Research Determination

12/18/2015

REQUEST FOR NCHHSTP PROJECT DETERMINATION & APPROVAL
NCHHSTP ADS/ADLS Office on behalf of CDC (New, Continuation, or Amendment)

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
([email protected]) of these projects indicates approval by CDC. This review and approval process
complies with obligations for adherence of projects to federal regulations, state laws, ethics guidelines,
CDC policies, and publication requirements.
For research that involves identifiable human subjects in which CDC/NCHHSTP is engaged, use CDC
Human Research Protection Office forms and submit them to CDC Human Research Protection Office
through the NCHHSTP ADS human subjects email box after approval at the branch and division levels.

RELEVANT INFORMATION
What is a project?
A project is defined as a time-limited activity that is funded for a specific period of time, an activity with
specified funds for a limited time, or as a limited time responsibility by specific CDC employees or staff,
including projects that might be ongoing or continuous for an extended period. A project has defined
objectives, tasks (e.g., essential public health services), dedicated resources, and is funded for a specified
time. NCHHSTP reviews and approves projects for the four project categories listed on this form. Every
project officer, project team and staff, NCHHSTP branch, and NCHHSTP division or office is responsible
for submitting this form for each project and for obtaining NCHHSTP OD/ADS or ADLS approval on behalf
of CDC before project initiation, continuation, or amendment. Such programs as surveillance are
approved and funded as specific projects for certain periods.

What is research?
The federal regulations and CDC/OD/ADS office define research as a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition constitute research, regardless if these activities are
conducted or supported under a program that is not considered research for other purposes. For
example, demonstration and service programs sometimes include research activities.

What is a human subject?
A human subject is a living individual about whom an investigator (whether professional or student)
conducting research obtains
1. data through intervention or interaction with the individual or
2. identifiable private information.

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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12/18/2015

What is private information?
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is occurring and information that has been
provided for specific purposes by an individual and that the individual can reasonably expect will not be
made public (e.g., a medical record). Private information identifies individuals (i.e., the identity of the
person is or might be readily ascertained by the investigator or associated with the information) for the
information to constitute research involving human subjects.

What does being “engaged” mean?
An institution becomes “engaged" in human subjects research when its employees or agents intervene
or interact with living individuals for research purposes, or obtains individually identifiable private
information for research purposes. An institution is automatically considered to be engaged in human
subjects research whenever it receives funding or resources (e.g., a direct award) to support such
research. In such cases, the awardee institution has the ultimate responsibility for protecting human
subjects under the award.

What is surveillance?
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health
data essential to the planning, implementation, and evaluation of public health practice, closely
integrated with the timely dissemination of these data to those who need to know. The final link of the
surveillance chain is the application of these data to prevention and control. A surveillance system
includes a functional capacity for data collection, analysis, and dissemination linked to public health
programs.”

What is program evaluation?
Program evaluation is the systematic collection of information about the activities, characteristics, and
outcomes of programs to make judgments about the program, improve program effectiveness, or inform
or guide decisions about future program development. Program evaluation should not be confused with
treatment efficacy, which measures how well a treatment achieves its goals and that can be considered
research.

Sources (links)
 http://intranet.cdc.gov/od/oads/osi/hrpo/
 http://www.hhs.gov/ohrp/index.html

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PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
■

New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
Continuation: For projects expected to continue beyond NCHHSTP approved date; include brief description
of changes and attach clean and marked copies of approved determination (approval is for continued work
by CDC/NCHHSTP employees).
Amendment: Include brief description of changes and attach relevant documentation and a copy of
approved project (approval is for continued work by CDC/NCHHSTP employees).

Project Information:

Project Title: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA,
NCHHSTP Project Number:

Division: DHAP

Project Location/Country(ies):
Atlanta, GA; Philadelphia, PA; and Washington, DC

Telephone: (404) 784-2612

CDC Project Officer or CDC Co-Leads:

Damian J. Denson and Deborah Gelaude

Project Dates:
Start 09/16/2015
End 05/15/2017
Laboratory Branch Submission:
If applicable, select the checkbox:

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
I. Activity is not human subject research. The primary intent of the project is public health practice or a disease
control activity.
A. Epidemic or endemic disease control activity; collected data directly relate to disease control. If this
project is an Epi-AID; provide the Epi-AID number and documentation of the request for assistance,
per division policy. Epi-AID no.
B. Routine disease surveillance activity; data will be used for disease control program or policy
purposes.
C. Program evaluation activity; data will be used primarily for that purpose.
D. Post-marketing surveillance of effectiveness or adverse effects of a new regimen, drug, vaccine, or
device.
E. Laboratory proficiency testing.
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II. Activity is not human subjects research. The primary intent is public health program activities.
A. Public health program activity (e.g., service delivery; health education programs; social marketing
campaigns; program monitoring; electronic database construction or support; development of patient
registries; needs assessments; and demonstration projects to assess organizational needs, management,
and human resource requirements for implementation).
B. Activity is purely administrative (e.g., purchase orders or contracts for services or equipment).
III. Activity is research but does NOT involve identifiable human subjects.
A. Activity is research involving collection or analysis of data about health facilities or other
organizations or units (i.e., not individual persons.)
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research using unlinked or anonymous data or specimens: ALL (1–4) below are required:
1. No one has contact with human subjects in this project; and
2. Data or specimens are or were collected for another purpose; and
3. No extra data or specimens are or were collected for this project; and
4. Identifying information was (one of the following boxes must be checked)
a. not obtained;
b. removed before this submission, or before CDC receipt, so that data cannot be linked
or re-linked with identifiable human subjects; or
c. protected through an agreement (i.e., CDC investigators and the holder of the key
linking the data to identifiable human subjects enter into an agreement prohibiting
the release of the key to the investigators under any circumstances. A copy of the
agreement must be attached.)
■

IV. Activity is research involving human subjects, but CDC involvement does not constitute “engagement in
human subject research.” Select only one option by checking the box: A indicates the project has current
funding; B or C indicates no current funding is applicable.
■

A. This project is funded under a grant, cooperative agreement, or contract award mechanism. ALL of
the following 3 elements are required:
■

1. CDC staff will not intervene or interact with living individuals for research purposes.

■

2. CDC staff will not obtain individually identifiable private information.

■

3. Supported institution(s) must have a Federalwide Assurance (FWA), and the project must be
reviewed and approved by a registered IRB or an institutional office linked to the
supported institution’s FWA.*
Supported institution of primary investigator or co-Investigators/entity name:*
Abt Associates
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Supported institution/entity FWA Number:* 664
FWA expiration date:* 08/10/2017
Expiration date of IRB approval:* 08/08/2017
*Attach copy of IRB approval letter(s) supporting project review and approval.
B. CDC staff provide technical support that does not involve possession or analysis of data or interaction
with participants from whom data are being collected (no current CDC funding).
C. CDC staff are involved only in manuscript writing for a project that has closed. For the project, CDC
staff did not interact with participants and were not involved with data collection (no current CDC
funding).

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Project Title: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA
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Project Description
Participating project staff must complete all 18 elements of this section.
This is a required description from CDC employees or staff for review and approval of a project plan or
proposal (or for changes) for projects conducted by CDC or in which CDC is involved. All 18 elements
are required to standardize the review and approval process across NCHHSTP, document that all 18
elements have been addressed, expedite review and approval by the NCHHSTP ADS or ADLS office, and
minimize CDC/OD/ADS office audit requests for additional information. A protocol may be attached to
this form, but it does not eliminate the requirement to complete all 18 elements.

PROJECT TITLE: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA

Instructions: Use the following boxes to complete the 18 items. Each box will expand as you type, and you are not
limited in the length of your answers. Formatting features and symbols also may be used.
1. CDC Principal Investigator(s) or Project Directors and branch/division/office affiliations:
Damian J. Denson, PhD, MPH (CDC/DHAP/PRB PI, Technical Monitor)
Deborah Gelaude, MA (CDC/DHAP/PRB Co-PI)

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:

Damian J. Denson, PhD, MPH (CDC/DHAP/PRB PI, Technical Monitor)
James W. Carey, PhD, MPH (Contract Officer Representative for overall iQual IDIQ contract
mechanism)

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Jamie Hart, PhD, MPH, Atlas Research, Inc.(Contractor PI, non-CDC), Clarke Erickson, MHA (Contractor Project
Manager/Data Collection Lead ), Julia Rollison, PhD (Contractor Data Collection and Analysis Advisor), Dianne Fragueiro,
MPH (Contractor Data Analyst), Reva Stidd, BA (Contractor Data Analyst), JoAnne Keatley, MSW (Contractor Subject
Matter Expert), Cynthia Klein, PhD (Contractor Senior Qualitative Research Advisor), Alex Mijares, MPH (Contractor Data
Analyst Lead), Marian Creasy, MPH (Contractor Data Analyst), Susan G. Pfefferly, PhD (Contractor On-call Psychologist),
Arlene Edwards, PhD, MPH (CDC Subject Matter Expert), Sara Bresee, MPH (CDC Subject Matter Expert), Nicole Pitts
(CDC Subject Matter Expert), Evelyn Olansky, MPH (CDC Subject Matter Expert), and Neal Carnes, MPH (CDC Project
Coordinator)

4. Institution(s) or other entity(ies) funding the project:
NA

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5. Project goals:
This study will collect qualitative data from 20 HIV-positive transgender women, 20 HIV-negative transgender women,
and 10 healthcare providers who provide care to transgender women. This diverse sample will allow us to explore
barriers and facilitators to HIV prevention, care, and treatment among transgender women from multiple perspectives.
Data collection for this study relies on in-depth interviews and demographic questionnaires to capture the unique
perspectives of transgender women and healthcare providers. This qualitative research can provide crucial
information for future HIV prevention, care, and treatment efforts to successfully reach and engage transgender
women, and improve the care they receive to one that is culturally competent.

6. Project objectives:
This study seeks to ask the following key research questions:
1. What are the individual, interpersonal and structural barriers and facilitators to HIV prevention,
care, and treatment experienced by transgender women?
2. What is the role of healthcare providers in providing HIV prevention, care, and treatment to
transgender women?

7. Public health (program or research) needs to be addressed:
Although HIV incidence is higher among transgender women than other populations, little research has been
conducted to understand the unique complexities surrounding transgender women’s experiences related to HIV
prevention, care, and treatment. To effectively address the HIV epidemic in this population, more must be
known and understood about the nature of transgender women’s risks for HIV infection, and what
evidence-based HIV prevention, care and treatment strategies are available and can be adapted to better meet
the needs of transgender women. Qualitative research provides a unique opportunity to address these gaps.

8. Population(s) or groups to be included:
This study will collect qualitative data from 20 HIV-positive transgender women, 20 HIV-negative
transgender women, and 10 healthcare providers who provide care to transgender women.

9. Project methods:
This study will sample 40 HIV negative and positive transgender women identified and recruited through local transgender serving community based organizations (CBOs), and a small convenience sample of 10 healthcare providers referred by participants or identified by study staff. Study
instruments will include an in-depth qualitative interview with both close- and open-ended questions.
Participants will be selected from three Metropolitan Statistical Areas (MSAs) with high HIV prevalence: Atlanta, GA; Philadelphia, PA; and Washington, DC. Due to potential challenges in identifying and recruiting transgender women, we anticipate that multiple sampling and recruitment
strategies will be utilized to ensure an adequate number of participants. Sampling approaches and recruitment strategies will vary by target group (i.e., transgender women and healthcare providers).
We will utilize convenience and snowball sampling to select 40 transgender women to participate in the study (20 HIV-positive transgender women and 20 HIV-negative transgender women). Transgender women will be screened for eligibility until each target is met in each MSA. During
data collection, study staff will assess whether adjustments to these proposed targets are needed in order to reach 40 participants. The Atlas Team has partnered with three CBOs that have extensive experience serving and coordinating programs for transgender women. CBO partners will
identify, recruit, and enroll 40 transgender women participants. The level of staff will be coordinators and outreach staff. CBOs will be compensated for their recruitment efforts to include recruitment training, participant eligibility screening, and scheduling of interviews through a subcontract
agreement with Atlas Research. Given the potential difficulties anticipated in recruiting transgender women as a hard-to-reach population, our team will rely first on convenience sampling and implement two recruitment strategies concurrently:
• Facility-Based Recruitment: CBO staff will approach potential participants seeking services on site at the CBO facility using the script in Appendix B and administer the eligibility screener (in-person or via phone) to interested individuals.
• Outreach-Based Recruitment: CBO staff currently conduct outreach activities and provide services at various off-site locations such as mobile units, offsite testing locations, and, if the CBO has previous authorization to conduct outreach in these locations, clubs and bars known to be
frequented by transgender women as part of their ongoing CBO activities. As feasible, CBO staff will approach potential participants at these locations using the script in Appendix B and administer the eligibility screener to interested individuals. Study staff will train recruiters and include
instructions in script to approach potential participants discreetly if outreach-based recruitment occurs.
In order to identify and enroll a diverse group of transgender women (e.g. age, race/ethnicity), CBOs will be asked to recruit participants using both facility-based and outreach-based recruitment strategies.
This study will use a purposive sampling approach to identify healthcare providers who provide routine care, HRT, and/or HIV treatment and care to transgender women participants (n=10) (e.g. physicians, nurse practitioners (NPs) and physician assistant (PA). The study target is to recruit
three providers in Atlanta, GA, four providers in Philadelphia, PA, and three providers in Washington, DC. A pool of healthcare providers within each MSA will be identified through 1) interviews with transgender women participants asked to indicate their providers for general health care,
HT, or HIV treatment or care services, 2) internet searches and 3) study staff’s previous experience with clinics indicating provision of services to transgender women within each MSA.
We will purposively sample healthcare providers from this pool taking into account type of provider (e.g., infectious disease physician primary care physician, endocrinologist), number of transgender women participants that cited the provider during their interview, number of years providing
HIV care and/or HRT to transgender women, and number of transgender women patients where feasible.
Providers will be recruited using multiple recruitment strategies:
• Our primary recruitment strategy will be to obtain referrals from transgender women participants. We will request that transgender women participants identify their general health care, HRT, and HIV treatment and care providers. Following the interviews, our team will contact the providers
first by phone to confirm eligibility and interest in participating in the study using the recruitment script provided in Appendix B. If providers express an interest in participating we will send them the study information sheet that includes study purpose, data collection methods, procedures,
and detailed description of the requirements for participation.
• Our secondary recruitment strategy will be to recruit healthcare providers that the study team, (including subject matter expert consultants) has identified through an Internet search as having experience providing care to transgender women in each of the MSAs.
• Our third recruitment strategy will be to utilize study staff’s previous experience with clinics indicating provision of services to transgender women within each MSA to identify and recruit healthcare providers that provide care to transgender women.

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10. Selection, inclusion, or sampling of participants (persons or entities):
The following inclusion and exclusion criteria will be used to determine eligibility for transgender women to participate in this study:
Inclusion Criteria
• Adult (at least 18 years of age)
• Assigned male sex at birth
• Identifies as transgender woman or female
• Self-reported engagement in anal or vaginal sex in the previous six (6) months
• HIV-positive: Self-reported HIV diagnosis for at least 12 months, regardless of current engagement in care
• HIV-negative: Self-reported negative HIV test result within the previous 3-months confirmed by CBO staff or by HIV rapid testing at the CBO
Exclusion Criteria
• Non-English speaker
• Current signs of being under the influence of alcohol or illicit substances (e.g. belligerent, slurred speech, swaying, drowsy, stumbling)

The following inclusion and exclusion criteria will be used to determine eligibility for healthcare providers to participate in this study:
Inclusion Criteria
• At least 6 months of experience providing care to transgender women
• Referred by a transgender study participant as her health care provider or known provider of services to transgender women based on previous work by study staff or subject matter experts

11. Incentives to be provided to participants:
Exclusion Criteria
Non-English speaker

Each CBO will be compensated based on the number of participants their organization is responsible for recruiting which equates to approximately $125
per completed interview. The amount each CBO receives will correlate with the number of interviews conducted (e.g., if the target number of participants is
not reached, the CBO will only be payed $125 per interview conducted). Atlas Research will pay the CBOs in one lump sum once the final interview has
been completed, at which point, Atlas Research will instruct the CBOs to cease recruitment. For the purposes of the subcontract agreement, we have
assumed that up to three individuals will need to be screened in order to recruit one participant.
Transgender women will receive a $40 token of appreciation and healthcare providers will receive $40 token of appreciation for completing the interview
and quantitative questionnaire. Atlas/Abt staff will provide the gift cards or money orders to the interview participants at the conclusion of each interview.

12. Plans for data collection and analysis:
Qualitative Analysis
Coding Data with NVivo 10.0. The codebook will describe the information that coders will “tag” for abstraction across all documents included in the study. We will use the instrument as the initial basis of our coding structure. As the analysis progresses, the codes can be refined, reorganized,
subdivided or merged using the NVivo 10.0 software (stand alone, non-network version). In addition to coding for the categories that are defined prior to reviewing the data, we expect to also use an inductive coding process to include new themes that emerge from the data. As the project
progresses, the study team will monitor the data processing steps and coding steps. The final codebook structure will include the following components: code, brief description, a full definition, guidelines for when to use the code, guidelines for when not to use the code and examples
(MacQueen, McLellan-Lemal, Bartholow, & Milstein, 2008; Salazar, Mijares, Crosby, & DiClemente, 2015).
Reviewing Reliability of Coding. Three members of the analysis team will code one-third of the transcripts). This double coding not only assists the definitional clarity but is an important reliability check. To ensure inter-coder reliability, we will run a coding comparison query in NVivo 10.0 to
generate a kappa coefficient (a statistical measure which takes into account the amount of agreement that could be expected to occur through chance). The goal is to reach an inter-coder reliability that has a kappa score of .8 or above (Hruschka, Schwartz, Cobb St. John, Picone-Decaro,
Jenkins, & Carey, 2004). Based on the results, codes are clarified, and rules about use defined. Once the coders reach inter-coder reliability after several rounds of coding and testing for reliability, the remaining data will be divided and independently coded by the two coders.
Querying the Data. Once the data are coded, the analysis team will use NVivo 10.0 to run a series of queries to identify patterns in the data. The team will begin with simple queries between main themes and coding structures (as described above). We will compare results across sites and
key participant characteristics.
Given the complex experiences of transgender women, we will also the use the Model of Gender Affirmation during the interpretation phase of the analysis to help explain the pathway of HIV risk for transgender women. This model suggests that when the need for gender affirmation is high
for transgender women and the receipt is low, they might look for situations that can give them that affirmation or validation. These situations might increase risk to their health and wellbeing. An example might be having unprotected receptive anal sex to affirm their femininity (Sevelius,
2013; Sevelius, Patouhas, Keatley, & Johnson, 2014).
Triangulation of Data. In this study, we will perform three types of triangulation: data source triangulation (i.e. a HIV positive transgender women, HIV negative transgender women and health care provider); method triangulation (i.e. qualitative data and quantitative data); and theoretical
triangulation (i.e. use of MSEM and Model of Gender Affirmation) (Salazar, Mijares, Crosby, & DiClemente, 2015).

13. Confidentiality protections:

Quantitative Analysis
Closed-ended interview data and demographic questionnaire data will be entered into an SPSS database. Frequencies and descriptive statistics will be created to describe population characteristics (e.g. age, amount of time in HIV treatment, etc.). Data will be aggregated and any
comparisons are only meant to be descriptive.

A potential breach of privacy could occur if data are lost or a participant is identifiable in a manuscript, presentation or data deliverable to CDC. Our team has taken steps to decrease the likelihood of a breach of privacy as outlined in the Data Security Plan (Appendix G). Since our team will
be collecting sensitive data from study participants, we will apply for a Certificate of Confidentiality (CoC) to the CDC Office of Scientific Integrity after receiving IRB Approval and CDC’s Project Determination.
All quantitative and qualitative data will be linked by ID number and de-identified. Once the data are entered into a dataset, they will be transferred between Atlas and Abt using CDC’s External SharePoint site for partners, and stored on password protected/encrypted non-network laptops.
Hard copies will be destroyed at the end of the study.
Data will be reported in ways that protect the privacy of participants and comply with CDC’s Data Sharing Policy. As needed, the study team and CDC researchers will implement other needed measures to ensure privacy (e.g., reporting data as multi-racial for situations when individuals
identify with more than one race or ethnicity; removing any components from quotes or anecdotes in interview notes that may re-identify a participant).
The Atlas team will not provide PII to CDC in any manuscripts, presentations or data deliverables. Further, we will inform participants that CDC will receive de-identified data and that there is a potential risk of breach of privacy and that, given the nature of interview data, they may be
re-identifiable. We will also inform participants that we cannot ensure privacy but that our team is committed to taking steps to protect their privacy to the best of our ability.
Eligibility Screeners. A hardcopy eligibility screener will be administered by CBO recruitment staff to each potential transgender participant as part of the CBO’s HIV rapid testing procedures, during outreach and when potential participants call-in to inquire about the study. The screeners will
be stored in a locked file cabinet at the CBO, and given to the interviewer prior to the interview to verify the participant’s identity. The upper right corner of the eligibility screener will include the participant’s first name and initial of last name (in case more than one participant have the same
first name). After the participant’s identity is verified, the participant’s name will be torn off by the interviewer from the screener and the same ID assigned to the interview guide will be assigned to the eligibility screener. CBO staff will provide Atlas/Abt staff with ineligible screeners. After
counting the number of ineligible screeners, Atlas/Abt staff will enter these numbers in to database (e.g., number of ineligible HIV-positive transgender women, number of HIV-negative transgender women) and securely shred screener. CBO recruitment staff and Atlas/Abt staff will not
maintain a copy of the participant’s proof of HIV-negative status, rather will initial on the Eligibility Screener that proof has been reviewed and verified.
Any reference to full name or other identifying information that arises unintentionally during the discussion will be redacted from the transcripts by Atlas. Transcripts will be transferred between Atlas and Abt using CDC’s External SharePoint site for partners, and stored on password
protected/ encrypted non-network laptops. Recordings will be deleted by Atlas/Abt staff at the end of the study. No individual names will be used in any reports. In order to increase the level of privacy, demographic summary data will be reported separately from any quotes used. No PII will
be delivered to CDC as part of this project.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):

Verbal informed consent will be obtained for all potential participants (screener) and interview participants as requested by a waiver of documentation of consent under 45 CRF46.117(c) because the only record linking the participant and the research would be the consent and the principal
risk would be potential physical and psychological harm to transgender women resulting from a breach of privacy. Prior to administering the eligibility screener, the CBO recruitment staff will read the consent form script (included in the eligibility screener in Appendix C). Upon receiving the
potential participant’s verbal consent, CBO study staff will document this consent by signing their name under the consent portion of the eligibility screener as designated. The eligibility screener consent will include potential benefits of participation, such as improving the understanding of
barriers and facilitators for consistent HIV prevention, care, and treatment for transgender women, and the risks associated with participation. Taking part in this research study may not benefit you personally. The information may help us learn new things that will help others. It may also
help us develop better programs.
Prior to beginning the in-depth interview, the interviewer will also document verbal consent by signing their name to the consent form (found in Appendix J) for study record. This consent will address in more detail the potential benefits of participation, such as increasing our knowledge of
transgender women to help us develop better programs. It will also address the potential risks of participation, such as a breach of privacy. The interviewer will provide the consent form to each participant for them to read and review, and interviewers will answer any questions or concerns,
and ask each participant if they have a clear understanding of the study, its purpose, risks, benefits, and right to withdrawal from the study without consequence. The literacy level of participants is expected to be approximately at 6th grade. If an interview participant is unable to read or
understand the consent form, the study team will read the consent aloud to further clarify any questions. Once verbal consent has been obtained, the interviewer will sign and date the informed consent for the study record. A copy of each consent form will be provided to the participant,
though all participants will be informed that they do not have to keep a copy if they prefer not to. All interviewer-signed forms will be securely stored by Abt for at least 6 years.
All incidents (e.g., breach of privacy or protocol), adverse events, or unanticipated problems related to human subjects will be reported to the Abt Associates IRB, Abt IT Security team, Abt Information Technology Service Center, CDC TM and the CDC COR. This report will be submitted as
soon as possible, and in the case of events or problems occurring within the Atlas Team or involving research conducted by the Atlas/Abt staff, no later than five (5) working days after the event or problem is discovered. Advance notification of the problem must occur by telephone call to
the Abt IRB Administrator within 48 hours of the occurrence of such an event or problem. CDC Associate Director for Science must be notified within 48 hours of an incident or adverse event. In the case of potential security incidents, the team will report as soon as possible. Investigators
will provide their assessment of the event or problem and suggest any proposed changes to the study protocol, project description, data security plan and/or the informed consent document.
Adverse Event Protocol
Given the sensitive nature of the interview topics and potential vulnerability of individual participants, our team has developed and will implement an adverse event protocol in which all recruitment and data collection staff will be trained. The adverse event protocol includes examples of
possible adverse events to include issues encountered during eligibility screening, scheduling of interviews and interview data collection. The adverse event protocol also includes action steps for emergency and urgent situations for each of the above data collection activities.
To support the action steps, our team will work with each CBO to identify a list of resources and referrals to local healthcare providers, substance abuse providers, and mental health providers. Additionally, our team will have on call a trained clinical psychologist to talk with Atlas or Abt staff
to discuss any potential issues that arise during the data collection process. Jamie Hart and Alex Mijares will consult with Abt IRB Chair Teresa Doksum or Administrator Katie Speanburg via phone or email within 48 hours to determine if the incident qualifies as an Adverse Event and will
submit the appropriate documentation as indicated with 5 business days.

15. Projected time frame for the project:
09/16/2015 to 05/15/2017

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16. Plans for publication and dissemination of the project findings:
Study staff will draft at least one peer-reviewed article, conference abstract, and slide presentation describing study results. The peer reviewed article,
conference abstract and slide presentations will include:
• Interview Data. Data will be reported by themes. Quotes used in manuscripts or presentations will only include type of participant (i.e. HIV positive, HIV
negative, type of health care provider (doctor, nurse), age range, and race/ethnicity of participants). To protect the privacy of participants, reports will not include
facility names or cities. Additionally, any detailed or potentially identifying stories or quotes used during interviews will be redacted from interview transcripts.
Reporting will also be in line with CDC’s Data Sharing Policy.
• Summary Demographic Data. Demographic data will be reported in aggregate.
CDC, in partnership with Atlas and Abt staff, will identify and develop appropriate dissemination opportunities for these findings. Stakeholders from the CBOs will
also be briefed by Atlas/Abt on the study findings (e.g., memo summarizing findings).

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
See attached protocol and appendices:
Appendix A: Individual Investigator Agreement
Appendix B: Participant Recruitment Materials
Appendix C: Study Instruments
Appendix D: CBO Progress Report Template
Appendix E: Interview Schedule Templates
Appendix F: Provider Roster
Appendix G: Data Security Plan
Appendix H: Receipt for Transfer of Stipend
Appendix I: Adverse Event Protocol
Appendix J: Participant Informed Consent Forms

18. References (to indicate need and rationale for project):
Baral, S., Logie, C. H., Grosso, A., Wirtz, A. L., & Beyrer, C. (2013). Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health , 13 (482), 1-8.
Bauer, G. R., Travers, R., Scanlon, K., & Coleman, T. A. (2012). High heterogeneity of HIV-realted sexual risk among transgender people in Ontario, Canada: a province-wide respondent-driven sampling survey. BMC Public Health , 29 (2), 1-12.
Bockting, W. O., Robinson, B. E., & Rosser, B. R. (1998). Transgender HIV Prevention: A qualitative needs assessment. AIDS Care , 10, 505-526.
Bockting, W., Robinson, B., Forberg, J., & Scheltema, K. (2005). Evaluation of a sexual health approach to reducing HIV/STD risk in the transgender community. AIDS Care , 17 (3), 289-303.
Brennan, J., Kuhns, L. M., Johnson, A. K., Belzer, M., Wilson, E. C., & Garofalo, R. (2012). Syndemic theory and HIV-related risk among young transgender women: the role of multiple, co-occurring health problems and social marginalization. American Journal of Public Health , 102 (9),
1751-1757.
Crosby, R. A., & Pitts, N. L. (2007). Caught between different worlds: how transgendered women may be "forced" into risky sex. Journal of Sex Research , 44 (1), 43-48.
Deutsch, M. B., Glidden, D. V., Sevelius, J., Keatley, J., McMahan, V., Guanira, J., et al. (2015). HIV pre-exposure prophylaxis in transgender women: A sub-group analysis of the iPrEx trial. The Lancet .
Garofalo, R., Deleon, J., Osmer, E., Doll, M., & Harpe, G. (2006). Overlooked, misunderstood and at-risk: Exploring the lives and HIV risk of ethnic minority male-to-female transgender youth. J Adolesc Health , 38, 230-236.
Garofalo, R., Johnson, A., Kuhns, L., Cotten, C., Joseph, H., & Margolis, A. (2012). Life Skills: Evaluation of a theory-driven behavioral HIV prevention intervention for young transgender women. J Urban Health , 89 (3), 419-31.
Gelaude, D. J., Sovine, M. L., Swayzer, R. I., & Herbst, J. H. (2013). HIV Prevention Programs Delivered by Community-Based Organizations to Young Transgender PErsons of Color: Lessons Learned to Improve Future Program Implementation. International Journal of Transgenderism ,
14, 127-139.
Golub, S. A., Gamarel, K. E., Rendina, J., Surace, A., & Lelutiu-Weinberger, C. L. (2013). From Efficacy to Effectiveness: Facilitators and Barriers to PrEP Acceptability and Motivationos for Adherence among MSM and Transgender Women in New York City. AIDS Patient Care and STDs ,
27 (4), 249-254.
Herbst, J. H., Jacobs, E. D., Finlayson, T. J., McKleroy, V. S., Neumann, M. S., & Crepaz, N. (2008). Estimating HIV Prevalence and Risk Bheaviors of Transgender Person in the United States: A Systematic Review. AIDS Behavior , 12 (1), 1-17.
Hruschka, D. J., Schwartz, D., Cobb St. John, D., Picone-Decaro, E., Jenkins, R. A., & Carey, J. W. (2004). Reliability in coding open-ended data: lessons learned from HIV Behavioral Research. Field Methods , 16 (3), 307-331.
Hruschka, D. J., Schwartz, D., Cobb St. John, D., Picone-Decaro, E., Jenkins, R. A., & Carey, J. W. (2004). Reliability in Coding Open-Ended Data: Lessons Learned from HIV Behavioral Research. Field Methods , 16, 307-331.
Kosenko, K. A. (2011). Contextual influences on sexual risk-taking in the transgender community. Journal of Sex Research , 48 (2-3), 285-296.
Lombardi, E., Wilchins, R. A., Priesing, D., & Malouf, D. (2001). Gender violence: transgender experiences with violence and discrimination. J Homosex , 42 (1), 89-101.
MacQueen, K. M., McLellan-Lemal, E., Bartholow, K., & Milstein, B. (2008). Team-baesd codebook development: structure, process, and agreement. In G. Guest, & K. M. MacQueen, Handbook for Team-Based Qualitative Research (pp. 119-135). Lanham: AltaMira Press.
Mizuno, Y., Frazier, E., Huang, P., & Skarbinski, J. (2015). Characteristics of Transgender Women Living with HIV Receiving Medical Care in teh United States. LGBT Health , 2, 1-7.
Nemoto, T., Operario, D., Keatley, J., & Villegas, D. (2004). Social context of HIV risk behaviours among male-to-female transgenders of colour. AIDS Care , 16 (6), 724-35.
Nemoto, T., Operario, D., Keatley, J., Han, L., & Soma, T. (2004). HIV Risk Behaviors Among Male-to-Female Transgender Persons of Color in San Francisco. American Journal of Public Health , 94 (7), 1193-1199.
Nuttbrock, L., Bockting, W., Rosenblum, A., Hwahng, S., Mason, M., Macri, M., et al. (2013). Gender abuse, depressive symptoms, and HIV and other sexually transmitted infections among male-to-female transgender persons: a three year prospective study. American Journal of Public
Health , 103 (2), 300-307.
Operario, D., & Nemoto, T. (2010). HIV in Transgender Communities: Syndemic Dynamics and the need for Muti-component Interventions. Journal of Acquired Immune Deficiency Syndrome , 15 (2), S91-S93.
Salazar, L. F., Mijares, A., Crosby, R. A., & DiClemente, R. J. (2015). Qualitative Research Strategies and Methods for Health Promotion. In L. F. Salazar, R. A. Crosby, & R. J. DiClemente, Research Methods in Health Promotion (pp. 209-255). San Francisco: Jossey-Bass.
Sevelius, J. M. (2013). Gender Affirmation: A framework for conceptualizing risk behavior among transgender women of color. Sex Roles , 68 (11-12), 675-689.
Sevelius, J. M., Patouhas, E., Keatley, J. G., & Johnson, M. O. (2014). Barriers and facilitators to engagement and retention in care among transgender women living wtih Human Immonodeficiency Virus. Annals of Behavioral Medicine , 47, 5-16.
Taylor, R., Bimbi, D., Joseph, H., Margolis, A., & Parsons, J. (2011). Girlfriends: Evaluation of an HIV-risk reduction intervention for adult transgender women. AIDS Educ Prev , 23 (5), 469-478.

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Project Title: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA,
12/18/2015

PROJECT APPROVAL
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DIVISION PROJECT

NCHHSTP BRANCH AND DIVISION ADS REVIEW AND APPROVAL (Sign electronically by clicking next to the X
and following the prompts)

X

Yuko Mizuno S

Digitally signed by Yuko Mizuno -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Yuko Mizuno -S,
0.9.2342.19200300.100.1.1=1001626222
Date: 2016.08.18 09:45:08 -04'00'

Branch Chief or Branch Science Officer

X

Laura J. Fehrs
-S

Digitally signed by Laura J. Fehrs -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Laura J. Fehrs -S,
0.9.2342.19200300.100.1.1=1000767525
Date: 2016.08.26 17:02:35 -04'00'

Division ADS, Acting ADS, or Deputy ADS

CENTER/OD PROJECT

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the prompts)

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Office Associate Director or Designee

NCHHSTP ADS or Designee

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Project Title: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL

Project Title: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA

Date received in NCHHSTP ADS or ADLS office:
Date received by NCHHSTP Deputy ADS or ADLS:
Select the checkbox for each applicable comment for Nos. 1–5 or select the checkbox for No. 6 if all of the comments apply.
Additional applicable comments may be added to No. 7. If additional information is required before approval can be
granted, select No. 8.

1. This project is approved by NCHHSTP/CDC and CDC (per CDC policies and federal regulations) for CDC staff
participation.
2. Participating partners and sites must obtain project review and approval, according to their institutional
policies and procedures and according to local, national, and international regulations and laws, including
45 CFR 46 regulations and state laws. CDC project officers must maintain a current copy of local sites’
approvals in project records.
3. CDC investigators and project officers need to adhere to the highest ethics standards of conduct and to
respect and protect the privacy, confidentiality, autonomy, data, welfare, and rights of participants and
integrity of the project. All applicable country, state, and federal laws and regulations must be followed.
4. Informed consent or script is needed as required by laws and regulations. Information conveyed in an
informed consent or script process needs to address all applicable required elements of informed consent.
Consent of employees in related projects about their institutions needs to include a statement that their
voluntary participation or withdrawal would not affect their employment status or opportunities.
5. OMB Paperwork Reduction Act determination by the NCHHSTP OMB/PRA Coordinator might be needed for
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6. All previous comments apply.
7. Other applicable comments: Type your comment in the box. The space will expand as you type.

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12/18/2015

Approval must be granted by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Associate
Director for Science (ADS), Acting ADS, or Deputy ADS, or for laboratory-associated projects, by the Associate
Director for Laboratory Science (ADLS) or Acting ADLS.

Project Title: T-Qual: Barriers and Facilitators to HIV Prevention, Care, and Treatment among Transgender Women in Atlanta, GA

X

Janella
Dodson

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DN: cn=Janella Dodson,
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