Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic
Phase: NA
Conditions: Hiv
Sponsor: Florida State University

Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) 
Intervention for the Dominican Republic 
Identiﬁer: NCT04491539    
Unique Protocol ID: 526497 
Document Date: August 24, 2022 

This page has intentionally been left blank; no participant names have 
been included in this document developed for public release. 
 
 

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Human Subjects Protocol (HSP, Original) 
Form Version: July 29, 2019 
 
 
• 
To avoid delay, respond to all items in order and include all required approvals and documents. For more tips, see the UAB IRB website. 
• 
To complete the form, click the underlined areas and type or paste in your text; click checkboxes to check/uncheck. 
• 
All responses should be Times New Roman, Bold, and Underlined. 
• 
NOTES REGARDING VA RESEARCH: BVAMC research cannot be reviewed by an external IRB (only UAB IRB). Ensure you complete this form for any 
BVAMC research. BVAMC Research must be signed off by the BVAMC supervisor for scientific/scholarly review via PORF prior to submission of this 
form. 
 
 
INDICATE THE TYPE OF REVIEW YOU ARE APPLYING FOR: 
☐ Convened (Full) IRB 
    OR 
☐ Expedited - See the Expedited Category Review Sheet, and indicate the category(ies) here: 
☐1  ☐2  ☐3  ☐4  ☒5  ☐6  ☒7 
 
 
1. IRB Protocol Title: Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
 
2. Investigator and Contact Person 
a. Name of Principal Investigator: Henna Budhwani 
Degree(s)/Title: PhD, Asst Prof 
 
BlazerID: bhenna 
Dept/Div: Health Care Organization and Policy  
Mailing Address: RPHB 330C UAB ZIP: 0022 
Phone: (205) 975-7613 
 
 
E-mail: budhwani@uab.edu 
 
b. Name of Contact Person: 
Title:       
 
 
Phone:       
E-mail: 
 
 
 
 
 
INVESTIGATOR ASSURANCE STATEMENT & SIGNATURE 
By my signature as Principal Investigator, I acknowledge my responsibilities for this Human Subjects Protocol, 
including: 
• Certifying that I and all key personnel comply with reporting requirements of the UAB Conflict of Interest Review 
Board; 
• Certifying that the information, data, and/or specimens collected for the research will be used, disclosed and 
maintained in accordance with this protocol and UAB policies; 
• Following this protocol without modification unless (a) the IRB has approved changes prior to implementation or 
(b) it is necessary to eliminate an apparent, immediate hazard to a participant(s); 
• Verifying that all key personnel listed on the submission have completed initial IRB training and will complete 
continuing IRB training as required; 
• Verifying that all personnel are licensed/credentialed for the procedures they will be performing, if applicable; 
• Certifying that I and all key personnel have read the UAB Policy/Procedure to Ensure Prompt Reporting of 
Unanticipated Problems Involving Risks to Subjects or Others to the IRB, Institutional Officials, and Regulatory 
Agencies and understand the procedures for reporting; 
• Applying for continuing review of the protocol at least annually unless directed by the IRB to apply more 
frequently; 
• Conducting the protocol as represented here and in compliance with IRB determinations and all applicable local, 
state, and federal law and regulations; providing the IRB with all information necessary to review the protocol; 
refraining from protocol activities until receipt of initial and continuing formal IRB approval. 
 
 

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3. Protocol Personnel
a. Complete the IRB PERSONNEL FORM to list all key personnel (each individual involved in the design and conduct of this protocol).
b. Non-UAB Personnel Relying on UAB IRB - If you are requesting that the UAB IRB serve as the IRB of record for any non-UAB personnel, list these 
individuals below. Add additional rows as necessary. 
Name and Degree 
From Institution with or without own IRB? 
Financial Interest?* 
Protocol Responsibilities and 
Qualifications (indicate if this 
person obtains consent) 
Name: 
Degree:  
Institution: 
Email: 
☐Has own IRB but requests that UAB IRB serve as 
IRB of record?-OR-
☐Does not have own IRB and needs to rely on UAB 
IRB.
☐No
☐Yes
* If the individual has a Financial Interest, include a copy of the report from his/her own institution’s conflict of interest review with this submission to 
the UAB IRB. 
VA Personnel: The VA Financial Conflict of Interest (fCOI) form must be submitted to the VA fCOI Committee Chair. Include in 3.a above any financial 
conflict of interest as submitted on that VA fCOI form. If there is a conflict, submit a copy of the management plan with this submission. 
c. Are any of the investigators listed on the IRB PERSONNEL FORM students using this research for their thesis or
dissertation?  
 
 
 
 
 
 
 
 
 
 
       ☐Yes ☒No
If No, continue with Item 3d. 
If Yes, provide the name of the student and the Thesis/Dissertation Title: 
d. Is the principal investigator a student, fellow, or resident?
☐Yes ☒No
If Yes, complete items below and obtain signature of faculty advisor or supervisor:
 
 
Supervisor’s Name:     
Supervisor’s Signature:_____________________________________________ 
e. Is medical supervision required for this research?
☐Yes ☒No
If Yes, who will provide the medical supervision?
☐PI will provide -OR-
☐Other:
Name: 
 Telephone: 
If other than PI, obtain signature of person providing medical supervision: 
Signature 
f. Describe the principal investigator's activities related to this protocol and provisions made by the PI to devote
sufficient time to conduct the protocol:
The PI will devote her effort to this project. She will be responsible for all administrative and financial 
aspects of the project and will oversee all scientific aspects of the project. She will work closely with the 
team in the Dominican Republic (DR) to oversee human subjects research activities performed there 
and ensure that all activities are in compliance with the local IRB approval.  
g. Describe your process for ensuring all key personnel are adequately informed about the protocol and their
research-related duties and functions:
At the beginning of the study, the team will meet (virtually) weekly and will correspond by email almost 
daily. As the study gets underway, the team will meet (virtually) weekly or more often if needed. UAB 
personnel, including the PI, will be responsible for training the DR team who will directly interact and 
intervene with participants. This training will occur on-site in the DR as well as electronically.  
4. Funding
Is this protocol funded?
☒Yes ☐No

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If No, specify that costs of the protocol will be covered by funds from the UAB department or other source 
named:    
If Yes, attach one copy of completed application or request for funding sent to sponsor, and complete a-d. 
a. Title of Grant, Contract, or Agreement: Adapting the Finding Respect and Ending Stigma around HIV
(FRESH) Intervention for the Dominican Republic
b. UAB PI of Grant, Contract, or Agreement: Henna Budhwani is contact PI
c. Office of Sponsored Programs (OSP) Assigned Number: OSP #000526497
(If not yet available, enter “Pending” and provide upon receipt from OSP.)
d. Sponsor, Funding Route:
(Check and describe all that apply)
(If subaward, list both the funding source and the institution receiving the direct award) 
☒Gov’t Agency or Agencies—Agency name(s): NIH/FIC
☐Department of Defense (DoD): Identify DoD component:
☐Department of Energy (DOE)
☐Department of Justice (DOJ)
☐Department of Education
☐NIH Cooperative Group Trial - Group name:
☐Private Nonprofit (e.g., Foundation) - Name:
☐Industry-sponsored, industry-initiated - Name:
NOTE:  The UAB IRB typically only reviews industry-sponsored protocols that are investigator initiated or
when the protocol qualifies for expedited review or involves gene therapy.
☐Industry-sponsored, investigator-initiated - Name:
Describe the funding arrangement:
NOTE:  The UAB IRB typically only reviews industry-sponsored protocols that are investigator initiated or
when the protocol qualifies for expedited review or involves gene therapy.
☐UAB Departmental/Division Funds—Specify:
☐VA Funding —Specify:
5. Locations Involved
a. Indicate all performance sites that will provide space, services, or facilities for the conduct of this protocol.
☐UAB Hospital
☐UAB Hospital - Highlands
☐The Kirklin Clinic of UAB Hospital
☐The Kirklin Clinic at Acton Road
☐UAB Callahan Eye Hospital
☐UAB Clinical Research Unit
☐Children's of Alabama
☐Birmingham Veterans Affairs Medical Center NOTE: Research may only be conducted by investigators who
have a BVAMC appointment
☐Jefferson County Department of Health
☒Other (i.e., any performance site not listed above, including those covered by subawards related to this
protocol) - Describe:
UAB School of Public Health and government HIV clinics in Santo Domingo and Santiago, 
Dominican Republic: Hospital Cabral y Baez, Hospital Periferico Juan XXIII, and Hospital 
Calventi.  
NOTE:  Documentation of IRB approvals from sites receiving subawards must be received by the UAB OIRB 
before funding will be released for that subaward. 

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b. Describe the space, service, or facilities available for the conduct of the research in the performance sites 
listed in Item 5.a (For research on UAB campus, include building names):  
At UAB, the research will take place in the Ryals Public Health Building, in the private offices of the 
investigators. The primary academic research site in the Dominican Republic is the Universidad 
Iberoamericana (UNIBE), a Higher Education Center that emerged in 1982 as a result of the initiative 
expressed by the Ibero-American Cooperation Institute and by a Management Committee in the 
Dominican Republic. UNIBE’s mission is to promote academic excellence, research and training of 
highly qualified professionals, capable of generating and leading changes, with ethical values necessary 
to contribute to the development of local and global society. Our vision includes commitment to the 
integral development of society and academic excellence, which is characterized by forging responsible 
leaders and by its permanent innovative vocation. 
 
c. Does this protocol require clinical services at one of the sites listed in Item 5.a above? 
☐Yes ☒No 
If Yes, will any of the services be billed to either participants/their insurance or to the study account through 
the Hospital Billing Office (PFS) or the HSF Billing Office (MSO)? 
☐Yes ☐No 
 
If Yes, submit a Fiscal Approval Process (FAP)-designated unit submission and send to fap@uab.edu. For 
more on the UAB FAP requirements, go to FAP - SiteMinder Processes. 
 
d. Is this a field study? 
☐Yes ☒No 
If Yes, describe the community and include information about how the community will be involved in the 
design, implementation and analysis of the research. This would include focus groups, training local 
facilitators/community health advisors:       
 
e. Has this protocol been rejected or disapproved by another review board (another IRB, similar review board, or 
departmental review committee(s)) that authorizes the use of its patient populations? 
☐Yes ☒No 
 
If Yes, provide name(s) of the review board(s) and reason(s) not approved:       
Attach copies of the disapprovals. 
NOTE:  If this protocol is subsequently rejected or disapproved by another review board, promptly notify UAB 
IRB. 
 
f. Will the protocol be conducted at or recruit participants from the Birmingham Veterans Affairs Medical Center 
(BVAMC)? 
☐Yes ☒No 
If Yes, describe the involvement of the BVAMC:       
Attach the BVAMC consent form(s), if applicable. Attach any other applicable BVAMC forms (such as the 
Privacy and Information Security Checklist and The BVAMC FCOI forms). 
NOTE:  Investigators conducting research at BVAMC must have a BVAMC appointment. 
NOTE:  See the BVAMC section of the IRB Guidebook for more information. 
 
g. Will the protocol be conducted at or recruit participants from the Jefferson County Department of Health 
(JCDH)? 
☐Yes ☒No 
If Yes, describe the involvement of the JCDH and list the JCDH clinics being used:       
Attach the JCDH Research Review Panel approval, if applicable. 
NOTE:  Human subjects research conducted at certain JCDH clinics requires review by the JCDH Research 
Review Panel. See the JCDH section of the IRB Guidebook for more information. 
 
6. Clinical Trial 
Does this protocol meet the following definition of a clinical trial? 
☒Yes ☐No 
*A research study in which one or more human subjects are prospectively assigned to one or more interventions 
(which may include placebo or other control) to evaluate the effects of those interventions on health-related 
biomedical or behavioral outcomes. For more information, see the full definition of clinical trial here. 

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If Yes, you will need to fulfill the following requirements (regardless of funding): 
a. All key personnel must complete the Good Clinical Practices (GCP) training. For information on this
requirement, visit the IRB website here.
b. This protocol must be registered on ClinicalTrials.gov. Provide the National Clinical Trial (NCT) identifier
number: We will register as soon as the official Notice of Award is received
If you have any questions regarding registering a study on ClinicalTrials.gov, email the UAB Center for Clinical 
and Translational Science at ccts@uab.edu. 
7. Multi-Site Studies
a. Is this a multi-site study?
☐Yes ☒No
b. Is the UAB Investigator the lead investigator?
☒Yes ☐No
c. Is this a multi-site study with a coordinating site?
☐Yes ☒No
d. Is this a multi-site study with UAB as a coordinating site?
☐Yes ☒No
If Yes to a, b, c, or d, describe the management of information obtained in multi-site research that might be 
relevant to the protection of participants:  
UAB will have an IRB approval and the primary DR site will have an IRB approval. All DR sites will rely 
on the IRB approval given in the DR. Unanticipated problems will be addressed as described in 20b and 
20c. UAB is responsible for all reports to the sponsor and for alerting the UAB IRB to all protocol 
modifications throughout the project.  
Include, at a minimum, how the following items are managed: IRB approvals from other sites; Unanticipated 
problems involving risks to participants or others. (For example, if there is an unanticipated problem involving 
risks to participants or others, which site is responsible for reporting it?); Interim result; & Protocol 
modifications.        
8. Drugs
Will any drugs or supplements be used or studied in this protocol?
☐Yes ☒No
If Yes, attach the completed Drug Review Sheet. 
If BVAMC, attached the completed BVAMC Drug Review Sheet .
9. Devices
a. Will any devices be studied in this protocol?
☐Yes ☒No
b. Will any not FDA-approved devices be used or studied in this protocol?
☐Yes ☒No
If Yes to a or b, attach the completed Device Review Sheet.
10. Special Approvals
a. Does this protocol involve the use of radioisotopes?
☐Yes ☒No
If Yes, attach documentation of approval from the Radiation Safety Division.
b. Does this protocol include patients with contagious infections (e.g., mumps, measles, chickenpox, TB,
meningitis)? 
☐Yes ☒No
If Yes, attach documentation of approval from the Infection Control Committee of the appropriate facilities. 
c. Does this protocol involve obtaining remnant biopsy or surgical material from the Department of Pathology or
any other source? 
☐Yes ☒No
If Yes, attach documentation of approval from the entity or individual providing the materials (e.g., the UAB 
Division of Anatomic Pathology Release of Pathologic Materials). 

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d. Does this protocol require obtaining any remnant clinical laboratory biospecimens, body fluids, or
microbiological isolates from the Department of Pathology or any other source? 
☐Yes ☒No
If Yes, attach documentation of approval from the entity or individual providing the materials (e.g., the UAB 
Division of Laboratory Medicine Release of Pathologic Materials). 
e. Does this protocol use stored (existing) biospecimens from a repository? 
☐Yes ☒No
If Yes, attach documentation of approval for use of biospecimens, and describe how existing biospecimens
are labeled: 
11. Use of Biospecimens
Does this protocol involve the collection of biospecimens?
☐Yes ☒No
If Yes, complete 11.a-11.h.
If No, skip to Item 12.
a. How will biospecimens be obtained, processed, distributed, and stored?
b. How will biospecimens be labeled (e.g., unique identifier, medical record number, Social Security number,
name, date of birth)?
c. How will clinical data associated with the biospecimens be collected and stored?
d. What participant-identifying information will be collected and linked to the biospecimens?
e. What steps will be taken to maximize the confidentiality of linked identifiers? For example, procedures could
include using a password-protected computer database to link identifiers, with limited personnel
knowledgeable of the password, or coded identifiers released without the ability to link to clinical data (also 
called “stripped” or “anonymized” biospecimens).     
f. Is genetic testing planned as part of this protocol?
☐Yes ☐No
If Yes, describe the planned genetic testing here.
i.
Does this include whole genome sequencing?
☐Yes ☐No
ii.
Will participants be informed of the results of any DNA testing?
☐Yes ☐No
g. Will biospecimens be stored for future use? 
☐Yes ☐No
If Yes, indicate whether they will be used for the disease under study in this protocol or research on other
diseases. In addition, indicate where the biospecimens will be banked 
•
If above is a BVAMC location, what IRB is responsible for overseeing the operations of the
biospecimens bank (i.e., local IRB or other multi-site or central IRB?)
h. Will biospecimens be shared with other investigators in the future?
☐Yes ☐No
i.
What identifiers, clinical information and demographic information will be shared; or will the
biospecimens be stripped of identifiers (i.e., anonymized)?
NOTE: Coding data is not considered anonymous. 
ii.
Outline your procedure for assuring IRB approval for release and use prior to release of
biospecimens.
NOTE:  Investigators who receive and/or use these biospecimens must document approval from the 
appropriate IRB(s) before the biospecimens may be released. 
i. Will specimens be destroyed after the project-specific use is completed?
☐Yes ☐No
j. Will specimens be used and/or shared for commercial profit?
☐Yes ☐No
k. Will specimens be destroyed after the project-specific use is completed?
☐Yes ☐No
l. Will participants be informed of the results of the specimen testing?
☐Yes ☐No

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m. Are there any implications for family members based on specimen testing results?
☐Yes ☐No
(If yes, the family members may be participants.)
12. Gene Therapy
Does this protocol involve gene therapy or administering recombinant materials to humans? 
☐Yes ☒No
If Yes, submit the Gene Therapy Project Review Panel Report -OR- the Protocol Oversight Review Form For
Clinical Vaccine Trials, as applicable.
13. HIPAA Privacy and Security
Will the PI or others obtain, review, or make other use of participants' “protected health information” (i.e.,
information, whether oral or recorded in any form or medium that (a) is created or received by a health care
provider and (b) relates to past, present, or future physical or mental health or condition of an individual; or
provision of health care; or payment for provision of heath care)? 
☒Yes ☐No
If Yes, complete Items 13.a-13.f.
If No, skip to 14.
a. Will the data/information be stored or managed electronically (on a computer)?
☒Yes ☐No
b. Is the principal investigator requesting that the UAB IRB waive patient HIPAA authorization from another
institution or entity (e.g., insurance company, collaborating institution)? 
☐Yes ☒No
If Yes, attach copies of the privacy notices from each institution/entity, and provide the name of each 
institution/entity:  
c. Indicate which of the entities would provide health information for this protocol, maintain health information
as it was collected for this protocol, and/or store health information after it has been collected for this
protocol. 
☐UAB Hospital or UAB Hospital - Highlands
☐The Kirklin Clinic of UAB Hospital or Acton Road (and/or associated clinics)
☐UAB Callahan Eye Hospital
☐Children's of Alabama
☐Jefferson County Department of Health
☐School of Dentistry
☐School of Health Professions
☐School of Medicine
☐School of Nursing
☐School of Optometry
☐University of Alabama Health Services Foundation
☐UAB Health Centers
☐Viva Health
☐Ophthalmology Services Foundation
☐Valley Foundation
☐Medical West - UAB Health System Affiliate
☐Birmingham Veterans Affairs Medical Center
☒None - If None, skip to Item 14.
d. Indicate any information systems that will be the sources of information used for the protocol.
☐A system maintained centrally by UAB Health System (these include the following: HealthQuest for
registration, billing, and patient administration; PowerInsight (clinical data warehouse); Cerner IMPACT
for PowerNotes for meds, Lab, Radiology, UED, Surgery

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NOTE:  If a researcher needs information in a specified format or a specified time, the researcher must 
confirm with the unit who can supply the information/service that the request can be met before writing 
the information/service into the research protocol. In addition, the researcher must be aware that these 
services may have a cost attached that should be considered in the research budget. 
 
To request access to clinical systems for research purposes, visit 
https://www.oneuabmedicine.org/web/hsis/technical-support, click “Accounts Request” and complete 
the form indicating access for research purposed. 
☐ Another system on a UAB or BVAMC server - Describe:       
 
e. Indicate which of the listed identifiers will be accessed, associated and/or linked with the protected health 
information (PHI) used for this protocol. 
☐ Names 
☐ Geographic subdivisions smaller than a state 
☐ Elements of dates (except year) related to an individual 
☐ Telephone numbers 
☐ Fax numbers 
☐ Email addresses 
☐ Social security numbers 
☐ Medical record numbers 
☐ Health plan beneficiary numbers 
☐ Account numbers 
☐ Certificate/license numbers 
☐ Vehicle identifiers and serial numbers 
☐ Device identifiers and serial numbers 
☐ Biometric identifiers 
☐ Web universal resource locators (URLs) 
☐ Internet protocol address numbers 
☐ Full-face photographic images 
☐ Any other unique identifying number - Describe:       
NOTE:  Codes are not identifying as long as the researcher cannot link the data to an individual 
☐ None - If None, skip to Item 14. 
 
f. Choose one plan to describe your use of the personal health information: 
☐ The data collected meet the specifications for a “limited data set” (LDS) 
-If the LDS will leave the covered entity or will be received from another covered entity you will need a 
Data Use Agreement 
 
☐ Research staff will obtain authorization from each participant to use the information 
-Include the HIPAA Authorization form, complete except for participant name and IRB protocol number, 
as the final page of the consent form 
 
☐ PI requests waiver of authorization to use the information 
-Attach Waiver of Authorization and Informed Consent form 
NOTE: For BVAMC research, the BVAMC HIPAA authorization form or UAB HIPAA waiver form must be 
completed and submitted with the HSP. 
 
PROPOSED RESEARCH 
• The IRB will not accept grant applications and/or sponsor's protocols in lieu of the items as outlined below. 

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• Do not separate responses from items. Instead, insert your response to each item below the item, keeping the 
information in the order of this form. 
 
14. Purpose - in nontechnical, lay language 
a. Summarize the purpose and objectives of this protocol in one short paragraph.  
The purpose of this research is to adapt an educational intervention (Finding Respect and Ending 
Stigma around HIV) that has been proven to be effective in Africa and the US to meet the needs of HIV 
clinics in the Dominican Republic. Health outcomes, as well as perceptions/attitudes/beliefs, will be 
measured before and after the intervention.  
 
b. Describe how outcomes will be measured for this protocol.  
Outcomes related to changes in stigma, perceptions, beliefs, etc. will be collected before and after the 
educational workshop (intervention). Data  
 
15. Background - in nontechnical, lay language 
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the design of this protocol. 
Include any relevant past or current research by the PI. For drug and device studies, summarize the previous 
results (i.e., Phase I/II or III studies).  
There are high levels of stigma against sexual and gender minorities (SGMs) in the Caribbean. Many 
Caribbean nations have a dominant conservative ideology that criminalizes MSM sexual behaviors and 
shames young SGM, particularly those who are living with HIV. In the DR, stigmatizing views are 
commonplace, and policies that perpetuate stigma towards PLWH and SGMs are embedded in DR laws. 
Stigmatizing attitudes toward PLWH and SGMs are often reflected in the behaviors of health workers, and 
thus stigmas may become embedded in HIV clinics, leading PLWH to be reluctant to engage in care. In the 
DR, PLWH routinely experience intersectional stigma for being a PLWH and for identifying as an SGM. 
This intersectional stigma may increase the amount and intensity of stigma experienced by SGMs who are 
living with HIV, with synergistic effects on health outcomes. Research shows that these stigmas are 
significant barriers to HIV treatment services and contribute to the DR’s low 16% viral suppression rate. 
 
HIV and intersectional stigmas in healthcare settings are significant barriers to care in the DR. Consejo 
Nacional para el VIH y el SIDA (CONAVIHSIDA) recently released results from its national study on HIV 
stigma. This study found that over a third of HWs had no stigma training; a third of HWs were afraid to 
draw blood from PLWH, and 56% of HWs did not want to provide services to SGMs living with HIV, 
because they felt SGMs deserved to be HIV-infected. Findings from the THS further validate the notion 
that stigma is a significant barrier to HIV services in the DR. In fact, it was only after advocates took their 
demands to the Inter-American Human Rights Commission that antiretroviral therapy (ART) was 
approved as a covered medical expense in the DR, and it wasn’t until 2009 that PLWH were allowed to 
enroll in the DR National Health Insurance System. Stigmatizing attitudes from HWs push the epidemic 
underground and promote the spread of HIV, because PLWH and SGMs may avoid engaging in care due 
to fears of stigma from HWs. Thus, it is imperative that tailored interventions to reduce stigmas in clinics 
be developed and tested. If stigmas are not addressed, the DR will likely see a rise in new infections and 
worsening of HIV outcomes in PLWH. 
 
There are surprisingly few intersectional stigma reduction interventions for healthcare settings. Clinic-
based stigma-reduction interventions have primarily been developed for Asian and African settings, 
making the adaptation of FRESH for the Caribbean unique. In assessing interventions for appropriateness, 
we applied Nyblade’s key criteria for stigma-reduction efforts. Evidence-based strategies include selecting 
interventions that involve PLWH and HWs, use of participatory methods, address actionable drivers of 
stigma in the short term, put PLWH at the core of the response, and create partnerships between PLWH 
experiencing stigma and HWs to model non-stigmatizing behaviors. Considering the lack of HIV-stigma 
research in the DR and that FRESH is one of the few interventions that meets these  criteria, the DR is a 

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priority setting for the cultural adaptation and testing of the FRESH intervention that involves both PLWH 
and HWs.  
The Finding Respect and Ending Stigma around HIV (FRESH) intervention is ideal to adapt and test. The 
FRESH intervention was originally developed in a study in five African nations,30 then was adapted for the 
United States. Since we have data showing that FRESH is adaptable, revising it for Latinx and Hispanic 
populations could yield scientific evidence leading FRESH to become a validated multi-region stigma-
reduction intervention. The FRESH intervention brings together HWs of all types and PLWH to 
collaborate in a workshop to increase understanding of HIV-related and intersectional stigmas. FRESH 
facilitates conversations on effects of stigma on health and well-being and guides participants to better 
recognize and understand stigmas. FRESH includes didactic content and interactive activities. Each topic 
includes contact-theory informed activities designed to bring HWs and PLWH together to change 
perceptions of each other while enhancing empowerment and empathy. Facilitators use a standard manual 
for consistent content delivery. FRESH was efficacious in reducing stigmas in Africa, and the United States 
pilot had promising results (Preliminary Studies). We are confident that FRESH is an excellent 
intervention to adapt for the DR because, 1) FRESH is sustainable. Facilitators can train other trainers. 2) 
FRESH is low-cost. As a socio-structural intervention, there are no clinical costs. 3) FRESH is extensible. 
We have shown that FRESH was adapted from African contexts to the United States, and 4) FRESH is 
flexible. FRESH was adapted to address a spectrum of relevant intersectional stigmas in the US Deep 
South, among other modifications. 
16. Participants (Screening and Selection)
a. How many participants are to be enrolled at UAB (if other sites relying on UAB IRB, list the number for each
site)? 0
If multi-site study, total number at all sites/institutions:  
40 in intervention workshops; half providers and hald PLWH clients. 
b. Describe the characteristics of anticipated or planned participants (if multiple groups, repeat list for each
group).
PLWH participants 
Sex: all 
Race/Ethnicity: all 
Age: 16+ 
Health status: HIV positive 
healthcare workers 
Sex: all 
Race/Ethnicity: all 
Age: 18+ 
Health status: not applicable 
c.
From what population(s) will the participants be derived?
Healthcare workers and patients from the clinics in the DR
Describe your ability to obtain access to the proposed population that will allow recruitment of the
necessary number of participants:
We will collaborate with multiple organizations in the Dominican Republic that have an established
track record of recruiting and retaining our target population.
d. Describe the inclusion/exclusion criteria:

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Inclusion Criteria for Healthcare worker (HW) participants: 
• Minimally 18 years and 0 months of age 
• Works at one of the three study sites 
• Interacts with PLWH  
• Spanish speaking 
• Can read Spanish text 
• Able and willing to provide informed consent 
 
Inclusion Criteria for PLWH participants: 
• Minimally 16 years and 0 months of age 
• Is HIV-positive 
• Spanish speaking 
• Receives treatment at one of the three study sites 
• Identifies as a Sexual or Gender Minority person (SGM) 
• Able and willing to provide informed consent 
 
 
e. If participants will comprise more than one group or stratification, describe each group (e.g., 
treatment/intervention, placebo, controls, sham treatment) and provide the number of participants 
anticipated in each group.  
 
Adaptation Site: At Site 1, we will engage 44 PLWH patients (men and women) and 12 HW to 
participate in focus groups and in-depth interviews. This feedback will inform how the FRESH 
intervention is adapted and then implemented at Sites 2 and 3.  
 
Site 2: 10 PLWH and 10 HW will participate in the educational workshop; it is expected that the 
workshop will benefit all patient-provider interactions and not just those of workshop participants.  
 
Site 3: 10 PLWH and 10 HW will participate in the educational workshop; it is expected that the 
workshop will benefit all patient-provider interactions and not just those of workshop participants. This 
will be a delayed-start site.  
 
f. Indicate which, if any, of the special populations listed below will be involved in the protocol. Include the 
Special Populations Review Form (SPRF) if indicated. 
☐ Pregnant Women: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Fetuses: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Neonates/Nonviable Neonates: SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Prisoners: Attach SPRF—Prisoners 
☒ Minors (<18 years old): Attach SPRF—Minors NOTE: For BVAMC Research <19 years old 
☐ Employees or students at institution where research conducted 
☐ Persons who are temporarily decisionally impaired 
☐ Persons who are permanently decisionally impaired 
☒ Non-English Speakers 
For each box checked, describe why the group is included and the additional protections provided to protect 
the rights and welfare of these participants who are vulnerable to coercion:  
For youth living with HIV participants (aged 16-17), we will take written or verbal informed consent 
from both the youth and his or her legal guardian. In cases where these youth have been legally 
emancipated; we will attach a copy of the participant’s emancipation record (often kept clinic) with 
his/her informed consent. This human subjects research will be delivered to a Spanish-speaking 
population by native Spanish speakers who are local DR residents. This protocol will also be reviewed 
by a local DR IRB as to make sure that the research complies with local cultural norms and regulations.  

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g. List any persons other than those directly involved in the protocol who will be at risk. If none, enter “None”:
None
h. Describe the recruitment process (e.g., medical record review, referrals, letter of invitation, existing patients)
that will be used to seek potential participants (e.g., individuals, records, specimens). Research recruitment
by non-treating physicians/staff may require completion of Partial Waiver of Authorization for 
Recruitment/Screening.  
Leadership at sites have agreed to participate and PLWH will be recruited during events hosted by 
clinics or during their clinical visits. 
i. If you will use recruitment materials (e.g., advertisements, flyers, letters) to reach potential participants,
attach a copy of each item. If not, identify the source (e.g., IRB Protocol Number for approved databases) 
from which you will recruit participants.  
These need to be developed with DR collaborators; when ready, pre-recruitment, we will share via 
an amendment to UAB’s IRB. 
j. Describe the screening process/procedures for potential participants.
Potential participants will complete a pre-workshop assessment on paper or via an ipad survey to assess
eligibility. 
17. Protocol Procedures, Methods, and Duration - in nontechnical, lay language
a. Describe the procedures for all aspects of your protocol. Tell us what you are doing.
The DR sites will be randomly assigned. Site 2 will be the site randomized to receive the adapted
FRESH intervention first. Site 3 will receive the FRESH intervention at a later date. 10 sexual and 
gender minority PLWH and 10 HW will participate in the workshop at each site (total n from both 
sites=40). From workshop participants, we will collect pre- (N=40) and post- (N=40) surveys to assess 
satisfaction, feasibility, acceptability. We will collect outcome information on demographics, stigma-
related measures, and HIV-related behavioral outcomes by asking all HWs and PLWH in Site 2 and 3 
clinics.
UAB specific research activities include: traveling to DR sites to provide training on FRESH and the 
adapted FRESH, overseeing FRESH workshop implementation, possibly interacting with study 
participants participating in workshops and surveys, receiving all study data, data analysis, manuscript 
writing, presentations.  
b. What is the probable length of time required for the entire protocol (i.e., recruitment through data analysis to
study closure)? 4 years
c. What is the total amount of time each participant will be involved? 12 months

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d. If different phases are involved, what is the duration of each phase in which the participants will be involved?
If no phases are involved, enter “None.” None
e. List the procedures, the length of time the procedure takes, the total # of times the procedure is performed,
and indicate whether each is performed solely for research or would already be performed for treatment or
diagnostic purposes (routine care) for the population. 
-Insert additional table rows as needed.
-If procedure is sometimes research and sometimes routine care, include on separate lines with number of
times as each.
Procedure 
Length of Time Required of 
Participants 
Total # of Times the Procedure 
is Performed 
Research (Res) –OR- Routine 
Care  
Site 1: focus 
group 
1 hour 
1 
☒Res  ☐Routine
Site 1: in-depth 
interviews 
1 hour 
1 
☒Res  ☐Routine
Site 1: feedback 
on adapted 
intervention 
1 hour 
2 
☒Res  ☐Routine
Site 2: pre-
workshop stigma 
surveys 
30 minutes 
2 
☒Res  ☐Routine
Site 2: workshop 
participation 
16 hours 
1 
☒Res  ☐Routine
Site 2: post-
workshop stigma-
related surveys 
30 minutes 
2 
☒Res  ☐Routine
Site 3: pre-
workshop stigma 
surveys 
30 minutes 
2 
☒Res  ☐Routine
Site 3: workshop 
participation 
16 hours 
1 
☒Res  ☐Routine
Site 3: post-
workshop stigma-
related surveys 
30 minutes 
2 
☒Res  ☐Routine
f. Will an interview script or questionnaire be used? 
☒Yes ☐No
If Yes, attach a copy. All interviews/scripts will be submitted to UAB IRB via amendment once developed
and approved by DR sites and IRB. 
g. Will participants incur any costs as a result of their participation?
☐Yes ☒No
If Yes, describe the reason for and amount of each foreseeable cost.
h. Will participants be compensated?
☒Yes ☐No
If Yes, complete i-v.
i. Type: (e.g., cash, check, gift card, merchandise): cash
ii. Amount or Value: $50 USD (distributed as DR currency)
iii. Method (e.g., mail, at visit): at visit
iv. Timing of Payments: (e.g., every visit, each month): each workshop day
v. Maximum Amount of Compensation per Participant: $100 USD
18. Benefits

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Describe the potential benefits of the research. Participants in this study are HWs and PLWH. If successful, 
this project will yield a model for sustainable implementation of an intervention to reduce stigma and 
improve outcomes across the HIV cascade in resource-poor settings. Given the limited risks associated with 
this intervention study, the benefits outweigh the risks. PLWH are at particular risk of being stigmatized, 
yet few interventions exist that specifically reduce stigma in healthcare settings for the Caribbean. This 
study will ultimately benefit both PLWH and their healthcare providers by creating stigma-free healthcare 
environments and improving outcomes along the HIV continuum of care. 
19. Risks - in nontechnical, lay language
a. List the known risks for participants as a result of participation in the research. This should not include the
minimal risk of loss of confidentiality. However, it should include any physical, psychological, social,
economic, and/or legal risks. If there is a greater than minimal risk of loss of confidentiality describe why this 
is so. Do not list risks associated with the standard-of-care procedures. 
NOTE:  Risks included here should be included in the consent form or information sheet, as applicable. 
Psychological distress. Our team has significant experience conducting intervention studies and 
behavioral surveys in the field of HIV stigma-reduction, including in the proposed setting (Dominican 
Republic). It has been our experience that it is rare for a participant to find an interview upsetting. We 
have infrequently encountered episodes of mild embarrassment or awkwardness, which quickly 
dissipate. 
Breaches of confidentiality. The main potential risk of this study is breach of confidentiality. This is one 
of the most common risks of participation in research studies on sensitive topics such as stigma and 
HIV, especially in socially conservative communities. We acknowledge that unwanted disclosure may 
result in adverse consequences for participants, including negative psychological and social 
consequences. PLWH participants are particularly vulnerable due to the likelihood of being members of 
highly stigmatized groups in DR society, including MSM, sex workers, and trans persons. Healthcare 
workers may also be vulnerable if they are HIV-infected, members of any of these groups, or if they face 
consequences for voicing stigmatizing attitudes. Accordingly, our team has designed a strategy to 
protect participant confidentiality, as detailed below. 
b. Estimate the frequency, severity, and reversibility of each risk listed.
Psychological distress- rare, moderate, reversible
Breach of confidentiality- rare, sever, irreversible
c. Is this a therapeutic study or intervention?
☐Yes ☒No
If Yes, complete i.-iii.
i. Describe the standard of care in the setting where the research will be conducted:
ii. Describe any other alternative treatments or interventions:
iii. Describe any withholding of, delay in, or washout period for standard of care or alternative treatment
that participants may be currently using:
d. Do you foresee that participants might need additional medical or psychological resources as a result of the
research procedures/interventions? 
☐Yes ☒No
If Yes, describe the provisions that have been made to make these resources available. 
e. Do the benefits or knowledge to be gained outweigh the risks to participants?
☒Yes ☐No
If No, provide justification for performing the research:
20. Precautions/Minimization of Risks
a. Describe precautions that will be taken to avoid risks and the means for monitoring to detect risks.
The team will make every effort to protect all participants’ confidential and private information in
order to minimize possible study-associated risks. We will inform all participants that their 

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participation is voluntary, and we will utilize study identification codes in place of personal identifiers 
on study materials. We will also employ storage and encryption techniques in compliance with UAB 
Data Security standards to safeguard all electronic data, as well as the protections outlined in Subpart 
C of title 45, part 46 of Code of Federal Regulations. All study personnel are required to renew Human 
Subjects trainings biannually. No data will be accepted from or distributed to investigators or study 
staff if regulatory training is not current.  
Protections for participant discomfort. Participants will be informed that they may stop the study at 
any time if they feel uncomfortable. Additionally, if a participant appears to be in emotional distress, 
study staff will inquire as to the participant’s well-being and whether they wish to stop the study visit. 
Participants who opt to stop the study visit, or who disclose potentially harmful information (e.g., 
suicidality) will be immediately referred for an assessment by a clinic social worker, psychologist, or 
counselor. We will enact the clinic’s emergency protocol for persons who need immediate attention for 
escort to the local emergency department. Interviewers will be trained to minimize distress/discomfort 
to participants, to recognize any signs of symptoms of distress, and to make appropriate referrals to 
appropriate community-based services, if necessary. Experienced mental health counselors will be 
consulted or referred to should a participant exhibit severe symptom of mental distress. Should a 
participant experience distress after-hours or on weekends, a back-up system will be in place in the 
event a mental health or medical professional is needed for assessment or immediate referral. Through 
our prior work in the Dominican Republic, we have compiled a list of community-based resources for 
PLWH, including mental health counseling, general health services, substance use, and other issues. 
These lists will continue to be updated, and a copy will systematically be provided to participants during 
interviews, focus groups, and questionnaires. Providing them to all participants (both HWs and PLWH) 
will reduce the likelihood that any one participant would be identified as needing a particular service, 
and implying that they have a particular need for a type of service.  
Protections for breaches of confidentiality. All participants will be informed of study procedures and 
gauged for understanding of study tasks. In addition, study personnel will follow regulatory guidelines 
for obtaining written or verbal informed consent. All interviews and intervention activities will be 
conducted in private spaces, in so far as possible. For all participants, research data will be stored using 
a code (sequence number based on entry to the study) instead of names or other personal identifiers. 
Consent forms with links to participant study numbers will be kept in a in a locked file in a locked room 
with the PI (Budhwani) if paper-based or in an encrypted, password-protected file at UAB if electronic. 
According to UAB regulatory policy, records relating to research, including informed consent 
documents, shall be securely retained for one year after completion of the research. All records shall be 
accessible for inspection and copying by authorized representatives of the department or sponsor 
agency at reasonable times and in a reasonable manner. All electronic study data are kept on UAB 
secure encrypted password protected servers, and will only be available to research personnel. All study 
personnel will complete HIPPA and human subjects training in accordance with UAB Institutional 
Review Board policy. 
If the protocol involves drugs or devices skip Items 20.b. and 20.c. and go to Item 21. Instead, include this 
information in the Drug Review Sheet or Device Review Sheet, as applicable. 
b. If hazards occur to an individual participant, describe (i) the criteria that will be used to decide whether that
participant should be removed from the protocol; (ii) the procedure for removing such participants when
necessary to protect their rights and welfare; and (iii) any special procedures, precautions, or follow-up that 
will be used to ensure the safety of other currently enrolled participants.  
Once the project has begun, all clinically significant AEs will immediately be brought to the attention of 
the MPIs. The event will be categorized as an SAE or non-SAE, as expected or unexpected, and as likely 
or unlikely to be related to the study. The DSMB will review all AE reports for concurrence regarding 

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relatedness to the intervention, seriousness, and appropriate resolution. The DSMB will track all SAEs 
until resolution has been achieved. All SAEs and AEs will be entered into the study database so that 
they may be tracked. If an SAE is determined to be related to the intervention, it will be reported within 
48 hours of occurrence or identification to the UAB IRB in accordance with UAB reporting protocols. 
 
c. If hazards occur that might make the risks of participation outweigh the benefits for all participants, describe 
(i) the criteria that will be used to stop or end the entire protocol and (ii) any special procedures, 
precautions, or follow-up that will be used to ensure the safety of currently enrolled participants.  
If the incidence of SAEs and/or AEs probably or definitely related to participation in the study is 
unexpectedly high (overall or at any site), or differs substantially by Site (P < 0.001), the study team will 
discuss with the DSMB whether the study should be stopped or modified in some way in order to reduce 
the risk of potential harms to study participants. The DSMB will be given quarterly reports of any AEs 
and SAEs that occur. The DSBM may recommend modifications to the study procedures to minimize 
potential harms to study participants. If there are no serious concerns raised by the DSBM, the Chair 
will approve the protocol to continue as planned immediately following a DSMB meeting. If significant 
concerns are raised by the DSMB, the concerns will be forwarded to the MPIs as well as 
recommendations made to the IRBs. Recommendations may include modifying, suspending, or 
terminating the protocol. 
 
21. Informed Consent 
a. Do you plan to obtain informed consent for this protocol? 
☒Yes ☐No 
If Yes, complete the items below. 
If No, complete and include the Waiver of Informed Consent or Waiver of Authorization and Informed 
Consent, as applicable. 
*For research being conducted at the BVAMC, the UAB Consent waiver form must be completed and 
submitted with the HSP. 
 
b. Do you plan to document informed consent (obtain signatures) for this protocol? 
☒Yes ☐No 
If Yes, complete the items below. 
If No, complete the items below and include the Waiver of Informed Consent Documentation. 
 
c. How will consent be obtained?  
Consent will be obtained by the research team located in the Dominican Republic (DR). We will utilize a 
written Spanish-language consent form that describes that no special privileges or considerations will be 
conferred as a result of study participation and that access to services will not be affected by the 
potential participant’s decision to enroll in the study. A physical or electronic signature will be required 
on the written informed consent form, but verbal informed consent will not require this. For those 
eligible for any part of the study, informed consent will be obtained prior to participation in study-
related procedures. Informed consent procedures for all participants will take place in a private space. 
DR study staff will be trained to communicate all components of the written or verbal informed consent 
clearly, so that potential participants understand that their consent is voluntary and to avoid coercion. 
Consent will use clear language that explains that the participant’s relationship with the clinic will not be 
affected by his or her decision to participate or not participate in this study. The informed consent 
language will be developed at no greater than a 5th grade reading level and may be read aloud to the 
potential participant, if deemed necessary. During the creation of the informed consent document, 
research staff will embed a series of basic questions to gauge the potential participant’s understanding of 
procedures, in order to assure that participants are able to comprehend the details of the study. If the 
potential participant fails to answer these questions appropriately, he or she will not be enrolled into the 
study.  
 
d. Who will conduct the consent interview?  
Only trained study personnel in the DR, who speak Spanish, will facilitate the written or verbal 
informed consent processes with potential participants. 

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e. Who are the persons who will provide consent, permission, and/or assent?
For the health care workers, they will provide consent for themselves. For the patients at each clinic,
they will provide consent for themselves if they are 18 years of age or older (legal age of adulthood in 
DR is 18). If patients at each clinic are aged 16-17, we will take informed consent from both the youth 
and his or her legal guardian unless youth provides proof of emancipation, which will be collected and 
documented along with his/her consent.  
f. What steps will be taken to minimize the possibility of coercion or undue influence?
Informed consent procedures for all participants will take place in a private space. DR study staff will
be trained to communicate all components of the informed consent clearly, so that potential participants 
understand that their consent is voluntary and to avoid coercion. Consent will use clear language that 
explains that the participant’s relationship with the clinic will not be affected by his or her decision to 
participate or not participate in this study. The informed consent language will be developed at no 
greater than a 5th grade reading level and may be read aloud to the potential participant, if deemed 
necessary. During the creation of the informed consent document, research staff will embed a series of 
basic questions to gauge the potential participant’s understanding of procedures, in order to assure that 
participants are able to comprehend the details of the study. If the potential participant fails to answer 
these questions appropriately, he or she will not be enrolled into the study. 
g. What language will the prospective participant and the legally authorized representative understand? Spanish
h. What language will be used to obtain consent? Spanish
i. If any potential participants will be, or will have been, in a stressful, painful, or drugged condition before or
during the consent process, describe the precautions proposed to overcome the effect of the condition on
the consent process. If not, enter “None.” None 
j. If any protocol-specific instruments will be used in the consenting process, such as supplemental  handouts,
videos, or websites,  describe these here and provide a copy of each. If not, enter “None.” None
k. How long will participants have between the time they are told about the protocol and the time they must
decide whether to enroll? If not 24 hours or more, describe the proposed time interval and why the 24-hour
minimum is neither feasible nor practical. Because these are clinical patients who are living with HIV, 
often with inconsistent circumstances, it is important that we are able to inform and enroll in a single 
session. There will be a delay between when they learn of the protocol and each Aim, so they will be able 
to change their mind. 
22. Procedures to Protect Privacy
Describe how you will protect the privacy interest of the participants. Include how you will make sure others
cannot overhear your conversation with potential participants and that individuals will not be publicly identified
or embarrassed.
Study personnel will follow regulatory guidelines for obtaining written or verbal informed consent. All
interviews and intervention activities will be conducted in private spaces, in so far as possible.
23. Procedures to Maintain Confidentiality
a. Describe how you will store research data to maintain confidentiality (both paper records and electronic data),
including how access is limited. If data will be stored electronically anywhere other than a server maintained
centrally by UAB, identify the department and all computer systems used to store protocol-related data.
The team will make every effort to protect all participants’ confidential and private information in order to
minimize possible study-associated risks. For all participants, research data will be stored using a code
(sequence number based on entry to the study) instead of names or other personal identifiers. Research team
members analyzing the study-related data will not attempt link the participant to identifying information or
learn of his/her identity. Only the designated site personnel (and MPIs) can track the use of participant or

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patient identifiers. Consent forms with links to participant study numbers will be kept in a in a locked file in a 
locked room with the PI (Budhwani) if paper-based or in an encrypted, password-protected file at UAB if 
electronic. According to UAB regulatory policy, records relating to research, including informed consent 
documents, shall be securely retained for one year after completion of the research. All records shall be 
accessible for inspection and copying by authorized representatives of the department or sponsor agency at 
reasonable times and in a reasonable manner. All electronic study data are kept on UAB secure encrypted 
password protected servers, and will only be available to research personnel. All study personnel will complete 
HIPPA and human subjects training in accordance with UAB Institutional Review Board policy. 
 
b. Will any data from this protocol be given to any person, including the subject, or any group, including 
coordinating centers and sponsors? 
☐Yes ☒No 
If Yes, complete i-iii. 
i. Who will receive the data?   
Study participants and the larger scientific community  
ii. What data will be shared?  
Findings related to this research will be provided to study participants in dissemination meetings 
and materials. Study data will only be shared with the larger scientific community in coded 
fashion. No data will be accepted from or distributed to investigators if regulatory approval has 
lapsed. Requests for study-related datasets will be submitted to the MPIs. Copies of each of these 
regulatory documents will be kept on file at UAB. 
 
iii. How will the data be identified, coded, etc.?  
Coded 
 
24. Genomic Data Sharing (GDS) 
Researchers who collect genomic data as part of a NIH grant funded after January 25, 2008 may be required to 
submit those data to a NIH database for broad scientific sharing. See Genomic Data Sharing in the IRB Guidebook 
for more information. 
 
a. Does this protocol involve the proposed submission of genetic data into genomic repositories created to share 
genetic information for research purposes? 
☐Yes ☒No 
 
b. Will UAB be uploading the final genomic data to the central repository (e.g., dbGaP)? 
☐Yes ☐No 
If Yes to both a and b, submit a Detailed Data Sharing Plan to the IRB for review. This plan should include any 
known data use limitations and indicate whether aggregate-level data are appropriate for general research 
use. For guidance see the NIH Genomic Data Sharing Policy. 
 
c. Submit a copy of the NIH Institutional Certification Form. 
To determine which certification form to include, answer i-ii. 
i. Was this protocol funded prior to January 25, 2015? 
☐Yes ☐No 
• If yes, and consent will be obtained, submit the Extramural Institutional Certification - Before January 
25 - With Consent. 
• If yes, and consent will not be obtained, submit the Extramural Institutional Certification - Before 
January 25 - Without Consent. 
ii. Was this protocol funded after January 25, 2015? 
☐Yes ☐No 
• If yes, submit the Extramural Institutional Certification - After January 25. 
 
25. Additional Information 
In the space below, provide any additional information that you believe may help the IRB review the proposed 
research, or enter “None.” None 

Page 1 of 17 
Revised: June 27, 2022
Secondary (Move from UAB to FSU) Protocol
PROTOCOL TITLE: 
Adapting the Finding Respect and Ending Stigma around HIV (FRESH) 
Intervention for the Dominican Republic 
PRINCIPAL INVESTIGATOR: 
Henna Budhwani, PhD, MPH 
College of Nursing 
(205) 296-3330
hbudhwani@fsu.edu
VERSION NUMBER/DATE: 
Version 1: 08/20/22 
REVISION HISTORY 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
 
Page 2 of 17 
Revised: June 27, 2022 
Table of Contents 
1.0 
Study Summary........................................................................................................ 3 
2.0 
Objectives................................................................................................................. 4 
3.0 
Background .............................................................................................................. 4 
4.0 
Study Endpoints ....................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved................................................................................................. 6 
7.0 
Data and Specimen Banking .................................................................................... 7 
8.0 
Sharing of Results with Subjects ............................................................................. 8 
9.0 
Study Timelines ....................................................................................................... 8 
10.0 Inclusion and Exclusion Criteria.............................................................................. 8 
11.0 Vulnerable Populations ............................................................................................ 9 
12.0 Local Number of Subjects........................................................................................ 9 
13.0 Recruitment Methods ............................................................................................... 9 
14.0 Withdrawal of Subjects .......................................................................................... 10 
15.0 Risks to Subjects .................................................................................................... 10 
16.0 Potential Benefits to Subjects ................................................................................ 12 
17.0 Data Management and Confidentiality .................................................................. 12 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 14 
19.0 Provisions to Protect the Privacy Interests of Subjects.......................................... 14 
20.0 Compensation for Research-Related Injury ........................................................... 15 
21.0 Economic Burden to Subjects ................................................................................ 15 
22.0 Consent Process ..................................................................................................... 15 
23.0 Process to Document Consent in Writing .............................................................. 15 
24.0 Setting .................................................................................................................... 15 
25.0 Resources Available............................................................................................... 16 
26.0 Multi-Site Research................................................................................................ 15 
 
 
 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
 
Page 3 of 17 
Revised: June 27, 2022 
1.0 
Study Summary 
 
Note: We are only applying for IRB approval for the remainder of the project. Most of 
the study has already been completed. (See UAB IRB protocol document for orientation.) 
We are only applying for the remainder of what was previously approved at UAB. We 
are not proposing any changes to the approval we had at UAB. All local personnel in the 
Dominican Republic are covered under the local reviewing IRB at UNIBE.  
 
Study Title 
Adapting the Finding Respect and Ending Stigma around 
HIV (FRESH) Intervention for the Dominican Republic 
Study Design 
Survey 
Primary Objective 
Analyze perceptions/attitudes/beliefs around HIV 
Secondary 
Objective(s) 
Health outcomes (per de-identified, anonymous clinical data) 
Research 
Intervention(s)  
N/A 
Study Population 
Clients and health workers 
Sample Size 
N=100 clients and N=20 health workers 
Study Duration for 
individual 
participants 
One time survey 
Study Specific 
Abbreviations/ 
Definitions  
PLWH: people living with HIV 
SGM: sexual and gender minorities 
MSM: men who have sex with men 
 
 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
Page 4 of 17 
Revised: June 27, 2022
2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives. 
The overall purpose of this research project is to adapt an 
educational intervention (Finding Respect and Ending Stigma 
around HIV) that has been proven to be effective in Africa and the 
US to meet the needs of HIV clinics in the Dominican Republic. 
Health outcomes, as well as perceptions/attitudes/beliefs, will be 
measured before and after the intervention. 
The purpose of this IRB submission is to just collect the last round of 
in-clinic survey data and the last round of de-identified and 
anonymous clinical data.  
2.2 State the hypotheses to be tested. 
N/A 
3.0 
Background 
3.1 Describe the relevant prior experience and gaps in current 
knowledge. 
There are high levels of stigma against sexual and gender minorities 
(SGMs) in the Caribbean. Many Caribbean nations have a dominant 
conservative ideology that criminalizes MSM sexual behaviors and 
shames young SGM, particularly those who are living with HIV. In 
the DR, stigmatizing views are commonplace, and policies that 
perpetuate stigma towards PLWH and SGMs are embedded in DR 
laws. Stigmatizing attitudes toward PLWH and SGMs are often 
reflected in the behaviors of health workers, and thus stigmas may 
become embedded in HIV clinics, leading PLWH to be reluctant to 
engage in care. In the DR, PLWH routinely experience intersectional 
stigma for being a PLWH and for identifying as an SGM. This 
intersectional stigma may increase the amount and intensity of 
stigma experienced by SGMs who are living with HIV, with 
synergistic effects on health outcomes. Research shows that these 
stigmas are significant barriers to HIV treatment services and 
contribute to the DR’s low 16% viral suppression rate. 
HIV and intersectional stigmas in healthcare settings are significant 
barriers to care in the DR. Consejo Nacional para el VIH y el SIDA 
(CONAVIHSIDA) recently released results from its national study on 
HIV stigma. This study found that over a third of HWs had no stigma 
training; a third of HWs were afraid to draw blood from PLWH, and 
56% of HWs did not want to provide services to SGMs living with 
HIV, because they felt SGMs deserved to be HIV-infected. Findings 
from the Transgender Health Study further validate the notion that 
stigma is a significant barrier to HIV services in the DR. In fact, it 
was only after advocates took their demands to the Inter-American 
Human Rights Commission that antiretroviral therapy (ART) was 
approved as a covered medical expense in the DR, and it wasn’t 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
Page 5 of 17 
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until 2009 that PLWH were allowed to enroll in the DR National 
Health Insurance System. Stigmatizing attitudes from HWs push the 
epidemic underground and promote the spread of HIV, because 
PLWH and SGMs may avoid engaging in care due to fears of stigma 
from HWs. Thus, it is imperative that tailored interventions to reduce 
stigmas in clinics be developed and tested. If stigmas are not 
addressed, the DR will likely see a rise in new infections and 
worsening of HIV outcomes in PLWH. 
3.2 Describe any relevant preliminary data. 
N/A 
3.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how 
will it add to existing knowledge. 
There are surprisingly few intersectional stigma reduction 
interventions for healthcare settings. Clinic-based stigma-reduction 
interventions have primarily been developed for Asian and African 
settings, making the adaptation of FRESH for the Caribbean unique. 
In assessing interventions for appropriateness, we applied Nyblade’s 
key criteria for stigma-reduction efforts. Evidence-based strategies 
include selecting interventions that involve PLWH and HWs, use of 
participatory methods, address actionable drivers of stigma in the 
short term, put PLWH at the core of the response, and create 
partnerships between PLWH experiencing stigma and HWs to model 
non-stigmatizing behaviors. Considering the lack of HIV-stigma 
research in the DR and that FRESH is one of the few interventions 
that meets these  criteria, the DR is a priority setting for the cultural 
adaptation and testing of the FRESH intervention that involves both 
PLWH and HWs. 
The Finding Respect and Ending Stigma around HIV (FRESH) 
intervention is ideal to adapt and test. The FRESH intervention was 
originally developed in a study in five African nations, then was 
adapted for the United States. Since we have data showing that 
FRESH is adaptable, revising it for Latinx and Hispanic populations 
could yield scientific evidence leading FRESH to become a validated 
multi-region stigma-reduction intervention. The FRESH intervention 
brings together HWs of all types and PLWH to collaborate in a 
workshop to increase understanding of HIV-related and 
intersectional stigmas. FRESH facilitates conversations on effects of 
stigma on health and well-being and guides participants to better 
recognize and understand stigmas. FRESH includes didactic content 
and interactive activities. Each topic includes contact-theory 
informed activities designed to bring HWs and PLWH together to 
change perceptions of each other while enhancing empowerment 
and empathy. Facilitators use a standard manual for consistent 
content delivery. FRESH was efficacious in reducing stigmas in 
Africa, and the United States pilot had promising results 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
Page 6 of 17 
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(Preliminary Studies). We are confident that FRESH is an excellent 
intervention to adapt for the DR because, 1) FRESH is sustainable. 
Facilitators can train other trainers. 2) FRESH is low-cost. As a 
socio-structural intervention, there are no clinical costs. 3) FRESH 
is extensible. We have shown that FRESH was adapted from African 
contexts to the United States, and 4) FRESH is flexible. FRESH was 
adapted to address a spectrum of relevant intersectional stigmas in 
the US Deep South, among other modifications. 
4.0 
Study Endpoints 
4.1 Describe the primary and secondary study endpoints. 
In-clinic data will be collected for one month. If approved in time, 
we expect to start in-clinic data collection September 1, 2022.  
Retrospective clinic data will be collected after IRB approval for the 
months of July 1st-August 31st, 2022.  
5.0 
Study Intervention 
1.1 Description: Describe the study intervention that is being evaluated. 
N/A: The intervention has already been delivered to participants. They are 
no longer enrolled in the study.  
6.0 
Procedures Involved 
6.1 Describe and explain the study design. 
The remainder of the study is a one-time survey for participants. 
6.2 Provide a description of all research procedures being performed 
and when they are performed, including procedures being performed 
to monitor subjects for safety or minimize risks. 
We will collect outcome information on demographics, stigma-
related measures, and HIV-related behavioral outcomes by asking 
all HWs and PLWH in Site 2 and 3 clinics to complete in-clinic 
anonymous surveys (we expect the effects of the workshop to impact 
stigma throughout the whole clinic, not just the workshop 
participants). In-clinic stigma surveys will be completed at 4 time 
points pre- and post- workshop (intervention). Time points 1-3 have 
already been completed.  
Research personnel at FSU will not be collecting data. However, the 
surveys, attached to this submission, will be held through FSU’s 
Qualtrics forum. Research personnel at FSU will not have any way 
to identify the individual participants (i.e. no names or identifiers 
are being collected). All data collection methods will be done by the 
local team in the Dominican Republic, who have separate IRB 
approval at UNIBE.  
In addition, outcomes related to HIV care will be collected from the 
national HIV medical records system monthly. Data will include 1) 
Number of new-to-care PLWH, 2) ART initiation, and 3) Viral load 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
 
Page 7 of 17 
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suppression rates. These data will be used to compare site-level HIV 
cascade outcomes pre- and post- FRESH. This data is de-identified 
and will be collected by the local team in the Dominican Republic. 
There is no way to trace data to individuals, as the data will be 
collected through the Ministry of Health. FSU personnel, if 
approved, will receive the anonymous data from the local 
Dominican Republic team.  
6.3 Describe: 
• 
Procedures performed to lessen the probability or magnitude 
of risks. 
• 
The source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection 
forms.) 
All data collection is anonymous. There is no way to trace data to 
back individuals. Contact with human subjects will not be done 
through FSU.  
The surveys are in Spanish but will be attached to the submission. 
English translations of the surveys are also provided with a letter 
from the local Dominican Republic team verifying that the surveys 
are translated accurately and match.  
6.4 Describe what data will be collected during the study and how that 
data will be obtained. Note that IF the data will include any health 
information that is subject to the HIPAA Privacy Rule, refer to the 
IRB’s HIPAA requirements [link] and follow any applicable 
instruction accordingly, including describing how the HIPAA 
Privacy Rule requirement will specifically be implemented in 
sections 17 (Data Management and Confidentiality) and 19 
(Provisions to Protect the Privacy Interests of Subjects) of this 
protocol. 
Survey data (copies attached) will be collected by the Dominican 
Republic team. FSU study personnel will not collect data. The survey 
will be taken anonymously through FSU’s Qualtrics forum. 
The Dominican Republic team will collect the relevant clinical data 
from the Ministry of Health. They will share the anonymous data 
with FSU personnel for data analysis.   
6.5 If there are plans for long-term follow-up (once all research related 
procedures are complete), what data will be collected during this 
period.  
N/A 
7.0 
Data and Specimen Banking 

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the Dominican Republic 
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7.1 If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens. 
N/A 
7.2 List the data to be stored or associated with each specimen. 
N/A 
7.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
N/A 
8.0 
Sharing of Results with Subjects 
8.1 Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) will be shared with subjects or others (e.g., the 
subject’s primary care physicians) and if so, describe how the results 
will be shared. 
Results will not be shared, as all remaining data is anonymous. 
9.0 
Study Timelines 
9.1 Describe: 
•
The duration of an individual subject’s participation in the
study.
•
The duration anticipated to enroll all study subjects.
Individuals will participate in a one-time survey. FSU study 
personnel will not be enrolling participants.  
10.0 Subject Population 
10.1 Describe generally the individuals that will be included in your 
study. 
The study population for the surveys includes clients at the clinics 
and health workers at the clinics.  
10.2 Describe any subject populations that will be specifically targeted, 
or specifically excluded from your sample. 
N/A 
10.3 Indicate specifically whether you will include or exclude any of the 
following special populations: (You may not include members of 
these populations as subjects in your research unless you include 
them in the description of your subject population.) 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
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•
Adults unable to consent
•
Individuals who are not yet adults (infants, children, teenagers)
•
Pregnant women
•
Prisoners
We will not include any of the above populations. 
11.0 Vulnerable Populations 
11.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
N/A 
12.0 Local Number of Subjects 
12.1 Indicate the total number of subjects to be accrued locally, if known. 
In total, we estimate samples of N=400 PLWH client surveys; N=80 
HW surveys.  HIV care data, at the clinic-level and not the 
individual-level, will be obtained from the sites monthly for the full 
24-months. 
13.0 Recruitment Methods 
13.1 Describe when, where, and how potential subjects will be recruited. 
If recruitment will involve a non-FSU site, describe whether site 
approval for recruitment is required, and attach documentation of 
site approval. 
We will not be recruiting participants at FSU. 
13.2 Describe the source of subjects. 
Survey participants are clients or health workers at the clinics. 
13.3 Describe the methods that will be used to identify potential subjects. 
See above. 
13.4 Describe materials that will be used to recruit subjects. (Describe 
materials that will be used to recruit subjects. For advertisements 
and all other recruitment materials, attach the final copy of printed, 
web-based, online or other electronically conveyed materials in the 
Local Site Documents/Recruitment materials section of the RAMP 
IRB submission workspace for the study. When advertisements are 
taped for broadcast, attach the final audio/video tape; you may 
submit the wording of the advertisement prior to taping to preclude 
re-taping based upon required or suggested IRB revisions, provided 
the IRB reviews the final audio/video tape). Refer to 
“WORKSHEET: Advertisements & Other Recruitment Materials 
(HRP-315)” to ensure that recruitment procedures and recruitment 
materials will conform to requirements for IRB review and approval. 
See above. 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
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13.5 Describe as applicable whether and how subjects will be paid, earn 
course or other credits, reimbursed or provided with any financial or 
other incentive, token or gift for taking part in the research. Include 
a description and schedule of the total amount or value as well as 
the timing of any payments, credits, reimbursement or other 
incentive, token or gift. Indicate how if at all any amount is pro-
rated for research visit or activity completion, and whether and how 
subjects’ refusal to answer any question or subjects’ withdrawal 
from or discontinuing taking part in the study or any study activity 
will reduce or preclude subjects from earning part or all of such any 
payment, credit, reimbursement or other incentive, token or gift. 
Also describe the proposed method (how, by whom, form etc.) of 
payment/disbursement. While payment should not be contingent 
upon completion of the entire study, a proportion or progressive 
partial payment as an incentive for completion of the study is 
acceptable. 
Refer to this FSU link regarding use of gift cards: 
https://procurement.fsu.edu/vendors/NationalGiftCard. 
Refer to this FSU Controller link regarding use of cash payments for 
human subject incentive payments:  
https://controller.vpfa.fsu.edu/services/accounts-
payable/unencumbered-payments/employee-cash-advance-requests.  
Incentives will not be processed through FSU. 
13.6 Describe as applicable whether and how student subjects will be 
provided with course or other academic credit for taking part in the 
study. Include a description about whether student subjects’ refusal 
to answer any question or withdrawal from or discontinuing taking 
part in the study or any study activity will reduce or preclude student 
subjects from earning part or all of such credit. 
N/A 
14.0 Withdrawal of Subjects 
14.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
N/A 
14.2 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
N/A 
15.0 Risks to Subjects 
15.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
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Revised: June 27, 2022
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks. For each of these risks, describe in detail how the 
risks will be minimized. 
There should not be any risks at Florida State University. Survey 
data will be collected via FSU Qualtrics, but there will be no 
interaction with participants at FSU. FSU personnel will only have 
access to the anonymous data.  
Participants may experience temporary stress due to the nature of 
some of the survey questions. The local Dominican Republic team 
will inform the participant that they may stop the survey at any time 
if stress occurs. 
15.2 If information about the study’s actual purpose will not be 
completely or accurately described to study subjects, or in any way 
be withheld, obscured, masked, or blinded from study subjects (e.g., 
you want to avoid participation bias or priming prospective 
subjects), you are required to describe here that you will: (a) as part 
of the consent process provide subjects with a statement to the effect 
that subjects may not be made aware of some features about the 
study, such as its exact purpose, study questions and materials, or 
subjects’ responses that you would like to collect, and that subjects 
will be provided with additional information about the study at the 
end of their participation or at any time they withdraw, (b) debrief 
subjects at the end of their participation or at any time they 
withdraw, and (c) provide the IRB with a copy of all materials that 
will be used to debrief subjects. 
N/A 
15.3 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
N/A 
15.4 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
N/A 
15.5 If applicable, describe risks to others who are not subjects (e.g., 
family members, colleagues, acquaintances or other persons) but 
about whom subjects will or may, as part of any study activity, 
identify, reference or provide identifiable, private information about 
these other individuals). 
N/A 
15.6 Special instructions if children (individuals less than 18 years of 
age) will be included as subjects: Federal law at 45 CFR 46, section 
46.406 permits the involvement of children as human subjects in 
research for which there is no prospect of direct benefit to individual 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
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Revised: June 27, 2022
child subjects, but ONLY IF the risks in the research represent only 
a minor increase over minimal risk to a child. 
Minimal risk means that the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during 
the performance of routine physical or psychological examinations 
or tests of healthy children. 
If applicable (i.e., there is no prospect of direct benefit to individual 
child subjects), describe how the probability (e.g., likelihood) and 
magnitude (e.g., severity, duration, reversibility) of any harm or 
discomfort anticipated in the research involving children represents 
only a minor (i.e., slight, negligible) increment beyond minimal risk 
to healthy children as subjects.   
N/A 
16.0 Potential Benefits to Subjects 
16.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
Participants in this study are HWs and PLWH. Overall, if successful, 
this project will yield a model for sustainable implementation of an 
intervention to reduce stigma and improve outcomes across the HIV 
cascade in resource-poor settings. Given the limited risks associated 
with this intervention study, the benefits outweigh the risks. PLWH 
are at particular risk of being stigmatized, yet few interventions exist 
that specifically reduce stigma in healthcare settings for the 
Caribbean. This study will ultimately benefit both PLWH and their 
healthcare providers by creating stigma-free healthcare 
environments and improving outcomes along the HIV continuum of 
care. 
16.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others. Also, payment to research subjects for 
participation in studies is not considered a benefit so do not list 
payment to research subjects in this section; if a recruitment 
incentive will be offered, described this in section 13 under 
Recruitment Methods. 
There is no direct benefit to the specific participants taking the 
survey.  
17.0 Data Management and Confidentiality 
17.1 Describe the data analysis plan, including any statistical procedures 
or power analysis. 
Our analysis plan includes three steps: 1) Evaluate reliability of  
translated scales; 2) Assess acceptability of the adapted intervention; 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
Page 13 of 17 
Revised: June 27, 2022
3) Analyze stigma and related constructs pre- and post-intervention 
and between intervention sites. To ensure reliability of newly translated 
stigma scales, we will calculate Cronbach’s alphas and compare the 
statistic for the Spanish version to the English version. To examine 
acceptability 
of 
the 
intervention, 
we 
will 
analyze 
post-FRESH 
questionnaire data on workshop satisfaction. We will use descriptive 
statistics for stigma outcomes and potential mediators and moderators of 
interest. We will compare changes from pre-FRESH to post-FRESH. Data 
from all time points will be used. Analyses will be performed for 
healthcare workers and people living with HIV separately and in 
aggregate. Analyses will include all participants who provide pre- and 
post-workshop data. Thus, final data will be presented as pre- and post-
intervention changes in healthcare workers and people living with HIV. 
Estimates 
of 
correlations, 
intra-cluster 
correlation, 
within-period 
correlation, etc. will be calculated to inform future trial designs. Due to 
the small number of pilot participants, we will not conduct mediation 
analyses 
to 
examine 
pathways. 
We 
will 
conduct exploratory 
analyses of associations of potential mechanisms with outcome variables. 
HIV 
cascade 
outcomes 
will 
be 
compared 
pre- 
and 
post-
intervention to provide guidance on the design of the future R01 trial. As 
a pilot study to develop preliminary estimates, this study is not powered to 
show efficacy. However, in preparation for the full-scale R01 trial, we 
conducted precision estimates for this study and a power analysis for the 
future R01.
17.2 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission. 
17.3 Describe any procedures that will be used for quality control of 
collected data. 
We are requesting IRB approval for data analysis and the final two 
steps of data collection including collecting anonymous, de-
identified post-visit survey data from patients and providers and 
anonymous, de-identified medical records data. 1) Password-
protected clinical records data will be delivered from the Dominican 
Republic to the United States via encrypted and secure box.net 
folder; once the data has been delivered to the folder, the FSU 
research team will verify the data and share with the biostatistician 
at the University of Alabama at Birmingham (UAB) for analyses. 
The UAB biostatistician is covered under the UAB IRB. There are no 
patient identifiers in the data. 2) Qualtrics data will be collected via 
the FSU approved Qualtrics system. Data will be downloaded 
intermittently during the two week data collection window into a 
secure box.net folder dedicated to these anonymous, identifier-less 
data. Once downloaded. The data will be password protected with a 
strong password and only shared for analysis purposes, as detailed 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
Page 14 of 17 
Revised: June 27, 2022
in the original proposal. No additional steps will be taken for quality 
control. These procedures led to successful outcomes for the prior 
three rounds of data collection without any breeches. 
17.4 Describe how data or specimens will be handled study-wide: 
•
What information will be included in that data or associated
with the specimens?
•
Where and how data or specimens will be stored?
•
How long the data or specimens will be stored?
•
Who will have access to the data or specimens?
•
Who is responsible for receipt or transmission of the data or
specimens?
•
How data or specimens will be transported?
N/A 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
This section is required for any study that may involve any harm or 
discomfort for which the probability or magnitude is greater than those 
that may be ordinarily encountered by healthy persons in daily life or 
during the performance of routine physical or psychological examinations 
or test. 
A DSMB was not required by the NIH. Because data collection is 
anonymous and de-identified, there is no way to map back to 
individuals. The medical records data contain limited information, 
none of which would indicate and AE or SAE, since the data is purely 
administrative. However, in- clinic data is being collected from 
patients and providers. These data are also anonymous and therefore 
unidentifiable; these data primarily focus on experiences of stigma 
and discrimination in the clinic setting. Upon the completion of the 
study, findings will be reported to the clinics. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 
FSU study personnel will not have contact with participants. 
19.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
FSU study personnel will not have contact with participants. 

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
Page 15 of 17 
Revised: June 27, 2022
19.3 Indicate how the research team is permitted to access any sources of 
information about the subjects. 
All remaining data is anonymous. 
20.0 Compensation for Research-Related Injury 
This section is required for any study that may involve any harm or 
discomfort for which the probability or magnitude is greater than those 
that may be ordinarily encountered by healthy persons in daily life or 
during the performance of routine physical or psychological examinations 
or test. 
20.1 Describe the available compensation in the event of research related 
injury. 
N/A 
20.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
N/A 
21.0 Economic Burden to Subjects 
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
N/A 
22.0 Consent Process 
22.1 Indicate whether you will you be obtaining consent, and if so 
describe: 
FSU study personnel will not be consenting participants. All 
consenting will be done by the Dominican Republic team, who have 
IRB approval at UNIBE.  
23.0 Process to Document Consent in Writing 
23.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be documented in writing. 
FSU study personnel will not be consenting participants. All 
consenting will be done by the Dominican Republic team, who have 
IRB approval at UNIBE. 
24.0 Setting 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
•
Identify where your research team will identify and recruit
potential subjects.

Adapting the Finding Respect and Ending Stigma around HIV (FRESH) Intervention for 
the Dominican Republic 
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Revised: June 27, 2022
Lotes y Servicios and Centro Sanitario in the Dominican 
Republic  
•
Identify where research procedures will be performed.
Lotes y Servicios and Centro Sanitario in the Dominican
Republic
•
Describe the composition and involvement of any community
advisory board.
N/A at FSU.
•
For research conducted outside of the organization and its
affiliates describe:
o
Site-specific regulations or customs affecting the
research for research outside the organization.
None noted; any relevant considerations were addressed
in the local IRB review by UNIBE.
o
Local scientific and ethical review structure outside the
organization.
IRB at UAB (Alabama) and UNIBE (Dominican
Republic).
•
Describe non-FSU site approval to conduct research at any
non-FSU site or location, and attach approval documentation.
If no such approval was required, so state and be prepared to
provide documentation. Studies involving non-FSU sites,
institutions or agencies, such as TMH, CRMC, FAMU, state
agencies and other organizations, may require those sites' IRB,
research review or other approvals. Before submitting your
studies for FSU IRB review, you must contact such sites to
ascertain their review requirements and comply accordingly.
The FSU IRB may require documentation of such site contact.
Collaborations involving TMH are subject to specific
requirements; click here for more information.
We have received IRB approvals from UAB (Alabama) and
UNIBE (Dominican Republic). See letters.
25.0 Resources Available 

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Revised: June 27, 2022
25.1 Describe the resources available to conduct the research: For 
example, as appropriate: 
•
Justify the feasibility of recruiting the required number of
suitable subjects within the agreed recruitment period. For
example, how many potential subjects do you have access to?
What percentage of those potential subjects do you need to
recruit?
•
Describe the time that you will devote to conducting and
completing the research.
•
Describe your facilities.
•
Describe the availability of medical or psychological resources
that subjects might need as a result of an anticipated
consequences of the human research.
•
Describe your process to ensure that all persons assisting with
the research are adequately informed about the protocol, the
research procedures, and their duties and functions.
N/A at FSU 

Statistical Analysis Plan, Overall 
Our analysis plan includes three steps: 1) Evaluate reliability of Spanish 
translated stigma scales; 2) Assess acceptability of the adapted 
intervention; 3) Analyze stigma and related constructs pre- and post-
intervention and between intervention sites. To ensure reliability of newly 
translated stigma scales, we will calculate Cronbach’s alphas and compare 
the statistic for the Spanish version to the English version. To examine 
acceptability of the intervention, we will analyze post-FRESH questionnaire 
data on workshop satisfaction. We will use descriptive statistics for stigma 
outcomes and potential mediators and moderators of interest. We will 
compare changes from pre-FRESH to post-FRESH. Data from all time 
points will be used. Analyses will be performed for healthcare workers and 
people living with HIV separately and in aggregate. Analyses will include all 
participants who provide pre- and post-workshop data. Thus, final data will 
be presented as pre- and post-intervention changes in healthcare workers 
and people living with HIV. Estimates of correlations, intra-cluster 
correlation, within-period correlation, etc. will be calculated to inform future 
trial designs. Due to the small number of pilot participants, we will not 
conduct mediation analyses to examine pathways. We will conduct 
exploratory analyses of associations of potential mechanisms with outcome 
variables. HIV cascade outcomes will be compared pre- and post-
intervention to provide guidance on the design of the future R01 trial. As a 
pilot study to develop preliminary estimates, this study is not powered to 
show efficacy. However, in preparation for the full-scale R01 trial, we 
conducted precision estimates for this study and a power analysis for the 
future R01.
Statistical Analysis Plan, Primary Outcomes 

While we will collect various forms of data, primary outcomes will be 
assessed from the pre-post workshop data. Cronbach’s alphas will be 
calculated for each multi-item scale to examine for the internal consistency. 
Assumption of normality will be checked. Pre -and post- survey measures will 
then compare to assess the change after the workshop intervention using  
paired t-tests if the normality is conﬁrmed, and Wilcoxon signed rank tests if 
the normality assumption was violated. The signiﬁcance level will be p<0.05. 
All analyses will be performed with SAS (Version 9.4, Cray, North Carolina, 
USA), but SPSS can be used in its place if needed.