipment sanitization. To reduce potential
cancellations (<5% thus far), we completed the COVID-19
symptom checklist over the phone the day before the sched-
uled visits and sent a reminder text message the day of the
visit. If conducted at home, research personnel completed a
symptom checklist and temperature assessment of all family
members in the vicinity. Participant incentives, in the form of
a reloadable debit card, were distributed at the time of the in-
person visit.

Our approach addressed several barriers to research partici-
pation and retention including, limited time/scheduling con-
flicts and lack of transportation.11 First, our flexible scheduling
procedures included evenings and weekends. Thus, we accom-
modated participants with various work schedules. Our option
for home visits also accommodated participants with limited
transportation and individuals in need of childcare or eldercare
(�25%). This strategy is particularly important for our age

group (40-60 y) since many participants are responsible for
children, grandchildren, or aging parents.

Providing biological/physiological data and referrals
We implemented several precautions to protect participants

and research personnel during biological/physiological data
collection. During in-person visits, we explained each step of
the data collection process. To instill trust, we were transpar-
ent about the purpose of each piece of data collected and our
handling of any biospecimen. Storage of biospecimens has
been a concern for participants in prior studies, particularly
given historical abuses marginalized populations have
endured when their biospecimens are stored without their
knowledge or informed consent.16,17 We reiterated the impor-
tance of social distancing during home visits, which helped
ensure privacy during data collection.

Moreover, we provided participants with the results of their
lipid panel, fasting blood glucose, blood pressure readings,
pulse wave velocity measurements, and other clinical indi-
cators of wellness. Participants reviewed their physiological
data with a licensed Family Nurse Practitioner securely via
telephone or in-person. This individualized wellness session
provided a safe, private space for participants to discuss
concerns and for potential referrals to be made within the
community. We referred participants as needed to local health
clinics that provided low-cost care, extended hours, accepted
uninsured patients and Spanish-speaking personnel. These
strategies were consistent with prior studies showing partici-
pant desire for more transparency in research, including
reviewing results, meeting the lead investigator, working with
staff from the community, and observing professional-stan-
dard specimen collection procedures.18

TABLE 2. Challenges and countermeasures outlining various challenges and COVID-19 specific adaptations implemented in Menopausia,
Salud, Corazón since the Summer of 2020 through the Spring of 2021

Challenges Countermeasures

Recruitment during COVID-19 Primarily bilingual, Latina research team.
Worked with Latino community based organizations and local parishes. Attended public cultural events,

health fairs, town hall meetings, and resource distribution events.
Remote recruitment via phone, email, social media, and word-of-mouth.
In-person, outdoor recruitment with physical distancing and personal protective equipment.
Distribution of personal protective equipment (ie, hand sanitizer, alcohol swabs, gloves, masks) and

information related to COVID-19 vaccines, testing, and community resources.
Data collection Completed informed consent remotely via phone, videoconferencing, or e-consent.

Participants had option to complete surveys by phone, videoconference, or to self-administer questionnaire.
Collected biological/physiological data during a shortened in-person visit at the participant’s home or the

University’s Biobehavioral Laboratory.
Participant completed standardized COVID-19 screener the day before the in-person visit and at the

beginning of the visit. At the beginning of the visit, participant temperature was assessed.
If in-person visit was conducted in the home, requested a private area when possible. Family members in the

vicinity were asked to socially distance, wear a mask, and temperature assessed as well.
Participant engagement and retention Maintained contact with participants via phone, mail, text message, Whatsapp, and social media. Mailings

included holiday cards, birthday cards, and a quarterly newsletter.
Provided participants results or their biological/physiological measures, including weight, blood pressure,

lipid panel, blood glucose, and pulse wave velocity. A nurse practitioner reviewed results with participants
via phone or in-person.

Connected participants to timely, appropriate healthcare resources in their community that were Spanish-
inclusive and offer services at free or reduced costs.

Delivery of intervention Pivoted in-person intervention sessions to a virtual format. Intervention materials were delivered to
participant homes.

Assessed participant technology needs during enrollment and baseline—provided infographics, videos, and
technical support to help participants manage remote intervention sessions.

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Delivering intervention remotely
To maintain COVID-19 safety precautions, we delivered a

technology-assisted intervention using a video conferencing
format. Participants were sent pre-recorded videos of the
intervention content when they missed a session. In prepara-
tion for this delivery format, community health workers
contacted participants to decide the most convenient time
for these group sessions. Participants were sent an infographic
and video recording demonstrating how to use the video
conferencing format. Those participants that were still having
difficulty connecting to the live video conferencing sessions
were personally contacted by phone for further assistance. To
help offset the cost of the internet and the use of their
technology device, participants were provided a $5 incentive
after each session they attended.

Several strategies were implemented to engage partici-
pants remotely in the intervention to maintain social con-
nections and interactive discussions. During the education
session, the community health worker integrated illustra-
tions, videos, and group activities. Physical activity sessions
were conducted by videoconferencing, or participants were
sent a video of the session, including a warm-up, stretches,
Zumba, and a cool down. Various stress management strat-
egies such as meditation, mindfulness, art therapy, and
aromatherapy were incorporated in each session. Participants
received a tote bag with all necessary materials for the
intervention, including a yoga mat, stretch bands, essential
oils, recipes, and workbook/handouts. One strength of pro-
viding the intervention remotely was that we extended our
outreach to individuals unable to attend in-person sessions
due to logistical concerns such as lack of time, transporta-
tion, or lack of childcare. Since it may be difficult to
maintain social connections and a sense of social support
when delivering the intervention remotely, community
health workers created a WhatsApp group so that partic-
ipants could ask questions and share their experiences.

Retention strategies
Addressing sociocultural factors

Cardiovascular health promotion interventions for
Latinos typically have attrition rates of 10% to 30%.19 This
is the first intervention to target Latins during the menopause
transition. To strengthen recruitment and retention, we
developed a plan that integrated key sociocultural factors
such as familismo (ie, commitment and loyalty to family),
personalismo (ie, emphasis on building relationships), con-
fianza (trust and familiarity), and respeto (ie, respect, polite-
ness). We addressed these cultural values by making family
members feel included in the research process and providing
family-oriented scenarios during the intervention sessions.
Additionally, the research team engaged with participants
remotely via phone check-ins, individualized text messages,
video, mailings (eg, holiday cards, birthday cards, and
quarterly newsletter), and in group chats where participants
in the intervention group share their experiences. These
strategies have enabled us to maintain personal connections

with our participants during COVID-19, which has been a
socially isolating period.

CONCLUSION
Although Latinos comprise the fastest-growing minority

group in the U.S.,1 Latinas remain underrepresented in the
clinical research of midlife women’s health, particularly during
themenopause transition.ThenovelCOVID-19pandemicposed
many unprecedented challenges for the research community,
which had the potential to further limit the representation of
Latinos in clinical research. We report several key strategies we
adopted in our workwithmidlife Latinas to enhance recruitment
and enrollment. A diverse research team that is relatable and
understands the cultural values of potential participants is impor-
tant to clinical research. Flexible modalities of recruitment, data
collection, and intervention delivery that address these key
cultural values are also necessary. Linking participants to com-
munity resources and providing personalized health information
is key to build trust and rapport. Collaborating with community-
based organizations and Latino-owned businesses can also
increase outreach. Future studies of midlife women’s health
should invest in these strategies to increase recruitment and
enrollment of Latinas in clinical research.

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