Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
Phase: NA
Conditions: Human Immunodeficiency Virus, Cardiometabolic Risk
Sponsor: University of Miami

IRB Study Number: 20181032
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Full Protocol Title: Preventing Cardiometabolic Disease in HIV-
Infected Latino Men through a Culturally-Tailored Health Promotion 
Intervention
Protocol Number (eProst ID): 20181032
Protocol Version: 8
Protocol Version Date: 7/16/2021
PI Name: Daniel E. Jimenez, Ph.D.
NCT number: NCT03839212
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1)
Protocol Title
Preventing Cardiometabolic Disease in HIV-Infected Latino Men through a 
Culturally-Tailored Health Promotion Intervention
2)
IRB Review History*
This protocol has not been submitted for review by an external IRB.
3)
Objectives*
This study will address the following specific aims and test the following primary 
hypotheses:
Aim 1 (primary outcome): To evaluate the feasibility of recruitment, assessment 
procedures, retention, acceptability, and implementation of HOLA in a sample of 
midlife and older Latinos living with HIV.
Aim 2 (secondary outcome): To identify modifications needed in the design of a 
larger, confirmatory randomized controlled trial.
Aim 3 (secondary outcome): To explore changes in cardiometabolic risk factors 
(waist circumference, dyslipidemia, hypertension, and glucose), psychosocial 
functioning (depression and anxiety severity, social support), and health-related 
quality of life in a sample of midlife and older Latinos living with HIV enrolled in 
the HOLA health promotion intervention.
In addition, a career development and mentoring plan has been developed, 
comprised of expert mentorship, scholarly didactics and seminars, hands-on 
experience, as well as measurable productivity, including peer- reviewed 
manuscripts and an NIH grant application.
4)
Background*
Midlife and older Latinos living with HIV have been disproportionately 
affected by the epidemic and experience a compounded health disparity 
that has deepened over time. First, combination antiretroviral therapy 
(ART) has increased the longevity of people living with HIV spurring 
increased rates of hyperlipidemia, insulin resistance, and lipodystrophy 
and subsequent development of metabolic syndrome (MetS). Second, 
midlife Latinos with HIV have a greater prevalence of MetS and diabetes 
compared to their non-Latino White counterparts. Taken together, these 
data underscore the public health importance of increased efforts to 
redress the compounded and unequal burden of HIV, MetS, and diabetes 
shouldered by midlife and older Latinos. These health disparities are 
largely related to lifestyle and are either preventable or amenable to early 
detection or intervention. Despite existing resources to deliver an 
intervention to reduce this compounded health disparity, there is little 
information on the effects of health promotion interventions on indices of 
cardiometabolic risk in midlife and older Latinos living with HIV.
The Happy Older Latinos are Active (HOLA) intervention is an innovative 
health promotion program that is uniquely tailored to meet the diverse 
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needs and circumstances of midlife and older Latinos living with HIV. 
HOLA builds on prior research using health promotion to prevent 
depression and anxiety in older Latinos. In the present context, HOLA 
uses a lay community health worker (CHW) to lead a health promotion 
program in order to reduce cardiometabolic risk and improve psychosocial 
functioning and health-related quality of life in midlife and older Latinos 
living with HIV. Such an approach could appeal to midlife and older 
Latinos living with HIV as a nonstigmatizing and culturally acceptable 
intervention. HOLA addresses multiple concerns that are prevalent in this 
community (cardiometabolic risk, psychological distress). In addition, 
cultural values and beliefs were included in the formative and 
development phases of the intervention to ensure that the different socio-
cultural influences that have a role in the health of Latinos were 
incorporated. Thus, HOLA is the optimal choice to address an urgent 
medical and public health issue, and one that is rapidly growing. The 
objectives of this pilot study are two-fold: (1) to evaluate the feasibility 
and acceptability of HOLA among HIV-infected Latinos aged 50 and 
older and (2) identify modifications needed in the design of a larger, 
ensuing hypothesis testing study. HOLA, which is informed by Behavioral 
Activation and Social Learning theory is a CHW-led, multicomponent, 
health promotion intervention consisting of: (1) a social and physical 
activation session; (2) a moderately intense group walk led by a CHW for 
45 minutes, 3x/week for 16 weeks; (3) pleasant events scheduling. The 
proposed pilot study will recruit and enroll 18 community dwelling 
Latinos living with HIV aged 50+. Participants will be assessed at three 
time points (baseline, post intervention, and 3 months post intervention) 
on measures of cardiometabolic risk factors (waist circumference, 
dyslipidemia, hypertension, and glucose), psychosocial functioning, and 
health-related quality of life. Consistent with recommendations from 
biostatistical workgroups funded by NIH, this pilot study is not powered to 
test a hypothesis. Rather, this pilot study is a requisite initial step in 
exploring an innovative application of the HOLA health promotion 
intervention.
5)
Inclusion and Exclusion Criteria*
Inclusion Criteria:
The following conditions must be met for study eligibility: 

are Latino (self-identified); 

are age 50+; 

are male; 

are HIV infected but are virologically suppressed (viral load <200 
copies/mL); 

volunteer informed consent

 have medical clearance by a physician; 

expect to stay in Miami for the next 6 months; and 
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
have documented risk of cardiometabolic disease.
Exclusion Criteria:
Individuals meeting any of the following criteria will not be eligible to 
participate in the study: 

have a diabetes diagnosis; 

at baseline meet criteria for current major depressive disorder or 
generalized anxiety disorder; 

meet criteria for current alcohol or other substance abuse disorders; 

have a lifetime history of bipolar disorder or other psychotic disorder; 

have a diagnosis of any neurodegenerative disorder or dementia 
(Parkinson’s disease, Alzheimer’s, vascular, frontotemporal dementia, 
etc.) or significant cognitive impairment as indicated by a Mini Mental 
Status Exam score <24; 

have contraindications to physical activity outlined in the American 
College of Sports Medicine standards; (g) have high suicide risk i.e., 
intent or plan to attempt suicide in the near future (a response of “yes” 
to questions 3, 4, and/or 5 on the Paykel Questionnaire); 

are unable to complete 10 m walk test;  

currently residing in a nursing or group home; 

have a terminal physical illness expected to result in the death within 
one year; 

have an acute or severe medical illness that precludes them from safely 
participating in a health promotion intervention (e.g. progressive, 
degenerative neurologic disease, such as Parkinson’s Disease, multiple 
sclerosis, ALS; severe arthritis or orthopedic condition that would 
prevent participation in a physical activity program; lung disease 
requiring either oral or injected steroids, or the use of supplemental 
oxygen; New York Heart Association Class III or IV congestive heart 
failure, clinically significant aortic stenosis, history of cardiac arrest, 
use of a cardiac defibrillator, or uncontrolled angina; renal disease 
requiring the use of dialysis; cancer being actively treated with 
radiation or chemotherapy; myocardial infarction, CABG, or valve 
replacement within the past 6 months; serious conduction disorder, 
such as 3rd degree heart block; uncontrolled arrhythmia; pulmonary 
embolism or deep venous thrombosis within past 6-months; 
uncontrolled diabetes with recent weight loss, diabetic coma or 
frequent insulin reactions; stroke, hip fracture, hip or knee 
replacement, or spinal surgery in the past 6 months; receiving physical 
therapy for gait, balance, or other lower extremity training; severe, 
uncontrolled hypertension -systolic blood pressure >200 mmHg and/or 
diastolic blood pressure >110 mmHg); or 

are currently taking antidepressant medications in doses indicated for 
weight reduction.
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This study will not include women in that the specific research questions 
are targeted toward males. This study will specifically target Latinos. 
Individuals from other ethnic backgrounds are excluded as the study 
intervention is specifically tailored to address and target the specific needs 
and preferences of older Latinos with risk of cardiometabolic disease. This 
study is specific to only Latino males and will only report data on Latino 
males; findings from the study are intended to only be generalizable to 
Latino males. Both Black and White Latino males will be included in the 
study. We are not powered to detect differences between racial groups of 
Latino men. Previous research indicates that the outcomes in this study 
along with engagement with the intervention suggests no differences 
between racial groups of Latino males; no significant differences have been 
found in any outcomes in HOLA pilot data. We will use respondent self-
report or self-identification to collect data on ethnicity and race. Though 
this application talks of racial/ethnic disparities and refers to Latino as an 
ethnicity, we are aware of the limitations of this construct. We 
acknowledge that ethnicity is a social construct and that Latinos are not a 
homogeneous, monolithic group even though the U.S. Census definition 
classifies them into one uniform ethnicity. Also, many racial/ethnic 
differences that have been identified in previous research are in fact 
confounded by socioeconomic status (SES). However, even though SES is 
indeed a central determinant of health status and overlaps with the concept 
of race, SES does not account for all racial health disparities.
6)
Number of Subjects*
18 older Latinos age 50+ will be enrolled. 
7)
Study-Wide Recruitment Methods*
Recruitment procedures will protect participant confidentiality.
We will use a multi-faceted recruitment strategy that has been successfully 
implemented at the University of Miami/Jackson Memorial Medical Center 
(UM/JMMC) Adult HIV Outpatient Clinic consisting of advertisements, informing 
clinic staff of the study, and direct recruitment by the CHW. The CHW  (a UM 
employee who is to be determined) will coordinate with the Clinical Sciences Core 
and the Behavioral/Social Science & Community Outreach Core of the Miami 
Center for AIDS Research (CFAR). The CFAR Clinical Sciences Core (Core C) 
provides state-of-the-art facilities for implementation of clinical studies, clinical 
research and services including sample and data collection. The location of Core C 
next to the Special Immunology clinics allows recruiting participants in an efficient 
manner on the same day of clinic visit. Behavioral/ Social Science & Community 
Outreach Core (Core E) provides CFAR investigators with consultation and 
resources to expand behavioral clinical studies. HIV-infected patients receive 
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primary care from their HIV care providers at the UM/JMMC Adult HIV 
Outpatient Clinic. The CHW will work with Clinic staff to educate them about the 
study as well as the inclusion/exclusion criteria. Clinic staff will identify potential 
participants through the electronic medical records and matched with the weekly 
clinic census. Clinic staff will introduce the CHW to potential participants during 
their regularly scheduled HIV care visit at the Clinic. The CHW will describe the 
study to the potential participant. If he is interested, then the CHW will go over the 
consent form. After the participant has signed the consent form, he will be asked to 
sign HIPAA Research Authorization – Form B, which authorizes study personnel to 
access the participant’s protected health information, specifically the 
cardiometabolic parameters of interest, HIV/AIDS status, and viral load. No other 
individually identifiable health information will be shared with study investigators. 
In addition, we will also collaborate with another study, the Clinic Registry Project 
(IRB#20160911), which serves as a consent to contact database, to contact eligible 
participants. They will provide us with contact information for participants in their 
study who have consented to be contacted by other studies. When contacting 
participants, the CHW will follow the phone script for calling UHealth consent to 
contact participants that has been tailored to this study.
8)
Procedures Involved*
Participants will be assessed at three time points (before starting the study, 4, and 7 
months after the first interview) on measures of cardiometabolic risk factors (waist 
circumference, dyslipidemia, hypertension, and glucose), psychosocial functioning, 
and health-related quality of life. 
All participants will read and sign an informed consent document and a HIPAA 
Research Authorization – Form B approved by the University of Miami 
Institutional Review Board (IRB). They will initially be provided with a verbal 
summary of the study and for those who appear to have problems reading the 
consent form it will be read aloud. Participant payments will be graduated. 
Participants will receive $15 on the first visit, $25 on the second visit, and $35 on 
the third visit (total of honoraria = $75).
Prior to starting the baseline assessments, blood draws will take place at the 
UM/JMMC Adult HIV Outpatient Clinic. Study staff will obtain initial HDL-C, 
LDL-C, triglycerides, insulin, and HbA1c levels via review of the electronic 
medical records. Trained and certified research assistants (RAs) who have at least a 
bachelor’s degree will conduct all assessments in private offices at the  UM/JMMC 
Adult Outpatient HIV Clinic, at a private interview room at the CTRS located on 
the 7th floor of the Don Soffer Clinical Research Center, or the participant’s home. 
To ensure privacy in the home, we will conduct the interview in a private room with 
a door of the participant’s choosing away from any common areas. In the event that 
there are other people in the house, the door can be closed to maintain privacy. In 
the event that an in-person interview is not feasible then the interview will be 
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conducted over the telephone. At 4 and 7 months after the initial interview, fasting 
blood samples will be drawn via venipuncture and stored at 4ºC until analysis. 
HOMA will be calculated, providing a measure of insulin resistance. Study 
measures will be administered after the blood draws.  
Assessment Measures  
Cardiometabolic Risk: list of current medications, waist circumference, total 
cholesterol, HDL-C, LDL-C, triglycerides, blood pressure, and HbA1c, will be used 
to measure cardiometabolic risk.
Dementia Screen: The Mini Mental Status Exam (MMSE) will be used to screen for 
dementia. A Mungas-adjusted score of 23 or below indicates cognitive impairment. 
Walking Ability: The 10 meter walk test will be used to evaluate walking ability, 
which has been used as a screening instrument to measure functional mobility and 
gait speed in physical activity interventions with older adults. 
Demographics: The CLaRO Demographics Form will be used to collect 
demographic information (e.g., gender, education, income, preferred language, 
country of origin, time in the US, etc.) and will include a list of all diagnosed 
medical conditions and medications.
Acculturation: The 24-item Bidimensional Acculturation Scale (BAS) will be used 
to measure acculturation. 
Depression Severity: The 20-item Center for Epidemiologic Studies Depression 
(CES-D) Scale and the 9-item Patient Health Questionnaire (PHQ-9) will be used to 
measure depression severity.
Anxiety Severity: The 7-item Generalized Anxiety Disorder (GAD-7) scale and the 
14-item Perceived Stress Scale will be used to measure anxiety severity. 
Social Support: Perceived social support will be measured using the 12-item 
Multidimensional Scale of Perceived Social Support (MSPSS).
Health Related Quality of Life: The SF-12 will be used to assess for health related 
quality of life.
Physical Activity: The 16-item Global Physical Activity Questionnaire (GPAQ) 
will be used to measure physical activity.
Stigma: The HIV Stigma Scale (HSS) is a 40 item measure of stigma and 
psychosocial aspects of having HIV.
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Project Evaluation: we will use a project evaluation questionnaire developed by 
investigators at the CNSA and used in previous studies. The items are a mix of 
rating scales, yes/no questions, and open-ended questions that allow participants to 
give feedback in short answer format with specific interest in understanding the 
participants’ opinions regarding the specific components of the intervention.
After the baseline assessment, participants will be enrolled into the HOLA 
intervention. 
Intervention Description: Content and Structure of HOLA 
HOLA is a 16-week multi-component, health promotion intervention for older 
Latinos with subthreshold depression or anxiety. Aside from the maintenance phase 
(described below), the length and content of the intervention remain unchanged 
from the pilot study. 
The first component of HOLA consists of two manualized social and physical 
activation sessions. Prior to beginning the group walk phase, each participant will 
meet individually with a CHW for the physical and social activation session. This 
session will last 30 minutes. The purpose of this session is to (a) educate potential 
participants about the goals of the intervention; (b) to motivate participants to 
engage in physical activity; (c) to increase participants’ social activities (d) identify 
potential obstacles that may interfere with meeting the demands of the intervention; 
and (e) to brainstorm ways to overcome these obstacles. Participants will meet 
individually with the CHW for 30 minutes during week 8 to discuss progress of 
physical and social activity goals. These meetings will be held in the participants’ 
homes. 
The second component is a group walk, led by a CHW for 45 minutes, 3 times a 
week. The group walk protocol uses the concept of interval training. An interval 
program requires that the work phase be higher intensity than the active recovery 
phase. The program starts slowly and gradually increases in workload by 
manipulating three factors: (a) intensity: governed by speed; (b) volume: duration 
and/or distance; and (c) work/recovery cycle: how long work phase lasts compared 
to the recovery phase. The intensity of the workout will be governed by the 
participants own perceived effort. The subject should learn to "feel" three intensity 
levels: low, medium and high. Low intensity can be defined as walking at a level 
that is equivalent to walking through a mall while easily having a conversation with 
a friend. Moderate intensity is when the subject notices his/her breathing increasing 
to slight discomfort, and he or she is walking at a good pace. High intensity is 
walking at a speed where the participant is short of breath and can't maintain the 
pace. Our decision to use walking as the exercise mode for activation is 
scientifically sound since no mode or location of aerobic exercise appears to be 
superior to another. Walks will be conducted with a group of six participants. Each 
walk will begin with 10 minutes of stretching and warm up. Then, participants will 
walk for 30 minutes. The walk will conclude with 5 minutes of cool down. The 
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groups will be mixed gender and will include bilingual and monolingual Spanish 
speaking participants. 
The third component consists of scheduling pleasant events. During the cool down 
phase of each walking session, the CHW will ask each participant to identify a 
pleasant event that they intend to do with another person before the next meeting. 
The CHW will be trained to problem solve (e.g. brainstorming) if a member of the 
group cannot think of a pleasant event. Subsequent sessions will start with 
participants reporting on how effectively they implemented their pleasant event 
plan while the CHW and the group provide positive reinforcement and feedback. 
This component provides a means to generalize the intervention into the 
participants’ every day lives. Mood ratings will be taken directly before and after 
each walk so participants can see, in real time, changes in their moods. These 
motivational tools stem from our qualitative study in which participants reported 
feeling motivated to engage in health promotion when they received positive 
reinforcement through clear indicators of progress. Participants will walk at a 
centrally located public park.
The final component is a maintenance phase consisting of one “booster” walking 
session twice a month for three months post intervention to reinforce the behavior 
change and maintain the effects of the intervention. We believe that we are more 
likely to detect sustained effect if maintenance is provided.
Should unavoidable circumstances arise and in-person meetings are not possible 
then the CHW will have regularly scheduled phone call with the participants to 
maintain motivation for increased physical activity and pleasant events.
Management of safety concerns
If a participant meets criteria for major depressive disorder or an anxiety disorder, 
the following steps will be taken. First, the RA will seek written permission from 
the participant to contact his/her PCP or a mental health professional. Second, the 
RA will contact the PI to discuss the situation. Third, the PI will contact the PCP or 
a mental health professional informing them of their patient’s positive screen. 
Fourth, the PI will coordinate with the PCP or mental health professional and the 
participant to set up an appointment.
9)
Data and Specimen Banking*
Data will be collected using an Apple ipad with pre-programmed questionnaires. 
Data will be exported to SPSS for analysis. All electronic data will be stripped of 
identifiers and will be stored in password-protected files. For each data file, a code 
number will be assigned, and the master list, linking code numbers with names, will 
be stored separately. The data will be stored on password protected, network 
computer hard drives at the CNSA, which will only be accessible to the PI. 
Blood samples will be stored at the University of Miami Center for AIDS Research 
Laboratory Sciences Core (D) at -80 ºC until analysis. The labels on the blood 
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sample tubes will not contain participant ID numbers. The blood samples will be 
stored in locked freezers in locked rooms within access-limited sections of the 
building. 
All the data will be stored and secured using the procedure implemented by 
the Data Manager of the CNSA. The access to records and participants data 
will be allowed only to the study personnel. 
Study data request goes through a web-based check-in and check-out 
procedure implemented by the CNSA. The Data Manager of the Center or 
designee monitors the logs. Upon de granting of the approval, the requester 
will either get the hard copy of the data or link to access the electronic data. 
All the data will not contain any identifying information.
Other parties interested in utilizing the samples for research will be required 
to provide a written protocol to the PI and the gatekeeper(s) for approval. 
Should samples be shared, no identifying information will be provided. 
Material Transfer Agreement will be negotiated between UM and the 
investigators requesting the data.
10) Data Management*
As a pilot study, we will evaluate the feasibility of recruitment, assessment 
procedures, retention, acceptability, and implementation of HOLA in a 
sample of midlife and older Latinos living with HIV (Aim 1). Consistent 
with recommendations from biostatistical workgroups funded by NIH, this 
pilot study is not powered to test a hypothesis. This approach to analysis 
of feasibility data mirrors the structure of the first HOLA trial and other 
pilot trials conducted at the CNSA. Successful recruitment will be defined 
as meeting 100% of targeted sample (N = 18), with 20% or less of eligible 
subjects refusing to participate. Adequate retention will be defined as 85% 
or more of randomized subjects completing the post-intervention 
assessment. Acceptability is defined as 80% or more of sessions attended 
by subjects. To identify modifications needed in the design of a larger, 
confirmatory randomized controlled trial (Aim 2), we will use a project 
evaluation questionnaire developed by investigators at the CNSA and used 
in previous studies. The items are a mix of rating scales, yes/no questions, 
and open-ended questions that allow participants to give feedback in short 
answer format with specific interest in understanding the participants’ 
opinions regarding the specific components of the intervention. To explore 
changes in cardiometabolic risk factors (waist circumference, 
dyslipidemia, hypertension, and glucose), psychosocial functioning 
(depression and anxiety severity, social support), and health-related 
quality of life (Aim 3), a one-way ANOVA will be used to illustrate the 
change in scores from baseline to post-intervention in all the outcome 
measures used. 
A repeated measures ANOVA, as we have proposed, is appropriate to 
explore the intervention effects on cardiometabolic risk factors, 
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psychosocial functioning, and health-related quality of life given that this 
type of analysis is often used in studies that investigate either changes in 
mean scores over three or more time points. In the exploratory analyses, 
we will use age, SES, and years of education as covariates. In addition, a 
list of current medications will also be collected at baseline. Should the 
participants’ medications be dose-adjusted, changed altogether, or if they 
are started on new medications such as statins, then we will adjust for 
them in them in the exploratory analysis as well. Covariates will be tested 
as moderators of treatment response.
Maintenance of Confidentiality:
Our staff is CITI certified and trained with maintenance of confidentiality. 
The information provided by study participants will be held as personal 
and confidential to the extent permitted by law. In addition to the 
safeguards included as part of the recruitment and screening process by 
assigning a patient a study ID to de-identify participants, all study 
participants will be given the contact information for the Principal 
Investigators to answer any questions that may arise. Participants will be 
informed that they may end their participation at any time without 
affecting access to any other services they may receive from the 
UM/JMMC Adult HIV Outpatient Clinic. All study procedures will be 
conducted according to good clinical practice and all other relevant 
regulatory guidelines.
All electronic data will be stripped of identifiers and stored in password-
protected files on servers at the University of Miami Center on Aging. 
These data are password secured for minimal access to authorized 
personnel associated with the study. For each data file, a code number will 
be assigned, and the master list, linking code numbers with names, will be 
stored separately. At the conclusion of the project, the record linking the 
assigned research number and participant identity will be destroyed. Data 
will be entered into password secured databases by staff authorized by the 
principal investigator to do this, and they will abide by confidentiality 
regulations of the HSRO. No subject will be identified by any published 
report.
11) Provisions to Monitor the Data to Ensure the Safety of Subjects*
The Principal Investigator, Dr. Daniel E. Jimenez, assumes responsibility 
for developing and implementing a data and safety monitoring plan to 
assure minimal risk and data integrity in this study. The plan assures that 
all data collected concur with all local, state and federal guidelines. The PI 
will work closely with his collaborators and will follow any data 
monitoring and safety requirements set forth by NIH.
The PI will examine accumulating data to assure protection of 
participants’ safety while the study’s scientific goals are being met and 
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will conduct periodic reviews of accumulating safety and efficacy data. 
Along with his collaborators at the University of Miami Miller School of 
Medicine, he will determine whether there is support for continuation of 
the study, or evidence that study procedures should be changed, or if the 
study should be halted, for reasons relating to the safety of the study 
participants, the feasibility of the intervention under study, or inadequate 
study procedures (e.g., poor recruitment).
Procedures for the study will follow quality assurance (QA) procedures 
established by CLaRO for data management and safety, to ensure quality 
and consistency in the implementation of the protocol and data quality, to 
adhere to regulatory requirements and, most importantly, to protect the 
safety of study participants. The study will be monitored by the CLaRO 
Study Monitoring Unit, which is based at the School of Nursing and 
Health Studies. The Study Monitoring Unit will (1) verify compliance 
with regulatory requirements, (2) ensure that the PI and engaged study 
team members are fully informed of regulatory requirements and properly 
trained to perform the duties assigned, and (3) monitor procedures to 
prevent errors and minimize protocol deviations that can negatively affect 
quality of the data collected and compromise human subjects’ protection. 
The project will have a quality assurance (QA) review: prior to initiation, 
upon conducting baseline procedures with the first wave of study 
participants; and bi-annually for interim reviews. For the initiation review 
the Study Monitoring team reviews protocol procedures and their 
manualization, documentation of staff training, evaluates that the study 
site is prepared to conduct the study, and ensures that the Regulatory 
Binder is complete. Interim monitoring visits will verify that study 
screening, consent, and data storage procedures are being conducted as 
stated in protocol. After each QA visit the Study Monitoring team prepares 
a written report that is sent to the study PI and to the CLaRO Executive 
Committee. These reports include deficiencies noted and plans for 
corrective action. The Study Monitoring team follows up with the study 
team to ensure that the corrective plan and any required reports to the IRB 
are filed in a timely manner. Protocol violations that are recurrent or 
serious will be brought to the attention of the CLaRO Executive 
Committee for determinations regarding corrective action.
Adverse Event Reporting
In the event that an adverse event or otherwise untoward incident occurs as a 
direct result or in the context of the project, we will closely follow IRB directives 
and reporting policies. Specifically, we will report to the University of Miami IRB 
within 10 working days, in writing, all serious adverse or otherwise untoward 
events associated with procedures. To ensure monitoring of other study-related 
participant safety events or incidents, procedures regarding confidentiality and 
data integrity will be continually monitored and regularly audited.
In our experience, serious, unexpected adverse events related to study 
participation are rare. In addition, screening for adverse events potentially related 
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to the study intervention will occur during the routine administration of study 
assessment measures. These interview-based indicators will augment required
Serious Adverse Event (SAE) reports by the CHWs and study personnel, 
including specific items in the assessment interviews evaluating episodes of 
muscle or fall-related injuries, unexpected medical events, medical emergency 
room admissions, medical hospitalizations, or unplanned medical clinic visits. 
Should an adverse event occur, Dr. Jimenez (PI) will report it to the University of 
Miami Institutional Review Board (IRB) using the IRB SAE form. Dr. Jimenez, 
in collaboration with co-investigators, will review the adverse event report and 
gather other information as needed to investigate it and determine the need for 
subsequent action. Dr. Jimenez will ensure that all adverse events are reported to 
the IRB in accordance with the University of Miami policies and in a timely 
manner. Any subsequent action will be documented and reported to the IRB.
Identifying Events: As noted, we will operationalize adverse/safety events for the 
study and protocols for their resolution. All interventionists and assessors will be 
trained on these protocols. Initially we will base these protocols on those 
developed for the HOLA pilot trial. For that trial, there were two categories of 
events: adverse events and safety alerts. These events may be identified during the 
baseline interview or the intervention period. Baseline adverse events are items 
that are identified and recorded by the interviewer during the baseline interview 
and are unrelated to the study or intervention. Adverse events are situations that 
occurred during the intervention period and are identified by the interventionist or 
by the interviewer during the 3 month assessments or any off-protocol interaction 
with a participant. All off-protocol contacts will be recorded. Adverse events 
occur anytime following randomization until study completion. Safety alerts are 
identified by the interviewer during the baseline interview or occur anytime 
following randomization until study completion. Below are the specific events 
that trigger a formal response:
Acute Baseline Alerts/Adverse Events
•
Hospitalization of Participant
•
Institutionalization of Participant
•
Emergency Room Visit of Participant
•
Death of Participant
Safety Alerts/Adverse Events
•
Severe Medical Problem of Participant
•
Participant has CES-D score greater than or equal to 20
•
Participant Abuse
•
Participant threatens to harm him or herself or others
The baseline adverse events and adverse events that occur during the study period 
are events that fall within the standard definition of adverse events within a 
clinical intervention study. Safety alerts are those events that do not fall within the 
standard definition of adverse events but are specific to the participant population.
Reviewing and Reporting Adverse Events: When an alert or adverse event is 
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identified by a member of the research team the event must be reported to the PIs 
or designee within 24 hours and recorded on the Alert/Adverse Event Form. The 
event must be resolved using the approved protocol within 3 days of learning of 
the event. For example, any uncovering of incidental findings by the research staff 
will immediately be reported to Dr. Jimenez who will a) review the information; 
b) meet with participants to make appropriate referrals and to c) take any actions 
that are required by state law to insure the safety of participants. As noted, the 
informed consent will make clear to participants that any incidental findings that 
suggest that there is imminent danger may engender certain reporting 
requirements by state and federal law. For example, if participant abuse is 
suspected during a participant contact, the assessor/interventionist will report the 
event to the PIs or designee (e.g., clinical supervisor, project manager) will 
contact the participant to determine the nature of the situation and to devise a plan 
of action. The participant will be advised to contact their primary care physician. 
If the participant refuses or is not able to able to control the situation Adult 
Protective Services may be contacted. In the event that an unclassified or 
emergency situation does arise, personnel are advised to consult with the PI,or if 
circumstances do not allow for such consultation to use their best judgment (e.g., 
call 911 if necessary). Documentation of all adverse/safety events will be 
maintained in locked files in the Center for Cognitive Neuroscience and Aging.
Dr. Jimenez will promptly inform other collaborators of any proposed changes in 
recruitment or in the protocol that are relevant to safety, as well as any actions 
taken by the IRB as a result of their continuing review of the project. In the event 
of any major changes in the status of an ongoing protocol, which will occur only 
with IRB approval, the PI will inform CLaRO staff immediately. Such changes 
would include, but are not limited to: 
●
Amendments to the protocol 
●
Temporary suspension of participant accrual, or of the protocol 
●
Any change in informed consent or IRB approval status 
●
Termination of participant accrual, or of the protocol 
●
Other problems or issues that could affect the human subjects in the study 
12) Withdrawal of Subjects*
If a subject finds the research procedures to be upsetting or aversive, they 
will have the option to withdraw from the study. Participation will be 
completely voluntary, and will not affect the treatment they are receiving. 
Participants will be told that they may choose not to answer any questions 
and may decide to terminate the interview at any time. Research staff will 
be instructed to terminate interview sessions if participants appear to be 
stressed by the process. Additionally, the research staff will know how to 
link participants immediately with treatment personnel including case 
managers or therapists if participants appear to be stressed.
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13) Risks to Subjects*
The risks associated with participation in the study are deemed to be low 
and are outweighed by the potential benefits. Nevertheless, this study 
involves the administration of assessment instruments that may cause 
minor discomfort, and the risk of loss of confidentiality. All participants 
will be informed that information obtained in these interviews is 
confidential and that they can choose not to answer any questions. If 
participants feel uncomfortable during the research interview, they will be 
encouraged to take a break and to continue again later or will be asked if 
they want to stop the interview. The research assistant (RA) may also offer 
to call a case manager, another staff member, or concerned others (such as 
a close friend) to make sure the participant has someone to talk with about 
the interview. Some questions or tasks may cause some individuals to 
become uncomfortable. This has happened rarely with similar interview 
sessions. In fact, most participants experience the interview process in a 
positive way and enjoy the opportunity to be heard by an interested 
listener. Individuals with depression and anxiety typically feel enhanced 
rather than diminished by these interviews. Nevertheless, several 
precautions will be taken to prevent stress from developing during the 
interview. 
Overall, study personnel and collecting outcomes data are all experienced 
in conducting clinical research and are able to engage subjects without 
causing them distress. If a subject finds the research procedures to be 
upsetting or aversive, they will have the option to withdraw from the 
study. Participation will be completely voluntary, and will not affect the 
treatment they are receiving at the UM/JMMC Adult HIV Outpatient 
Clinic. Participants will be told that they may choose not to answer any 
questions and may decide to terminate the interview at any time. Research 
staff will be instructed to terminate interview sessions if participants 
appear to be stressed by the process. Additionally, the research staff will 
know how to link participants immediately with treatment personnel 
including case managers or therapists if participants appear to be stressed. 
Protection for Suicide and Depression Risk: Subjects who become suicidal 
or psychotic will be withdrawn from the study and offered (or when 
necessary, involuntarily given) appropriate treatment. Our screening 
process will include an assessment to identify participants at risk of 
suicide. Potential participants will be told before screening that a positive 
screen will lead to disclosure of this information to their primary care 
provider (PCP) or to a mental health professional to maintain safety. The 
Paykel Suicide Items152 will be administered by a trained RA at every 
baseline and follow up assessment. In the unlikely event that suicidal 
ideation is detected the following steps will be taken. First, the RA will 
inform the participant that this information is very important and needs to 
be shared with his/her PCP or with a mental health professional 
immediately (as discussed prior to the screener). Second, the RA will then 
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contact the principal investigator (PI) to discuss the situation. Third, the PI 
will contact the participant’s PCP to ensure the participant is evaluated 
promptly for safety. Fourth, if the PCP is not available, the PI will arrange 
for transportation to the nearest emergency room. The RA will remain 
with the participant until the individual is assessed by a mental health 
professional or ER physician.
 If a participant meets criteria for major depressive disorder or an anxiety 
disorder, the following steps will be taken. First, the RA will seek written 
permission from the participant to contact his/her PCP or a mental health 
professional. Second, the RA will contact the PI to discuss the situation. 
Third, the PI will contact the PCP or a mental health professional 
informing them of their patient’s positive screen. Fourth, the PI will 
coordinate with the PCP or mental health professional and the participant 
to set up an appointment.
Protection of Risk of Physical Discomfort: Because the HOLA 
intervention involves physical exercise, to which some participants may be 
unaccustomed, we will put several safeguards in place to avoid injury or 
harm. These safeguards have been used successfully in other studies 
involving exercise done by Dr. Signorile (co-investigator). First, the 10 
meter walk test will be used to evaluate walking ability. The use of this 
test is recommended in order to obtain the most valid clinical assessment 
of walking speed when using it as a 1-time indicator of health status. 
Second, all participants will be required to have a written medical 
clearance for participation in the study. In addition, all participants will be 
evaluated with a set of screening questions to identify individuals who 
may be at risk of harm from engaging in exercise. We will require these 
individuals to additionally obtain written recommendations for physical 
exertion from their physicians specifically responding to the identified 
health concern before engaging in HOLA. Third, CHWs will work with 
participants to set exercise goals that are safe and reasonable in relation to 
their exercise capacity. Furthermore, exercise plans and instructions to 
participants will be within the accepted range recommended by the 
American College of Sports Medicine guidelines. Fourth, CHWs will 
supervise all walks to observe participants’ ability to tolerate exercise. 
CHWs will maintain a list of the phone numbers of the participants’ 
physicians to contact with health concerns about participants. CHWs will 
be certified in CPR and will have cell phone capacity in the unusual event 
of a medical emergency. In the case of minor effects of exercise such as 
muscle soreness, CHWs will be trained to provide advice regarding 
stretching or other remedies to ameliorate symptoms. If symptoms worsen, 
the exercise protocol will be modified after discussion with Dr. Signorile.
Protection of Risks During Venipuncture: Blood draws will be performed 
by certified phlebotomists who routinely perform venipuncture; steps will 
be taken to diminish the risk of minimal discomfort, bruising, excessive 
bleeding, clotting, and/or fainting. If subjects have unusual symptoms, 
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pain, or any other problems arising due to venipuncture, they can also 
contact the CHW or PI directly.
14) Potential Benefits to Subjects*
The potential benefits of the project to the participant is that the participant may 
acquire and practice health behaviors that lead to a decreased risk of developing 
cardiometabolic disease. The benefit to society is that the project may help 
demonstrate the effectiveness of the HOLA health promotion intervention in 
preventing cardiometabolic disease in HIV-infected patients.
In relation to the anticipated benefits, the risks to the subjects are reasonable in 
relation to the benefit of not developing a life-threatening cardiometabolic disease. 
Participants are de-identified to minimize loss of confidentiality; suicidality or 
severe depressed can be addressed by trained mental health professionals; 
discomfort during venipuncture is mitigated by trained phlebotomists.
15) Vulnerable Populations*
N/A
16) Multi-Site Research*
This is not a multi-site study. 
17) Community-Based Participatory Research*
N/A 
18) Sharing of Results with Subjects*
Study results will be published in scientific journals. Individual subject 
results will not be shared unless the safety of the participant is at risk.  
19) Setting
Group walks will be conducted at a public park that is centrally located to 
the participants. All assessments and blood draws will be conducted in 
private rooms at the at the UM/JMMC Adult HIV Outpatient Clinic. 
20) Resources Available
Department of Psychiatry and Behavioral Sciences 
The Department of Psychiatry and Behavioral Sciences offers clinical 
evaluation and treatment services for a broad range of emotional, 
cognitive, and behavioral disorders in patients of all ages, socioeconomic 
levels, and cultural backgrounds. Services are available on an outpatient, 
inpatient, or partial hospitalization basis and include individual, family, 
and group approaches. Specialty areas include geriatric psychiatry, anxiety 
and mood disorders, stress and psychobiologic dysfunction; biofeedback; 
behavioral medicine; memory disorders; psychopharmacology; alcohol 
and substance abuse; and women’s mental health, among others. The 
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Center on Aging, among others, link other organizations in research, 
education, and treatment for special populations at risk. The Department’s 
outpatient programs are located in the Jackson Mental Health Hospital 
Center. Inpatient facilities for children, adolescents, and adults are located 
at the Jackson Mental Health Hospital Center and the Highland Park 
Pavilion, as well as the University of Miami Hospital and Miami VA 
Medical Center. Through its Division of Consultation Psychiatry and 
Psychosomatic Medicine, the Department provides consultation to all 
clinical departments as well as programs of illness prevention and long 
term care management. The Department provides educational and 
consultative services to the Dade County Jail, the South Florida 
Evaluation and Treatment Center, and various courts and governmental 
agencies through its Forensic Psychiatry Program. 
Center for Latino Health Research Opportunities (CLaRO)  
The NIMHD has renewed support of health disparities research at the 
SONHS through the Center for Latino Health Research Opportunities 
(CLaRO; U54MD002266-11). CLaRO, an interdisciplinary center led in 
collaboration with Florida International University, is funded from 2017-
2022.  CLaRO’s unifying theme is conducting and promoting multi-level 
community-based participatory research to prevent substance use, 
violence/trauma and HIV/AIDS syndemic conditions and reduce their 
adverse health and mental health outcomes. CLaRO’s focus is on tailored 
interventions for Latino subgroups who represent pockets of vulnerability 
and require precise and specialized interventions that optimize access to 
and impact of interventions. CLaRO contains two community-based 
randomized trials of  culturally-tailored behavioral interventions: (1) 
HoMBRES de Familia, which is testing an intervention to prevent HIV, 
substance abuse and violence among Latino seasonal farmworker fathers 
and their sons; and (2) Computer Assisted Family Intervention to Treat 
Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth (CA 
CIFFTA), which tests a family intervention for Latinas and sexual/gender 
minority youth.  CLARO also sponsors a Pilot Projects Program, scientific 
resources, training and mentorship to serve as an engine for the 
advancement of early-stage investigators and for diversifying the 
workforce of successful health disparities investigators. The CLaRO 
theme, agenda and priorities were developed in collaboration with a 
network of community partners who will play an ongoing role as a 
Community Advisory Board, in guiding and disseminating CLaRO 
science and advancing neighborhood capacity building and multilevel 
interventions to promote health in Latino communities. 
As a CLaRO pilot awardee, I will have access to training and mentoring 
activities throughout the pilot award, which will enhance the success of 
this proposal. CLaRO keeps a database of common measures for 
constructs relevant to their studies, which I will utilized for my proposal 
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and will continue to use. I will also benefit from oversight from CLaRO’s 
Investigator Development Core and Executive Committee. As stated in my 
training plan, I will continue participating in CLaRO’s training activities, 
such as the recent summer training program focused on Latino health 
disparities research. Finally, I will be part of a cohort of pilot awardees 
who are also conducting research related to Latino health disparities and 
we will meet monthly for ongoing support and potential collaboration.
21) Prior Approvals
N/A
22) Confidentiality
This is not a multicenter study. Please see above for information how we 
will maintain confidentiality. 
23) Provisions to Protect the Privacy Interests of Subjects
Participants will sign a statement attesting to their understanding that their 
information will be kept private and confidential to the extent permitted by 
law. Participants know that they will be assigned unique case numbers 
(and their names will not be used) to protect their identity. Participants 
will be encouraged to ask questions throughout the consent process and 
will be provided contact information for Dr. Jimenez (PI) and the 
University of Miami’s Human Subjects Research Office. Data will only be 
available to researchers approved by the IRB and to the study monitoring 
unit. Participants will be reminded of their ability to stop the interview or 
refuse to answer questions that make them uncomfortable. During all 
study procedures (e.g., recruitment, consent process), participants will be 
assured that their information is confidential and will sign a statement 
attesting to their understanding that their information will be kept private 
and confidential to the extent permitted by law. 
Participants know that they will be assigned unique case numbers (and 
that their names will not be used) to protect their identity 
24) Compensation for Research-Related Injury
Although risks are unlikely, an injury may occur. If an injury should 
occur, treatment will in most cases be available. If participants have 
insurance, their insurance company may or may not pay for these costs. If 
they do not have insurance, or if their insurance company refuses to pay, 
they will be expected to pay. Funds to compensate for pain, expenses, lost 
wages and other damages caused by injury are not routinely available.
25) Economic Burden to Subjects
There are no costs associated with your participation in this study.
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26) Consent Process
For individuals that are interested in the participating in the research study, 
the study will obtain an informed consent form from the participant. The 
study will provide the participant a copy of the consent form, and, because 
the participant may have a low level of literacy, will then read the consent 
form out loud. 
Once the entire consent form has been read and explained, the assessor 
will give the participant a chance to ask any additional questions. If the 
participant agrees to participate, they will be asked to sign the informed 
consent form and will be given a copy of the signed form.
The consent form for participation in the study are submitted within this 
protocol for approval to the University of Miami Institutional Review 
Board (IRB) Behavioral Subcommittee for the Protection of Human 
Subjects.
Non-English Speaking Subjects
Should the need arise, we will translate and back-translate the informed 
consent forms and submit them to the IRB for approval.
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception)
N/A
Subjects who are not yet adults (infants, children, teenagers)
N/A
Cognitively Impaired Adults
Cognitively impaired adults will be excluded from this study.
Adults Unable to Consent
Adults who are unable to consent will be excluded from this study.
27) Process to Document Consent in Writing
Signed consent will be collected. After the study is explained and the 
study participant verbally indicates that he or she understands study 
procedures, the participant will sign and date the consent form. The 
participant will be given a copy of the signed consent form for his/her 
records, and the second copy will be stored in a locked office.
28) Drugs or Devices
N/A
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