A Multicomponent Intervention to Address Gender-based Violence in HIV
Phase: NA
Conditions: Acceptability of Health Care, HIV Primary Infection
Sponsor: University of Michigan

 
 
Addressing violence and HIV cascade of care outcomes among transgender women 
Phase II Research Protocol 
1R21-MH-121974-01 
 
A Love Her Collective Study 
 
 
 
 

Page 2 of 34 
 
V2 - HIV Care 
 
22 June 2021 
Contents 
I. 
Research Team ..................................................................................................................... 5 
II. 
Acronyms ............................................................................................................................... 6 
III. Study Objectives .................................................................................................................... 7 
IV. Specific Aims ......................................................................................................................... 7 
IV-1. Aim 1 ................................................................................................................................. 7 
IV-2. Aim 2 ................................................................................................................................. 8 
IV-3. Aim 3 ................................................................................................................................. 8 
V. 
Background Information ........................................................................................................ 9 
VI. Study Team Experience ...................................................................................................... 13 
VII. Study Design ....................................................................................................................... 14 
VII-1. Intervention Overview .................................................................................................... 14 
VII-2. Assessing Acceptability and Feasibility ......................................................................... 15 
VIII. Study Procedures ................................................................................................................ 15 
VIII-1. COVID-19 Safety .......................................................................................................... 15 
VIII-2. Recruitment .................................................................................................................. 16 
VIII-3. Eligibility Screening ....................................................................................................... 16 
VIII-4. Enrollment Procedures ................................................................................................. 16 
VIII-4.1. Informed Consent. .................................................................................................. 17 
VIII-4.2 Locator Form ........................................................................................................... 17 
VIII-4.3 Baseline Survey ...................................................................................................... 17 
VIII-4.4 Violence & Gender Affirmation Screener ................................................................ 17 
VIII-5. Intervention Procedures ................................................................................................ 17 
VIII-5.1 1-on-1 Sessions ...................................................................................................... 17 
VIII-5.2 Group sessions ....................................................................................................... 18 
VIII-6. Follow Up Visits ............................................................................................................ 18 
VIII-5.1 Exit Interview ........................................................................................................... 18 
VIII-5.2 Post-Intervention Follow Up Survey ........................................................................ 19 
VIII-5.3 1-Month Post-Intervention Follow Up Survey .......................................................... 19 
VIII-7. Participant Incentives .................................................................................................... 19 
VIII-8. Retention Strategies ..................................................................................................... 19 
IX. Data Collection and Management ....................................................................................... 20 
IX-1. Data Collection Methods ................................................................................................. 20 
IX-2. Storage and Security ...................................................................................................... 20 

Page 3 of 34 
 
V2 - HIV Care 
 
22 June 2021 
X. 
Human Subjects Research Protections ............................................................................... 22 
X-1. Protection of Human Subjects ......................................................................................... 22 
X-2. Inclusion and Exclusion Criteria ....................................................................................... 22 
X-2.1 Inclusion criteria. ........................................................................................................ 22 
X-2.2 Exclusion criteria. ....................................................................................................... 22 
X-2.3 Rationale for Involving Proposed Populations. .......................................................... 22 
X-3. Informed Consent ............................................................................................................ 22 
X-4. Risk/Benefit Assessment ................................................................................................. 23 
X-4.1. Potential Risks. ......................................................................................................... 23 
X-4.2. Protection Against Risk ............................................................................................. 23 
X-4.3. Potential benefits of the proposed research to the subjects and others ................... 25 
X-4.4. Importance of the knowledge to be gained ............................................................... 25 
X-9. Study Withdrawal and Discontinuation ............................................................................ 25 
XI. Data Safety and Monitoring Plan ......................................................................................... 27 
XI-1. Safety and Monitoring ..................................................................................................... 27 
XI-2. Contents of Monitoring .................................................................................................... 27 
XI-3. Frequency of Monitoring ................................................................................................. 27 
XI-4. Adverse Events ............................................................................................................... 27 
XI-5. Reporting Plan ................................................................................................................ 28 
XII. Protocol Amendments ......................................................................................................... 29 
XXII-1. Ame00113458 ............................................................................................................. 29 
XIII. References .......................................................................................................................... 30 
XIV. List of Separate Appendices ................................................................................................ 34 
XII-1. Group Sessions Manual ................................................................................................ 34 
XII-2. Individual Sessions Resource and Referral List - Draft ................................................. 34 
XII-3. Violence and Gender Affirmation Screener ................................................................... 34 
XII-4. Intervention Log ............................................................................................................. 34 
XII-5. Adapted Client Satisfaction Questionnaire .................................................................... 34 
XII-6. Exit Interview Guide – Participants ................................................................................ 34 
XII-7. Exit Interview Topic Guide – Program Staff ................................................................... 34 
XII-8. Survey Measures ........................................................................................................... 34 
XII-9. Consent Form ................................................................................................................ 34 
XII-10. Suicide Risk Assessment ............................................................................................ 34 
XII-11. Screener Script ............................................................................................................ 34 
XII-12. Eligibility Survey ........................................................................................................... 34 

Page 4 of 34 
 
V2 - HIV Care 
 
22 June 2021 
XII-13. Locator Form ............................................................................................................... 34 
XII-14. Incentive Survey .......................................................................................................... 34 
XII-15. Adverse Events and Unanticipated Problems Log ...................................................... 34 
XII-16. Individual Sessions Guide ........................................................................................... 34 
 
 
 

Page 5 of 34 
 
V2 - HIV Care 
 
22 June 2021 
I. 
Research Team 
 
University of Michigan School of Public Health 
Principal Investigator: Kristi Gamarel, Ph.D., M.A. 
Co-Investigator/Project Director: Laura Jadwin-Cakmak, M.P.H. 
Co-Investigator:  Gary W. Harper, Ph.D., M.P.H.  
Research Associate: Racquelle Trammell 
Data Manager: Wesley M. King, M.Ed.  
 
Trans Sistas of Color Project (Ruth Ellis Center) 
Co-Investigator/TSoCP Site PI: Lilianna Reyes, M.S.W. 
Peer Health Educators: Latrice Ward, Julisa Abad, and Harmony Harris 
 
 
 

Page 6 of 34 
 
V2 - HIV Care 
 
22 June 2021 
II. 
Acronyms 
 
ART: Anti-retroviral therapy 
CAB: Community Advisory Board 
Co-I: Co-Investigator 
GBV: Gender-based violence 
IPV: Intimate partner violence 
HIV-CoC: HIV Continuum of Care  
IRB: Institutional Review Board 
LGBT: Lesbian, gay, bisexual, transgender 
NIMH PO: National Institutes of Mental Health Project Officer 
PD: Project Director 
PHE: Peer Health Educator 
PHI: Protected health information 
PI: Principal Investigator 
PTSD: Post-Traumatic Stress Disorder 
RA: Research Associate 
RCT: Randomized Controlled Trial 
SSP: Seeking Safety Program 
STI: Sexually transmitted infection 
TasP: Treatment as Prevention 
TSoCP SSP: Trans Sistas of Color Project Seeking Safety Program 
TSoCP: Trans Sistas of Color Project 
TW: Transgender women 
TWOC: Transgender women of color 
UM-SPH: University of Michigan School of Public Health 
VL: Viral Load 
 
 
 

Page 7 of 34 
 
V2 - HIV Care 
 
22 June 2021 
III. 
Study Objectives 
This protocol outlines the research procedures for Phase II of “Addressing violence and HIV 
cascade of care outcomes among transgender women” (1R21-MH-121974-01). Phase I of this 
study included the systematic adaptation of the Seeking Safety Program (SSP) for transgender 
women of color (TWOC) living with HIV to improve engagement in the HIV Cascade of Care, 
using the ADAPT-ITT model. The objectives of Phase II of this study are: (1) to examine the 
feasibility, acceptability, and preliminary efficacy of the adapted behavioral intervention by 
conducting a one-arm pilot with 30 transgender women of color (TWOC) living with HIV who 
have a history of trauma; and (2) to identify strategies for large-scale rigorous implementation of 
intervention research with transgender women through exit interviews with pilot participants.  
IV. 
Specific Aims 
HIV disproportionately affects transgender women (TW; individuals with a feminine and/or 
female gender identity who were assigned male at birth). Evidence suggests that TW have 49 
times higher odds of infection compared to the general adult population,1 and in the U.S. they 
have the highest rates of new diagnoses by gender, with TW of color (TWOC) representing a 
majority of these cases.2 The HIV Continuum of Care (HIV-CoC) framework emphasizes rapid 
diagnosis of HIV upon seroconversion, linkage to care, and ultimately, maintaining viral load 
suppression; however, there is substantial drop-off at each step of the HIV-CoC among TWOC 
with significant disparities in rapid diagnosis and linkage to and retention in care.3,4 
TWOC experience frequent discrimination and oppression due to their gender identity and/or 
expression, often in the form of violence from partners, strangers, law enforcement, and in 
public accommodations.5 TWOC experience these gender-related stressors in combination with 
other social and structural factors affecting communities of color, such as high rates of poverty 
and incarceration, less access to healthcare and quality education.6-8 Violence is a significant 
public health concern for TWOC, and is consistently linked with worse HIV outcomes, post-
traumatic stress disorder (PTSD), and substance use, which is also a major issue among some 
communities of TWOC.9-11 Epidemics of HIV, violence, and substance use are concurrent and 
mutually reinforcing, constituting a “syndemic” or synergistic interaction that contributes to 
documented inequities in HIV-CoC outcomes among TWOC.12-18 Existing interventions 
designed for cisgender individuals do not meet the needs of TWOC with regard to violence and 
HIV.19 Currently there are few evidence-supported, trauma-informed strategies for meeting the 
unique needs of TWOC living with HIV. The “Seeking Safety Program” (SSP) is an empirically 
based, flexible, empowering, and trauma-informed group-level intervention designed to reduce 
PTSD symptoms and substance use among a variety of populations.20 Primary acceptability 
data of an adaptation of this program with TW in San Francisco lends support to the relevance 
of the intervention with TWOC living with HIV.21 Guided by our team’s expertise working with 
TWOC and SSP, we respond to RFA-MH-20-2010 (Addressing the Role of Violence on HIV 
Care and Viral Suppression) by proposing to adapt this intervention (the adapted intervention 
will be referred to as “Trans Sistas of Color Project Seeking Safety Program (TSoCP SSP).” 
TSoCP SSP will include individual and group sessions that will address unique experiences of 
violence, power, and gender affirmation needs of TWOC living with HIV, with a specific focus on 
engagement in HIV care and PTSD symptoms.  
There are three specific aims of the parent study (1R21-MH-121974-01). Aim 1 was completed 
in Phase I. Aims 2 and 3 will be completed in Phase II, the current study:  
IV-1. Aim 1: To conduct a systematic adaptation of SSP for TWOC living with HIV, with a focus 
on addressing trauma caused by experiences of violence and intersectional oppression, gender 
affirmation needs, and engagement in HIV care.  

Page 8 of 34 
 
V2 - HIV Care 
 
22 June 2021 
In Phase I of this study, the ADAPT-ITT model22 was be used to systematically adapt this 
intervention. To achieve this aim, we conducted interviews with TWOC (n=15-20) and key 
stakeholders (n=5-10; i.e., organization leaders, healthcare providers) to inform the adaptation. 
Our community advisory board of TWOC living with HIV will review all adapted materials. 
IV-2. Aim 2: To examine the feasibility, acceptability, and preliminary efficacy of the adapted 
SSP intervention on engagement in care (primary outcome), PTSD symptoms (secondary 
outcome), viral load (tertiary outcome) and the potential mediating roles of gender affirmation, 
empowerment, self-efficacy, and collective self-esteem. 
To address Aim 2, we will conduct a feasibility and acceptability one-arm pilot of the adapted 
intervention by enrolling 30 TWOC living with HIV with a history of trauma. We will collect 
feasibility, acceptability data related to identifying, recruiting, enrolling, intervening with, and 
retaining participants (i.e. length of recruitment period, screening procedures, feasibility of 
conducting group sessions, acceptability of the intervention, rates of retention, feasibility of 
verifying self-reported and medical chart review data on retention in care and viral load) and 
conduct exit interviews with participants and staff at program conclusion. Preliminary efficacy 
data will be collected at baseline, end of program, and 1-month post-intervention follow-up.  
IV-3. Aim 3: To identify strategies for large-scale rigorous implementation of intervention 
research with TW. 
To address Aim 3, we will gather information from one-arm pilot participants during exit 
interviews to identify strategies to overcome barriers to implementing rigorous efficacy trials with 
TW within close-knit communities and limited-resources settings.  
The proposed study has the potential for high public health impact by evaluating the feasibility, 
acceptability, and preliminary efficacy of an adapted, evidence-based program to address 
violence and HIV CoC outcomes among a highly vulnerable and overlooked population 
disproportionately impacted by HIV. Our focus on TWOC is in line with the prioritization of 
sexual and gender minority communities for health disparities research,23,24 as well as the “treat” 
and “respond” strategies of the new HHS plan for ending the U.S. HIV epidemic.25 Study 
findings will provide the necessary groundwork to examine the efficacy of intervention in a 
future, large-scale clinical trial. Findings also have the potential to provide a “blueprint” to guide 
future research efforts with TWOC who are often embedded in close-knit communities with few 
culturally-responsive services. 
 
 

Page 9 of 34 
 
V2 - HIV Care 
 
22 June 2021 
V. 
Background Information 
HIV disproportionately affects TW (i.e., individuals with a feminine and/or female gender identity 
who were assigned male at birth). TW have 49 times higher odds of infection compared to the 
general adult population.26,27 Reports of HIV prevalence and incidence rates for TWOC are 
among the highest of all risk groups.27 Treatment as Prevention (TasP) involves preventing new 
infections by treating existing infections through early diagnosis, immediate initiation of 
antiretroviral therapy (ART) and maintaining viral load (VL) suppression 28-31 and presently 
represents the most promising HIV prevention strategy.32 TasP is estimated to be highly 
beneficial—in both simulation work and population-based data, achieving and maintaining high 
levels of VL suppression within a community has been shown to lead to substantial reductions 
in HIV transmission.29-31,33-35 Though there have been great strides in achieving the UNAIDS 90-
90-90 targets, there are notable inequities in timely care engagement, ART adherence, and VL 
suppression,36-40 and we have yet to achieve these goals with TWOC in the U.S.3,41,42 Thus, 
research is urgently needed to understand to develop interventions that achieve optimal 
movement along the HIV-CoC among TWOC living with HIV.3,41,42  
Violence is a significant public health crisis for TW and undermines HIV-CoC outcomes.43-45 TW 
living with HIV experience violence in a variety of contexts, including from intimate and sex 
partners, strangers, law enforcement, and in public accommodations.5,9 Data suggest extremely 
high burden of violence among transgender populations, with prevalence estimates of 58-89% 
in the US.5,26 Exposure to violence has been linked to substance use, post-traumatic stress 
disorder symptoms, stress, anxiety, and depression among TW.12-17,46 Among people living with 
HIV, violence is linked to avoiding care, suboptimal ART adherence, and a lower odds of viral 
suppression, via pathways including chronic stress, immune inflammatory response, PTSD, and 
substance use.47-51 These epidemics of violence and HIV are concurrent and mutually 
reinforcing, constituting a “syndemic” that contributes to documented inequities in HIV-CoC 
outcomes among TW.8,17 Despite the dual and interconnected associations between violence 
and HIV-CoC outcomes, there are few public health strategies for meeting the unique needs of 
TWOC living with HIV. 
 
Gender affirming, trauma-informed, and culturally-responsive HIV interventions are critically 
needed for TWOC. Gender affirmation refers to “an interpersonal, interactive process whereby a 
person receives social recognition and support for their gender identity and expression”.52 For 
TW, positive gender affirmation is a source for positive identity development, self-esteem, and 
self-efficacy;52,53 the lack of gender affirmation can contribute to adverse health outcomes and 
has been shown to be a barrier to progression through the HIV CoC for TW youth living with 
HIV.54 On the contrary, gender-affirming services are essential for recognizing and reinforcing 
the identities and unique experiences of TWOC, including experiences of violence that affect 
their psychological health and risk behaviors.55,56 Trauma-informed care, which recognizes and 
responds to the prevalence and impact of trauma, are also needed due to the high prevalence 
of violence and other sources of trauma among TWOC.57,58 Finally, given the transphobia, 
racism, and HIV stigma that TWOC face,59 culturally-responsive interventions must be 
developed in partnership with and led by TWOC. Health and counseling services that are 
gender affirming and are responsive to TWOC’s intersectional identities and unique experiences 
are warranted to reduce internalized transphobia/racism, enhance feelings of self-efficacy, and 
build collective-self-efficacy and empowerment.60-62 Thus, to be maximally effective, 
interventions designed to address HIV-CoC outcomes with TWOC need to incorporate gender 
affirmation, address the role of violence, and be responsive to the unique needs and 
experiences of TWOC.  

Page 10 of 34 
 
V2 - HIV Care 
 
22 June 2021 
Seeking Safety Program (SSP) is an evidence-based intervention that represents a promising 
approach to improving HIV-CoC outcomes and PTSD symptoms among TWOC. Our formative 
qualitative data with 32 TWOC in Detroit highlighted the need for gender affirming group-based 
interventions that address trauma and mental health concerns TWOC experience as a result of 
violence and intersectional oppression.63 They also expressed the need for individual sessions 
focused on personal needs and referrals to gender affirming healthcare and social services, and 
emphasized the importance of programs for TWOC being led by TWOC.63 SSP is a trauma-
informed manualized, group-based intervention conceptually grounded in Cognitive Behavioral 
Therapy,64 and includes modules focused on: PTSD; Taking Back Your Power; Detaching from 
Emotional Pain; Taking Good Care of Yourself; Compassion; Commitment; Setting Boundaries 
in Relationships; Respecting Your Time; Healthy Relationships; and Healing from Anger. This 
psychoeducational approach helps participants understand the links between trauma (including 
violence), substance use, and coping skills with a focus on the present and future, discouraging 
detailed discussions of past trauma.64 A 2016 meta-analysis concluded SSP had positive effects 
on co-occurring substance use and PTSD symptoms, including increased treatment retention 
and attendance, reduced PTSD symptoms, and reduced substance use, among multiple 
populations.65 Dr. Dawson-Rose recently successfully adapted SSP to 12 sessions for TW living 
with HIV in San Francisco, with promising improvements in PTSD symptoms and substance 
use.21 We will build on the success of Dr. Dawson-Rose, again conducting the SSP with TW 
living with HIV, but focusing on co-occurring HIV and PTSD symptoms, shifting the primary 
outcome of focus from substance abuse to engagement along the HIV-CoC. This adaptation will 
also be specific to TWOC living with HIV in settings where there are limited resources for TW, 
like Detroit. Intervention content will be adapted to prioritize HIV-CoC outcomes and enhance 
the cultural relevance and contextual depth of the program for TWOC living with HIV. We will 
retain the general SSP structure, but adapt individual sessions (# of sessions to be determined) 
to assist TWOC to access gender affirming care for HIV, mental health, and substance use, as 
well as gender-related care and other needed social services. Finally, program facilitation and 
individual sessions will be provided by TWOC in the community who are trained as Peer Health 
Educators (PHEs).  
 
This study develops a foundation for rigorous randomized controlled trials (RCT) addressing 
violence and HIV with TW in limited-resource settings. Consistent with RFA (MH-20-2010), this 
R21 exploratory/ developmental grant application will provide essential understandings about 
the community readiness for rigorous efficacy trials addressing the dual issues of violence and 
HIV treatment outcomes in this highly vulnerable population. RCTs in bio-behavioral research 
are the “gold standard” in evaluations of interventions; however, the responsible and ethical 
conduct of RCTs in vulnerable populations requires consideration of the target community’s 
perspectives about methodological criteria and standards that are valued by the scientific 
community. For example, community perspectives are needed to inform the selection and 
delivery of a control condition, which will be essential in larger efficacy trials. Moreover, it has 
long been noted that cross-contamination, or the interchange of information among participants 
from different study conditions, may be a source of considerable bias.66 Although procedures 
are often adopted to reduce these threats the validity (e.g., blinding to study condition), TWOC 
have close-knit communities and often live in limited-resource settings such that there is the real 
potential for differential effects of cross-contamination vis-à-vis sharing intervention content 
between conditions. Compounding these methodological issues is the deep rooted mistrust of 
researchers by communities of color – which affects recruitment, retention, and engagement of 
participants in intervention research.67,68 As such, the adaptation of promising and urgently 
needed interventions requires input from community members to identify solutions to implement 
rigorous research designs.  
 

Page 11 of 34 
 
V2 - HIV Care 
 
22 June 2021 
In summary, violence is a public health priority for TWOC and has been consistently linked with 
avoiding care, suboptimal ART adherence, and lower odds of viral suppression among TWOC 
living with HIV. These epidemics are concurrent and mutually reinforcing, constituting a 
“syndemic” that contributes to documented inequities in HIV-CoC outcomes among TWOC. 
Despite the dual and interconnected associations between violence and HIV-CoC, there are few 
evidence-supported and trauma-informed strategies for meeting the unique needs of TWOC 
living with HIV. SSP is a promising, flexible, empowering, and trauma-informed group-level 
intervention that has had positive effects on PTSD symptoms and substance use among a 
variety of populations with a history of violence, including TW. The intervention developed 
through the proposed research will be based in a gender affirmation framework on engagement 
in care and PTSD symptoms. Findings will also provide critical insights into solutions to 
overcome challenges to implementing RCT designs (e.g. mistrust, contamination, control 
conditions) in geographical locales with limited resources for TWOC.  

Page 12 of 34 
 
V2 - HIV Care 
 
22 June 2021 
 
 
Table 1. Intervention  Selection and Adaptation 
System-Level (Institutional) Screening 
Screening Intimate Partner Violence 
Screening assessed by 
healthcare providers  
Self-administered screener to increase 
comfort that PHE’s use for navigation 
sessions. Information is provided to health 
care and mental health providers to facilitate 
“warm hand-offs”. There is a need to expand 
beyond intimate partners to be inclusive of 
experiences of violence from dates, family, 
and strangers. Violence also took on 
psychological forms (e.g., controlling 
behaviors, partners keeping relationship on 
the “down low”). The screener would also be 
most useful if it included gender affirmation 
needs (i.e., legal and medical) to assist with 
linkage to appropriate services. 
Group-Level (Interpersonal) Seeking Safety Program (SSP) 
SSP 
Peer Health Educator deliver 8 
two hour group sessions that are 
approximately 1 week apart 
focused on teaching effective, 
concrete cognitive and behavioral 
skills.  
PHE’s need to be TWOC and deliver the 
intervention. The intervention needs to be 
condensed to 8 sessions maximum for TWOC 
to complete the entire program. After 
reviewing the content of all of the SSP 
sessions, the team decided on the following 
sessions: 1) Prioritizing Safety, 2) 
Understanding trauma and PTSD; 3) Getting 
support from yourself and others; 4) Taking 
care of your whole self; 5) Knowing your 
triggers and how to handle them; 6) Setting 
boundaries in relationships; 7) Healthy 
relationship beliefs; 8) Review game and 
Graduation. Sessions will also be adapted to 
include gender-based violence, and gender 
affirmation. 
 
Individual-Level Peer Navigation 
HIV Peer 
Services 
One-to-one navigation to help link 
people to healthcare systems and 
identify and reduce barriers to 
care. Navigation services also 
include working together to create 
an individualized health behavior 
change plan.  
PHE’s who are also TWOC need to deliver the 
navigation services, which is key to building 
trust and safety planning based on shared 
experience. PHE’s will need to provide 
assistance with identifying trans-friendly HIV 
prevention and care services, as well as 
gender affirmation services (e.g., name 
changes, hormones). Individualized health 
behavior change plans will also identify and 
work to address barriers to reducing HIV 
transmission risk (e.g., violence from dates) 
and engagement in HIV services. 
 

Page 13 of 34 
 
V2 - HIV Care 
 
22 June 2021 
VI. 
Study Team Experience 
This project is led by the Love Her Collective, a community-academic partnership between the 
Trans Sistas of Color Project (TSoCP) in Detroit, MI and researchers at the University of 
Michigan School of Public Health (UM-SPH). After informally partnering since 2015, Ms. Reyes, 
Dr. Gamarel, Ms. Jadwin-Cakmak, and Dr. Harper had several meetings to discuss future 
research and service endeavors as a partnership, gaps in research for TWOC, and how to work 
together to meet TSoCP’s objective to build the organization’s research capacity. We applied 
and received internal funding to formalize the community-academic partnership between TSoCP 
and the UM-SPH to identify the priorities of TWOC in Detroit and build the research 
infrastructure of our TSoCP partners. Subsequently, Dr. Gamarel received additional pilot 
funding to hire TSoCP member, Ms. Trammell as a Research Associate (RA) at UM-SPH. 
Between January and March 2019, the Love Her Collective conducted focus groups with TWOC 
in Detroit (5 groups, n=32). In this study, 85% of participants reported violence and safety as a 
priority health area.63  
 
Our collective experience leads to this proposal to adapt and pilot the SSP to address violence 
and engagement in HIV care. Dr. Gamarel, PhD, EdM (PI) has over 6 years of HIV-related, 
empowerment-based research with TW, including serving as PI on a couples-focused HIV 
prevention intervention for TW (R01MH115765). Ms. Reyes, MSW (Community Lead) is a 
TWOC, who is the Executive Director of TSoCP and brings over 8 years working with TWOC, 
including implementing HIV-focused programs with TW. Dr. Harper, PhD, MPH (Co-I) is a 
clinical psychologist who brings over 25 years of community-based HIV-focused intervention 
development, implementation, and evaluation experience with LGBT communities, including 
TWOC. Ms. Laura Jadwin-Cakmak, MPH (Co-Investigator and Project Director) brings 
significant expertise in community-engaged research with TWOC, including directing 
intervention development and evaluation with transgender communities. Ms. Trammel (RA) is a 
TWOC with extensive experience working with and for transgender communities in Detroit 
related to health and advocacy. Mr. Wesley King, EdM (Doctoral Student) will assist the team 
with database development and data management. Ms. Latrice Ward, Ms. Julisa Abad, and 
Ms. Harmony Harris (health educators) are TWOC who each have significant experience 
facilitating health promotion groups with trans women of color in Detroit. Ms. Abad has 
experience facilitating TREM for transgender women, a similar group-based program to help 
transgender women of color health from trauma, at All Well-Being Services, a community-based 
organization in Detroit. Ms. Harris and Ms. Ward are the facilitators of Tweet, a group program 
to help transgender women engage in HIV prevention and care services, through Henry Ford 
Health System. Together our team brings complementary skills and knowledge to the proposed 
study.  
 
 

Page 14 of 34 
 
V2 - HIV Care 
 
22 June 2021 
VII. Study Design 
In this R21, we propose to adapt, integrate, and pilot a culturally-relevant multicomponent 
trauma-informed intervention, which includes peer-led individual sessions, an adaptation of SSP 
group-level intervention (the TSoCP SSP), and a GBV and gender affirmation needs screening 
aimed at improving HIV Care Continuum outcomes.59-61 We will achieve this through the use of 
the ADAPT-ITT model, which is a systematic framework used previously by Drs. Gamarel, 
Harper, and Ms. Jadwin-Cakmak for adapting HIV interventions.62,63 ADAPT-ITT is a pragmatic 
framework for adapting interventions that includes eight prescriptive phases.62 Table 2 outlines 
how the ADAPT-ITT model will be applied to the multicomponent intervention for TWOC 
detailing the planned activities during each phase of the model. 
 
Aim 1, completed in Phase I of the parent study, is to conduct a systematic adaptation of the 
intervention components for TWOC, with a focus on the unique aspects of GBV experienced by 
TWOC, gender affirmation needs, and engagement in the HIV continuum of care. To achieve 
this aim, we have conducted interviews with TWOC (n=10) and key stakeholders (n=5-10; i.e., 
organization leaders, healthcare providers) to inform the adaptation and implementation 
process. Phase I of the parent study included “ADAPTT-ITT Phases 4-7” (see Table 2 below).  
 
Aim 2, the focus of the current protocol, is to evaluate the feasibility and acceptability of the of 
the trauma-informed intervention to improve HIV Care Continuum outcomes including the 
development of community-informed strategies for subsequent RCTs. Process and outcomes 
measures will also be collected to assess feasibility, performance, and program impact.67 Phase 
II of the parent study involves “ADAPT-ITT Phase 8,” which involves conducting a one-arm pilot 
of the adapted TSoCP SSP behavioral intervention (see Table 2 below).  
 
 
 
 
 
VII-1. Intervention Overview 
The TSoCP SSP intervention (referred to as “Kickin’ it with the Gurlz” with participants and in 
intervention materials) includes 8 weekly group sessions focused on topics related to 
Table 2. Adaptation process using ADAPT-ITT 
ADAPT-ITT Phase 
Project Stage 
Methodology 
1. Assessment 
Preliminary 
Studies 
(pre-proposal) 
Assessed preliminary data and consulted 
experts 
2. Decision 
Identified peer navigation, SSP, violence 
screening as interventions to be adapted 
3. Administration 
Made initial decisions about elements to be 
adapted 
4. Production 
Preparation 
Consult with community partners and CAB 
5. Topic Experts 
Formative 
Data Collection 
Conduct qualitative interviews with key 
stakeholders and TWOC to gather curriculum-
specific input 
6. Integration 
Adaptation and 
Training 
Analyze data to refine manuals and develop 
training materials 
7. Training 
Generate training manual and conduct training 
with PHE 
8. Testing 
RCT 
Conduct one-arm pilot.  

Page 15 of 34 
 
V2 - HIV Care 
 
22 June 2021 
understanding trauma and PTSD, healing from trauma, and taking care of your health and well-
being. Each group session will be co-facilitated by two PHEs who identify as transgender 
women of color, and will include up to 12 transgender women of color participants. Each group 
session will last 2 hours. (See Appendix XII-1. Group Sessions Manual). In addition to group 
sessions, participants will have 1-on-1 sessions with a PHE as part of the intervention. 1-on-1 
intervention sessions will focus on identifying health-related needs and linking participants to 
affirming healthcare referrals and community resources, as well as individualized follow-up from 
group sessions (see Appendix Y. Resource and Referral List). During enrollment visit study 
procedures, participants will complete a Violence and Gender Affirmation Screener (see 
Appendix XII-3. Violence & Gender Affirmation Screener) that PHEs will access that collects 
participant needs related to violence and safety as well as medical and legal gender affirmation; 
additional needs and priorities will be assessed through conversation. The first introductory 1-
on-1 session will occur before the start of group sessions. Participants have the choice of 
attending optional additional 1-on-1 sessions with a PHE during the 8 weeks they are attending 
group sessions, up to once a week.  
VII-2. Assessing Acceptability and Feasibility  
To assess feasibility, we will monitor rates of outreach, recruitment, eligibility, enrollment, 
attendance, retention, and assessment completion. PHEs will complete a structured 
“intervention log” after each session to assess fidelity to intervention, time needed, and 
feasibility of delivering the intervention curriculum as designed (see Appendix XII-4. Intervention 
Log). To assess acceptability, we will use a modified version of the Client Satisfaction 
Questionnaire (see Appendix XII-5. Adapted Client Satisfaction Questionnaire), which 
participants will complete at the end of each group and individual session. We will also assess 
acceptability using data on participants’ reactions to various program components gathered 
from PHEs “intervention logs”. We will also explore the feasibility and acceptability of verifying 
HIV care engagement and viral load data by asking participants to sign releases to contact their 
provider and/or clinic for verification of their self-reported health care behaviors. Feasibility will 
be evaluated by monitoring staff hours required to verify data and rates of verifiable 
engagement reports. Acceptability of our verification methods by participants will be assessed 
by rates of agreement to provide consent to contact providers (90% or higher will be considered 
acceptable) and will be explored during exit interviews with participants and staff. Finally, we will 
conduct 30-minute exit interviews at the conclusion of the program with both participants and 
program staff to gather qualitative feedback about the structure, content, and experience of the 
intervention. Participant exit interviews will also explore barriers to RCT designs and 
implementation. (See Appendix XII-6. Exit Interview Guide – Participants, Appendix XII-7. Exit 
Interview Topic Guide – Program Staff).  
 
VIII. Study Procedures 
VIII-1. COVID-19 Safety 
Before the COVID-19 pandemic, the proposed study activities were to occur in-person. In 
response to the pandemic, we have altered plans so that all study procedures have an option to 
occur virtually without in-person activity. However, the qualitative formative research conducted 
in Phase I indicated that many from the focus population had a strong preference for study 
activities to occur in-person when possible, and that certain activities (specifically, individual and 
group intervention sessions and the exit interview) are anticipated to provide greater potential 
benefit to participants if delivered in person. Given this, if we are able to do conduct activities in-

Page 16 of 34 
 
V2 - HIV Care 
 
22 June 2021 
person safely, and if we obtain approval from the U-M Office of Research and the HBHS IRB, 
these study activities will occur in person.  
Before conducting any in-person interaction, the PI will complete the University of Michigan 
Human Research Activation procedures to outline the specific COVID-19 safety procedures that 
will be followed during all in-person interactions between study staff and/or participants, based 
on current guidelines. The PI will also submit for approval an IRB amendment at that time with 
updates to the study procedures in alignment with the approved COVID-19 safety procedures 
for in-person activities. No in-person research activities will occur until both approvals are 
received.   
VIII-2. Recruitment 
Consistent with our ongoing and prior studies, we will employ a multi-pronged outreach strategy 
to recruit trans women of color, including 1) Online recruitment: Banner ads and digital flyers will 
be placed social media platforms used by TW, such as the Trans Sistas of Color Facebook 
page; 2) Print Ads: Flyers will be placed in healthcare and social service agencies in the Detroit 
Metro Area where transgender women seeks services; 3) Outreach: If safe and approved to do 
in-person, study staff will also conduct outreach in areas where transgender women congregate. 
Through decades of experience, the Trans Sistas of Color Project has identified optimal sites, 
days, and times to reach transgender women including the bars, clubs, street corners, mini 
markets, restaurants, boutiques, wig shops, and nail salons. Recruitment and promotional 
activities and materials will be discussed at Community Advisory Board (CAB) meetings.  
 
VIII-3. Eligibility Screening 
Those interested in the study will call the study RA, who will provide more information about the 
study (see Appendix XII-11. Screener Script). Interested potential participants will complete an 
eligibility survey programmed into Qualtrics. The same eligibility survey will be utilized for the 
current study (focused on engagement in HIV care for transgender women of color who are 
living with HIV) as for our concurrent study, which will evaluate the feasibility, acceptability, and 
initial efficacy of the TSoCP SSP for transgender women of color who are HIV-negative or have 
an unknown status, with a goal of improving engagement in HIV prevention services (“A 
multicomponent intervention to address gender-based violence in HIV prevention for women: 
Phase 2”; HUM00190671). Potential participants who meet eligibility criteria outlined in Section 
X-2.1 Inclusion Criteria will be informed that they are eligible for the study and given the choice 
to continue to the informed consent. Potential participants who are ineligible for this study but 
who are eligible for the concurrent study focused on HIV care (HUM00190671) will be informed 
they are eligible for that study, and will be given the choice to continue to that study’s informed 
consent, following the HIV prevention study’s protocol. Potential participants who are ineligible 
for both studies will be informed that they are ineligible to participate and thanked for their time. 
(See Appendix XII-12. Eligibility Survey.)  
VIII-4. Enrollment Procedures 
The enrollment study visit will consist of 4 components: informed consent, locator form, baseline 
survey, and violence and gender affirmation screener. All 4 components will be programmed 
into Qualtrics and completed by the participant online. If the enrollment visit occurs in person, 
she may complete the Qualtrics surveys on a tablet with assistance from the study RA as 
needed. If the enrollment visit occurs virtually, the study RA will send participants a link to 
complete the Qualtrics surveys on their own personal device.  

Page 17 of 34 
 
V2 - HIV Care 
 
22 June 2021 
VIII-4.1. Informed Consent. Eligible participants who indicate they are interested will be linked to 
the Informed Consent (see Appendix XII-9. Consent Form), which will be programmed into 
Qualtrics and linked to their Study ID. Given the sensitive nature of data collected we will 
request a waiver of documentation of informed consent. After providing informed consent, 
participants will be asked if they are willing to provide a medical release; if willing, participants 
will be directed to a separate Qualtrics survey to complete the medical release, so that their 
medical information will not be linked to the consent form. Participants will also be asked to 
provide contact information for their primary health care provider and HIV healthcare provider 
and to sign a release of information. This information will be used to facilitate obtaining data 
related engagement in HIV treatment services, including lab test results indicating viral load. 
Participants may decline to provide a medical release and still participate in the study.  
VIII-4.2 Locator Form. After informed consent is obtained, participants will complete a Locator 
Form in a Qualtrics survey. Participants will be asked for a working cell phone number. 
Participants will be asked to provide additional contact sources including but not limited to email, 
social media (e.g., Facebook, Twitter, Instagram, Snapchat) usernames. Participants will also 
be asked to provide valid contact information for a family member and/or friend who can be 
called in the event the participant cannot be reached by phone or email, as well as locations 
where they typically spend time and could be reached if necessary. Participants will be asked if 
messages can be left at the numbers provided. Staff will not leave messages unless expressly 
permitted to do so by the participant, which will be documented on this form. If permission is 
given to leave messages, study staff will assure participants that messages left with a family 
member or friend will only ask that the participant contact study staff and will not include any 
protected health information (PHI) or information related to study participation. (See Appendix 
XII-13. Locator Form.) 
VIII-4.3 Baseline Survey. After completing the Locator Form, participants will be linked to the 
Baseline Survey on Qualtrics (see Appendix XII-8. Survey Measures). The baseline survey will 
take approximately 40 minutes to complete. If a participant indicates she would like to take the 
baseline survey at a later time, or exits the survey before completion, the RA will contact the 
participant and send her a link to complete the survey at a later date.  
VIII-4.4 Violence & Gender Affirmation Screener. Immediately after completing the baseline survey, 
participants will be linked to the Violence and Gender Affirmation Screener (see Appendix XII-3. 
Violence and Gender Affirmation Screener). Participants will be informed that their PHEs will 
receive the information entered into this screener.  
VIII-5. Intervention Procedures 
VIII-5.1 1-on-1 Sessions. Once a participant has completed enrollment procedures, she will be 
connected to one of the Peer Health Educators (PHEs). The PHE will reach out and schedule 
an initial individual session with the participant. In the initial individual session, the PHE will get 
to know the participant and answer any questions she may have about the TSoCP SSP 
intervention, including group sessions. The PHE will review the participant’s responses on the 
Violence and Gender Affirmation Screener (see Appendix XII-3. Violence and Gender 
Affirmation Screener) and discuss immediate safety and referral needs with the participant. 
Once immediate needs are addressed, the PHE will discuss other needs related to healthcare, 
gender affirmation, and community resources; together the PHE and participant will determine 
which referrals to prioritize. Participants may choose how frequently they would like to have 

Page 18 of 34 
 
V2 - HIV Care 
 
22 June 2021 
additional individual sessions throughout the intervention period (through the end of the group 
sessions), up to once a week. Individual sessions may be delivered in-person in a private space 
at the Ruth Ellis Center, by phone, or by Zoom. Mode of contact/interaction for individual 
sessions will be dependent on current guidelines and approvals related to COVID-19; if/when in-
person research activities are not permitted, all sessions will be virtual and occur by Zoom or 
phone. If/when in-person research activities are allowed, then PHEs will defer to the 
participant’s preference. Regardless of the location/format of individual sessions, PHEs will 
ensure they are in a location that maintains the participant’s privacy. PHEs may follow up with 
participants in between individual sessions to facilitate referrals and connection to community 
resources. (See Appendix XII-16. Individual Sessions Guide, and Appendix XII-2. Individual 
Session Resources and Referrals List.)  
VIII-5.2 Group sessions. After all participants in one group cohort have been enrolled and had an 
initial individual session with their PHE, weekly group sessions will commence. Group sessions 
will include participants in this study, as well as another study our research team has running 
concurrently, “A multicomponent intervention to address gender-based violence in HIV 
prevention for women: Phase 2” (HUM00190671); that study involves testing the feasibility, 
acceptability, and initial efficacy of the TSoCP SSP intervention on engagement in the HIV 
prevention continuum of care and mental health outcomes among transgender women who are 
HIV negative or have an unknown HIV status in the Detroit Metro Area. Group sessions will be 
held once a week for eight weeks (see Appendix XII-1. Group Sessions Manual). Group 
sessions will either occur in-person in a private room at Ruth Ellis Center or virtually via Zoom, 
depending on current guidelines and restrictions related to COVID-19. It is possible that due to 
inclement weather or an emergency situation, session(s) may need to be rescheduled. In this 
event, a group session may be rescheduled for a later time that week or postponed to the 
following week; if a session is postponed by one week, this would delay the end of the 
intervention (as well as follow up assessments and exit interview) by one week. Participants will 
be encouraged to attend all group sessions; however, if a participant misses session(s), she will 
still be allowed to remain in the intervention and attend future sessions. If a participant misses a 
group session, whenever feasible, she will be offered the opportunity to review the group 
session content with a PHE in an individual session before the next group.   
VIII-6. Follow Up Visits 
The preferred timeframe for all follow-ups is within 14 days prior to or 28 days after the target 
study visit date. If the participant is unable to complete the necessary study procedures within 
this timeframe, study staff will work with the participant to identify a day as soon as possible to 
complete the procedures. Scheduling of study procedures will not be recalibrated based on the 
actual date that the study procedures were completed. The exit interview, immediate-, and 1-
month post-intervention follow-up assessment must be based on the elapsed time from the date 
of final session completion. 
VIII-5.1 Exit Interview. After completion of the final group session, participants will complete a brief 
in-depth interview about their experiences with the intervention to further assess acceptability 
and generate strategies for conducting research and RCTs with similar communities. Exit 
interviews with participants will be conducted by the study RA or Project Director, will last 
approximately 30 minutes, and will be audio-recorded. Exit interviews may occur in-person at 
the Ruth Ellis Center, by phone, or by Zoom (See Appendix XII-6. Exit Interview Guide – 
Participants).  

Page 19 of 34 
 
V2 - HIV Care 
 
22 June 2021 
VIII-5.2 Post-Intervention Follow Up Survey. After completion of the final group session, participants 
will receive a link to complete a follow up survey on Qualtrics. The follow up survey will take 
approximately 30 minutes to complete. If in person, the Qualtrics survey may be completed on a 
study tablet; otherwise the participant will receive a link to complete the survey on her own 
personal device.  
VIII-5.3 1-Month Post-Intervention Follow Up Survey. One month after the final group session, 
participants will receive a link to complete a second and final follow up survey on Qualtrics. The 
follow up survey will take approximately 30 minutes to complete. If in person, the Qualtrics 
survey may be completed on a study tablet; otherwise the participant will receive a link to 
complete the survey on her own personal device.  
VIII-7. Participant Incentives 
To incentivize participation, participants in the one-arm trial will receive $40 for baseline, $35 for 
immediate post-intervention, and $50 for the 1-month post-interventions follow-up surveys, as 
well as $20 for attending each group session and completing an exit interview. Incentives will be 
provided in the form of a gift card. Participants will also be compensated for their travel for 
assessments (transportation provided through Uber or Lyft or a $20 gas card) and intervention 
sessions that are conducted in person, and provided a meal at in-person group sessions. To 
receive an incentive, participants will complete a brief incentive survey programmed into 
Qualtrics. (See Appendix XII-14. Incentive Survey.)  
VIII-8. Retention Strategies 
Our team has extensive experience in retaining transgender women of color in research studies. 
Much of our success can be attributed to our community-engaged approach to research efforts, 
including TSoCP serving our community partners located at the Ruth Ellis Center, which 
provides services for young adults and is in close proximity to Corktown Health Center, which 
provides healthcare services for all study participants regardless of age. Using these methods, 
our prior studies with transgender women of color have regularly yielded follow-up rates above 
80%-90%. We will apply our rigorous multi-pronged approach to ensure high rates of follow-up.  
 
Study staff are trained to emphasize several times throughout the enrollment process that it is 
critical that we be able to reach participants for follow-up. Participants will complete a detailed 
Locator Form with multiple methods of contact information after consenting to be in the study, 
which will aid in follow up. Staff will inquire about and update any changes to contact information 
at each study visit. We also request that participants inform study staff if any of their contact 
information changes. Participants are told that it is important that we reach them to see how 
they are doing, regardless of whether they respond to the intervention components, whether or 
not they engage in HIV care, whether or not they are doing well or poorly; that their participation 
in the study could increase scientific knowledge about whether this program is meaningful to the 
community; that their research information will be confidential; and that we are grateful for their 
contribution to the study. When participants are seen in-person, they will be given Ms. 
Trammell’s business card, which is filled in with their approximate follow-up appointment date 
and the incentive amount.  
 
Follow-up status and challenges will be routinely reviewed at weekly staff meetings. If follow-up 
rates fall, we will use a proactive management approach to identify the root source of the 
challenges and troubleshoot potential solutions. This may include meetings with our CAB to 
brainstorm solutions or modifying procedures.   
 

Page 20 of 34 
 
V2 - HIV Care 
 
22 June 2021 
 
IX. 
Data Collection and Management 
IX-1. Data Collection Methods 
Data collection is the responsibility of the study trained staff under the supervision of the PI. 
Data will be collected on study specific electronic forms (templates) in a study specific database. 
These forms will be completed on an ongoing basis during the study. Additional data elements 
will be abstracted from medical records and entered directly into a study designed database. 
Additional participant data will be collected using computerized self-report surveys, therefore, 
participants will enter their own data (except in the case when the PI provides approval for a 
research staff person to enter data for a participant, e.g. when a participant is physically unable 
or is illiterate). Finally, qualitative data will be collected in the form of an in-depth interview.  
IX-2. Storage and Security 
We will utilize Qualtrics and a study designed REDCap database for secure remote data 
collection. Interested potential participants will contact the study RA by phone; the RA will 
assign the potential participant a unique Study ID, and enter her contact information into the 
secure REDCap database. The Study RA will then send the potential participant a unique link to 
a Qualtrics eligibility screener survey, which will not contain/gather any personally identifiable 
data but will include the unique study ID. For those potential participants who screen eligible 
and provide informed consent to enroll in the study, their screener data will be linked to the rest 
of their longitudinal data (by continuing to use the same Study ID throughout the study). The 
purpose of linking screener data to baseline data is to reduce participant burden by not re-
asking questions multiple times (e.g., rather than asking about experiences of trauma in 
childhood and adulthood in the screener and then again at baseline, this allows us to only ask 
once). For those potential participants who screen ineligible and those who screen eligible but 
do not provide informed consent to enroll in the study, we will remove the identifier (study ID) 
from the screener data and we will delete their contact information from the REDCap database, 
both within 2 weeks of screening ineligible. De-identified (and unlinked to study ID) screener 
data will be kept for ineligible/not enrolled potential participants in order to report on reasons for 
ineligibility at the end of the study. 
 
The surveys completed by participants will run as web browser applications on a University of 
Michigan Qualtrics account or the study designed REDCap database. Participants will receive 
an individual link to access the survey on either Qualtrics or REDCap. Participant surveys will 
be coded by their study ID number and will not be linked to personally identifying information. 
Participants cannot access or change previously entered data through the web-based 
application. No data are stored on the local personal computer, but are transmitted in real time 
to the secure server at the University of Michigan. Study staff will enter data into the study 
designed REDCap database. Logging in to the application requires a unique User ID and 
password. As with participant-entered data, no data entered by study staff are stored on the 
local personal computer, but are transmitted in real time to the secure server at the University of 
Michigan. All data will be identified by a unique study ID number. Study staff will enter data from 
a private location (office at Ruth Ellis Center, School of Public Health, or from home while 
working remotely) where the information cannot be seen by others who are not listed on the IRB 
application. 
 

Page 21 of 34 
 
V2 - HIV Care 
 
22 June 2021 
Identifiers will be retained for six months after completion of data collection for enrolled 
participants. Identifiers for potential participants who are ineligible or who are eligible but do not 
enroll in the study will be deleted within two weeks. 
 
We will conduct a qualitative exit interview with participants at the end of the intervention 
sessions. The qualitative interviews will either be conducted in a private room at the Ruth Ellis 
Center, by phone, or by Zoom. If conducted by phone or by Zoom, participants will be instructed 
to join the interview from a private location where they cannot be overheard by others. The 
interviewer will ensure she is in a private space where she cannot be overheard by others. The 
in-depth interviews will be audio-recorded using an external recording device. After the 
interview, the audio file will be immediately uploaded to a password protected Box folder and 
deleted from the recording device. The audio files will be retained until the interviews are 
thematically analyzed; this will be completed and the audio files deleted within 6 months of 
completing data collection. Because the audio files contain identifying information (the 
participant’s voice), and because the exit interviews do not need to be linked to participants’ 
surveys or other longitudinal data, we will remove even the participants’ unique study ID from 
the files when storing them in order to maximally protect the participants’ privacy. Participants 
will also be instructed not to share their name or other identifying information on the interview 
recording.  
 
Data will be stored in a password-protected database on University of Michigan computer that 
requires a separate ID and password. We will take the following additional steps to protect 
subjects from the risk of a breach in confidentiality. 1) All project staff will sign a confidentiality 
agreement requiring them to keep private the information obtained in this study. 2) All data will 
be collected using coded ID numbers; no surveys or other data that we collect will contain 
identifying information. 3) All hard copy materials (e.g., signed consent forms, tracking 
information) will be stored in a locked file cabinet in the office of Dr. Gamarel or the Project 
Director (as appropriate). 4) Only aggregate data that cannot be used to identify individuals will 
be included in any reports released to other agencies or for publication. Identifying information 
linking participants to their study ID number will be stored in a separate location from data 
including the participants’ study ID number and separate from any information including the 
participants’ names (such as the contact database), and will be password-protected accessible 
only to authorized members of the study team. Confidentiality policies and procedures are 
reviewed with all new staff and reviewed annually with current staff. 
 

Page 22 of 34 
 
V2 - HIV Care 
 
22 June 2021 
X. 
Human Subjects Research Protections 
X-1. Protection of Human Subjects 
This human subjects’ research meets the definition of “Clinical Research.” All procedures will be 
conducted in accordance with 45 CFR Part 46 and will be approved by the University of 
Michigan Human Research Protections Program’s Institutional Review Board (IRB). The study 
will also be registered with ClinicalTrials.gov.  
 
X-2. Inclusion and Exclusion Criteria 
X-2.1 Inclusion criteria. Research participants must be (1) at least 18 years old; (2) assigned male 
at birth; (3) identifies as female, transgender woman, or another feminine gender identity; (4) 
self-identifies as a person of color (any racial/ethnic identity except non-Hispanic white); (5) self-
reports positive HIV status; (6) history of trauma (i.e., endorses at least 2 items on the adapted 
Trauma History Screener which includes IPV and experiencing or witnessing other forms of 
violence;15,59 (7) living in the Detroit Metro Area or willing to travel to Detroit for in-person 
sessions; (8) English-speaking; and (9) willing and able to provide informed consent.  
 
X-2.2 Exclusion criteria. Evidence of severe cognitive impairment or active psychosis that may 
impede ability to provide fully informed consent, determined by the Ms. Trammel (RA) and Dr. 
Gamarel in consultation with Dr. Harper.  
 
 
 
X-2.3 Rationale for Involving Proposed Populations. This study targets transgender women of color 
who are living with HIV. This population has been selected due to their high prevalence of HIV 
infection and exposure to violence, and because there are limited culturally-responsive 
evidence-based trauma-informed violence prevention interventions to improve HIV care 
continuum outcomes developed for this priority population. Vulnerable populations such as 
fetuses, neonates, pregnant women, prisoners, or institutionalized individuals will not be 
involved. This research will not involve children under the age of 18. All enrolled participants will 
receive a local resource sheet for HIV prevention and care services and mental health services. 
Any unexpected ethical issues that arise with our study population will be discussed during 
regularly scheduled meetings with PI Dr. Gamarel and Co-I Dr. Harper, a clinical psychologist.  
 
X-3. Informed Consent 
Informed consent will be obtained before conducting any study activities. Participants will 
access the consent form online via a Qualtrics survey. The online consent will also include a 
video of the study team reading through and explaining the informed consent document to 
ensure that participants understand study procedures, their rights, and the risks associated with 
the disclosure of information likely to be interpreted as abuse and required to be reported by 
study staff. Because this study involves no more than minimal risk, we will request a waiver of 
documentation of informed consent. See the Section VIII-4.1 Informed Consent for procedures 
and Appendix XII-9. Consent Form for additional information.  
Once enrolled in the study, the PI or Project Director will reach out to study participants to ask 
them to provide a medical release of information (HIPAA authorization) to the researchers from 
their HIV care provider; participants will be informed that this is optional and that their status in 
the study will not change if they choose to not release their medical records.  

Page 23 of 34 
 
V2 - HIV Care 
 
22 June 2021 
X-4. Risk/Benefit Assessment 
X-4.1. Potential Risks.  
Potential risks to subjects are considered minimal and include: (1) potential discomfort during 
the assessment/data collection process; (2) breaches of privacy and confidentiality; and (3) 
potential coercion.  
Potential discomfort during the assessment/data collection process.  It is possible that 
participants may experience some discomfort in responding to questions during completion of 
the interviews. It is also possible that participants will experience distress in responding to 
quantitative questions about violence, mental health, substance use, and HIV-related behaviors. 
 
Potential breach of confidentiality. One of the primary potential risks to participants is breach of 
confidentiality. It is possible that data collection could result in breach of confidentiality. For 
participants in the proposed project, breach of confidentiality in self-report data could reveal they 
are engaging in illegal behavior (i.e., breaking laws against drug use possession and use of 
controlled substances). However, the risk of breach of confidentiality is also modest, given the 
safeguards protecting participants’ data. Given the nature of the group-level intervention, there 
is also the possibility that confidentiality can be broken. However, the informed consent and the 
Peer Health Educators will continually reinforce the importance of confidentiality at the 
beginning and throughout each session. 
 
 
Potential Coercion. The risk of coercion is also low, as the total amount of compensation during 
the study is modest in comparison to the amount of effort required by participants. See Section 
VIII-7. Participant Incentives for more information.  
 
X-4.2. Protection Against Risk.  
We have made every attempt to minimize risks to participants throughout the study protocol, 
including loss of privacy or confidentiality and psychological and physical discomfort. Based on 
our prior experiences, we believe that our planned procedures (described below) will be highly 
effective for minimizing risk.  
Minimizing Discomfort or distress during research. All study staff will follow an aggressive set of 
safety procedures to make sure that participants receive a high level of monitoring which will 
meet IRB standards. Because there is potential for psychological discomfort due to the research 
topic, we will make every effort to create a secure and trustworthy environment prior to 
conducting study visits at the Ruth Ellis Center or virtually. Participants will be reminded often 
that they may refuse to answer any question and that they may end their participation at any 
point during the interview, during the intervention sessions, exit interview, or survey 
assessments. Participants experiencing mild distress during the session, interview, or 
assessments will be offered to take a small break or to reschedule the assessment or session at 
a later date. In the unlikely event that a participant experiences considerable distress, they will 
be offered a voluntary suicide risk assessment (see Appendix XII-10. Suicide Risk Assessment) 
and appropriate referral. If any person is judged by PI to be a danger to self or others, or judged 
to be in grave danger due to medical or other conditions, the decision will be made to break 
confidentiality in order to inform law enforcement authorities to intervene in order to prevent an 
adverse event. All staff will receive yearly training for identifying suicide/homicide risk and/or 
dangerous intoxication, and de-escalation of agitated or angry persons and are trained to 
appropriately evaluate and respond to these circumstances. In addition, our resource listings will 
include emergency housing shelters, programs, clinicians, and support groups specializing in 

Page 24 of 34 
 
V2 - HIV Care 
 
22 June 2021 
relationship abuse and violence. All participants will be informed that they can withdraw at any 
point in time.  
Minimizing the risks to privacy of individuals or confidentiality of data. The study consent form 
will inform participants of confidentiality guidelines and standards. Given the nature of the 
group-level intervention, there is also the possibility that confidentiality can be broken. However, 
the informed consent process and the Peer Health Educators (PHEs) will continually reinforce 
the importance of confidentiality at the beginning and throughout each session. Strict 
confidentiality will be maintained and all data will be coded by a unique individual study number. 
Personal identifier records will be kept in a secure password-protected location accessible to 
only authorized members of the study team, and any files with identifying information will be 
stored separately from other study data. Records will be kept confidential to the level allowed by 
law and only the staff assigned to the study will have access to non-anonymous records. 
Information provided by study participants will not be released to outside sources unless written 
consent is provided by the study participant.   
All research data will be kept in locked cabinets. Screening ID numbers will be used to identify 
specific forms. Any files that link participant’s names with an ID number will be stored separately 
in a locked file. No released presentation or publications will identify study participants 
individually. The exceptions to confidentiality are those defined by law and include suspicion of 
child abuse, elder abuse, and threat of imminent action on suicidal or homicidal ideation. 
Participants will be informed of the exceptions to confidentiality in the consent process. The 
University of Michigan Institutional Review Board and NIH representatives will have limited 
access to records (i.e. the IRB may request a review of the associated chart). Prior to any 
sharing of data sets, all personal identifiers will be removed. Data will only be shared with other 
researchers who have received IRB approval and who have agreed not to identify specific study 
participants and who will destroy or return dataset information after completing their analyses. 
All assessment and intervention procedures will be closely supervised by the PI. All audio 
recordings will be erased upon completion of data analysis. All in-person study activities will be 
conducted in a private room at the Ruth Ellis Center or virtually by Zoom or phone.    
This study involves a group-level intervention. Before potential participants are screened and in 
the informed consent document, participants will be informed that the study will involve 
participating in group sessions with other community members. Participants will be informed 
that given the nature of the group-level intervention, there is also the possibility that 
confidentiality can be broken. However, the informed consent process and the Peer Health 
Educators (PHEs) will continually reinforce the importance of keeping information shared within 
the group private at the beginning of the study and throughout each group session. This will 
include reviewing a set of "ground rules" established and agreed to during the first group 
session, which includes keeping information shared during the group confidential. At the start of 
group sessions, participants will also be reminded that they do not have to share any personal 
information during the group and may decline to answer any questions. If group sessions are 
able to occur in-person, they will occur in a private room at the Ruth Ellis Center. If group 
sessions must occur virtually, they will occur using a secure Zoom platform. Participants will be 
instructed to join the Zoom group from a private location where the group conversation will not 
be overheard by others. Participants will also be asked to utilize headphones with a microphone 
to join the Zoom group session, so that if other people are nearby a participant during a Zoom 
group session, they are unable to hear things said by other participants. Headphones with a 
microphone will be provided to participants who need them at the start of the study. 
 

Page 25 of 34 
 
V2 - HIV Care 
 
22 June 2021 
Minimizing potential for coercion. Any study that pays a stipend may engender coercion. 
Eliminating the possibility of coercion by not awarding stipends would make it impossible to 
conduct many studies, and would shortchange participants who provide time and energy, and 
may incur costs such as bus, Lyft/Uber, taxi, or car fares. The resolution of this problem is to 
insure that stipends are not inappropriately large, to probe potential subjects to make sure they 
have not been coerced, and to give persons who may have been coerced the opportunity not to 
enroll in the study in a manner that will protect them from retribution by the person coercing 
them. See Section VIII-7. Participant Incentives for amounts. The visit stipends proposed are in 
use in similar HIV prevention studies and have been reviewed by our own and other IRBs for 
potential coerciveness.  
X-4.3. Potential benefits of the proposed research to the subjects and others 
Potential benefits include the following. First and foremost, all participants will receive a referral 
list of services in Southeastern, Michigan. Participants may improve in care as a result of their 
participation in the study, which could have a positive impact on their health. Participants are 
also provided with the opportunity to spend time talking about feelings and experiences, and 
they may gain insight into violence and HIV prevention. Participants in our previous studies 
have indicated that they benefited from this opportunity and that the prospect of providing 
information for the possible future benefit of transgender women of color was motivating for 
them. Furthermore, participants in our prior research projects have indicated a desire to be 
contacted for future studies, indicating the positive opportunities participation may provide. 
Given that the risks to subjects are considered to be minimal, the risk-benefit ratio is deemed 
favorable. Study procedures are carefully developed and followed to minimize risks. The 
potential social and psychological risks to participants described are reasonable given the need 
to adapt and pilot test culturally-relevant evidence-based violence prevention interventions to 
improve engagement in the HIV care continuum among transgender women. 
 
X-4.4. Importance of the knowledge to be gained 
The proposed study has the potential for high public health impact by evaluating the feasibility, 
acceptability, and preliminary efficacy of an adapted, evidence-based prevention program to 
address violence and HIV engagement in care outcomes among a highly vulnerable and 
overlooked population disproportionately impacted by HIV. Our focus on transgender women of 
color is in line with the prioritization of sexual and gender minority communities for health 
disparities research, as well as the strategies of the new HHS plan for ending the U.S. HIV 
epidemic. Study findings will provide the necessary groundwork to examine the efficacy of 
intervention in a future, large-scale clinical trial. Findings also have the potential to provide a 
“blueprint” to guide future research efforts with transgender women of color who are often 
embedded in close-knit communities with few existing services. Given the substantial health 
risks associated with documented inequities in violence and HIV outcomes and the relatively 
minority risks to participants, the importance of the potential knowledge to be gained relative to 
the subject risk is favorable. 
 
X-9. Study Withdrawal and Discontinuation 
A participant may be discontinued from the study at any time if the participant, the investigator, 
or the Sponsor feels that it is not in the participant’s best interest to continue. All participants are 
free to withdraw from participation at any time, for any reason, specified or unspecified, and 
without prejudice. Reasonable attempts will be made by the investigator to provide a reason for 
participant withdrawals. The reason for the participant’s withdrawal from the study will be 
specified in the study records. 

Page 26 of 34 
 
V2 - HIV Care 
 
22 June 2021 
The following is a list of possible reasons for early study termination: 
• 
Participant withdrawal of consent. 
• 
Participant is not compliant with study procedures. 
• 
Participant relocates outside of study geographic area. 
• 
Adverse event, inclusive of participant distress, that in the opinion of the investigator 
would be in the best interest of the participant to discontinue study participation. 
• 
Protocol violation requiring discontinuation of study participation. 
• 
Sponsor request for early termination of study. 
 
 
 

Page 27 of 34 
 
V2 - HIV Care 
 
22 June 2021 
XI. 
Data Safety and Monitoring Plan 
XI-1. Safety and Monitoring 
The Study PI Dr. Gamarel will conduct oversight of internal monitoring of participants’ safety and 
data integrity. The Study PI will also be supported by Co-Investigator Dr. Harper who will 
participate in the development and administration of the data and safety monitoring plan. Both 
Dr. Gamarel and Dr. Harper have extensive experience with HIV prevention clinical trials. Dr. 
Gamarel and Dr. Harper are experienced at training study staff in handling sensitive and 
confidential data and in the handling, storage and processing of confidential data. Certain 
routine administrative, personnel, physical security, information management, and computer 
system or network security practices are always in place given the University of Michigan’s 
policies. See protocol Section IX. Data Collection and Management for procedures to ensure 
data security and integrity. See protocol Section X-4.2 Protection Against Risk for procedures to 
ensure participant safety.  
Given the relatively low level of risk involved for participants, we do not plan to have a data 
safety and monitoring board (DSMB) unless asked to establish one by NIH. However, in any 
case we will monitor for any serious adverse events caused by study participation and report 
them to the University of Michigan’s IRB and NIH as appropriate and as described below. We 
will have several mechanisms to ensure data integrity. 
XI-2. Contents of Monitoring 
Monitoring is done of all procedures to ensure that they conform to the approved protocol; of 
unforeseen circumstances that might arise and affect safety; of all reports of serious adverse 
events as defined in 38 CFR 46 and the FDA 312.32 (death, life-threatening experience, new or 
prolonged hospitalization, persistent or significant disability/incapacity); of other significant 
adverse events (adverse events that lead to drop out by participant or termination by the 
investigator, or medical treatment needed to prevent withdrawal); of unexpected adverse events 
resulting from the study; of expected adverse events; unanticipated problems involving risk to 
participants, serious or continuing non-compliance, and protocol violations.  
 
XI-3. Frequency of Monitoring 
Data and safety monitoring will be a component of regularly-scheduled weekly meetings with 
the study team. Meetings will involve a review of collected data (including adverse events, 
unanticipated problems, and participant withdrawals) to determine whether there is any change 
to the anticipated benefit-to-risk assessment of study participation and whether the study should 
continue as originally designed, should be changed, or should be terminated. Dr. Gamarel will 
ultimately be responsible for participant safety, protocol violations, and ongoing evaluation of the 
study’s progress. If necessary, Dr. Gamarel will make appropriate recommendations for 
changes in protocol. The University of Michigan IRB will conduct the monitoring at the 
continuing reviews as scheduled, whenever modification requests are considered, and upon 
receiving reports of SAEs and AEs from the PI or anyone else. The NIMH PO will monitor the 
study upon receipt of annual progress reports and whenever other information is received.   
 
XI-4. Adverse Events 
We define adverse events (AEs) and serious adverse events (SAEs) as follows: An AE is any 
unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory 
finding), syndrome or disease which either occurs during the study, having been absent at 
baseline, or if present at baseline, appears to worsen. AEs will be reported regardless of their 

Page 28 of 34 
 
V2 - HIV Care 
 
22 June 2021 
relationship to the study intervention. An SAE is any adverse event that results in death, is life-
threatening, or places the participant at immediate risk of death, requires or prolongs 
hospitalization, causes persistent or significant disability or incapacity, or any other condition 
which Study PI Dr. Gamarel deem to represent significant hazards.  
 
XI-5. Reporting Plan  
All AEs and SAEs will be reported regardless of their relationship to the study intervention. The 
study team will document all adverse events and unanticipated problems (see Appendix XII-15. 
Adverse Events and Unanticipated Problems Log). We will detect AEs and SAEs during 
participant visits and via survey responses. Any serious adverse events that are observed 
and/or reported will be immediately reported to Dr. Gamarel. We will report all AEs and SAEs by 
alerting the University of Michigan IRB. The Research Director will prepare the appropriate IRB 
documentation, and review it with Drs. Gamarel and Harper and determine severity and relation 
to study participation. As for all clinical trials, these events will be classified along the following 
dimensions: 1) severity; 2) whether it was expected or not; and 3) the extent to which it was 
related to study participation. A report detailing all AEs and SAEs will be submitted to the 
University of Michigan IRB. SAEs will require expedited reporting (i.e., within 24 hours of the PI 
becoming aware of the SAE). For events that are judged to be ongoing, the Project Director will 
make weekly calls to the participant to collect updated data regarding the event. This process 
will continue until the PI determines that the event is terminated, at which time a follow-up report 
will be submitted to the University of Michigan IRB.  
 
PI Dr. Gamarel will promptly inform the NIMH PO and IRB of any changes in recruitment or in 
the protocol relevant to safety as the study is being performed. Dr. Gamarel will notify the NIMH 
PO of any actions taken by the IRB during continuing study review and of any major changes in 
the status of the ongoing protocol that would only occur with IRB approval. Such changes would 
include but are not limited to: amendments to the protocol, temporary suspension of participant 
accrual or of the protocol, any changes in informed consent or IRB approval status, termination 
of participant accrual or of the protocol, or other problems or issues that could affect the human 
subjects in the study. SAEs, unanticipated problems involving risk to participants or others, and 
AEs will be reported the NIMH PO within 10 business days of Dr. Gamarel learning of the event. 
Deaths related to study participation will be reported within 5 business days of learning of the 
event by Dr. Gamarel to the NIMH PO. Any serious or continuing noncompliance concerns will 
be reported to the NIMH PO within 10 business days of the IRB determination and suspension 
or termination of IRB approval will be promptly reported to the NIMH PO within 3 business days 
of receipt. The NIMH PO will be provided copies of these reports and informed of any actions 
taken by the IRB as a result of such events. As mandated by law, we will notify officials if a 
participant reports intentions to harm him/herself or others, or reports child abuse or abuse of an 
elder. Co-I Dr. Harper is a clinical psychologist who will be available on call in case of any 
psychological adverse events. In the event a participant were to report a need or interest in 
treatment for psychiatric disorder, or distress, an appropriate referral to resources will be 
provided based on an extensive list of referral resources maintained at the Ruth Ellis Center. All 
events and protocol violations related to the study will be reported annually in the Progress 
Report sent to the NIMH PO.  
 

Page 29 of 34 
 
V2 - HIV Care 
 
22 June 2021 
XII. Protocol Amendments 
XXII-1. Ame00113458 
The University of Michigan is no longer requiring completion of the Human Research Activation 
Checklist to authorize in-person research activities. All research procedures will adhere to 
current University guidelines and IRB-approved procedures; if/when University COVID-19 
guidelines change, we will adjust procedures accordingly, obtaining IRB approval as 
appropriate.   
The informed consent process will not accessed online via a Qualtrics survey; instead, informed 
consent be led by the Study RA by phone, Zoom, or in-person in a private office (in alignment 
with current COVID-19 guidelines). The Study RA will call potential participants who are 
identified as eligible in the eligibility survey. She will read the consent form to the participant, 
answer any questions she may have, confirm the participant understands the study procedures, 
and obtain verbal informed consent. The Study RA will document the informed consent process 
and whether the participant consented to study procedures in the study database.  
 
 
 
 

Page 30 of 34 
 
V2 - HIV Care 
 
22 June 2021 
XIII. References 
1. 
Poteat T, German D, Kerrigan D. Managing uncertainty: a grounded theory of stigma in 
transgender health care encounters. Soc Sci Med. 2013;84:22-29. 
2. 
Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in 
transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013;13(3):214-
222. 
3. 
Becasen JS, Denard CL, Mullins MM, Higa DH, Sipe TA. Estimating the prevalence of HIV and 
sexual behaviors among the US transgender population: A systematic review and meta-analysis, 
2006–2017. American journal of public health. 2019;109(1):e1-e8. 
4. 
Herbst J, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N. Estimating HIV 
prevalence and risk behaviors of transgender persons in the United States: a systematic review. 
AIDS & Behavior. 2008;12(1):1-17 17p. 
5. 
Clark H, Babu AS, Wiewel EW, Opoku J, Crepaz N. Diagnosed HIV infection in transgender 
adults and adolescents: results from the National HIV Surveillance System, 2009–2014. AIDS 
and Behavior. 2017;21(9):2774-2783. 
6. 
McNairy ML, El-Sadr WM. A paradigm shift: focus on the HIV prevention continuum. Clinical 
Infectious Diseases. 2014;59(suppl_1):S12-S15. 
7. 
Reisner SL, Jadwin-Cakmak L, Hughto JMW, Martinez M, Salomon L, Harper GW. 
Characterizing the HIV Prevention and Care Continua in a Sample of Transgender Youth in the 
US. AIDS and Behavior. 2017;21(12):3312-3327. PMC5706332 
8. 
Bukowski LA, Chandler CJ, Creasy SL, Matthews DD, Friedman MR, Stall RD. Characterizing the 
HIV Care Continuum and Identifying Barriers and Facilitators to HIV Diagnosis and Viral 
Suppression Among Black Transgender Women in the United States. J Acquir Immune Defic 
Syndr. 2018;79(4):413-420. 
9. 
Pitasi MA, Oraka E, Clark H, Town M, DiNenno EA. HIV testing among transgender women and 
men—27 states and Guam, 2014–2015. MMWR Morbidity and mortality weekly report. 
2017;66(33):883. 
10. 
Kuhns LM, Reisner, S.L.,Mimiaga, M.J.,, Gayles T, Shelenich M, Garofalo R. Correlates of PrEP 
indication in a multi-site cohort of young HIV-uninfected transgender women. AIDS Behav. 
2016;20(7):1470-1477. 
11. 
Kalichman SC, Hernandez D, Finneran S, Price D, Driver R. Transgender women and HIV-
related health disparities: falling off the HIV treatment cascade. Sexual health. 2017;14(5):469-
476. 
12. 
Jin H, Restar A, Biello K, et al. Burden of HIV among young transgender women: factors 
associated with HIV infection and HIV treatment engagement. AIDS care. 2019;31(1):125-130. 
13. 
Gamarel KE, Sevelius J, Reisner SL, Sutten Coats C, Nemoto T, Operario D. Commitment, 
intepersonal stigma, and mental health in romantic relationships between transgender women 
and cisgender male partners. J Soc Pers Relat, 2019; 36(7): 2180-2201. PMC6510026 
14. 
Gamarel KE, Reisner SL, Laurenceau J-P, Nemoto T, Operario D. Gender minority stress, mental 
health, and relationship quality: A dyadic investigator of transgender women and their cisgender 
male partners. J Fam Psychol. 2014;28(4):437-447. PMC4122619 
15. 
Yerke AF, DeFeo J. Redefining intimate partner violence beyond the binary to include 
transgender people. Journal of family violence. 2016;31(8):975-979. 
16. 
USAID. United States strategy to prevent and respond to gender-based violence globally. 2012. 
17. 
Sevelius JM. Gender affirmation: a framework for conceptualizing risk behavior among 
transgender women of color. Sex roles. 2013;68(11-12):675-689. 
18. 
Wirtz AL, Poteat T, Malik M, Glass N. Gender-based violence against transgender people in the 
United States: A call for research and programming. Trauma, Violence, & Abuse. 2018:1-15. 
19. 
Richmond KA, Burnes T, Carroll K. Lost in trans-lation: Interpreting systems of trauma for 
transgender clients. Traumatology. 2012;18(1):45-57. 
20. 
Herbst JH, Jacobs ED, Finlayson TJ, et al. Estimating HIV prevalence and risk behaviors of 
transgender persons in the United States: A systematic review. AIDS Behav. 2008;12(1):1-17. 
21. 
Beattie TS, Bhattacharjee P, Suresh M, Isac S, Ramesh B, Moses S. Personal, interpersonal and 
structural challenges to accessing HIV testing, treatment and care services among female sex 

Page 31 of 34 
 
V2 - HIV Care 
 
22 June 2021 
workers, men who have sex with men and transgenders in Karnataka state, South India. J 
Epidemiol Community Health. 2012;66(Suppl 2):ii42-ii48. 
22. 
Coulter RW, Blosnich JR, Bukowski LA, Herrick A, Siconolfi DE, Stall RD. Differences in alcohol 
use and alcohol-related problems between transgender-and nontransgender-identified young 
adults. Drug and alcohol dependence. 2015;154:251-259. 
23. 
Cramer RJ, McNiel DE, Holley SR, Shumway M, Boccellari A. Mental health in violent crime 
victims: Does sexual orientation matter? Law and human behavior. 2012;36(2):87. 
24. 
Duncan DT, Hatzenbuehler ML. Lesbian, gay, bisexual, and transgender hate crimes and 
suicidality among a population-based sample of sexual-minority adolescents in Boston. American 
journal of public health. 2014;104(2):272-278. 
25. 
Keuroghlian AS, Reisner SL, White JM, Weiss RD. Substance use and treatment of substance 
use disorders in a community sample of transgender adults. Drug and alcohol dependence. 
2015;152:139-146. 
26. 
Operario D, Nemoto T, Iwamoto M, Moore T. Risk for HIV and unprotected sexual behavior in 
male primary partners of transgender women. Arch Sex Behav. 2011;40(6):1255-1261. 
27. 
Goldenberg T, Jadwin-Cakmak L, Harper GW. Intimate partner violence among transgender 
youth: Associations with intrapersonal and structural factors. Violence and gender. 2018;5(1):19-
25. PMC5865252 
28. 
Cavanaugh CE, Hansen NB, Sullivan TP. HIV sexual risk behavior among low-income women 
experiencing intimate partner violence: The role of posttraumatic stress disorder. AIDS and 
Behavior. 2010;14(2):318-327. 
29. 
Hien D, Ruglass L. Interpersonal partner violence and women in the United States: An overview 
of prevalence rates, psychiatric correlates and consequences and barriers to help seeking. 
International journal of law and psychiatry. 2009;32(1):48. 
30. 
Zlotnick C, Johnson DM, Kohn R. Intimate partner violence and long-term psychosocial 
functioning in a national sample of American women. Journal of interpersonal violence. 
2006;21(2):262-275. 
31. 
Brennan J, Kuhns LM, Johnson AK, et al. 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. 2012;102(9):1751-1757. 
32. 
Garofalo R, Kuhns LM, Reisner SL, Mimiaga MJ. Behavioral interventions to prevent HIV 
transmission and acquisition for transgender women: A critical review. J Acquir Immune Def 
Syndr. 2016;72(Suppl 3):S220-S225. 
33. 
Reisner SL, Jadwin-Cakmak L, Sava L, Liu S, Harper GW. Situated Vulnerabilities, Sexual Risk, 
and Sexually Transmitted Infections' Diagnoses in a Sample of Transgender Youth in the United 
States. AIDS Patient Care STDS. 2019;33(3):120-130. PMC6442265 
34. 
Sevelius J. Gender affirmation: A framework for conceptualizing risk behavior among transgender 
women of color. Sex Roles. 2013;68(11-12):675-689. PMC3667985 
35. 
Harper GW, Jadwin-Cakmak LA, Popoff E, Campbell BA, Granderson R, Wesp LM. Transgender 
and Other Gender-Diverse Youth's Progression Through the HIV Continuum of Care: 
Socioecological System Barriers. AIDS Patient Care STDS. 2019;33(1):32-43. PMC6338455 
36. 
Harper GW, Jadwin-Cakmak LA, Popoff E, et al. Transgender and Other Gender-Diverse Youth's 
Progression Through the HIV Continuum of Care: Socioecological System Barriers. AIDS Patient 
Care STDs. 2019;33(1):32-43. PMC6338455 
37. 
Harper GW, Wagner RL, Popoff E, Reisner SL, Jadwin-Cakmak L. Psychological resilience 
among trans-feminine adolescents and emerging adults living with HIV. AIDS. In press. 
38. 
Substance Abuse and Mental Health Services Administration. Trauma-informed care in 
behavioral health sciences. Rockville, MD: Substance Abuse and Mental Health Services; 2014. 
39. 
Brezing C, Ferrara M, Freudenreich O. The syndemic illness of HIV and trauma: implications for a 
trauma-informed model of care. Psychosomatics. 2015;56(2):107-118. 
40. 
Grant J, Mottet L, Tanis J, Harrison J, Herman J, Keisling M. Injustice at every turn: A report of the 
National Transgender Discrimination Survey. Washington: National Center for Transgender 
Equality and National Gay and Lesbian Task Force;2011. 
41. 
Bones Rocha K, Rubim Barbosa LH, Zambom Barboza C, et al. Attitudes and Perceptions of the 
Brazilian Public Health System by Transgender Individuals. Forum Qualitative Sozialforschung / 
Forum: Qualitative Social Research,. 2009;10(2). 

Page 32 of 34 
 
V2 - HIV Care 
 
22 June 2021 
42. 
Sevelius J, Murray LR, Martinez Fernandes N, Veras MA, Grinsztejn B, Lippman SA. Optimising 
HIV programming for transgender women in Brazil. Cult Health Sex. 2018:1-15. PMC6483864 
43. 
Poteat T, German D, Kerrigan D. Managing uncertainty: a grounded theory of stigma in 
transgender health care encounters. Soc Sci Med. 2013;84:22-29. 
44. 
Herek GM. A Nuanced View of Stigma for Understanding and Addressing Sexual and Gender 
Minority Health Disparities. LGBT Health. 2016(2325-8306 (Electronic)). 
45. 
Wirtz A, Glass N, Pham K, et al. Comprehensive development and testing of the ASIST-GBV, a 
screening tool for responding to gender-based violence among women in humanitarian settings. 
Conflict and health. 2016;10(1):7. 
46. 
Klein SJ, Tesoriero JM, Leung S-YJ, Heavner KK, Birkhead GS. Screening persons newly 
diagnosed with HIV/AIDS for risk of intimate partner violence: Early progress in changing 
practice. Journal of Public Health Management and Practice. 2008;14(5):420-428. 
47. 
Empson S, Cuca YP, Cocohoba J, Dawson-Rose C, Davis K, Machtinger EL. Seeking safety 
group therapy for co-occurring substance use disorder and PTSD among transgender women 
living with HIV: a Pilot study. Journal of psychoactive drugs. 2017;49(4):344-351. PMID28524758 
48. 
Zuniga JM. IAPAC guidelines for optimizing the HIV care continuum for adults and adolescents. 
Journal of the international Association of Providers of AIDS Care. 2015;14:S3-S34. 
49. 
Nelson HD, Bougatsos C, Blazina I. Screening women for intimate partner violence: a systematic 
review to update the US Preventive Services Task Force recommendation. Annals of internal 
medicine. 2012;156(11):796-808. 
50. 
Garofalo R, Kuhns LM, Reisner SL, Biello K, Mimiaga MJ. Efficacy of an empowerment-based, 
group-delivered HIV prevention intervention for young transgender women: the Project LifeSkills 
randomized clinical trial. JAMA pediatrics. 2018;172(10):916-923. 
51. 
Trammell R, Burks C, Campbell BA, et al. Love Her Collective: Utilizing paticipatory-based 
research principles to improve the lives of trans women of color in Detroit, Michigan. Oral 
Presentation presented at National Transgender Health Summit; April 13, 2019, 2019; Oakland, 
CA. 
52. 
Najavits LM, Gallop RJ, Weiss RD. Seeking safety: A treatment manual for PTSD and substance 
abuse. New York, NY: Guilford Press; 2002. 
53. 
Hien DA, Morgan-Lopez AA, Campbell AN, et al. Attendance and substance use outcomes for 
the Seeking Safety program: Sometimes less is more. Journal of consulting and clinical 
psychology. 2012;80(1):29. 
54. 
Steward WT, Sumitani J, Moran ME, et al. Engaging HIV-positive clients in care: acceptability and 
mechanisms of action of a peer navigation program in South Africa. AIDS care. 2018;30(3):330-
337. 
55. 
Arnold EA, Fuller S, Kirby V, Steward WT. The Impact Of Medicaid Expansion On People Living 
With HIV And Seeking Behavioral Health Services. Health Affairs. 2018;37(9):1450-1456. 
PMID30179563 
56. 
Cook TD, Campbell DT. Quasi-experimentation: Design and analysis issues for field settings. 
Boston, MA: Houghton Mifflin; 1979. 
57. 
Andrasik MP, Yoon R, Mooney J, et al. Exploring barriers and facilitators to participation of male-
to-female transgender persons in preventive HIV vaccine clinical trials. Prev Sci. 2014;15(3):268-
276. 
58. 
Owen-Smith AA, Woodyatt C, Sineath RC, et al. Perceptions of Barriers to and Facilitators of 
Participation in Health Research Among Transgender People. Transgend Health. 2016;1(1):187-
196. 
59. 
Quinn DM, Chaudoir SR. Living with a concealable stigmatized identity: The impact of anticipated 
stigma, centrality salience, and cultural stigma on psychological distress and health. Journal of 
Personality and Social Psychology. 2009;97(4):634-651. 
60. 
Vittinghoff E, Sen S, McCulloch CE. Sample size calculations for evaluating mediation. Stat Med. 
2009;28(4):541-555. 
61. 
Koester KA, Morewitz M, Pearson C. Patient Navigation Facilitates Medical and Social Services 
Engagement Among HIV-Infected Individuals Leaving Jail and Returning to the Community. AIDS 
Patient Care STDS. 2014;28(2):82-90. 

Page 33 of 34 
 
V2 - HIV Care 
 
22 June 2021 
62. 
Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-
based HIV Interventions. JAIDS Journal of Acquired Immune Deficiency Syndromes. 
2008;47:S40-S46. 
63. 
Operario D, Gamarel KE, Iwamoto M, et al. Couples-focused prevention program to reduce HIV 
risk among transgender women and their primary male partners: Feasibility and promise of the 
Couples HIV Intervention Program. AIDS Behav. 2017;21(8):2452-2463. PMC5179320 
64. 
Carlson EB, Smith SR, Palmieri PA, et al. Development and validation of a brief self-report 
measure of trauma exposure: The Trauma History Screen. Psychological assessment. 
2011;23(2):463. 
65. 
Michigan Department of Community Health. Annual HIV Surveillance Report for Michigan. 2016. 
66. 
Rosenberg ES, Millett GA, Sullivan PS, del Rio C, Curran JW. Understanding the HIV disparities 
between black and white men who have sex with men in the USA using the HIV care continuum: 
a modelling study. Lancet. 2014;1:e112-118. 
67. 
Gamarel KE, Comfort ML, Wood T, Neilands TB, Johnson MO. A qualitative analysis of male 
couples' coping with HIV: Disentangling the "we". J Health Psychol. 2016;21(10):2125-2137. 
PMC4915963 
68. 
Golub SA, Gamarel KE, Surace A. Demographic differences in PrEP-related stereotypes: 
Implications for  implementation. AIDS Behav. 2017;21(5):1229-1235.PMC4701641 
69. 
Radix A, Lelutiu-Weinberger C, Gamarel KE. Satisfaction and health care utilization of 
transgender and gender non-comforming individuals in NYC: A community-based participatory 
study. LGBT Health. 2014;1(4):302-308. PMID267898585 
70. 
Saberi P, Gamarel KE, Neilands TB, et al. Ambiguity, ambivalence, and apprehension of taking 
HIV-1 pre-exposure prophylaxis among male couples in San Francisco: A mixed methods study. 
PLoS ONE. 2012;7(11):e50061. PMC3498189 
71. 
Nemoto T, Operario D, Keatley J, Villegas D. Social context of HIV risk behaviors among male-to-
female transgender of colour. AIDS Care. 2004;16(6):724-735. 
72. 
Srivastava A, Thompson SB. Framework Analysis: A Qualitative Methodology for Applied Policy 
Research. Journal of Administration & Governance. 2009;42(2):72-79. 
73. 
Attkisson CC, Greenfield TK. Client satisfication questionnaire-8 and service satisfaction scale-
30. In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcome 
Assessment. Hillside, NJ: Lawrence Erlbaum Associates; 1994:402-440. 
74. 
Gamarel KE, Darbes LA, Hightow-Weidman L, Sullivan P, Stephenson R. The Development and 
Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young 
Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We 
Prevent): Protocol for a Randomized Controlled Trial. JMIR research protocols. 
2019;8(1):e10370. PMID30602433 
75. 
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The posttraumatic stress disorder 
checklist for DSM‐5 (PCL‐5): Development and initial psychometric evaluation. Journal of 
Traumatic Stress. 2015;28(6):489-498. 
76. 
Radloff LS. The CES-D scale a self-report depression scale for research in the general 
population. Appl Psychol Meas. 1977;1(3):385-401. 
77. 
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety 
disorder: the GAD-7. Archives of internal medicine. 2006;166(10):1092-1097. 
78. 
Gamarel KE, Brown L, Kahler CW, et al. Prevalence and correlates of substance use among 
youth living with HIV in clinical settings. Drug Alc Depend. 2016;169:11-18. PMC5140709 
79. 
Crepaz N, Lyles CM, Wolitski RJ, et al. Do prevention interventions reduce HIV risk behaviours 
among people living with HIV? A meta-analytic review of controlled trials. Aids. 2006;20(2):143-
157. 
80. 
Crabtree B, Miller W. Using codes and code manuals: A template organizing style of 
interpretation. In: Crabtree B, Miller W, eds. Doing Qualitative Research. Newbury Park, CA: 
Sage; 1999. 
 
 

Page 34 of 34 
 
V2 - HIV Care 
 
22 June 2021 
XIV. List of Separate Appendices 
 
List of separate study appendices include:  
XII-1. Group Sessions Manual 
XII-2. Individual Sessions Resource and Referral List - Draft 
XII-3. Violence and Gender Affirmation Screener 
XII-4. Intervention Log 
XII-5. Adapted Client Satisfaction Questionnaire  
XII-6. Exit Interview Guide – Participants  
XII-7. Exit Interview Topic Guide – Program Staff 
XII-8. Survey Measures  
XII-9. Consent Form 
XII-10. Suicide Risk Assessment 
XII-11. Screener Script 
XII-12. Eligibility Survey 
XII-13. Locator Form 
XII-14. Incentive Survey 
XII-15. Adverse Events and Unanticipated Problems Log 
XII-16. Individual Sessions Guide