Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)
Phase: NA
Conditions: Cognitive Decline
Sponsor: University of Miami

IRB Study Number: 20201202
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Full Protocol Title: Preventing Cognitive Decline in HIV-infected Latinos through a 
Culturally Tailored Health Promotion Intervention (HOLA)
Protocol Number (eProst ID): 20201202
Protocol Version: 4.02
Protocol Version Date: 2/1/2021
PI Name: Daniel E. Jimenez, Ph.D.
NCT number:  NCT04791709
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1)
Protocol Title
Preventing Cognitive Decline in HIV-infected Latinos through a Culturally 
Tailored Health Promotion Intervention (HOLA)
2)
IRB Review History*
This protocol has not been submitted for review by an external IRB.
3)
Objectives*
The project will conduct a pilot single-arm trial with Latinos living with HIV 
(LWH) to assess feasibility, acceptability, and preliminary effects on cognition for 
a fully powered randomized trial (R01).
Specific Aim 1: To determine feasibility and acceptability of HOLA, adapted to 
incorporate a cognition focus, aimed at improving cognitive functioning among 
older Latinos LWH and incorporating activity tracking (Fitbit);
Specific Aim 2:  To explore whether HOLA will produce changes in cognitive 
functioning between baseline and post-test (16 weeks); 
Specific Aim 3: To explore whether HOLA will produce changes in activity, 
psychosocial functioning (depression, anxiety, social support) or biomarkers of 
cognition (myokines/cytokines [IL-15], adipokines [irisin and adiponectin], 
neurotrophic factors [BDNF, IGF-1 VEGF]) between baseline and post-test; and 
APOE e4 carrier status (a genetic risk for dementia) baseline only. 
Specific Aim 4: To explore whether changes in activity, psychosocial functioning 
or cognitive biomarkers correlate with changes in cognition, while accounting for 
genetic risk for dementia (APOE e4 carrier status).  
4)
Background*
Advancements in the treatment of HIV over the past two decades have greatly 
improved the longevity and health of people living with HIV (LWH). However, 
neurocognitive impairment among people LWH continues to be common and 
impactful and is observed in up to half of persons LWH. Non-pathological 
cognitive impairments are found in numerous aging studies and HIV studies. 
Although HIV-related dementia is not as prevalent with the advent of 
Antiretroviral Therapy (ART), adults with HIV remain susceptible to both cortical 
and subcortical insults that produce cognitive impairments. In 1,555 adults with 
HIV from across the United States, Heaton et al. found 52% experienced 
measurable cognitive impairments with 33%, 12%, and 5% experiencing 
Asymptomatic Neurocognitive Impairment, Mild Neurocognitive Disorder, and 
Mixed Neurocognitive Disorder, respectively.  Such cognitive impairments may 
be attributable to factors such as: the death of glial cells caused by HIV; elevated 
cortisol levels and inflammation caused by HIV; age- and HIV-associated 
comorbidities; and ART-induced metabolic complications such as 
hypercholesterolemia and insulin resistance. For example, Justice et al. found a 
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high prevalence of cognitive impairments (e.g., speed of processing, memory) in 
middle-aged and older veterans with HIV.  Both viral burden and older age are 
significant predictors of such cognitive impairment.  Studies have also found 
cognitive declines and changes in brain functioning in adults with HIV as early as 
1 year following infection. These declines occur across cognitive domains but are 
most often observed in speed of processing. Latinos LWH may be uniquely at risk 
for deleterious neuropathological and neurocognitive sequelae within the context 
of aging. Ethnic differences on cognitive impairments were evident across the 
domains of memory, executive functioning, and speed of information processing. 
Most of the neurocognitive domains in which there were significant ethnic 
differences are among the most commonly impacted by HIV in the combination 
ART era and are linked with problems in everyday functioning in people LWH. 
Furthermore, depression among older Latinos LWH has been reported at five 
times the level in the general population and is fueled by stigma and resultant 
loneliness due to rejection and withdrawal. Depression has been identified as an 
independent risk factor for cognitive impairment among older adults LWH. Thus, 
there is a growing population that is particularly vulnerable to dementia due to the 
co-occurrence of HIV, depression, and aging-related cognitive impairments.
5)
Inclusion and Exclusion Criteria*
Inclusion Criteria:
The following conditions must be met for study eligibility: 

are Latino (self-identified); 

are age 50+; 

are HIV infected but are virologically suppressed (viral load <200 
copies/mL); 

volunteer informed consent;
Exclusion Criteria:
Individuals meeting any of the following criteria will not be eligible to 
participate in the study: 

have diagnosis of any neurodegenerative disorder or dementia 
(Parkinson’s disease, Alzheimer’s disease, vascular, frontotemporal 
dementia, etc.) or significant cognitive impairment as indicated by a 
Telephone Interview for Cognitive Status (TICS) score less than or equal 
to 30;

have other conditions that could impact cognitive functioning or testing 
(e.g., legally blind or deaf), currently undergoing radiation or 
chemotherapy, a history of brain trauma with a loss of consciousness 
greater than 30 minutes.

have contraindications to physical activity outlined in the American 
College of Sports Medicine standards or severe medical illness that 
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precludes them from safely participating in a health promotion 
intervention. 

are unable to complete 10-meter walk test.

have plans to move outside of the Miami metropolitan area within the next 
6 months or are not living in stable housing (e.g. group home).
This study will include both men and women; no decision to exclude any 
person from this study will be based on gender. We do not expect there to 
be any difference in the number of women and men. 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 at increased risk 
for cognitive impairment.
6)
Number of Subjects*
30 older Latinos age 50+ will be enrolled. Consistent with recommendations from 
biostatistical workgroups funded by NIH, this pilot study is not powered to test 
hypotheses. The proposed project builds upon recruitment and intervention 
infrastructure that is being used in other HOLA studies. Participants will not be 
replaced if withdrawn or lost to follow-up.  
7)
Study-Wide Recruitment Methods*
We will collaborate with another study, the Clinic Registry Project 
(IRB#20160911), which serves as a 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 
community health worker (CHW) will follow the phone script.
8)
Procedures Involved*
Participants will be assessed at two time points (baseline and post intervention at 
16 weeks) on measures of neurocognitive and psychosocial functioning. Blood 
will be collected to determine APOE (baseline only) and biomarkers of cognition 
(baseline and 16-weeks).
All participants will read and sign an informed consent. 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 $25 on the first visit and $35 on the second 
visit (total of honoraria = $60). They will also be given the Fitbit tracking device 
to keep. 
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Prior to starting the baseline assessments, blood draws will take place at the 
CTRS . Approximately 20mL (2 tablespoons) of blood will be collected by a 
trained phlebotomist. Study staff will obtain biomarkers of cognition 
(myokines/cytokines [IL-15], adipokines [irisin and adiponectin], neurotrophic 
factors [BDNF, IGF-1 VEGF]) as well as apolipoprotein E (APOE) status, a 
genetic marker of dementia risk (baseline only). 
Trained and certified bilingual research assistants (RAs) who have at least a 
bachelor’s degree will conduct all assessments in private offices at the at the 
Soffer Clinical Research Building (CRB)  or another location convenient to the 
participant where privacy can be protected. The neurocognitive testing will be 
conducted under the supervision of a neuropsychologist. Approximate 
administration time of the assessment will be 60 minutes.
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Assessment Measures  
Dementia Screen: The Telephone Interview for Cognitive Status (TICS) will be 
used to screen for dementia. A score of 30 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 Center for Latino Health Research Opportunities (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 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 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).
Physical Activity: The 16-item Global Physical Activity Questionnaire (GPAQ) 
will be used to measure physical activity.
Processing Speed: Trails Making Test A will be used to measure processing 
speed.
Attention/Working Memory: The WAIS-IV Digit Span will be used.
Learning: Hopkins Verbal Learning Test-Revised (HVLT-R)
Memory: HVLT-R Delay
Verbal Fluency: Animal Fluency and Controlled Oral Word Association Test 
(COWAT)
Executive Function: Trails Making Test B
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Motor: Grooved Pegboard (dominant and non-dominant)
Biomarkers of cognition: Myokines/cytokines (IL-15), adipokines (irisin and 
adiponectin), and neurotrophic factors (BDNF, IGF-1 VEGF)
Genetic risk factor for dementia (baseline only): Apolipoprotein E (ApoE)
Intervention Description: Content and Structure of HOLA 
HOLA is a multi-component, health promotion intervention for older Latinos.
The first component 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 a 30 minute physical and social activation session to 
(a) educate potential participants about the goals of the intervention; (b) provide 
information surrounding cognitive functioning, age-related memory loss vs. 
dementia, difference between dementia and Alzheimer’s disease, how their 
comorbidities impacted cognition, and ways they can prevent cognitive decline 
and the; (c) motivate participants to engage in physical activity; (d) increase 
participants’ social activities (e) identify potential obstacles that may interfere 
with meeting the demands of the intervention; and (f) brainstorm ways to 
overcome these obstacles. Participants will again meet individually with the CHW 
for 30 minutes after week 8 to discuss progress of physical and social activity 
goals. In addition, during this session, the CHW goes over the ground rules for the 
intervention and reminds each participant that it is important that we create a 
comfortable environment where every member of the group is free to share 
thoughts, feelings and experiences. In order to do this, we ask that each 
participant not discuss other group members’ personal information with anyone 
outside of the walking group. This helps us to know that anything shared will not 
go beyond the walking group. These meetings are held in the participants’ homes.
The second component is a group walk, led by a CHW for 45 minutes, 3 times a 
week, for 16 weeks. The group walk protocol uses the concept of interval training. 
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. Walks will be conducted with a group of 6 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 groups 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 
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meeting. Individuals may choose to do this activity with another member of the 
group, with family, or with friends outside the group. 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’ everyday lives and relationships. Participants will walk at a 
centrally located public park, which is owned and operated by the Miami-Dade 
County Parks and Recreation Department.
A fidelity measure has been developed to assess the consistency with which 
different CHWs deliver the HOLA intervention. This is an anchored rating scale 
characterizing core components of HOLA. Mental health specialists will be 
supervised and give one-on-one feedback to the CHWs. If there is drift, 
adjustments will be made to make sure that what is being delivered is fully 
consistent with the intervention as designed. In addition, Dr. Jimenez will attend 
five walking sessions for every group to supervise and provide corrective 
feedback as needed. There will also be a detailed manual of operations.
Endpoints
Primary Outcome Measure Title: Feasibility and acceptability of HOLA 
Primary Outcome Measure Description: As measured by meeting 100% of 
targeted sample (N = 30), with 20% or less of eligible subjects refusing to 
participate, 85% or more of participants completing the post-intervention 
assessment, and 80% or more of sessions attended by participants. 
Primary Outcome Timeframe: Baseline to follow-up assessment (16 weeks).
Secondary Outcome Measure Title: Changes in neurocognitive impairment
Secondary Outcome Measure Description: As measured by the WAIS-IV Digit 
Span Processing and Trails Making Test A and B. The WAIS-IV Digit Span 
Processing is a summary score with the lower scores indicating increased 
cognitive impairment. For Trails Making Test A and B the primary score is the 
time to complete the task with higher times indicating increased cognitive 
impairment. 
Secondary Outcome Timeframe: Baseline to follow-up assessment (16 weeks).
Secondary Outcome Measure Title: Changes in changes in activity, 
psychosocial functioning, or biomarkers of cognition.
Secondary Outcome Measure Description: As measured by GPAQ (activity); 
PHQ-9, GAD-7, Multidimensional Scale of Perceived Social Support 
(psychosocial functioning); and interleukin-15, irisin, adiponectin, BDNF, IGF-1, 
and VEGF (biomarkers of cognition). The GPAQ is a summary score with higher 
scores indicating increased activity levels. PHQ-9 is a summary score with higher 
scores indicating increased depression levels. The GAD-7 is a summary score 
with higher scores indicating increased anxiety levels. The Multidimensional 
Scale of Perceived Social Support is a summary score with higher scores 
indicating increased levels of perceived social support. Levels of interleukin-15, 
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irisin, adiponectin, BDNF, IGF-1, and VEGF are calculated from blood draws 
with well-defined average ranges. 
Secondary Outcome Timeframe: Baseline to follow-up assessment (16 weeks).
9)
Data and Specimen Banking*
Data will be collected 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 in the Department of Psychiatry and Behavioral Sciences, 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 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 procedures outlined 
above. Access to records and participant 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 CLaRO. The Data Manager or designee 
monitors the logs. Upon 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.
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 LWH (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 = 30), 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 
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answer format with specific interest in understanding the participants’ 
opinions regarding the specific components of the intervention. To explore 
changes in cognitive decline 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, 
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 are currently receiving. 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 Department of Psychiatry and Behavioral Sciences. 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.
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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 
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 
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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 
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 16-week assessment 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
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•
Emergency Room Visit of Participant
•
Death of Participant
Safety Alerts/Adverse Events
•
Severe Medical Problem of Participant
•
Participant has PHQ-9 score 10 or higher
•
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 
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 Department of Psychiatry and Behavioral 
Sciences.
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 
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●
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.
13) Risks to Subjects*
Recruitment and Informed Consent: 
Written informed consent will be obtained at the visit prior to any research 
activities. All questions will be answered prior to obtaining their signature on the 
consent form.
 
Participants retain the right to have their questions answered by an investigator 
via telephone or an appointment for an in-person meeting. Because we believe 
that consent is an ongoing process in any study, we will continue to educate 
participants about the nature of the research and address any questions that may 
arise throughout the course of the study.
Participants will not receive their genetic results. Genetic testing is performed for 
research-only purposes and is not nor should it be considered usual medical care. 
The purpose of conducting the genetic testing and the fact that they will not be 
informed of results will be explained to participants as part of the informed 
consent process. 
Potential Risks
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 
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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 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.  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, pain, or any other problems 
arising due to venipuncture, they can also contact the CHW or PI directly.
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Breach of Confidentiality Risk: The study also involves talking in a group setting 
during the walking sessions. Participants will be asked not to discuss other group 
members’ personal information with anyone outside of the walking group. They 
will be asked to not share the names of fellow group members with anyone. 
Participants will also be reminded that they do not have to share information that 
they are not comfortable discussing.  Although the CHW will remind all 
participants to keep the walk discussions private, this cannot be guaranteed.
Our staff is CITI certified and trained in the 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 services they are receiving. 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 Department of Psychiatry and Behavioral Sciences. 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.
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 improved wellbeing. The benefit 
to society is that the project may help demonstrate the potential the HOLA health 
promotion intervention in improving cognition in HIV-infected patients.
In relation to the anticipated benefits, the risks to the subjects are reasonable in 
relation to the benefit of improved wellbeing. Participant information is de-
identified to minimize loss of confidentiality; psychological stress or discomfort 
can be addressed by trained mental health professionals; discomfort during 
venipuncture is mitigated by trained phlebotomists.
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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 
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. 
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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. 
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 
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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 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.
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 
initial screening will be conducted over the phone and verbal consent 
(waiver of documentation of consent) is requested for this portion only.  
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. 
Upon the completion of the telephone screening and if the participant 
appears eligible for the study, a baseline visit will be conducted. In light of 
COVID-19, investigators have decided to conduct the informed consent 
process through one of the following modalities: 1) in-person (when The 
University of Miami allows following and guidelines for safety), 2) via a 
HIPAA compliant telehealth platform (REDCap, HIPAA compliant zoom 
license) or 3) over the phone. For the new enrollments, participants who 
have expressed interest in our research studies and have completed the 
screening process will be contacted by phone. During the call, an 
appointment will be scheduled to conduct the informed consent process 
and an E-signature will be collected upon completing the consent process 
through the telehealth platform. The Informed Consent Form will be either 
mailed or emailed to the participants who prefer to be consented over the 
phone or are unable to be consented using the telehealth platform. An 
impartial witness will be required for the participants that are consented 
over the phone. The witness could be a staff member from the University 
of Miami who is not part of this study, or a participant's friend or relative. 
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The signatures for the participant and his/her witness will be collected. 
Signed consent could be either emailed or mailed by the participant to the 
University of Miami team member who is conducting the consent process. 
The team member consenting will thoroughly document the informed 
consent process on the research participant's chart. Documentation will 
include purpose for the remote consent (COVID-19), and the steps 
involving the process. The note will also address the specific reason why 
the research team doesn’t have the signed and dated document.
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.
The person obtaining consent should document how s/he confirmed that 
the participant consented and signed the consent form. The note should 
include a statement indicating why the informed consent document signed 
by the participant was not retained, (e.g., COVID-19 remote consent). If 
the participant cannot send a picture of the signed document, the person 
obtaining consent should document why a copy of the signed document is 
not available. See example below: 
“Informed consent was obtained on Date at Time. The participant could 
not come to the site for the consent process due to COVID-19 social 
distancing requirements. A copy of the consent document was 
emailed/mailed to the prospective participant before the consent 
discussion. The consent process was performed by phone/ZOOM and 
REDCap. The individuals attending the discussion were: (list the names of 
the individuals). The person obtaining consent explained the research to 
the participant and answered the participant’s questions. The person 
obtaining consent asked the participant questions to ascertain whether s/he 
understood the study, and the participant was able to answer the questions. 
The participant voluntarily agreed to participate. The subject signed and 
dated the consent document. The research was not able to obtain a copy of 
the signed original consent document because consent was obtained 
remotely due to COVID-19. After signing the consent document, the 
participant took a picture and sent it to the research team/ OR the 
participant was unable to send a picture of the document. If consent 
process was delivered by phone and no e-signature was collected. A 
witness observed and listened the entire process.”
Non-English Speaking Subjects
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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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