Strengthening Community Responses to Economic Vulnerability and HIV Inequities
Phase: NA
Conditions: Feasibility Studies
Sponsor: University of Michigan

 
 
HUM00239691 
Secure: Strengthening Community Responses to Economic Vulnerability among Trans 
Women 
Phase II Pilot RCT Research Protocol 
 
NCT: F00423 
IRB Approval Date: April 10, 2025  
 
 
 
 
 
 

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Contents 
I. 
Research Team ..................................................................... Error! Bookmark not defined. 
II. 
Acronyms ............................................................................................................................... 4 
III. Study Objectives .................................................................................................................... 5 
III-1. Aim 1 ................................................................................................................................. 6 
III-2. Aim 2 ................................................................................................................................. 6 
IV. Background Information ........................................................................................................ 6 
V. 
Study Team Experience ........................................................ Error! Bookmark not defined. 
VI. Study Design ......................................................................................................................... 8 
VI-1. Study Settings ................................................................................................................... 9 
VI-2. Pilot Randomized Controlled Trial Arm Overview ............................................................. 9 
VI-3. Assessing Acceptability & Feasibility .............................................................................. 10 
VI-4. Analytical Design ............................................................................................................ 11 
VI-4.1 Acceptability & Feasibility analyses. ......................................................................... 11 
VI-4.2 Exploratory analyses. ................................................................................................ 11 
VI-4.3 Power analyses. ........................................................................................................ 11 
VII. Study Procedures ................................................................................................................ 12 
VII-1. COVID-19 Safety ........................................................................................................... 12 
VII-2. Recruitment ................................................................................................................... 12 
VII-3. Eligibility Screening ........................................................................................................ 12 
VII-3.1 Eligibility Criteria. ...................................................................................................... 12 
VII-3.2 Eligibility Screening Survey. ..................................................................................... 12 
VII-4. Enrollment Procedures .................................................................................................. 13 
VII-4.1. Informed Consent: ................................................................................................... 13 
VII-4.2 Baseline Survey ....................................................................................................... 14 
VII-4.4 Randomization: ........................................................................................................ 14 
VII-5. Intervention Arm Procedures ......................................................................................... 14 
VII-5.1 In-Person Group Sessions ....................................................................................... 14 
VII-5.2 Individual Mentorship ............................................................................................... 15 
VII-5.3 Microgrant Funds ..................................................................................................... 15 
VII-5.4 Weekly Job Announcements .................................................................................... 16 
VII-5.5 Standard of Care ...................................................................................................... 16 
VII-6. Waitlist Control Arm Procedures .................................................................................... 16 
VII-6.1 One-time Emergency Assistance Funds: ................................................................. 16 

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VII-6.2 Legal Gender Affirmation Support: ........................................................................... 16 
VII-6.3 Waitlist Control Secure Content Access: ................................................................. 17 
VII-7. Follow Up Assessments and Additional Intervention Fidelity Documentation ............... 17 
VII-7.1 Follow-up Survey Assessments ............................................................................... 17 
VII-7.2 Qualitative Exit Interviews: ....................................................................................... 17 
VII-7.3 Additional Intervention Fidelity Documentation ........................................................ 17 
VII-8. Participant Incentives and Other Funds Provided ......................................................... 17 
VII-9. Retention Strategies ...................................................................................................... 18 
VIII. Data Collection and Management ....................................................................................... 18 
VIII-1. Data Collection Methods ............................................................................................... 18 
VIII-2. Storage and Security .................................................................................................... 19 
IX. Human Subjects Research Protections ............................................................................... 22 
IX-1. Protection of Human Subjects ........................................................................................ 22 
IX-2. Inclusion and Exclusion Criteria ...................................................................................... 22 
IX-2.1 Inclusion criteria. ....................................................................................................... 22 
IX-2.2 Exclusion criteria. ...................................................................................................... 22 
IX-2.3 Rationale for Involving Proposed Populations. ......................................................... 22 
IX-3. Informed Consent ........................................................................................................... 22 
IX-4. Risk/Benefit Assessment ................................................................................................ 22 
IX-4.1. Potential Risks ......................................................................................................... 22 
IX-4.2. Protection Against Risk ............................................................................................ 23 
IX-4.3. Potential benefits of the proposed research to the subjects and others .................. 25 
IX-4.4. Importance of the knowledge to be gained .............................................................. 25 
IX-5. Study Withdrawal and Discontinuation ........................................................................... 26 
X. Data Safety and Monitoring Plan ............................................................................................ 27 
X-1. Safety and Monitoring ...................................................................................................... 27 
X-2. Contents of Monitoring ..................................................................................................... 27 
X-3. Frequency of Monitoring .................................................................................................. 27 
X-4. Adverse Events ................................................................................................................ 27 
X-5. Reporting Plan ................................................................................................................. 28 
X. 
List of Appendices / Study Documents ................................................................................ 29 
XI. Amendments ....................................................................................................................... 30 
XII. References .......................................................................................................................... 32 
 
 
 

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I. 
Acronyms 
 
AE: Adverse event 
ART: Anti-retroviral therapy 
BIPOC: Black, Indigenous, and other People of Color 
CAB: Community Advisory Board 
CBO: Community-based organization 
Co-I: Co-Investigator 
CHC: Corktown Health Center 
DMA: Detroit Metro Area 
EE: Economic Empowerment  
EHE: Ending HIV Epidemic  
GLMM: Generalized linear mixed model 
HIVRR: HIV Risk Reduction 
IRB: Institutional Review Board 
LGBT: Lesbian, gay, bisexual, transgender 
MI: Multiple Imputation 
MLE: Maximum likelihood model 
NIH: National Institutes of Health  
PD: Project Director 
PHE: Peer Health Educator 
PHI: Protected health information 
PI: Principal Investigator 
PrEP: Pre-Exposure Prophylaxis 
RA: Research Associate 
RCT: Randomized Controlled Trial 
SAE: Serious adverse event 
TSoCP: Trans Sistas of Color Project  
U-M SPH: University of Michigan School of Public Health 
 

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II. 
Study Objectives 
This protocol outlines the research procedures for Phase II of "Secure" (R34-MH-130207), a 
microeconomic intervention to improve HIV prevention and care continua outcomes among 
transgender (trans) women of color. Phase I of this study (HUM00215727) included formative 
qualitative work to adapt a microeconomic intervention called EMERGE for trans women of 
color in Detroit, develop program materials, and review study procedures. The objective of 
Phase II of this study (the current application, HUM00239691) is to conduct a small randomized 
controlled trial (RCT) of the Secure program to evaluate feasibility and acceptability of the 
adapted intervention among a sample of N=40 trans women of color living in Detroit, MI. 
 
Specific Aims 
In the United States (US), Black, Indigenous, and other transgender women of color (herein 
“BIPOC trans women”) experience cyclical, interlocking systems of structural and institutional 
oppression rooted in racism and transphobia.1,2 This pervasive and systemic intersectional 
racism and transphobia fuels economic vulnerability (e.g., in education, employment, and 
housing) among BIPOC trans women.3-5 An estimated 38.5% of Black trans people in the US 
live below the poverty line.6 Our recent survey with BIPOC trans women in Detroit confirmed 
these economic hardships locally, finding that 66.7% of respondents earn less than $1,000 per 
month, 78.3% are experiencing food insecurity, 39% are homeless or unstably housed, and just 
18.3% report being able to get by in their current financial situation.7 Together, this cycle of 
intersecting racism, transphobia, and economic vulnerabilities create conditions that fuel the 
extreme HIV inequities seen among BIPOC trans women in the US, including high HIV 
prevalence, low uptake of pre-exposure prophylaxis among those not living with HIV, and low 
uptake and adherence to antiretroviral therapy among those living with HIV.8-13 Approximately 
19-21% of trans women are living with HIV in the US;14-16 with evidence suggesting racial/ethnic 
inequities. Black, Latina, and other trans women of color represent the majority of cases (51%, 
29%, and 11%, respectively).17,18  
 
Microeconomic interventions – designed to improve financial standing by increasing 
income generation and access to financial resources through entrepreneurship, cash transfers, 
and training — have the potential to address structural factors underlying HIV risk.19 Over the 
past few years, several BIPOC trans-led organizations have integrated microeconomic 
strategies, such as emergency assistance (i.e., unconditional cash grants) into usual care.20 
However, our formative work in Detroit highlighted a need for additional supports to improve 
financial standing, including components of a US-based microeconomic intervention to mitigate 
HIV risk among Black cisgender people developed and piloted by one of the PIs.21-23 
 
In alignment with the Ending the HIV Epidemic (EHE) plan and NIH priority areas for 
reducing HIV incidence,24,25 the goal of this study is to develop and pilot test an HIV status-
neutral, gender-affirming microeconomic intervention to decrease economic vulnerability and 
thereby promote HIV prevention (HIV testing and PrEP use) and care (viral suppression) among 
BIPOC trans women in Detroit, Michigan, an EHE priority jurisdiction.26,27 The gender-affirming 
microeconomic intervention named, “Strengthening Community Responses to Economic 
Vulnerability among Trans Women (Secure)” builds on our community’s existing usual care 
(UC) microeconomic intervention of: (1) an emergency unconditional cash grant (averaging 
$200)20 and (2) peer and legal support to obtain legal gender affirmation (i.e., legal name and 
gender markers on identification documents).26-28 The 12-week microeconomic intervention 
(Secure) will include our community partners’ UC plus: (1) weekly educational sessions on 
economic empowerment (i.e., job acquisition, income generation through micro-business, and 
financial literacy) and HIV prevention and care; (2) employment-focused mentoring; (3) weekly 
social media posts of job openings in Detroit; and (4) an unconditional grant ($1,200) for use 
towards acquiring self-led or formal employment. The specific aims are to: 

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III-1. Aim 1: Assess the feasibility of the Secure intervention to be implemented in the Detroit 
transgender community setting.  
 
III-2. Aim 2: Evaluate the acceptability of the Secure intervention to improve HIV prevention 
and care continua outcomes.  
 
To achieve these aims, we will recruit and randomize 40 BIPOC trans women, aged > 18 years, 
to intervention or a waitlist control for 12 weeks (e.g., 20 trans women per arm). Participants will 
complete baseline, end of program, and 3-month follow-up surveys. Immediately following the 
intervention program end, participants will also complete a qualitative exit interview regarding 
their experience. The specific feasibility benchmarks are to a) achieve a recruitment rate of at 
least 5-6 participants per month; b) maintain a retention rate of 70% or higher; and c) obtain 
estimates of outcomes (less than 10% missing data) and ensure measures and data collection 
are suitable to explore if participants who receive the intervention will report increased HIV 
prevention and care outcomes post-intervention compared to those in the control condition. We 
will also gather information from participants during exit interviews and interviews with key 
stakeholders and staff delivering the intervention to identify strategies for sustainability with 
BIPOC trans women in US-based settings, and we will use these data and input from our 
community advisory board (CAB) to refine the intervention for a future efficacy trial.  
 
The proposed study has the potential for high public health impact by evaluating the feasibility 
and acceptability of a community-centered microeconomic intervention. Our focus on BIPOC 
trans women is in line with the prioritization of sexual and gender minority communities for 
health disparities research,31,32 and NIH funding priorities to address social-structural drivers of 
inequities in both the HIV prevention and care continuum.25 Study findings will provide the 
necessary groundwork to examine intervention efficacy and implementation processes in a 
future, large-scale trial.  
III. 
Background Information 
Trans women represent one of the populations at highest risk for HIV infection.33 
Approximately 19-21% of trans women in the US are living with HIV.14-16 Evidence suggests 
substantial racial/ethnic inequities in HIV with Black, Latina, and other trans women of color 
representing the majority of the cases among trans women.17,18,34 The HIV Prevention and Care 
Continuum frameworks emphasize the need for reducing HIV transmission and acquisition risk 
via consistent condom use, regular HIV testing, pre-exposure prophylaxis (PrEP) among HIV-
negative individuals, and engagement and retention in HIV care in addition to uptake, 
adherence, and persistence to antiretroviral therapy (ART) to achieve virologic control among 
persons living with HIV.35-37 There are notable inequities in HIV prevention and care continua 
outcomes among BIPOC trans women.38,39 For example, evidence suggests that BIPOC trans 
women have a 40% lower odds of lifetime HIV testing and 50% lower odds of HIV testing in the 
past 12 months compared with gay/bisexual men.40 Studies also indicate very low PrEP uptake 
(3 to 32% use among PrEP-eligible trans women),41,42 and low rates of virologic control (68 to 
70%) among trans women living with HIV.38,43-52 Thus, interventions are needed that address 
inequities across both the HIV prevention and care continuum among BIPOC trans women in 
the US.38,51,52 

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Due to the convergence of structural racism and transphobia, BIPOC trans women 
experience high rates of income insecurity, 26,53-56 unstable housing,4,53,55-58 and 
unemployment.54,56,58,59 Unemployment rates among BIPOC trans women have been estimated 
to be nearly four times higher than the national average,60 with many trans women living below 
the poverty line (29-63%),54,60 and reporting unstable housing in their lifetime (30-49%).60,61 
Research suggests that persons experiencing economic hardship are less likely to prioritize HIV 
prevention and care in the face of needing to meet basic needs (i.e., housing, food), resulting in 
lower rates of HIV testing,62 PrEP initiation,63 ART adherence and engagement in HIV care.64 
Systemic racism and transphobia compound the economic vulnerability experienced by BIPOC 
trans women, placing them at heightened risk for HIV.10 HIV prevalence in lower-income urban 
areas in the US is 2 to 5 times higher than the national average, and individuals living below the 
poverty line are twice as likely to be living with HIV.65,66 Many BIPOC trans women are forced to 
turn to illegal means of securing income and housing, such as survival sex work, which 
increases their risk for HIV.67 Evidence suggests that economic inequities are exacerbated by a 
lack of employment-based health insurance coverage and the necessary funds to pay for 
gender affirming medical care (e.g., hormones), which may also contribute in part to 
engagement in survival sex work.60,68,69 Additionally, over a third of BIPOC trans women have 
not been able to have their name or gender marker changed due to financial costs, a significant 
barrier to seeking work and accessing sexual health services.60 In the US, state and federal 
legal identification documents are often required to access education, employment, housing, 
and health care facilities, including HIV and related PrEP/ART services.70 BIPOC trans women 
who lack legal gender affirmation are at greater risk for economic vulnerabilities,71,72 which fuel 
HIV inequities.73 Conversely, evidence suggests that having employment acquisition support in 
the form of linkages to jobs, financial assistance, and having legal gender affirmation needs met 
is associated with improvements in indicators of economic status (i.e., income and housing).56 
Employment acquisition support may also better enable vulnerable BIPOC trans women to 
attain gender affirming medical care (e.g., prescribed hormones), ultimately experiencing less 
discrimination.56 Behavioral interventions that address economic vulnerability that have only 
been exacerbated due the COVID-19 pandemic have the potential to alleviate HIV inequities 
among BIPOC trans women.61,74,75 
Despite alarming rates of racism, transphobia, and economic vulnerability, it is important to 
underscore that US BIPOC trans women are resilient and resourceful and find creative ways to 
leverage existing community and individual assets to address systemic oppression, unmet 
gender affirmation needs, and economic hardships in their communities.76-79 In 2017, the Trans 
Sistas of Color Project (TSoCP) launched a mutual aid fund that consists of a no-strings-
attached microgrant (i.e., unconditional grant) for up to $500 for one-time emergency assistance 
to BIPOC trans women in Detroit. During the COVID-19 pandemic, many other US-based trans-
led organizations and BIPOC trans communities have found ways to support their communities 
through the provision of mutual aid and organized advocacy for justice.80,81 Additionally, several 
trans-led organizations have formed legal partnerships that provide counsel in obtaining legal 
gender affirmation.28 Therefore, the proposed Secure microeconomic intervention 
(“Strengthening Community Responses to Economic Vulnerability”) is named after and 
premised on the principle of strengthening BIPOC trans communities in their endeavor to 
address underlying economic, legal, and other structural determinants of health. Our pilot work 
highlighted the multitude of benefits of existing community-led structural-level interventions in 
Detroit. However, our team also identified areas for improvement, which included adding 

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components from the MPI’s previously piloted microeconomic intervention for Black cisgender 
persons called EMERGE, which includes skill building for income generation, financial literacy, 
unconditional cash grants for self-led or formal employment costs, and employment-focused 
mentorship.21-23 
Microeconomic interventions are designed to improve financial status by increasing 
entrepreneurship, savings, and/or employment, thereby addressing the structural factors 
underlying HIV risk in economically marginalized individuals. Microeconomic strategies have 
included business loans, personal savings accounts, microgrants, vocational training, financial 
and business training, insurance provision, career planning, and employment-focused 
mentoring.21 Integrated microeconomic and HIV prevention strategies are predominately 
implemented in low-income countries among cisgender populations.82 In international settings, 
microeconomic interventions have been shown to improve savings,82 as well as other HIV 
prevention and care continua outcomes, such as HIV communication,83,84 condom use,83-87 HIV 
testing,84 viral suppression,88 and sexual risk-taking attitudes and behaviors.86,89-91 To date, 
BIPOC trans women have largely been omitted from HIV prevention-focused microeconomic 
intervention trials.92,93 Due to pervasive systemic barriers, traditional employment options may 
not always be considered viable poverty alleviation strategies for many BIPOC trans women.94,95 
That is, BIPOC trans women may be forced to turn to illegal means of securing income and 
housing, such as survival sex work and selling drugs and other informal income generating 
strategies.67,96-98 Owning assets (i.e., microenterprise) can give BIPOC trans women a sense of 
stability and enable them to expand their vision of possible and healthier opportunities.99,100 
Evidence suggests that the effects of cash incentives on HIV risk behaviors is mixed and often 
attenuates after incentives cease.23,88 However, increased skills, social networks, and resources 
for BIPOC trans women engaged in microenterprise may offer more sustainable, self-
perpetuated incentives that target economic vulnerabilities contributing to HIV inequities.10 
Microeconomic interventions can also extend beyond income generation and focus on 
enhancing skills (i.e., industriousness, perseverance, persistence) that support long-term safe 
sex, PrEP and/or ART medication adherence, and job acquisition and retention.21 Some 
microeconomic interventions have been critiqued because they require participants to repay 
loans and thereby incur debt; however, many do not require repayment.23,88 In line with MPI 
Jennings Mayo-Wilson’s prior microeconomic intervention, we propose to provide microgrants 
for use towards income generation (i.e., self-led microenterprise or costs related to gaining 
formal employment) that do not require repayment.21 A gender-affirming microeconomic 
intervention, such as the proposed Secure project, that builds on existing community services 
has the potential to sustainably reduce economic vulnerabilities and HIV inequities among 
BIPOC trans women in the US through employment-focused microgrant support, improved 
financial literacy, job announcements, and employment-focused mentoring. 
IV. 
Study Design 
To provide preliminary data on intervention feasibility and acceptability, N=40 trans women of 
color living in Detroit will be enrolled into a pilot RCT. Participants will be randomized into one of 
two conditions, 1) the intervention arm who will immediately receive the 12-week microeconomic 
intervention, Secure, in addition to standard community-based programming currently provided 
by TSoCP and Fair Michigan; and 2) a waitlist control arm who will receive TSoCP and Fair 
Michigan’s programming as standard of care to serve as the comparison group, and who will 
ultimately be offered the Secure intervention after the 3-month comparison follow-up period. The 
standard of care available to both experimental arms upon enrollment includes TSoCP’s one-
time $250 emergency assistance funds and Fair Michigan’s legal gender affirmation support. 

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Each condition receives survey assessments at baseline prior to randomization, post-program 
following the intervention arm’s completion of the 12-week Secure program, and 3-months after 
the intervention arm’s completion of the Secure program (approximately 24 weeks after 
completion of the baseline survey). Additionally, qualitative exit interviews are conducted within 
one month of completion of the Secure program for both the intervention and waitlist control 
conditions.  
 
 
 
Figure 1. Overview of Secure Study Design and Data Collection 
 
VI-1. Study Settings 
The proposed study will take place at the Ruth Ellis Center, a community center that serves 
homeless and at-risk sexual and gender minority youth and young adults of color. The Ruth Ellis 
Center also hosts social events and serves as a safe space that many BIPOC trans people 
regardless of their age utilize to get their basic needs met (e.g., food, linkage to community 
resources) and to socialize with peers and role models in their community. Importantly, the Ruth 
Ellis Center has been the fiduciary of TSoCP and provides a supportive space to develop and 
implement programs, including Fair Michigan’s legal gender affirmation services for BIPOC 
trans women.  
VI-2. Pilot Randomized Controlled Trial Arm Overview 
Waitlist Control Arm: The BIPOC trans women randomized into the control arm (n=20) will 
initially receive only standard of care derived from the existing community-based services of 
TSoCP and Fair Michigan during the 12-week period following randomization. Standard of care 
services include:  
1. One-time Emergency Assistance: Participants will receive up to $250 in emergency 
assistance funds to pay for immediate needs (e.g., housing, bills, food).  
2. Linkage to Legal Gender Affirmation Support: All participants will have access to 
legal name/gender marker change through Fair Michigan.  
Additionally, after the RCT follow-up period is complete (i.e., after completion of two follow-up 
surveys occurring at 12 and 24 weeks after baseline survey completion), waitlist control 
participants will be offered delayed access to the same Secure intervention that is provided 

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immediately to intervention arm participants. The Secure program components are described 
below.  
Experimental Secure Intervention (12 weeks): The BIPOC trans women randomized into the 
intervention arm (n=20) will be enrolled in the 12-week Secure program after randomization, in 
addition to the standard of care services described above. The Secure program includes the 
four following components:  
1. 12 weekly Economic Empowerment (EE) and HIV Risk Reduction (HIVRR) Educational 
Sessions lasting 2 hours each and will be conducted in-person with approximately 8-10 
participants. Session topics will focus on income acquisition assistance through skill 
development and goal setting relating to job-seeking (i.e., resumes, job application, 
interviewing), income generation through micro-business (i.e., self-employment, 
entrepreneurship, accessing clients, making a profit), and financial literacy (i.e., 
budgeting, managing credit). To address the relationship between economic vulnerability 
and HIV risk, session topics will also focus on knowledge and uptake of biomedical HIV 
prevention and treatment strategies (i.e., use of PrEP/ART) with particular attention to 
discussion of participants’ financial constraints and trade-offs to protecting against HIV, 
and how safer income generation can be leveraged to reduce their risk of HIV 
transmission or acquisition (i.e., paying for travel to PrEP/ART clinics, acquiring higher-
paying employment or health insurance, or refusing condomless sex work). Peer health 
educators (PHEs) will co-facilitate the interactive sessions, including role-play, 
discussions, games, and demonstrations. Each session will prioritize gender-affirming 
principles of social cohesion, mutual support, and identify affirmation.  
2. Employment-Focused Mentorship where participants will meet with an employment-
focused mentor weekly (~30 minutes/week) to assist her in acquiring or maintaining 
employment, initiating or expanding self-led income generation, or navigating financial 
decisions, including planning for use of their study-provided microgrants (see below). 
With the help of our team, we will identify approximately 8 mentors. Mentors will be 
offered an honorarium of $450 per mentee. 
3. Weekly Job Postings where study team members will collate three social media 
announcements each week (i.e., Instagram, Facebook) with job openings in the greater 
Detroit metropolitan area.  
4. Employment-Focused Microgrant of $1,200 (amount based on the first US government 
stimulus check; repayment not required). Each participant will be provided with the 
$1,200 in either one single payment or two separate payments of $600 to use to support 
income generation – either in engaging in self-led employment (i.e., purchasing business 
supplies, marketing, communication, and travel for selling hand-made goods and 
services, etc.) or in engaging in formal employment (i.e., traveling to job interview, 
paying for licensure or skills course, paying for gender transition supports to reduce 
employment discrimination, etc.). With their mentors, participants will develop an 
individualized Secure income generation plan that outlines how they will spend their 
microgrant. 
VI-3. Assessing Acceptability & Feasibility 
While our survey data collection includes measures to assess PrEP use among participants not 
living with HIV and viral load among participants living with HIV, our primary outcome is focused 
on descriptive analyses of the feasibility and acceptability indices. We will assess intervention 
target outcomes (i.e., HIV prevention and care), hypothesized mediators (e.g., economic 
improvement, gender affirmation), and background variables in baseline, immediate post-
program, and 3-month post-program follow-up surveys. These measures will be used to assess 
feasibility and acceptability. 

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To assess feasibility, we will monitor rates of outreach, recruitment, eligibility, enrollment, 
session attendance, retention, and assessment completion. Study team members will meet with 
PHEs the day following each group session to assess fidelity to intervention, time needed, and 
feasibility of delivering the interventions as designed. The information gathered from these 
meetings will be filled out by study team members in case report forms. To assess acceptability, 
we will modify previous intervention satisfaction evaluation surveys currently being used in our 
study with BIPOC trans women and implemented at the end of each session. We will also assess 
acceptability using data on participants’ reactions to various program components gathered from 
post-group feedback sessions with PHEs.  
 
In line with recommendations by NIH and the research methods literature, given the sample 
size and intent of the pilot study we will not conduct a formal test of outcomes or attempt to obtain 
an estimate of effect size.123-136 We will consider engagement in HIV prevention and care as an 
exploratory outcome defined as PrEP use and > 80% adherence among those not living with HIV 
and suppressed HIV viral load among those living with HIV, collected via self-report. These 
analyses will be conducted as a feasibility check to ensure all measures required to construct the 
primary outcome and that moderators and mediators for a larger formal RCT are present and will 
yield analyzable data. 
 
VI-4. Analytical Design 
VI-4.1 Acceptability & Feasibility analyses. The principal analytical aim of the pilot RCT is to 
measure feasibility and acceptability and evaluate whether feasibility and acceptability 
benchmarks are met. To fulfill this objective, frequency tables for all variables and measures of 
central tendency and variability for continuous variables will characterize the sample and 
quantify the intervention feasibility and acceptability outcomes. We will address incomplete data 
via direct maximum likelihood estimation (MLE) or multiple imputation (MI)150 assuming that 
incomplete data arise from a conditionally random (MAR) mechanism151 and include sensitivity 
analyses to evaluate the robustness of the MAR assumption. The proposed analyses will be 
conducted using validated algorithms in the general purpose statistical programs SAS or Stata. 
All statistical software programming code will be fully documented to enable future code review, 
transparency, and results reproducibility.  
 
 
VI-4.2 Exploratory analyses. To fulfill our secondary goal of generating preliminary effects of the 
intervention on the primary HIV serostatus-neutral HIV prevention and care engagement 
outcome, proportions of the outcome will be plotted by group over time to describe overall 
patterns of change across time in the Secure intervention group and the control group. 
Hypothesis testing will be de-emphasized in line with NIH152 and research methods literature 
cautions153,154 regarding the instability of inferential results from small-scale pilot studies. With 
that caveat, we anticipate that following the Secure intervention, intervention participants will 
exhibit higher odds of the HIV prevention and care outcome relative to control group participants 
in a time-averaged comparison of the post-baseline intervention and control groups’ outcome 
proportions. This exploratory comparison will be performed at alpha=.05 in a generalized linear 
mixed model (GLMM) suitable for this binary outcome. Repeated observations from each 
participant will be the unit of analysis. Alpha will be set at 5% for this exploratory analysis.  
 
VI-4.3 Power analyses. Although the main purpose of this study is to determine preliminary 
feasibility and acceptability and to visualize changes in outcomes and mechanisms of change 
over time rather than to perform formal hypothesis tests, we conducted several power analyses 
using NCSS PASS 21 156 to supply additional information. Assuming power=.80, α=.05, and N=32 
participants available at the last follow-up, we computed confidence interval widths for a) 
proportions for binary variables and b) means for continuous variables measuring feasibility and 
acceptability. For example, for the study enrollment proportion, assuming α=.05, power=.80, and 

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the 80% enrollment benchmark, the width of the confidence interval for single proportions is 
29.8% (standardized distance to the limit: .40).  For continuous variables, the distance from the 
mean to the confidence limit is .36. For mixed models proposed to explore group differences in 
outcomes, the minimum detectable proportion increase in HIV care and prevention ranged from 
33.7% to 42.8% (standardized effect size h=.75-.92; odds ratios=4.94-7.56). Taken collectively, 
this study is powered to detect small to medium distances to confidence limits for descriptive 
statistics to assess feasibility and acceptability (primary goal) and large effects for preliminary 
effectiveness effects (secondary goal), though, as noted above, formal hypothesis testing will not 
be the focus of this pilot study.  
 
V. 
Study Procedures 
VII-1. COVID-19 Safety 
The group session element of the Secure intervention is designed for in-person delivery while 
the mentorship component and study assessments may take place in-person or remotely. While 
the study team has successfully administered remote, at-home alternatives among trans women 
of color, previous experience in Detroit has demonstrated the strong preference for in-person 
activities among community members when possible. If levels of COVID-19 risk and community 
spread increase to the point that in-person group sessions are not safe, we will submit an 
amendment with virtual intervention procedures. All U-M affiliated study team members will 
complete the Environmental Health Services course entitled, “Working Safely at U-M” 
(EHS_OHS_COVIDW) and will be provided appropriate personal protection equipment when 
facilitating any in-person study activity (i.e., sterile single use masks). Partnered organizational 
sites where in-person study activities will be held (i.e., Ruth Ellis Center) have their own COVID-
19 risk reduction procedures that are in accordance with city and state health department 
guidelines.  
VII-2. Recruitment 
We will employ a multi-pronged outreach strategy to recruit BIPOC trans women including 1) 
Online recruitment: Banner ads and posts will be placed on social media platforms used by 
trans women of color (Facebook, Instagram); 2) Print Ads: Flyers will be placed in healthcare 
and social service agencies in Detroit; 3) Outreach: Our study research associate (RA) will 
conduct outreach in areas where BIPOC trans women congregate in Detroit. (See “Recruitment 
Materials” Appendices.) 
VII-3. Eligibility Screening 
Recruitment materials provide a study phone number or email to contact the study team 
about interest in participating.  
 
VII-3.1 Eligibility Criteria. To be eligible to participate, trans women will need to self-report 
being, (1) at least 18 years old; (2) assigned male at birth; (3) self identifies as female, 
transgender woman, or another feminine gender identity; (4) self identifies as a person of color 
(i.e., any racial/ethnic identity except non-Hispanic white); (5) reports earning less than $32,800 
gross annual income (current living wage in Michigan); (6) reports condomless sex in the past 6 
months; (7) lives in Detroit, MI greater metropolitan area (~50 mile radius); and (8) speaks 
English. 
 
VII-3.2 Eligibility Screening Survey. A member of the U-M study team will contact interested 
individuals by phone, share additional information about the study, and answer any questions 

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they may have. The study team member will then ask the interested individual if they would like 
to take a brief survey to see if they are eligible for the study. If yes, the study team member will 
send the interested individual a link to the eligibility screening survey via text message or email, 
depending on the interested individual’s preference. (See “Eligibility Screener Script” Appendix.)  
In the eligibility screening survey, the interested individual will first be asked to provide 
electronic consent to the screening process that at a minimum collects their first and last name. 
Those who consent will then be asked demographic questions associated with the eligibility 
criteria. The survey will take no longer than 5 minutes to complete and is not incentivized. To 
obscure which responses are eligible for participation, individuals will be asked all questions 
even if prior answers had already made them ineligible for the study. Additionally, if ineligible for 
any response, the screener survey will not detail which question(s) disqualified their ability to 
participate.  
If eligible, the potential participant will be asked to provide their date of birth and contact 
information for enrollment next steps, and informed that a member of the study team will contact 
them to conduct the informed consent process. Information collected from eligible respondents 
will include their date of birth, phone number, email address, and home postal address. This 
contact information will be automatically uploaded to the HIPAA compliant participant 
management software, Ripple, and recorded on a profile card. Each new profile cards will be 
assigned a randomly generated 17-character Study ID number by the Ripple platform (ex: 
k6uPBYjIJ4PrGFXh8).  
Respondents who screen ineligible will be asked if they are interested in participating in any 
future research studies. If they reply yes, they will be asked to provide an email address where 
they may be contacted again. Ineligible screening respondents will have their first and last 
name, ineligible reason, and potentially email automatically uploaded to the Ripple software 
where it will be recorded on a profile card. No other contact information will be collected from 
ineligible screening respondents. (See “Eligibility Screener Survey” Appendix.)  
 
VII-4. Enrollment Procedures 
The enrollment process will consist of up to 4 components: informed consent, baseline survey 
completion, enrollment activity, and randomization. These activities can be completed in person 
at Ruth Ellis or at-home remotely.  
VII-4.1. Informed Consent: Eligible potential participants who indicate they are interested in 
joining the study will need to complete an informed consent walkthrough with U-M a study team 
member either remotely by phone or video call, or in-person in a private location at the Ruth 
Ellis Center. If remote, potential participants will be emailed a link to the Informed Consent 
document, which will be programmed into Qualtrics and linked to their randomly generated 17-
character Study ID number. If in-person, this survey may be pulled up on a study team laptop or 
tablet. A member of the study team will read through the consent document with the potential 
participant and answer any questions they may have related to the study design, incentives, and 
procedures. The study team member will then ask the potential participant several questions to 
ensure their understanding of the study procedures, and provide additional clarification if 
needed. The potential participant will then be asked to proceed to the final page of the Qualtrics 
survey, where they will be asked whether they consent to join the research study and to provide 
their electronic signature and the date. To aid in follow-up (e.g., if participants’ phone number 
changes or their phone is shut off), those who consent will be asked to provide additional 
optional contact sources including social media (e.g., Facebook, Twitter, Instagram, Snapchat) 
usernames, contact information for a family member and/or friend who can be called in an 
emergency situation and/or in the event the participant cannot be reached by phone or email, as 

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well as locations where they typically spend time and could be reached if necessary. (See 
“Informed Consent Process Script” and “Informed Consent Programmed in Qualtrics” 
Appendices.) If a potential participant chooses not to consent, they will be thanked for their time 
and will not be able to proceed with the rest of the enrollment process. 
VII-4.2 Baseline Survey: After consenting to participate, potential participants will be asked to 
complete an online Qualtrics programmed baseline survey. (See “Baseline Survey” Appendix.) 
The survey should take approximately 40 minutes to complete and will be connected to their 
assigned Study ID. If they are in-person with the study team member at Ruth Ellis, they may 
complete the survey on the study team laptop or tablet; if remote they will be sent a link via 
email and/or text message to complete on their personal device. If a participant requests to 
complete the survey at another time during an in-person study visit or exits out of the survey 
remotely before completion, study team members will attempt contact via phone call, email, or 
text to remind about completing the survey and provide their unique Qualtrics survey link if they 
are no longer able to locate it. In order to receive their incentive, at the end of the Qualtrics 
survey, participants will be asked to provide their name, mailing address, email address, and 
social security number (required for incentive reconciliation for tax purposes due to the amount 
of funds provided over the study period). An IRB approved study team member will securely 
store participants’ social security number in a restricted Dropbox folder. (For specific incentive 
amount, see Section VII-8. Participant Incentives and Other Funds Provided.)  
VII-4.4 Randomization: After all previous enrollment activities are completed, participants will be 
randomized in a 1:1 ratio into Secure intervention or the TSoCP/Fair Michigan standard of care 
waitlist control condition using a computerized secure and fraud-resistant procedure used in our 
team’s prior studies. Assignment will occur until there is sufficient enrollment to form a group. A 
member of the study team will contact the participant to them know whether they are in the 
immediate intervention arm or the waitlist control arm. (See “Randomization Survey” Appendix.)  
VII-5. Intervention Arm Procedures 
During the approximately 12-week intervention period, participants who are randomized to the 
intervention arm will receive the Secure program components (in-person group sessions, 
individual mentorship, microgrant funds, and weekly job announcements), in addition to 
standard of care services (one-time emergency assistance funds, referral to legal gender 
affirmation services), as described below.  
VII-5.1 In-Person Group Sessions. When planning group session attendance, the study team will 
track enrolled participants newly randomized to the intervention arm. Once a sufficient number 
of intervention arm participants have been amassed, a study team member will assign them into 
a cohort. They will be contacted by U-M study staff over the phone, email, or text message to 
coordinate their participation in the group session content of Secure. Participants who state they 
are no longer able to commit to the group session series will be put back into the queue to be 
possibly included in a later cohort. Otherwise, participants will be reminded about each weekly 
in-person group session two days before and the morning of via text message. From these point 
on, those participants will have their weekly group session together once a week at the Ruth 
Ellis Center. 
There are 12 group sessions total that will be completed over approximately a 12-week period. 
(See “Group Sessions” Appendix for group session content.) Ideally each group will include 10-

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12 participants, with a minimum of 4 participants and a maximum of 14 participants. The group 
content focuses on micro-business development, entrepreneurship, financial literacy, and 
HIV/STI prevention and care. The group sessions will be facilitated by two BIPOC trans women 
that are a part of the study implementation team. 
Secure group sessions will occur in a private room. Members of the study team will explain the 
confidentiality expectations of the group. Participants will be required to agree not disclose 
information about any other participant attending to anyone outside of the group including that 
they are participating in the Secure study. Participants will be allowed to join the group late. The 
room where the group will take place will include free food and non-alcoholic beverages for 
those in attendance. The two group facilitators present will explain that they reserve the right to 
ask any participant to leave during the session if they are being overly disruptive to the content 
delivery. Participants who miss one or more of their 12 weekly group sessions will not be offered 
make-up sessions. Participant attendance and any reason(s) given for absences will be 
documented.  
After each group session ends, participants will complete a 6-question group session feedback 
survey programmed in Qualtrics. (See “Group Session Feedback Survey” Appendix.) They will 
then receive their incentive for attending. In addition to their incentive for session attendance, 
participants will be provided with transportation via Uber/Lyft to/from Ruth Ellis Center for the 
study session or, if they provide their own transportation, a gift card to reimburse them for gas 
money. (For specific incentive and transportation reimbursement amounts, see Section VII-8. 
Participant Incentives and Other Funds Provided.)  
VII-5.2 Individual Mentorship. After the first two group sessions, intervention arm participants will 
be connected with a mentor for additional employment-focused instruction on a semi-weekly 
basis for approximately 30 minutes during each contact. Mentors will be identified by the study 
team and CAB who: 1) Identify as a person of color (any race/ethnicity other than white non-
Hispanic), 2) Are 25 years of age or older, 3) Have varied job and business expertise working in 
the Detroit Metropolitan area and/or urban metropolitans similar to Detroit, and, 4) have 
demonstrated experience working alongside trans communities. Each Secure mentor included 
in the study will be assigned to one or more participants from an active cohort for one-on-one 
meetings where they will discuss issues related to employment, income generation, financial 
decision-making, and planning how to best spend their microgrant.  
Participants will be put into contact with their assigned mentor by a member of the study team 
either by phone, email, or text message depending on participant and mentor preference. 
Available dates and times to speak with mentors will be based on each individual mentor’s 
schedule and workload. Mentor contacts can be completed either remotely or in-person in any 
combination over the 12-week period. Depending on mentor and mentee comfort, remote 
contact options may include video calls, phone calls, or text messages. If the mentor contacts 
occur via phone or video call, the mentor will check with the participant to make sure they are in 
a safe and private location, or will reschedule for another time. In-person mentorship meetings 
are only offered to take place at the Ruth Ellis Center. No incentives or transportation will be 
offered for mentor sessions.  
VII-5.3 Microgrant Funds: After the group session where participants finalize their micro-business 
plan detailing how they will strategically spend their study provided microgrant funds, 
participants will be eligible to receive one or two installments of the $1,200 microgrant. A U-M 
study team member will disburse the funds to the participant in-person at Ruth Ellis Center 
where they will be required to sign and date a form documenting their receipt of the funds and 

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consenting to several stipulations regarding the fund transfer. The form will explain that after 
receiving the funds, participants will be solely responsible for the allotted funds and will not be 
provided with a replacement if their funds are lost or stolen. (See “Microgrant Disbursement 
Form” Appendix.)  Participants’ receipt of microgrant funds will be recorded within their 
individual participant profile within the Ripple platform. While group session facilitators and 
mentor contacts will ask about the funds to follow-up on the participant’s individual micro-
business plan, participants will not be required to provide receipts or any documentation 
detailing how the funds were spent. Follow-up surveys and qualitative exit interviews will assess 
how funds were spent only through self-report.  
VII-5.4 Weekly Job Announcements: The final component of the Secure intervention will be 
receiving weekly job postings in the Detroit Metro Area compiled by U-M study staff. The 
postings will be shared via study Facebook and Instagram pages to all intervention arm 
participants in an active cohort over the approximately 12-week intervention period. Study staff 
will search for local job opportunities that require skillsets and educational backgrounds that are 
representative of the active cohort participants. Prior to sharing, collated job postings will be 
vetted by the study team. 
VII-5.5 Standard of Care: During the intervention period, in addition to receiving the Secure 
program components described above, intervention arm participants will also receive standard 
of care services, described in detail below in Section VII-6.1 One-time Emergency Assistance 
Funds and Section VII-6.2 Legal Gender Affirmation Support.  
VII-6. Waitlist Control Arm Procedures 
During the approximately 12-week intervention period, participants who are randomized to the 
intervention arm will receive only standard of care services (one-time emergency assistance 
funds, referral to legal gender affirmation services). After the intervention period and the follow-
up assessments are complete, participants in the waitlist control group will be offered access to 
the Secure program if they are interested in receiving it. These components are described 
below.   
VII-6.1 One-time Emergency Assistance Funds: During an active intervention arm cohort’s receipt 
of the Secure intervention content, both intervention and waitlist control condition participants 
will receive a one-time payment of $250 to help pay for immediate needs such as housing, bills, 
food, etc. The $250 in emergency assistance funds that will be provided to participants is an 
existing community service that is available regardless of participation in this study; however, 
the grant budget includes covering $250 in emergency assistance to program participants.  A U-
M study team member will disburse the funds to the participant in-person at Ruth Ellis Center 
where they will be required to sign and date a form documenting their receipt of the funds and 
consenting to several stipulations regarding the fund transfer. The form will explain that after 
receiving the funds, participants will be solely responsible for the allotted funds and will not be 
provided with a replacement if their funds are lost or stolen. (See “Emergency Assistance 
Disbursement Form” Appendix.)  Participants’ receipt of these funds will be recorded within their 
individual participant profile within the Ripple platform. Participants will not be required to 
provide receipts or any documentation detailing how these funds were spent. Follow-up surveys 
and qualitative exit interviews will inquire what they spent the money only through self-report. 
VII-6.2 Legal Gender Affirmation Support: At any time during an active intervention arm cohort’s 
receipt of the Secure intervention content, both intervention and waitlist control condition 
participants may request to be referred to Fair Michigan Trans Renaming Program that provides 

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assistance with legal name/gender marker changes. A participant’s utilization of these services 
will be recorded within their individual participant profile within the Ripple platform.  
VII-6.3 Waitlist Control Secure Content Access: After the 12-week period when an active 
intervention arm cohort completes the Secure program content (i.e., completion of group 
session 12 when participants graduate from the program), both the intervention and waitlist 
control conditions will enter into a 3-month follow-up period. After the waitlist control arm 
participants complete a follow-up survey at the end of the 3-month follow-up period, they will be 
offered the opportunity to receive the Secure program. If interested, waitlist control participants 
will be placed into a group cohort and will follow the same study procedures outlined for 
intervention arm participants in section VII-5 over another approximately 12-week period.  
VII-7. Follow Up Assessments and Additional Intervention Fidelity Documentation 
VII-7.1 Follow-up Survey Assessments: After completing all the intervention or waitlist control 
study activities, participants will receive an immediate post-program follow-up survey following 
the completion of the intervention arm content (i.e., completion of group session), approximately 
3-months from when they completed the baseline assessment. Then three months after post-
program follow-up survey, both conditions will complete a final 3-month follow-up survey. The 
post-program and 3-month follow-up assessments will consist of online Qualtrics programmed 
surveys and disseminated over email and text message for remote completion. Survey 
hyperlinks will be unique for each participant with embedded metadata containing their Study ID 
number, and will not include personally identifying information. (See “Follow Up Survey” 
Appendix.)  
VII-7.2 Qualitative Exit Interviews: After completion of the final Secure group session, both 
intervention and waitlist control arm participants (who opt in to receive the delayed intervention) 
will complete an in-depth exit interview about their experiences with their condition’s study 
activities to further assess acceptability and generate strategies for conducting research and 
RCTs with similar communities. The exit interview will occur within one month of the last group 
session. Exit interviews with participants will be conducted by a member of the U-M study team 
will last approximately 30 minutes, and will be audio-recorded, then transcribed and reviewed 
for accuracy and to remove any identifying information. Exit interviews may occur in-person at 
the Ruth Ellis Center or remotely by phone or Zoom. If the exit interview occurs in person it will 
be conducted in a private room where others cannot overhear them. If the exit interview occurs 
remotely, when scheduling the interviewer will ask the participant to be in a safe place where 
others cannot overhear them. Before beginning the interview, the interviewer will confirm the 
participant is in a safe and private location; if they are not, the interview will be rescheduled. 
(See “Exit Interview Guide” Appendix.)  
VII-7.3 Additional Intervention Fidelity Documentation: U-M study staff will have regular meetings 
with group session facilitations to gather additional information related to intervention fidelity and 
acceptability, including which content/activities were covered in the session, what elements 
went well, what they would consider changing, and what challenges they experienced. This 
information will be saved in a Word document stored in a secure Dropbox folder only accessible 
to IRB approved study staff. (See “Secure Group Session Facilitator CRF” Appendix.)  
VII-8. Participant Incentives and Other Funds Provided 
For every group session participants attend, they will receive $20 for their attendance (up to 
$240 if all group sessions are attended). Additionally, participants will receive either 

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transportation to/from Ruth Ellis via Uber or Lyft, or $20 to reimburse them for gas expenses if 
they provide their own transportation (up to $240). Additionally, food will be provided at each 
session. To incentivize study activity completion, participants will receive $40 for completing the 
baseline survey, $40 for the post-program follow up survey, and $50 for the final 3-month follow 
up survey. Participants will receive $30 for completing an exit interview after completing the 
Secure program. Lastly, if participants complete all assessment activities (i.e., surveys and exit 
interview), they will receive a $50 completion bonus. In total, participants may receive up to 
$690 for completing these study activities.  
These incentives related to group session attendance and assessment completion are earned 
separately from the one-time $250 emergency assistance fund transfer and the $1,200 
microgrant fund transfer offered in the Secure program (total $1,450). In total, participants may 
earn up to $2,140 through participation in the study. All incentives will be dispersed after each 
study activity is completed regardless of whether they are randomized to the intervention or 
waitlist control condition.se 
VII-9. Retention Strategies 
Our team has extensive experience in retaining TWOC in research studies. Much of our 
success can be attributed to our community-engaged approach to research efforts, including our 
collaborations with TSoCP and Ruth Ellis. Using these methods, our prior studies with BIPOC 
trans women have regularly yielded follow-up rates above 80%-85%. 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 provide multiple forms 
of contact information after consenting to participate. 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 prevention or care services, 
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. At the beginning of the study, participants will be provided with an overview of all study 
activities, which will be filled in with their approximate follow-up dates and the incentive amount 
of each activity.  
 
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.   
 
VIII. Data Collection and Management 
VIII-1. Data Collection Methods 
Data collection is the responsibility of the study trained staff under the supervision of the PI and 
Co-Investigator/Research Director. Participant identifiable information and data on completion of 
study specific activities will be recorded in the HIPAA compliant Ripple participant management 
software. This data will be stored in participant profile cards that will be updated on an ongoing 
basis throughout the study period. Additional participant data will be collected using 

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computerized self-report online surveys programmed in Qualtrics. For these surveys, 
participants will enter their own data (except in the case when the PI or Co-I/Research Director 
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 in-depth interviews audio recorded over Zoom or in-person at Ruth Ellis Center and 
uploaded to a U-M Dropbox folder accessible only to study staff for storage.  
VIII-2. Storage and Security 
We will utilize Qualtrics programmed surveys (e.g., electronic informed consent, baseline 
survey, group session feedback survey, post-program survey, and 3-month follow-up survey) 
and a HIPAA-compliant participant management software called Ripple to capture and track 
enrolled participant information throughout the RCT. Individuals who are interested in the study 
and want to see if they are eligible to participate will be sent a unique hyperlink to a Ripple 
programmed eligibility screener survey. The screener survey will collect the full name of all 
individuals who consent to screening; for those who are eligible, the participant will be asked to 
enter their contact information (i.e., email, phone number, address). A participant profile card 
with these data will be created in the Ripple platform for potential participants who screen 
eligible, where they will be identified as potential participants and assigned a randomly 
generated 17-character Study ID number. Study staff will then meet with potential participants 
either in person or virtually to go through the informed consent process. Documentation of 
informed consent will be captured using Qualtrics, which will include their randomly assigned 
Study ID as metadata. After consent is provided potential participants will be able to complete 
the baseline survey disseminated via email or text message with their Study ID embedded as 
metadata. At the end of that survey, they will be requested to provide their social security 
number for U-M HSIP reconciliation purposes, due to the total amount of incentives and 
program funds provided. Participant social security numbers will be stored in a password 
protected excel spreadsheet in an access restricted Dropbox folder. Further participant survey 
assessments (the post-program survey, the 3-month follow-up survey, and the group feedback 
surveys) will be linked as longitudinal data only through the Study ID metadata included in those 
Qualtrics surveys.  
Potential participants who screen ineligible will be asked if they are interested in hearing 
about other studies that they may qualify for; those who are will be asked to provide contact 
information (email address, phone number), which will be retained along with their name in the 
Ripple database. For potential participants who screen ineligible and do not wish to be 
contacted for future studies and those who screen eligible but do not provide informed consent 
to enroll, we will remove any identifiers from the screener data (i.e. email address and/or phone 
number). We will retain ineligible or non-consenting potential participant profile cards in Ripple 
to avoid duplicate enrollment attempts during recruitment and we will delete their contact 
information from the Ripple database at the end of the study. De-identified (and unlinked to 
assigned 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. 
Participant personal identifiable information will be stored in Ripple 
(www.ripplescience.com), a secure web application designed for the storing and management 
of personally identifying information of research participants. Ripple was initially developed at 
the University of Michigan to provide a user-friendly, web-based secure interface where 
research teams can centralize the storage and management of research participants’ personal 

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information, including name, Study ID, demographics, and study workflow (e.g., group session 
appointments, date/amount of microgrant fund receipt, date of emergency assistance fund 
receipt). Participant information managed with Ripple is private and secure. This information is 
kept in a fully encrypted format inside dedicated databases that are segregated from other 
Ripple accounts and thus only authorized study staff will have access to the study data. 
Likewise, Ripple infrastructure complies with the privacy and security guidelines of the HIPAA, 
including 2048-bit data encryption in transit and at rest, automatic logoff, audit trail, daily 
backups in triplicate dedicated servers, firewall, custom access permission for lab members, 
zxcvbn password strength estimation, and enterprise administrative safeguards to prevent 
unauthorized staff from accessing participant information. Furthermore, Ripple is used only for 
storing personally identifiable information of participants and is not used to capture other 
research data (e.g., Qualtrics programmed surveys, exit interviews audio files, etc.). This 
ensures that the personally identifiable information and research data are segregated. Only IRB 
approved U-M study staff will have account logins to the Ripple database and will be able to 
view / edit participant identifiable information for study management purposes.  
 
The baseline and follow up surveys completed by participants will run as web browser 
applications that will be programmed using Qualtrics. Participants will receive an individual link 
to access the survey via email or text message. Apart from the eligibility screener survey and 
the electronic informed consent, participant surveys will not be linked to personally identifiable 
information and will be encoded with their Study ID number. Participants cannot access or 
change previously entered data through their individualized Qualtrics survey hyperlinks once 
they are completed. Survey data will be securely transmitted in real time to server systems 
managed by Qualtrics using transport layer security (TLS) encryption (also known as HTTPS) 
and will not be stored locally on the electronic devices that participants use to complete their 
surveys. Only IRB approved U-M study staff will have access to the Qualtrics account where 
raw survey responses are stored. Any survey datasets that are downloaded for quality 
assurance checks or study management purposes will only be temporarily stored on U-M 
encrypted computer systems. After any necessary work has been completed with the survey 
datasets, IRB approved staff may store a de-identified Excel spreadsheet in a restricted access 
Dropbox folder, but they are required to delete the dataset from their individual computer system 
by moving it to their system’s trash bin and clearing the bin before the close-of-business that 
same day.  
 
 
We will also conduct a qualitative exit interview with each participant, within one month 
of their last Secure group session. 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 safe, private location where they 
cannot be overheard by others. The interviewer will ensure they are in a private space where 
they cannot be overheard by others, and participants will be instructed to refrain from sharing 
any identifiable participant information during the live interview recording. 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 restricted access Dropbox folder and deleted from 
the physical recording device. Audio files will be transcribed and then reviewed for accuracy, 
with any identifying information removed from the transcript. The audio files will be retained until 
the interviews are thematically analyzed, within one year of completion of data collection, at 
which point they will be deleted from Dropbox. Fully de-identified transcripts of the exit 
interviews will be retained for future use in secondary analyses.  
 

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Study staff will enter case report form and process evaluation data collected from group 
session facilitators and mentors into the study designed case report form Word Documents that 
will be stored in a Dropbox folder only accessible to IRB approved U-M study staff. Any mention 
of participants in these collected process data will be recorded only in reference to their Study 
ID and will not include any personal identifying information.  
 
 
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) With the exception of the eligibility screener 
survey, the electronic informed consent, and the fund disbursement documentation, all other 
collected data will only be identified and linked via the 17-character Study ID number and will 
remain separate no surveys or other data that we collect will contain identifying information. 3) 
Any hard copy materials 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. 
Personally identifiable information linking participants to their Study ID number will be stored in 
Ripple, separate from survey stored in Qualtrics servers and interview data stored in Dropbox 
that is only demarcated with the participants’ Study ID number.  
 
 
Participant identifiable information will be retained for six months after completion of the 
study. After this point, all identifiable information except for zip code will be deleted from the 
Ripple participant software leaving only the Study ID as the linking criteria for all other collected 
data related to an individual participant. Data coded by Study ID that has been unlinked to 
participant identifiable information will be retained for secondary analyses, as well as record 
keeping purposes per NIH grantee requirements for 3 years. We will retain name and contact 
information (unlinked to any participant data) for participants who consented to being contacted 
for future research studies, as well as individuals who screen ineligible who indicated they would 
like to be contacted about future research studies, in an excel file stored in a U-M Dropbox 
folder, separate from study data, where access is limited to the PI and IRB approved study staff. 
De-identified quantitative data will be provided to the National Institute of Mental Health Data 
Archive (NDA) as part of a data sharing agreement required as a condition of funding.  
 
 

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IX. 
Human Subjects Research Protections 
IX-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 Research Protections Program’s Institutional Review Board (IRB). The study will also 
be registered with ClinicalTrials.gov.  
 
IX-2. Inclusion and Exclusion Criteria 
IX-2.1 Inclusion criteria. Participants must (1) at least 18 years old; (2) assigned male at birth; (3) 
self identifies as female, transgender woman, or another feminine gender identity; (4) self 
identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white); (5) 
reports earning less than $32,800 gross annual income; (6) reports any condomless sex in the 
past 6 months; (7) lives in Detroit, MI greater metropolitan area (~50 mile radius) as evidenced 
by a government-issued ID or mailing address; and (8) speaks English. 
 
IX-2.2 Exclusion criteria. Evidence of severe cognitive impairment or active psychosis that may 
impede ability to provide fully informed consent, determined by U-M study staff and PI Dr. 
Gamarel in consultation with Dr. Harper.   
 
 
 
IX-2.3 Rationale for Involving Proposed Populations. This study targets trans women of color who 
are HIV-negative, do not know their HIV status, or are living with HIV. This population has been 
selected due to their high prevalence of HIV infection and limited engagement in HIV prevention 
and care services and because there are limited culturally responsive, evidence-based, 
microeconomic interventions to improve HIV prevention 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.  
 
IX-3. Informed Consent 
Informed consent will be obtained before conducting any study activities. Participants will 
access the electronic consent form online via a Qualtrics programmed survey. Participants will 
be required to complete a remote or in-person informed consent walkthrough with study staff  
explaining key content presented 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. As part of the informed consent process, study 
staff will answer any questions that potential participants have and assess their understanding 
of the information provided. Documentation of informed consent will be collected via the 
Qualtrics consent form.  
IX-4. Risk/Benefit Assessment 
IX-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 undue influence.  

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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 personal finances, stigma, 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) or out their transgender identity by association. However, the risk of 
breach of confidentiality is also minimal, given the safeguards protecting participants’ data. 
Given the nature of the group-level intervention, there is also the possibility that privacy can be 
broken by other participants. However, the informed consent and the group session facilitators 
will continually reinforce the importance of confidentiality at the beginning and throughout each 
session, and participants will be required to agree to maintain the privacy of other group 
members prior to joining the group sessions. They will also remind participants that they do not 
have to share anything in the group sessions that they do not wish to share. 
 
 
Potential Undue Influence. Given the $1,200 microgrant and $250 emergency assistance funds 
allotted to enrolled participants, there may be a risk of undue influence associated with 
participating in the research program. To help mitigate this risk, the microgrant funds will not be 
advertised during active study recruitment. Additionally, participants will only receive the 
microgrant payment in the Secure intervention once they have developed a concise 
microbusiness plan with their group session facilitators and assigned mentor to help 
strategically use the funds. In this way, the microgrant is not provided without the participant’s 
thoughtful engagement with the Secure program’s professionalization content and guided utility 
of the funds. Lastly, the $250 emergency assistance is an active social service that is provided 
by TSoCP in the Detroit community and would be available whether or not a BIPOC trans 
woman of color enrolled in Secure study.  
 
IX-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, psychological discomfort, and undue influence. 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 exit interviews, during the intervention group sessions, and during survey 
assessments. Participants experiencing mild distress during the group sessions, surveys, or exit 
interviews will be offered to take a small break or to reschedule at a later date. In the unlikely 
event that a participant experiences considerable distress, they will be offered a voluntary 
suicide risk assessment and appropriate referral. (See “Suicide Risk Assessment” Appendix.) If 
any person is judged by the PI to be a danger to self or others or judged to be in grave danger 

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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 U-M 
staff will receive yearly training for identifying suicide risk, and Ruth Ellis staff / TSoCP members 
who will be the program facilitators are trained on 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 gender affirmation support 
groups. (See “Detroit Area Resource List” Appendix.) 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 the confidentiality guidelines and standards that structure this project. 
All participant survey data and exit interview audio files will be linked by a unique individual 
Study ID number. Personal identifiable information (e.g., first and last name, email address, 
phone number, social media accounts, external family or friend contacts, etc.) will be stored in 
our HIPAA compliant participant management software, Ripple, and will only be accessible to 
authorized IRB-approved members of the study team. The social security numbers collected for 
HSIP reconciliation of incentives will be stored in a password protected Excel spreadsheet kept 
in a restricted access Dropbox folder. Other data collected from participants such as the 
Qualtrics surveys or exit interviews will be stored separately from personally identifiable data. 
Records will be kept confidential to the level allowed by law and only IRB approved 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.   
The ability to link personally identifiable information to the other participant data labelled only 
with the Study ID number will be managed by user role access to the Ripple participant 
management platform. No released presentation or publications will identify study participants 
individually. Because this study is funded by the National Institutes of Health, data collected in 
this study is automatically covered by a Certificate of Confidentiality. 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 informed consent walkthrough. The U-M 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, who 
have agreed not to identify specific study participants, and who will destroy or return dataset 
information after completing their analyses. These shared dataset files will be uploaded to 
shared Dropbox folders with access restricted only to those researchers requiring access. 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. During the informed consent walkthrough, 
participants will be informed that the study will involve participating in group sessions with other 
shared identity 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 group session facilitators will continually reinforce the 

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importance of keeping information shared within the group private at the beginning of the study 
and throughout each group session. Participants will be required to agree to keeping other 
participants’ information private and confidential before joining the group sessions. 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. Group 
sessions will occur in a private room at the Ruth Ellis Center.  
 
Minimizing potential for undue influence. Any study that pays a stipend may engender undue 
influence. Eliminating this possibility 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 
ensure 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. The group session study visit stipends proposed are in use in similar HIV prevention 
studies and have been reviewed by our own and other IRBs for potential undue influence.  
In addition to typical incentives for completing study activities, this study includes a 
microeconomic intervention. The $1,200 microgrant is in alignment with the first stimulus check 
and MPI Jennings Mayo-Wilson’s promising NIH-funded pilot study (a similar microeconomic 
intervention that provided group sessions and a microgrant to African American youth in 
Baltimore), which serves as the basis for the current project. The microgrant funds associated 
with the Secure program will not be advertised during recruitment. The $250 in emergency 
assistance funds that will be provided to participants is an existing community service that is 
available regardless of participation in this study.  
IX-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 the Detroit metro area. Participants may improve their engagement in HIV 
prevention or HIV 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 gender affirmation and HIV 
services. Additionally, the professionalization content and microgrant funds provided by the 
Secure program may help participants initiate microbusiness development and improve 
personal financial status. Participants in our previous studies have indicated that they benefited 
from the opportunity to participate in group-based research studies with other BIPOC trans 
women, and that the prospect of providing information for the possible future benefit of BIPOC 
trans women 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 test culturally-relevant evidence-based microeconomic 
interventions to improve engagement in the HIV continuum of prevention and care among 
BIPOC trans women. 
 
IX-4.4. Importance of the knowledge to be gained 
The proposed study has the potential for high public health impact by evaluating the 
acceptability and feasibility of an adapted, evidence-based microeconomic intervention to 

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address health outcomes among a highly vulnerable and overlooked population 
disproportionately impacted by HIV. Our focus on BIPOC trans women is in line with the 
prioritization of sexual and gender minority communities for health disparities research, as well 
as the strategies of the new EHE plan for ending the U.S. HIV epidemic. Findings also have the 
potential to provide a “blueprint” to guide future intervention implementation efforts with BIPOC 
trans women who are often embedded in close-knit communities with few existing services. 
Given the substantial health risks associated with documented inequities in HIV outcomes and 
the relatively minor risks to participants, the importance of the potential knowledge to be gained 
relative to the participant risk is favorable. 
 
IX-5. Study Withdrawal and Discontinuation 
A participant may be discontinued from the study at any time if the participant, the MPIs, 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. 
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. 
• 
Participant creates a hostile environment for study staff. 
• 
Sponsor request for early termination of study. 
 
 
 

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X. Data Safety and Monitoring Plan 
X-1. Safety and Monitoring 
The study MPIs Dr. Gamarel and Dr. Jennings Mayo-Wilson will conduct oversight of internal 
monitoring of participants’ safety and data integrity. The MPIs will also be supported by Co-
Investigators Laura Jadwin-Cakmak and Dr. Gary Harper who will participate in the 
development and administration of the data and safety monitoring plan. The study team has 
extensive experience with HIV prevention clinical trials. The MPIs 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 U-M policies.  
Given the relatively low level of risk involved for participants, we do not plan to have a data 
safety and monitoring board (DSMB) per NIH guidelines. However, in any case we will monitor 
for any serious adverse events caused by study participation and report them to the U-M IRB 
and NIH as appropriate and as described below. We will have several mechanisms to ensure 
data integrity. 
X-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; of unanticipated problems involving risk to 
participants; of serious or continuing non-compliance; and of protocol violations. (See “Adverse 
Event and Unanticipated Problems Log” Appendix.)  
 
X-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. MPIs will 
ultimately be responsible for participant safety, protocol violations, and ongoing evaluation of the 
study’s progress. If necessary, MPIs will make appropriate recommendations for changes in 
protocol. The U-M IRB will conduct the monitoring at the continuing reviews as scheduled, 
whenever modification requests are considered, and upon receiving reports of adverse events 
(AEs) and serious adverse events (SAEs) from the MPIs or anyone else. The NIMH PO will 
monitor the study upon receipt of annual progress reports and whenever other information is 
received.   
 
X-4. Adverse Events 
We define AEs and SAEs as follows: An AE is any unfavorable and unintended diagnosis, 
symptom, 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 
relationship to the study intervention. An SAE is any adverse event that results in death, is life-

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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 MPIs deem to represent significant hazards.  
 
X-5. Reporting Plan  
All AEs and SAEs will be reported regardless of their relationship to the study intervention. The 
study team will document all AEs and unanticipated problems. We will detect AEs and SAEs 
during participant visits and via survey responses and exit interviews. 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 U-M IRB. The U-M PI or Project Director will prepare the 
appropriate IRB documentation and review it with MPIs 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 U-M 
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, PI or Co-I 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 U-M IRB.  
 
MPIs 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. MPIs 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 MPIs learning of the event. Deaths related to 
study participation will be reported within 5 business days of learning of the event by MPIs 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 
because 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. 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.  
 
 

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X. 
List of Appendices / Study Documents 
 
o Recruitment materials 
 
Social media post 
 
Print flyer 
o Eligibility screener script 
o Eligibility screener survey 
o Informed Consent Script 
o Informed Consent Document  
o Randomization Survey 
o Baseline Survey 
o Group Sessions 
o Group Session Feedback Survey 
o Microgrant Disbursement Form 
o Emergency Assistance Disbursement Form 
o Follow Up Survey 
o Exit Interview Guide 
o Secure Group Session Facilitator Guide  
o Suicide Risk Assessment 
o Detroit Area Resources 
 
 
 
 

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XI. 
Amendments 
This space in the protocol will be used to document any future amendments.  
XI-1. Ame00148836 
This amendment includes minor changes to the eligibility screening survey and eligibility 
screening script, the baseline and follow up surveys, and the exit interview guide. We have also 
added two documents in Section 44: a template to capture any social harms reported by 
participants throughout the course of the study that do not rise to the level of an adverse event, 
and a post-group session facilitator fidelity and feedback survey that will be completed by 
intervention facilitators (not participants) after each group session. These changes and 
justification for each proposed change are described below. The study protocol has not been 
updated, as the proposed changes do not alter the procedures described in the study protocol. 
 
In Section 8-1. Recruitment, we have made a minor update to the Eligibility Screener Script to 
make sure participants are aware that we will ask them about their identity, income, and sexual 
behavior in the eligibility screener. Also in Section 8-1 we have updated the Eligibility Screening 
Survey to remove the question that asks participants about HIV status, because HIV status is 
not an eligibility criterion (the study is HIV status-neutral and includes those living with HIV, 
those not living with HIV, and those who are unsure of their status), and in response to feedback 
that community members are not comfortable answering this question until after they have 
completed the informed consent process. 
 
In Section 29.1, we have made updates to the Baseline Survey and Follow Up Survey. None of 
the constructs measured have been changed, though we altered some of the measures used to 
assess the constructs to align more closely with other NIH network studies. We also cut some 
items because in testing the survey was taking more than the allotted time as described in the 
consent form. Lastly, we made minor edits to the exit interview guide, to make questions more 
open-ended, and to ensure we are learning about any potential social harms participants may 
have experienced that were not reported to facilitators or the research team previously. 
Lastly, in Section 44. Additional Documents, we have included a template on which any social 
harms reported by participants due to their participation in the study (e.g., losing their microgrant 
funds) that do not rise to the level of an adverse event will be recorded. Additionally, we have 
added a post-group session facilitator fidelity and feedback survey to Section 44. This survey 
will not be taken by participants, but instead used by facilitators to indicate fidelity to and 
feedback regarding group session content. Lastly, track changed documents of all documents 
updated in this amendment have been uploaded to Section 44. 
XI-2. Ame00156620 
This amendment is to update the study team (Section 1.3), adding research staff member. They 
will both assist with data management. 
XI-3. Ame00157187 
This amendment is to update the study team (section 1.3), adding a research staff member. 
They will assist with analyzing exit interview data. 

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XI-4. Ame00160383 
This amendment is to reduce the number of intervention group sessions and remove the exit 
interview received by the waitlist control group (described in the protocol, Section 5.1.1).  
We propose to reduce the number of group sessions provided to the waitlist control condition 
from 12 sessions to 5 sessions. All waitlist control participants are currently receiving the 
intervention. They have received a majority of the intervention components, including four group 
sessions, connection to a mentor for mentorship, and the microgrant payments totaling $1,200 
to invest in their business or other professional development goals.  
NIH originally funded this study as an RCT where the control condition received only standard of 
care, which consists of programs currently available in community settings. We proposed and 
received approval from NIH to alter the study design so that we also provided the SeCuRE 
intervention to the control group using a waitlist design, and planned to use PI’s discretionary 
funds to cover the additional expenses. We have now completed all research activities that were 
originally proposed to and approved by NIH – that is, we completed enrollment, the intervention 
condition received the SeCuRE intervention and completed an exit interview, and all participants 
completed the baseline and follow up surveys.  
Our research team has been greatly affected by multiple grant terminations. Because of this, we 
no longer have sufficient funds to finish the remaining group sessions and conduct exit 
interviews for the waitlist control group, which is leading us to submit this amendment. 
 
 

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