Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Phase: NA
Conditions: HIV Prevention
Sponsor: University of California, San Francisco

2. SPECIFIC AIMS
Globally, transgender (‘trans’) women experience extreme social and economic marginalization due to 
intersectional stigma1-3, defined as the confluence of stigma that results from the intersection of social identities 
and positions among those who are multiply oppressed4. Among trans women, gender- and race -based 
stigma intersect with social positions such as engagement in sex work and substance use5,6, generating a 
social context of increased vulnerability and HIV risk7. In Brazil, trans women are the ‘most-at-risk’ group for 
HIV8, with 55 times higher odds of HIV infection than the general population9; further, uptake of HIV testing and 
pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups10,11. 
Our team has developed the only trans-specific conceptual framework, gender affirmation theory12, to describe 
intersectional stigma faced by trans women, to frame investigations of how intersectional stigma results in 
health disparities, and to develop and test interventions to address intersectional stigma among trans women. 
Informed by gender affirmation theory, we propose to test a multi-level intervention to mitigate intersectional 
stigma and thereby increase HIV prevention uptake (HIV testing and PrEP use) among Brazilian trans women. 
The proposed multi-level intervention, ‘Guerreiras’ (‘warrior women’, as named by trans women participants in 
Brazil), represents decades of our HIV prevention research, including HIV self-testing (HIVST)13-18 and PrEP 
implementation with trans women19-21, by our collaborative team in the United States (US) and Brazil. 
The Guerreiras intervention is an integration of a suite of evidence-informed interventions and HIV prevention 
strategies, all of which have demonstrated feasibility and acceptability by trans women in Brazil, to increase 
self-care and reduce the negative health impacts of stigma. Guerreiras works at both the group- and individual-
level, comprised of two intervention components: 1) a group-level, peer-led intervention, which first 
demonstrated efficacy with trans women in the US as ‘Sheroes’22 and has been successfully adapted for 
Brazil, and 2) an individual-level peer navigation program, which is proving feasible and acceptable in current 
research with trans women in Brazil, and has demonstrated efficacy in other contexts23. At the group-level, 
highly trained peer navigators (PNs) will facilitate five group sessions with trans women using a manualized 
curriculum to address intersectional stigma and support HIV prevention uptake. At the individual-level, for six 
months following group sessions, the PNs will support participants one-on-one to engage in appropriate HIV 
prevention services (i.e. HIVST or clinic testing, PrEP, harm reduction, or HIV treatment if they test positive). 
Guerreiras will be evaluated using a randomized wait-list controlled trial among 400 trans women recruited 
from clinics, outreach events, and an ongoing observational cohort in São Paulo. We will compare uptake of 
HIV testing (self-testing and clinic-based), PrEP use, and other prevention services (e.g. harm reduction) 
among those in the intervention arm compared to those in a wait-list control arm. We will assess changes in 
intersectional stigma and its impact on observed differences between groups. We will also explore whether the 
effects of Guerreiras persist post-intervention. Longitudinal qualitative data collection with a diverse subsample 
will explore how intersectional stigma impacts engagement in Guerreiras and HIV prevention uptake. We will 
measure PrEP use with national electronic dispensing data and drug level testing, assess HIV testing with 
clinic records and surveys, and intersectional stigma through comprehensive survey measures. Aims include: 
Aim 1, HIV TESTING: To determine whether uptake of regular HIV testing, including both self- and clinic-
based testing, is higher among trans women randomized to an intersectional stigma intervention compared to 
those assigned to the control condition. Aim 2a (exploratory): To explore persistence of gains in regular HIV 
testing among intervention arm participants following the conclusion of their participation in the intervention. 
Aim 2, HIV PREVENTION: To determine whether PrEP initiation and persistence is higher among trans 
women randomized to an intersectional stigma intervention compared to those assigned to the control 
condition. Secondary prevention outcomes include PrEP adherence, condom use, and utilization of sexual 
health and harm reduction. Aim 2b (exploratory): To explore persistence of prevention gains post-intervention. 
Aim 3, MECHANISMS: To explore changes in intersectional stigma, including reductions in internalized 
stigma and increased resilience to anticipated and enacted stigma, among those assigned to intervention 
compared to those assigned to the control arm, and assess how changes in stigma result in prevention uptake. 
This study leverages 1) a productive multi-disciplinary HIV research partnership bringing extensive experience 
working with trans women in Brazil; 2) multi-level intervention components with demonstrated feasibility and 
acceptability by Brazilian trans women, informed by gender affirmation theory designed to address 
intersectional stigma; and 3) a context where PrEP and HIVST are available publicly, providing an opportunity 
to evaluate and scale-up an HIV prevention initiative in a key health disparity population, while contributing to 
nascent research in intersectional stigma.  
Document Date: January 23, 2019
NCT04114955 
Reducing Intersectional Stigma Among High-Risk Women in Brazil to 
Promote Uptake of HIV Testing and PrEP  

 
 
3. RESEARCH STRATEGY 
3.1 Significance 
Transgender (‘trans’) women have some of the highest rates of HIV in the world and are the highest 
HIV risk group in Brazil. A recent meta-analysis of pooled data among trans women from ten low-income 
countries found a 50-times increased odds of HIV infection compared with other adults and an HIV prevalence 
of 18%1. In South America, HIV prevalence estimates as high as 30% have been documented in population-
based studies among trans women24. One cross-sectional study of 284 trans women in southern Brazil (1997–
2014) found 25% living with HIV. In Rio de Janeiro, 31% of trans women recruited through respondent-driven 
sampling were HIV-positive, 7% were new diagnoses; almost one-third (29%) of their participants had not been 
previously tested 25. Additional data corroborate that trans women are the ‘most-at-risk’ group in Brazil8, with an 
estimated odds of HIV infection among trans women over 55 times higher than the general Brazilian population 
9, placing Brazil among countries with the greatest HIV disparities1.      
 
Despite high rates of HIV, HIV testing and uptake of pre-exposure prophylaxis (PrEP) among trans 
women is significantly lower than other at-risk groups. Trans women report multiple types of risky 
activities, including unprotected anal sex with multiple partners26,27, high number of sex partners28, sex while 
using drugs and alcohol29, and sex work30,31, yet they frequently underestimate their risk of acquiring HIV26 and 
have low rates of HIV testing32. Further, while oral PrEP has been shown to reduce risk of HIV infection by 
92% among adherent users33, uptake of and adherence to PrEP among trans women is significantly lower than 
other at-risk groups21. In Brazil, awareness of PrEP is low among trans women despite its free availability 
through the Brazilian universal health system or Sistema Unico de Saude (SUS)34. One study in Rio de Janeiro 
found that among 345 HIV-negative trans women, 76% were willing to use PrEP once they were aware of it 
and 67% met PrEP behavioral eligibility criteria35. Despite eligibility and willingness to use PrEP, as of August 
2018, only 74 Brazilian trans women had actually initiated PrEP through SUS nationally36. The São Paulo state 
PrEP monitoring report notes a need to find new strategies to attract transgender populations to PrEP .37 
Trans women in Brazil experience multiple stigmas that complicate their access to and adherence to 
healthcare, resulting in intersectional stigma and negative health outcomes. Stigma is a social process 
enacted through social structures and interpersonal interactions that devalues human difference, marginalizes 
stigmatized individuals, and creates a social hierarchy that reinforces social inequality38. Stigma is a 
fundamental cause of health disparities39. Intersectionality is a theoretical approach that highlights how 
multiple types of oppression intersect to create and reinforce social inequalities4. Thus, intersectional stigma 
is defined here as the confluence of multiple stigmatized identities, social positions, and stigma-related barriers 
that result in structural inequalities and health disparities4. Due to gender-based stigma, trans women face 
extreme social and economic marginalization that lead to additional stigmas based on social positions, such as 
engagement in sex work and substance use6,10, which also intersect with race-based stigma. Further, these 
identity- and social position-based stigmas intersect with stigma-related barriers such as PrEP stigma40 and 
HIV stigma41 to drive low rates of HIV testing, PrEP uptake and PrEP persistence among trans women.  
Experiences of enacted stigma (experiences of being stigmatized and/or discriminated against) often lead 
trans women to anticipate stigma (expectations of experiencing stigma) from healthcare providers, which in 
turn leads to healthcare avoidance and the internalization of stigma42 (adopting stigmatizing attitudes toward 
oneself; see Figure 1 for conceptual framework). Stigma resilience is the ability to cope with and/or challenge 
enacted stigma, seek healthcare despite anticipated stigma, and resist internalization of stigmatizing 
beliefs3,43,44, which includes being empowered in one’s healthcare45 despite the context of stigma.  
Multi-level interventions that address intersectional stigma to increase uptake of HIV testing and PrEP 
are urgently needed to improve health outcomes among trans women in Brazil. Working at both the 
group- and individual levels, we have developed Guerreiras, a trans-specific, gender-affirming group 
empowerment and peer navigation intervention to address intersectional stigma, thereby improving the HIV 
prevention continuum, namely HIV testing and PrEP uptake, among trans women in Brazil. While structural 
interventions are important for long-term social change, it is also critical to increase stigma resilience among 
trans women through support and empowerment that is urgently necessary to navigate existing systems of 
care that cannot be immediately reformed and where stigma is pervasively enacted against transgender 
people46,47 and continues to fuel HIV transmission2. To have an immediate impact on the lives of trans women, 
we must work to increase stigma resilience to support trans women in navigating current systems of care38,48.  
Furthermore, in Brazil, where trans women experience the highest rates of violence globally despite legislative 
protections for the LGBQT+ population49, the hostile political climate and current backlash against protections 
for marginalized populations makes this programming even more urgent. Our proposal considered a clear 

 
 
priority and supported by Municipal, State, and National HIV/AIDS programs (See Letters of support).  
Conceptual Framework: 
Our multi-level Guerreiras 
intervention is informed by 
an innovative, transgender-
specific theoretical model, 
gender affirmation theory50, 
that addresses 
intersectional stigma. MPI 
Dr. Sevelius has developed 
and tested a conceptual 
model that examines how 
intersectional stigma 
contributes to health 
disparities among trans 
women. Gender affirmation 
theory integrates 
objectification theory51,52 with 
the identity threat model of 
stigma53, and draws on 
research examining risk as 
an outcome of social 
oppression54. ‘Gender affirmation’ refers to an interpersonal, interactive process whereby a person receives 
social recognition and support for their gender identity and expression. Gender affirmation theory posits that in 
the context of intersectional stigma53,55, trans women attempt to reduce their experience of stigma by avoiding 
stigmatizing environments (e.g. healthcare settings) and undervaluing important health seeking behaviors (e.g. 
HIV testing, PrEP use) 55. Research has found that gender affirmation moderates the relationship between 
stigma and poor health outcomes56. Meeting trans women’s needs for gender affirmation, such as through 
gender-affirming relationships, decreases avoidance behavior and increases self-care and healthcare-seeking 
behavior, such as accessing HIV prevention services55,57,58. Peer networks and support are a primary source of 
information about PrEP, HIV testing, and safer sex behavior, while family and institutions are often stress 
factors59,60. Thus, peer-led interventions are critical for interventions that seek to reduce internalized stigma 
and increase stigma resilience for coping with anticipated and enacted stigma42. 
3.1.a Investigative team. Our research team brings extensive expertise in addressing intersectional stigma 
within HIV research with trans women, peer navigation of patients, community outreach and cohort retention in 
Brazil, and interdisciplinary mixed methods research. The team is co-led by UCSF Associate Professors, Drs. 
Sheri Lippman and Jae Sevelius. Dr. Lippman is an epidemiologist with long-standing collaborations in 
Brazil, where she conducted her dissertation on combination HIV prevention with sex workers, including trans 
women. Dr. Lippman, led the first study to explore use of HIV self-testing (HIVST) among trans women in the 
US; worked extensively on HIVST research in Brazil; has led multiple randomized trials, including the I-Care 
trial of peer navigation (NCT02417233) and a cluster randomized trial of community mobilization to promote 
testing and engagement in care in South Africa (R01MH103198); and is PI of the Trans Amigas peer 
navigation intervention (R34MH112177) in São Paulo. Dr. Jae Sevelius, a licensed clinical psychologist, is co-
founder of the UCSF Center of Excellence for Transgender Health and has led or collaborated on over 30 
studies focused on developing and testing some of the only evidence-based social-behavioral interventions for 
trans women to date. She is currently leading 2 NIH-funded efficacy trials of HIV interventions for trans women 
(1R01MH106373, R01MH115765) and the first trans-specific PrEP demonstration project. Dr. Sevelius led the 
feasibility and acceptability trials of Sheroes (1R34MH102109), the Sheroes adaptation for Brazil, and 
Girlfriends Connect (1R34DA038541). Dr. Sevelius was co-I on Dr. Lippman’s studies of HIVST among trans 
women and Trans Amigas. Dr. Lippman has collaborated for over 15 years with Brazilian site PI Dr. Maria 
Amelia Veras, MD, PhD, Professor of Collective Health at Santa Casa School of Public Health. Dr. Veras is a 
physician epidemiologist with over 25 years of experience in HIV prevention and care research and is site PI of 
Trans Amigas and Trans*National (R01MD010678). She leads the multidisciplinary LGBTI (Lesbian Gay 
Bisexual Transgender and Intersex) Human Rights and Health Study Group (NUDHES), and has extensive 
experience with LGBTI community-based research in Brazil. Dr. Gustavo Saggese, Post-Doctorate 

 
 
Researcher and early career investigator at Santa Casa, holds a PhD in anthropology and has over 10 years of 
experience conducting qualitative research among LGBTI populations. Dr. Saggese was the site PI of the 
adaptation and pilot testing of Sheroes in Brazil. Our team is uniquely positioned to lead this urgently needed 
research on intersectional stigma to improve HIV prevention among Brazilian trans women. 
3.1.b Preliminary Studies. Our team has conducted extensive preliminary research to inform this application. 
While there is additional research that provides groundwork for the strategies utilized here, our team has been 
leading the field to shape trans-specific HIV prevention research globally and in Brazil, as outlined below.  
Optimizing HIV programming for trans women in Brazil. To understand trans-specific HIV prevention and 
care needs in Brazil, our team conducted formative research in 2015 including focus groups with HIV-negative 
and positive trans women and local stakeholders to explore intervention needs and preferences2. Trans 
women and stakeholders alike advocated for peer-based support programs to address marginalization from 
both health and social services and to improve uptake of HIV prevention, HIV treatment, and complementary 
services. Key informants emphasized the need for empowerment-based, gender-affirming programming and 
skills building for successful engagement in health systems, including stigma resilience.  
Table 1. Preliminary studies conducted by investigative team 
Group-level, peer-led intervention 
for trans women and the adaptation 
for Brazil (Sheroes). Sheroes 
addresses intersectional stigma 
through gender affirmation, 
empowerment, gender pride, and 
understanding gender-based power 
inequalities to build healthcare-seeking 
skills supported by a sense of self-
worth66. In a pilot RCT with 77 trans 
women in the US, at 6-month follow up, 
HIV-negative and unknown status 
participants reported significant 
reductions in condomless intercourse 
and improved social support compared 
to control22 (Table 1). Encouraged by 
findings, we conducted a systematic 
translation and adaptation for trans 
women in Brazil. After translating 
materials from English to Portuguese, 
we collected and integrated input from stakeholders (potential participants, collaborating agency staff) into an 
adapted draft intervention. We then conducted a feasibility and acceptability pilot with Brazilian trans women, 
iterating and adapting suggested changes. Sheroes was highly feasible and acceptable. Of 5 sessions, 75% 
participated in at least 4 sessions, and 87.5% participated in at least 3 sessions. Participants requested 
additional sessions, with feedback including: “To be able to talk openly about sex, without being judged, was 
amazing!"; "I was thinking of injecting industrial silicone, but after hearing others' experiences, I'm leaving this 
room with certainty I will not do that"; "It was great to find out how wide the world of trans women is, even those 
who are HIV+". In the anonymous feedback survey, all participants endorsed high satisfaction and would 
recommend the program to a friend. The efficacious Sheroes program, feasible and acceptable in Brazil, 
provides the basis for Guerreiras. 
Individual-level peer navigation for trans women in Brazil (Trans Amigas). Following formative research 
with trans women and local stakeholders, who advocated for peer-based support programs to improve uptake 
of both HIV prevention and treatment2, we designed the Trans Amigas project.61 Trans Amigas is an adaptation 
of an efficacious peer navigation intervention developed by Dr. Lippman in South Africa, known as I-Care67, 
integrating principles from social-cognitive theory68 with the gender affirmation theory to meet the care and 
treatment needs of trans women in Brazil (Table 1). The intervention pairs participants with a peer navigator 
(PN) who is also a trans woman living with HIV to build trust based on shared experience. Trust then provides 
the foundation for the navigator and participant to work together to implement behavior change goals that 
facilitate engagement in care69. Among the most important social support mechanisms navigators play is aiding 
Preliminary studies 
Population 
Location  
Investigators 
Multi-level Guerreiras intervention components 
Group-level:  
Sheroes 
Feasibility & 
acceptability 
Trans women, 
any HIV status 
US, Brazil  
Sevelius (PI)22, 
Lippman, Veras, 
Saggese 
Efficacy 
Trans women, 
any HIV status 
US 
Sevelius (PI)22 
Individual-
level:  
Peer 
Navigation 
Feasibility & 
acceptability 
Trans women, 
living with HIV, 
Trans women on 
PrEP 
Brazil, US 
Lippman(PI)61, 
Sevelius PI)62,63, 
Veras, Saggese 
Efficacy 
Adults living with 
HIV, MSM living 
with HIV 
South Africa 
Lippman (PI)23,64 
HIV prevention strategies 
HIV self-testing 
Feasibility & 
acceptability 
MSM, trans 
women 
Brazil, US 
Lippman (PI)13-
15,18, Sevelius 
Efficacy 
MSM, Young 
women 
South Africa, 
US 
Lippman16,17,65 
PrEP 
Feasibility & 
acceptability 
Trans women 
US 
Sevelius19,20 
Efficacy 
Trans women 
US, Brazil 
Sevelius21 

 
 
in addressing stigma as a barrier to remaining in care69. While final results of the Trans Amigas PN intervention 
in Brazil are pending, to date participants and navigators alike have reported high levels of acceptability and 
the ongoing program is highly feasible: with 92% of eligible trans women approached accepting enrollment, 
84% of the cohort retained, and 70% of trans women randomized to PN in consistent (monthly) contact with 
their navigator. Similar interventions have been successful among trans women in the US,70 and, notably, in 
the I-Care trial, PN clients linked to care 1.60 times faster (95% CI: 1.29-1.99) and had nearly double the odds 
of being retained in HIV care (OR 1.83, CI: 1.01-3.33) than those in the control arm.23   
HIV self-testing among trans women. We have extensive experience introducing HIV self-testing (HIVST) for 
populations who may experience HIV stigma-related barriers to accessing clinic-based testing, including 
conducting the first U.S. study among trans women13 and early HIVST research with MSM in Brazil14,15,18; all 
demonstrating high levels of acceptability. Further, Dr. Lippman’s research has established that access to 
HIVST improves HIV testing frequency among at-risk populations17,65 and that peer-based distribution of 
HIVST is an efficacious, safe, and acceptable approach for disseminating test kits17,16,65. (Table 1) Following 
the 2017 release of the WHO Guidelines on HIV Self-Testing and Partner Notification71, the Brazil approved 
the first HIV self-test for sale in pharmacies. In 2018 the government announced availability of HIVST through 
SUS, aiming to increase testing uptake for those less likely to access testing or who test less frequently than 
recommended, including transgender women72. The locally manufactured DPP HIV 1/2 Rapid Assay can use 
blood or oral fluid samples and has been successfully utilized by key populations in Brazil73. Important to this 
application, HIVST has been found to be a feasible and acceptable method of increasing PrEP persistence 
among sex workers by eliminating stigma-related barriers to routine HIV testing required during PrEP use74. 
Identifying and addressing barriers to PrEP uptake and persistence among trans women. MPI Sevelius 
has extensive research experience related to PrEP and trans women and has authored numerous publications 
describing barriers and facilitators to PrEP uptake among trans women, including PrEP stigma, anticipated and 
enacted experiences of stigma from healthcare providers, and concerns about adverse interactions between 
antiretrovirals and hormones19-21,75. She is currently leading the first trans-specific PrEP demonstration project 
to identify best practices in PrEP provision to increase uptake, adherence, and persistence among trans 
people, which includes the provision of peer navigation and addressing PrEP stigma. One community-based 
clinic partner, La Clinica de la Raza, focuses on serving trans Latina women who have had little to no access 
to healthcare and identifying barriers to PrEP uptake among monolingual Spanish-speaking Latina trans 
women. Dr. Sevelius is also co-leading an exploratory study using social marketing strategies to develop trans-
specific PrEP messaging to address PrEP uptake barriers among trans women (R21MH110340).  
Our team is uniquely poised to conduct this research, with expertise in HIV prevention research with trans 
women in Brazil and a history of successful collaboration. We underscore that combined local acceptability and 
feasibility data and global efficacy data warrants a trial. Further incremental feasibility research to combine 
approaches already proven feasible in the target population (i.e. an R34) would delay urgent interventions for 
trans women for whom few proven interventions to address stigma and improve HIV outcomes exist. 
3.2 Innovation 
1) MULTI-LEVEL INTERSECTIONAL STIGMA INTERVENTION: Guerreiras is the first multi-level, multi-
component intervention designed specifically to increase HIV prevention uptake, namely HIV testing 
and PrEP, by reducing the impact of intersectional stigma among trans women, the group at highest 
risk of HIV acquisition in Brazil and globally. By integrating several evidence-based intervention 
components, all of which are feasible and acceptable in the target population, and all of which have evidence 
of efficacy with at-risk populations, we are uniquely poised to develop the first evidence-based approach to 
improving the HIV prevention continuum among trans women through the lens of intersectional stigma.  
2) TRANS-SPECIFIC CONCEPTUAL MODEL AND INTERVENTION APPROACHES: Our conceptual 
framework for the intervention, gender affirmation theory, developed by MPI Dr. Sevelius, uniquely 
addresses the lived experiences of trans women. Many HIV prevention interventions either subsume trans 
women under the category of ‘men who have sex with men (MSM)’ or attempt to adapt approaches that were 
developed for MSM to apply to trans women. Current best practices for public health research with trans 
women emphasize that trans women experience a unique social context and intersectional stigma impacts that 
cannot be accounted for by interventions that were developed for MSM19,76,77. Our intervention approaches 
represent decades of trans-specific research and intervention development and testing.  
3) STUDY OF MECHANISMS. Our study design, measurement, and analytic approach reflects the 
concept of intersectionality as more than an additive process of multiple stigmatized identities, 

 
 
recognizing that experiences of multiple types of stigma create a confluence that results in 
interlocking systems of oppression that cannot be meaningfully interpreted independently. For this 
reason, we will explore the confluence of stigmas quantitatively, assessing moderation or interaction of identity- 
and social position-based stigma as well as stigma-related barriers to prevention, which, to our knowledge, has 
not been done previously. We will also collect longitudinal qualitative data designed to elucidate how social and 
structural processes of intersectional stigma evolve over time and within the context of the intervention. This 
proposal can contribute to gaps in understanding how intersectional stigma impacts uptake of HIV prevention 
and provide insights regarding measurement and mechanisms of effect in an evolving field of study. 
3.3. Research Approach 
3.3.a Research Design Overview.  We will conduct a randomized controlled trial, where upon enrollment 
participants will be randomized to either the Guerreiras intervention or to a wait-list control condition, in which 
participants will also receive the Guerreiras intervention after a one-year waiting period. We chose a wait-list 
control to safeguard ethical treatment of participants by ensuring that a potentially impactful intervention will be 
available to all after a brief waiting period. Rolling enrollment of 400 participants will take place over one year, 
with the intervention initiating activities as participants are assigned to a Guerreiras group (8-10 participants); 
group assignment will occur as soon as sufficient participants are enrolled. Guerreiras includes five group 
sessions over the course of 6-8 
weeks, led by two peer 
navigators (PNs). Following 
group sessions, PNs will provide 
six months of peer navigation to 
each participant to support HIV 
testing (clinic or HIVST), PrEP 
uptake and persistence, harm 
reduction and other behavioral 
prevention as indicated, or HIV 
care (if participant tests 
positive). Groups will reconvene 
for a reunion session 3 months 
into navigation services (see 
Intervention Design 3.4). Follow-
up data collection for the main 
trial phase will be conducted every three months, with comprehensive interviewer-administered surveys 
conducted at enrollment (baseline), 6 months (interim survey), and 12 months (endline), with brief monitoring 
surveys at the 3-month visits (e.g. 3- and 9-months) to assess prevention uptake (HIV testing, PrEP use, etc; 
see Figure 2, Study Design). This results in four post-enrollment follow-up visits per participant to document 
regular prevention uptake and two visits to document changes in stigma measures during the main trial phase. 
Qualitative interviews will be conducted with 18 participants at two timepoints (36 interviews total) to provide 
context to our exploration of intersectional stigma and gender affirmation, including how intersectional stigma 
impacts engagement with Guerreiras and HIV prevention uptake, how gender affirming programming impacts 
intersectional stigma, and insight into psychosocial mechanisms of change over time.   
The second phase of the study, the delayed intervention phase, provides an opportunity for the control arm to 
receive the Guerreiras intervention and simultaneously to a) follow intervention arm participants for a further six 
months to assess the persistence of intervention effects, and b) replicate main trial findings utilizing wait-list 
control data. Wait-list control participants will be assigned to a Guerreiras group for initiation of the full 
intervention following the main trial and completion of their endline survey. HIV testing will be monitored 
through clinical records at partnering services, through PN forms on HIVST distribution, and through monitoring 
visits every 3 months. PrEP initiation and persistence will be monitored using the national medications 
dispensing system (SICLOM), which is utilized in all public clinics. Dried blood spots (DBS) testing will assess 
drug levels among those on PrEP to measure of adherence and collected at clinic visits for PrEP dispensation. 
Comprehensive surveys measuring stigma domains will occur at 6-month intervals (see Measures 3.7).  
3.3.b Study Setting and Population  
Study setting. The proposed study will take place in the São Paulo metropolitan area in Southern Brazil in 
collaboration with the Santa Casa School of Medical Sciences (Faculdade de Ciências Médicas da Santa Casa 
de São Paulo). São Paulo is the largest city in Latin America, among the first to document HIV among LGBTI 

 
 
communities, and both a global leader in equity of HIV treatment and a world center for gender transition care. 
The Brazilian investigative team has run a number of large state-funded surveys of the local transgender 
population, and has established the NIH-funded Trans*National Cohort (R01MD010678), an open cohort of 
trans women recruited through respondent driven sampling (RDS)78. Dr. Veras (site PI) has established 
relationships with a broad network of stakeholders, including public health and social services most frequented 
by the trans community and with the State HIV care reference and training center (CRT). The CRT includes a 
large outpatient clinic for HIV/AIDS (4000 patients currently in care), a small hospital, day-clinic, laboratory, 
HIV counseling and testing (HCT), a sexually transmitted infection (STI) clinic, and a prevention and research 
unit. CRT is also in charge of the HIV surveillance system for the state of São Paulo. Importantly, CRT is home 
to the largest and more comprehensive outpatient clinic for transgender health in the country and is the clinical 
research site for the Trans*National cohort and the Trans Amigas study (R34MH112177) of peer navigation for 
HIV-positive trans women. Procedures and activities for the proposal study will occur at the CRT and at SAE 
Campos Elíseos, which is the public health facility in central São Paulo catering to a large trans population. 
HIV testing, care and treatment, and PrEP are available at both clinic locations; participants who seroconvert 
will also be referred to one of these facilities for treatment. (see Letters of Support from State and Municipal 
Secretaries of Health and Trans*National). Finally, to ensure that participants who prefer not to engage with 
those specific clinic facilities also can participate, activities will also occur at the NUDHES community research 
office in central São Paulo. The easily accessible NUDHES space is home to a variety of NGOs and CBOs 
working with vulnerable populations (LGBT+, migrants, black communities) on social inclusion programming.  
Study population. The target population is adult trans women in the São Paulo metropolitan area. Despite 
Brazil’s progressive laws supporting LGBTI populations, including constitutional sanctioning of same-sex 
marriage, the right to change one’s legal name according to gender identity, and the codified universal right to 
healthcare, research in Brazil has confirmed trans women’s extreme vulnerability to violence, substance use, 
stigma and discrimination79, with limited access to public health and social services80,81. Many trans women in 
Brazil also engage in sex work, in part as a result of the difficulty in finding other work due to stigma and high 
levels of social vulnerability in terms of education and socio-economic status31,81-84. Recent findings from 
Projeto Muriel, a large survey of trans populations in São Paulo by Dr. Veras, indicate that 86.8% of trans 
women have experienced discrimination for being trans women, particularly from family (70.1%), in 
employment (63.9%), by police (57.7%), and by health providers (47.4%). We aim to enroll a broad cross-
section of trans women who mirror the demographics of the metropolitan area of São Paulo, approximately half 
of whom we will recruit from the Trans*National cohort and half from clinical services and outreach events.  
3.4. Intervention Design.  
3.4.a Overview. Guerreiras is a multi-level (group- and individual-level) intervention to improve engagement in 
the HIV prevention continuum among trans women in Brazil by addressing intersectional stigma, specifically 
identity-based stigmas related to gender identity and race, stigmas based on social position, e.g. engagement 
in sex work and substance use, and stigma-related barriers, specifically HIV and PrEP stigma. The group-level 
component of Guerreiras is facilitated by two peer navigators (PNs) and consists of 5 sessions conducted over 
6-8 weeks. To address HIV stigma, one PN will be living with HIV and the other will be HIV-negative. Group 
content (see Table 2) is informed by gender affirmation theory and designed to address intersectional stigma 
through building gender pride (reducing internalized stigma), role modeling (reducing HIV and PrEP stigma), 
and empowering participants to access healthcare by problem-solving anticipated stigma and effectively 
responding to enacted stigma (increasing stigma resilience). Following the group sessions, the individual-level 
component of Guerreiras consists of 6 months of peer navigation to support HIV prevention uptake including 
HIV testing (clinic-based or self-testing), PrEP, or HIV care (if participant tests positive during the intervention), 
and harm reduction services for those for whom these services are indicated. The six months of peer 
navigation re-affirm strategies learned during group sessions in one-on-one navigation sessions, with a reunion 
group session 3 months into navigation, which provides an opportunity to share experiences collectively.  
Table 2. Guerreiras intervention content 
Session 
Topic 
Objectives 
1 
Gender Pride / 
Orgulho Trans 
Explore and discuss trans identities and history in Brazil  
Discuss gender pride, identify positive role models to combat internalized stigma 
Introduce HIV self-testing and PrEP in relation to the concepts of self-care, self-worth, and sexual health  
2 
Looking Good, 
Feeling Good / 
Sou Bonita Meu 
Bem, e Daí? 
Discuss gender affirmation, its effect on self-image, self-care, empowerment to cope/respond to enacted stigma 
Discuss transition-related health care (i.e. hormone use/access, dangers of and safer injection silicone practices) 
Empower access to gender affirming healthcare, including HIV testing, PrEP, or engagement in HIV treatment  
Explore relationship between physical health (e.g., nutrition, sleep, HIV testing) and feeling good about oneself 

 
 
3 
Let’s Talk About 
Sex / Vamos 
Falar 
Abertamente 
Sobre Sexo 
Provide information on HIV rates and risk factors among trans women in Brazil 
Discuss self-protection in the context of gender affirmation, including HIV testing and PrEP  
Discuss the importance of knowing one’s HIV status and getting treatment if positive 
Empower access to HIV testing and treatment services; discuss barriers to HIV testing and treatment, such as 
anticipated stigma and/or previous experiences of enacted stigma, and coping strategies (e.g. HIV self-testing) 
4 
Taking Back the 
Power / Dando a 
Volta por Cima 
Discuss how trans-related stigma impacts one’s sense of personal power, explore ways to reclaim one’s power to 
confront stigma 
Explore assertiveness skills, practice communicating with healthcare providers to challenge structural and 
interpersonal enacted and anticipated stigma 
5 
Surviving and 
Thriving /  
Sobrevivendo e 
Crescendo 
Discuss how knowing one’s HIV status and getting tested and/or treatment for HIV is vital to self-care 
Discuss healthy ways of coping with transphobic stigma in relationships and the stress of sex work 
Consider the effect of substance use on one’s sexual health; offer harm reduction resources and support  
Celebrate trans community as a vital source of social support 
Reinforce gender pride to resist internalization of intersectional stigma 
Reunion  
(3 mos 
after 
session 5) 
Living Your 
Power / Vivendo 
o Seu Poder 
Explore ongoing self-care strategies, including gender affirmation, regular HIV testing and/or PrEP persistence 
Review assertiveness skills and discuss experiences communicating with health care providers to challenge 
structural and interpersonal enacted and anticipated stigma 
Reinforce gender pride to resist internalization of intersectional stigma 
Navigation 
(for 6 mos 
post-
groups) 
Staying 
Connected / 
Permanecendo 
Ligada 
Provide one-on-one individualized support for navigating current healthcare system, reinforcing concepts from 
group work, including problem-solving and strategies for coping with anticipated and enacted stigma   
 
3.4.b. HIV self-testing and/or navigation to clinic-based testing. HIV self-testing (HIVST) will be introduced 
and demonstrated in session 1 and will be made consistently available to all Guerreiras participants for free 
through our public sector partnerships. HIVST is available in Brazil in the public sector85. PNs will bring HIVST 
kits to each session; Guerreiras participants will have the option of utilizing HIVST in groups, with their PN, or 
on their own. At each group session participants will be invited to debrief their HIVST experience with the 
group if they so choose. PNs will offer one-on-one support for HIVST before and after each group session as 
needed and will offer navigation to clinic-based HIV testing to those who prefer clinic-based testing. PNs will be 
trained in test counseling to ensure they are prepared to debrief test results, though very few social harms 
have been reported in HIVST studies with vulnerable populations71,86,87. PNs will record HIVST distribution and 
tests conducted with them or in the group on standardized case report forms (see section 3.6.e). 
 
3.4.c. PrEP uptake, persistence, and adherence support. The most important indication for PrEP use is an 
expressed desire to use PrEP88. PNs will provide PrEP education and navigate participants to obtain PrEP 
upon request. PrEP uptake, persistence, and adherence support focus on empowering personal choice, self-
assessment of HIV risk, desire for feeling safe during sex, and daily habit formation. Group sessions include a 
trans-specific personal HIV risk assessment and PrEP decision-making tool developed specifically for trans 
women. PrEP-related group session content focuses on documented key facilitators of persistence and 
adherence, including: 1) daily habit formation; 2) knowledge that PrEP is highly effective when used; 3) 
disclosure of PrEP use to housemates who may discover the medication; 4) making plans for travel and 
substance use; 5) information about safety, including lack of known PrEP drug interactions with feminizing 
hormones21; 6) clear information that PrEP can be taken with or without food, at any hour, and with alcohol; 
and 7) information about the flexibility of the regimen including that forgotten tablets should be taken when 
remembered (even if late), that a tablet should be taken if one is not sure that the scheduled tablet was taken, 
and that PrEP is highly protective even if occasional doses are missed (i.e. don’t panic if you miss a dose)19,89.   
3.4.d. Ensuring a tailored prevention plan. While supporting PrEP uptake and persistence is urgent for trans 
women as a key population at high risk for HIV, PrEP will not be indicated for a small subset (~5-10%) who 
have clinical contraindications and/or low risk. Integral to Guerreiras intervention content and with support from 
PNs, participants will learn to accurately self-assess their HIV risk, options for accessing HIV prevention tools 
and support, and will adopt a prevention strategy tailored to their specific needs and preferences, e.g. HIV 
testing (clinic- or self-testing), PrEP, and/or behavioral risk reduction, such harm reduction or condom use.     
3.4.e. Peer navigator training:  Our team of investigators is experienced in staffing, training, and supervising 
clinical and behavioral intervention trials. We will identify and intensively train twenty potential peer navigators 
(PNs). Among these, 16 will be selected based on fit for facilitating the intervention. All PNs will be trans 
women, half will be living with HIV and currently receiving HIV care, and half will be HIV-negative and utilizing 
HIV prevention tools. PNs will be paired to ensure mixed status navigation teams to provide role modeling for 
HIV prevention and treatment, as well as to address HIV-related stigma for those who seroconvert or avoid 
testing due to fear of a positive result. PNs will be identified through stakeholders, clinics, and CBO partners as 
well as through NUDHES, a successful approach for identifying PNs for the Trans Amigas project.   

 
 
The multi-week PN training will adapt detailed manuals we developed for facilitating the Sheroes group 
sessions and conducting peer navigation in Trans Amigas. For the group-level component, PNs will acquire 
skills in group facilitation through coaching, role plays, and mock sessions. HIV-related training content will 
include personalized HIV risk assessment, HIV test counseling (including HIV self-testing), PrEP, and HIV 
treatment. Stigma-related training content will include the concepts of intersectional stigma and gender 
affirmation, with a focus on the types of stigma targeted by the intervention (identity, social position, and 
barriers) and building stigma resilience through coping skills (e.g. coping with anticipated and enacted stigma) 
and empowerment. For the individual-level component, PNs will be trained on the role of a PN, proving support 
to participants in developing a personalized HIV prevention plan, fostering an alliance, and ethical behavior, 
including maintaining appropriate personal/professional boundaries. PNs will learn about interactions they will 
have with participants (e.g., in-person meetings, phone calls, text messages) and how to record them (see 
3.6e for intervention monitoring), assessing participant needs, and strategies for addressing routine and more 
challenging barriers to prevention and care. To learn about potential resources for participants, PNs will tour 
trans-friendly service agencies in São Paulo, including the LGBT Citizenship Center, the Alcohol and Drugs 
Psychosocial Care Center, NGOs providing harm reduction support, the Racial and Intolerance Crimes Police 
Station, and the Social Assistance Reference Center. PNs will meet with the study coordinator weekly to 
conduct case conferences, receive support, and problem-solve. The study coordinator will have biweekly calls 
with investigators to discuss issues and strategize solutions. Refresher trainings will be conducted regularly to 
improve facilitation and navigation skills, to train new PNs if staff turnover occurs, and to address challenges.  
3.5. Participant Eligibility, Recruitment, Randomization, Retention.   
3.5.a. Eligibility: Participants must be 18 years or older; assigned ‘male’ at birth but currently identify as female, 
transgender, transsexual, or travesti (a common term for trans women in Brazil); not be known to be HIV 
positive; be a resident of the São Paulo area; and consent for study procedures, including review of clinical 
records. In Brazil, language that trans women use to describe themselves includes cultural terms such as 
‘transsexuais’, ‘mulher trans’, and ‘travesti’ among others. No restrictions will be placed on the degree to which 
the participant has transitioned legally or physically. Participants may be PrEP-naïve or have initiated PrEP; 
being on PrEP is not an exclusion criterion. While we do not anticipate encountering many trans women 
already taking PrEP, preliminary data indicate that a large proportion of trans women who initiate PrEP will 
struggle with persistence and require renewed engagement19. Based on current data, we expect a maximum of 
5% to have initiated PrEP prior to enrollment. We will not require HIV testing to enter the study; any participant 
who enrolls and either discovers she is positive or seroconverts will remain enrolled with navigation focused on 
HIV treatment. Recruitment staff will use a brief screening tool to establish eligibility prior to enrollment. 
3.5.b. Recruitment: Participants will be recruited from three sources over the course of 6 months: (1) those 
currently enrolled in the Trans*National Cohort in São Paulo; (2) trans women presenting for services at 
partnering clinics or presenting for HIV testing through the clinic run community-based programs; and (3) trans 
women recruited through targeted recruitment events. The Trans*National Cohort Study utilizes respondent-
driven sampling (RDS) and has enrolled 565 HIV-negative women. Any participants not known to have 
seroconverted in the cohort will be invited to participate in Guerreiras. We expect to recruit approximately half 
of the participants through this method. We will also invite trans women testing negative for HIV at either SAE 
Campos Elíseos, the CRT, or through the community-based testing programs run by CRT to participate. The 
community-based testing program, called “Fique Sabendo” or “be in the know” is a state-run operation that 
visits areas where trans women work and congregate for testing. Finally, we will conduct recruitment events, 
advertised through trans-friendly locations, the PN team, and through social media, to ensure we reach trans 
women not seeking services or already in Trans*National. We aim to enroll half of the study participants 
through clinic partners and outreach events. (for details see Form E, Recruitment and Retention). 
When a potential participant is interested in the study, staff will screen and enroll them, provide an appointment 
for screening and enrollment, or record preferred contact information to schedule an appointment. All 
participants will provide informed consent for study procedures, including clinical record extraction and PrEP 
eligibility exams (e.g. HIV and creatinine) if interested in PrEP, per national guidelines (see Human Subjects). 
3.5.c. Randomization: Participants will be randomly assigned 1:1 to one of two arms using a computer 
generated “random order of assignment” list such that 200 will be assigned to the intervention arm and 200 will 
be assigned to the wait-list control arm. The random assignments will be placed in advance in sealed, 
numbered envelopes in each study location. To avoid potential bias based on timing or location of enrollment, 
we will use “block randomization,” with randomly-permuted block sizes to avoid identification of the allocation 

 
 
of the last participant in a block. For participants allocated to intervention, assignment to a Guerreiras group 
will occur as soon as there is sufficient enrollment to form a group.   
3.5.d. Retention: Upon enrollment, participants will be asked to provide contact information, including address, 
cell phone/WhatsApp number, other social media contacts, and also to volunteer up to three individuals who 
can contact them should study staff be unable to do so. At each 3-month monitoring visit, staff will validate 
contact information in addition to completing data collection (see section 3.6.a & 3.6.b). The Brazilian study 
team has experience with these contact methods in retaining Trans*National and Trans Amigas study 
participants. (See Form E, Recruitment and Retention for further details on retention plans). Given the mobility 
and often unstable housing trans women experience, we expect to retain 75% of the cohort. To date just over 
50% of Trans*National participants (an observational study) and just over 80% of Trans Amigas participants 
(an intervention study with consistent contact) have been retained; as a result, we believe retention will be 
closer to Trans Amigas retention rates. We account for attrition in the statistical power (see section 3.8). 
3.6. Data Collection  
3.6.a Monitoring Visits and Surveys: The data collection schedule includes visits every 3 months: every other 
visit (every 6-months) will include a comprehensive survey (see Figure 2); all surveys are interviewer-
administered on encrypted study tablets. At enrollment, participants will provide informed consent and then 
respond to the first (baseline) comprehensive survey. Participants will complete two additional comprehensive 
surveys (interim and endline) during the main trial phase. During the delayed intervention phase all participants 
will respond to an additional interim survey and wait-list control participants will also respond to a final (endline) 
survey at the end of the period. Comprehensive surveys will assess hypothesized covariates and mediators of 
our primary and secondary outcomes (see Table 3). Brief monitoring surveys (15 minute) to record outcomes 
at 3-month intervals will capture: self-reported HIV risk behaviors and risk reduction practices (condom use or 
partner reduction); HIV testing; PrEP use (including refills and adherence); other prevention services sought 
and utilized (STI testing and treatment, harm reduction). The endline survey will include questions about 
engagement in study activities and interactions with navigators. We utilize measures that have been validated 
in Brazil when possible, including those we have used in prior studies and those we are currently validating in 
Trans Amigas (see Measures section 3.7 for more detail). Participants will be reimbursed for all study visits. 
Participants may choose to schedule visits at any of the three project sites, to optimize convenience. For those 
on PrEP, data collection visits will be scheduled at the participant’s clinic to ensure that PrEP distribution, HIV 
testing, DBS collection, and survey data collection is integrated efficiently into clinical care. Study staff will be 
available at each site. For participants with difficulty presenting at a study location, staff will offer interviews by 
phone or WhatsApp, to minimize missing data, though all attempts will be made to maximize in-person data 
collection. Interviewers will be trained on interviewing techniques, standard operating procedures, and human 
subjects research, including ensuring complete confidentiality. (See Form E, Human Subjects for details).  
3.6.b PrEP Data Extraction: Data regarding PrEP use, which became available nationally for at-risk 
populations in December 2017, will be extracted from the national SICLOM (Sistema de Controle Logístico de 
Medicamentos) database, which captures all ARV distribution nationally. PrEP dispensing will be extracted 
quarterly from SICLOM and stored securely, including visit dates, pill count and dose, and any associated 
observations. We will utilize clinical records at the facilities to note visits for other purposes, including visits 
related to PrEP side effects (see 3.6.c below). The investigators have successfully utilized SICLOM for 
extraction of medication dispensing information in the Trans Amigas project.  
3.6.c Clinic data extraction: Clinic-based HIV testing data and uptake of clinic-based prevention services, 
including STI testing and treatment, sexual health counseling, and HIV care visits (for those who seroconvert) 
will be extracted bi-annually, including visit purpose, dates, services received, HIV test result, and associated 
observations. Data from participant clinical files will be extracted electronically and uploaded to a secure data 
base kept by the study data managers (see Form E Human Subjects for details). Our team has successfully 
and safely extracted clinical data for Trans Amigas participants at the CRT and will utilize similar protocols.  
3.6.d Drug Concentration Testing: Drug concentrations in the blood have emerged as strong correlates of 
protection in PrEP trials, accounting for the majority of the variation in PrEP benefits. Dried blood spots (DBS) 
are easy to collect, require no processing in the field, are easy to store and ship, and are feasible for 
monitoring drug concentrations among trans women in our current PrEP demonstration project. The DBS will 
be collected at the clinical sites at each visit for PrEP dispensation by trained staff and processed in 
accordance with procedures developed for previous studies. (Investigators have all utilized DBS for drug 
concentrations in previous studies). Staff will use a medium gauge lancet to puncture the fingertip and extract 

 
 
whole blood onto filter paper, to be dried on a storage rack prior to placing the DBS in individual plastic zip lock 
bags with a dessicant packet and humidity indicator. DBS will be temporarily stored at each clinic in a freezer 
at -4C, then batch shipped monthly to the local laboratory for storage at -20C and batch tested quarterly using 
a validated method for quantification of drug concentrations of tenofovir and emtricitabine90. Adherence will be 
defined as having drug concentrations at levels required for protection (>4 pills per week)91.  
3.6.e Intervention Monitoring. We will monitor intervention quality and fidelity using strategies from Trans 
Amigas, including a group session form (GSF) and a peer contact form (PCF). GCFs will record attendance 
using participant ID, date, and content and activities completed in each group session, and note distribution of 
HIVST to each participant in each session. PCFs are designed to track PNs’ protocol-guided interactions with 
participants, noting each successful or attempted in-person navigation meeting, phone call, or text message. 
On PCFs, PNs note the date of contact, participant IDs, the topics discussed, and any required follow-up. 
Forms are entered into a database to monitor group session fidelity and track navigation contact over time. 
Each PN will meet weekly with the study coordinator to debrief intervention content and interactions with 
participants and to submit completed forms. The study coordinator will participate on weekly calls with the 
investigators to discuss client challenges or PN performance problems, re-training needs, and any modification 
or adaptation required to improve study processes. Investigators will review monitoring data on monthly calls.  
3.6.f Qualitative interviews. We will conduct semi-structured in-depth qualitative interviews (IDIs) with 18 
intervention participants at two time points (36 total IDIs). We aim to conduct one interview at the beginning of 
group sessions and one at the conclusion of peer navigation. PNs will identify participants who are early 
adopters or decliners of HIVST and/or PrEP (uptake or decline within the first two to three group sessions) and 
refer them for qualitative interviewing. If the participant is interested, the PN will describe the interview 
procedures and schedule an appointment. Qualitative interviews will be conducted in-person by a trained 
interviewer, supervised by co-I Saggese. Interviews will last approximately 1 hour, will be audio recorded, and 
will explore uptake/declination of and persistence with prevention tools in the context of the conceptual 
framework using probes specifically related to the intersectional stigma domains of interest: internalized, 
anticipated, and enacted stigma related to gender identity, race, HIV, PrEP, and other stigmas associated with 
marginalized social positions and behaviors (e.g. sex work, drug use), as well as stigma resilience. The 
structured interview guide will allow for organic exploration of additional emergent stigma domains, as 
appropriate, and explore how participants perceive intersections in identity-based stigma, social position-based 
stigma, and stigma related barriers to prevention and the impact of the intervention on stigma resilience.  
3.7 Measures  
Primary Exposure: Randomization arm – intervention or wait-list control – will be considered the primary 
predictor variable for all primary analyses and recorded on study enrollment forms. Because the degree of 
engagement with the intervention will vary by individual, we will also capture intervention dose on study 
monitoring forms as a secondary exposure measure for additional (per protocol) analyses. 
Primary Outcomes: (Evaluation: Aims 1 & 2): HIV testing uptake will be defined as any clinical evidence or 
report of HIV testing in each interval. This includes multiple data sources: documented HIV testing at a study 
clinic, report of having attended a non-study clinic for HIV testing, or evidence of HIVST kit receipt with self-
report of HIVST use and/or documented HIVST use by the PN during a group or individual navigation session.   
The primary PrEP use outcome measure is PrEP persistence, which is the PrEP measure utilized for sample 
size calculations. We will document PrEP initiation, defined as a participant filling their first PrEP prescription, 
through PrEP dispensing information in the national SICLOM database.  However, because initiation does not 
imply continued use, we will focus analyses of PrEP use on PrEP persistence – or documented use at every 
interval, defined as sufficient pill dispensation for complete 3-month coverage with no more than 10 days 
uncovered in the period. Secondary outcomes, including PrEP adherence and uptake of other prevention 
services (harm reduction, STI care) are listed in Table 3, below.  
Mediators: Intersectional Stigma: We will include a comprehensive suite of stigma measures that will be 
examined together in mediation and moderation analyses (see Analysis section 3.8). To explore the concept of 
intersectional stigma, we will analyze potential interactions between the stigma domains. This reflects the 
concept of intersectionality as more than an additive process of multiple stigmatized identities, but where 
experiences of multiple types of stigma create a confluence of interlocking systems of oppression that act 
synergistically as barriers to prevention and cannot be meaningfully interpreted independently. We will include 
quantitative measures of internalized, anticipated, and enacted stigma in the following domains: gender-related 
stigma, race-related stigma, stigma related to sex work and substance use, HIV and PrEP stigma. Stigma 
resilience is operationalized as coping self-efficacy and healthcare empowerment in the context of anticipated 

 
 
and enacted stigma. Comprehensive surveys will be conducted at enrollment, interim, and endline at 6-month 
intervals; we do not expect changes in stigma every 3 months (interval for outcomes monitoring).  
Covariates: We will measure demographic and other individual, social, and structural barriers or facilitators to 
care to assess potential covariates and confounders in analyses.        
Table 3: Primary and Secondary Measures 
Domain 
Instrument/measure 
Data source 
Frequency of data 
collection/extraction 
PRIMARY EXPOSURE 
 
 
 
Intervention  
 Randomization arm 
Enrollment/study records Continuous during enrollment 
PRIMARY OUTCOMES 
 
 
 
HIV testing 
Binary: Tested (HIVST or at a clinic) in past 3-months  
Clinical data extraction; 
study records (HIVST); 
self-report (testing) 
Extracted bi-annually, 
Continuous,  
Monitoring visits (3-monthly) 
PrEP initiation  
Binary: Initiation of PrEP in past 3-months* 
National data (SICLOM) 
Extract quarterly 
PrEP persistence 
Binary: PrEP dispensed with 80 or more days covered in 3-
months per dispensation records* 
National data (SICLOM) 
Extract quarterly 
SECONDARY OUTCOMES  
 
 
Prevention and service uptake  
Uptake of harm reduction services 
Self-report 
Monitoring visits (3-monthly)  
STI referrals and treatment 
Clinical data extraction; 
Self-report 
Extracted bi-annually, 
Monitoring visits (3-monthly) 
Condom use (consistent use with regular and occasional 
partners and clients) 
Clinical data extraction; 
Self-report 
Extracted bi-annually, 
Monitoring visits (3-monthly) 
PrEP adherence  
Drug levels 
Dried blood spots 
Monitoring visits (3-monthly) 
SECONDARY EXPOSURE  
 
 
Intervention dose  
Engagement with intervention (group sessions & navigation) Study monitoring forms 
Continuous 
COVARIATES/MEDIATORS  
 
 
Demographics 
Age, gender identity, SES, race, housing stability, mobility, 
employment, sex work 
Self-report - Surveys 
Comprehensive visits (6-
monthly) 
Intersectional stigma  
Internalized, anticipated, and enacted stigma related to: 
Identity-based stigma: gender92, race93 
Social position-based stigma: sex work94, substance use 
Stigma-related barriers: HIV stigma95; PrEP stigma 96  
Self-report - Surveys 
Comprehensive visits (6-
monthly) 
Stigma resilience: Coping self-efficacy 97-99  
Healthcare empowerment100 
Self-report - Surveys 
Comprehensive visits (6-
monthly) 
Gender affirmation 
Need for and experiences of gender affirmation12 
Transgender group identity92 
Self-report - Surveys 
Comprehensive visits (6-
monthly)  
Social, structural barriers to / 
facilitators of prevention 
Depression 101-103, substance use104, social support105,106, 
social cohesion107,108, relationship violence109, trauma110, 
access to clinical care and services received, food 
insecurity111,112. 
Self-report - Surveys 
Comprehensive visits (6-
monthly) 
*calculated among those with indications for PrEP use.  
 
3.8 Data Analysis Plan and Statistical Procedures: 
Preliminary analyses, missing data. Frequency tables for all variables and measures of central tendency and 
variability for continuous variables (e.g., stigma scores) will characterize the sample and will be stratified by 
randomization arm to check for imbalances. If arms differ significantly at baseline on one or more covariates, 
we will use causal modeling methods (e.g., propensity scores, targeted maximum likelihood estimation) to 
obtain the desired marginal effect estimates under the counterfactual assumption of balanced arms113-117. We 
will address incomplete data with multiple imputation (MI)118; MI makes the relatively mild assumption that 
incomplete data arise from a conditionally missing-at-random (MAR) mechanism119. Auxiliary variables will be 
included to help meet the MAR assumption120,121 and sensitivity analyses will be conducted with weighted MI122 
to assess the robustness of the MAR assumption123. SAS124 and Mplus125 will be used for analyses. 
Primary analyses for Aims 1 and 2. We expect HIV prevention outcomes to improve in the intervention arm 
relative to the control arm during the main trial phase. We hypothesize that, following the intervention, odds of 
HIV testing will be higher for intervention participants relative to control participants (Aim 1, Hypothesis 1). We 
also hypothesize that, following the intervention, the odds of PrEP initiation and persistence will be higher for 
the intervention group than for the control group (Aim 2, Hypothesis 2). Our primary interest is to estimate the 
marginal or population-average effects of intervention participation on these primary outcomes rather than the 
effect for a hypothetical average subject126. Moreover, within-subject outcome correlations are considered 
nuisance parameters rather than quantities of interest to be modeled explicitly. Accordingly, generalized 
estimating equations (GEE) will be used for the primary analyses to test Hypotheses 1 and 2 using time-
averaged comparisons of post-baseline (follow-up) measurements of intervention group with control group in 
the main trial phase. Alpha (α) will be set at .05 for these two planned comparisons. The alternating logistic 

 
 
regression (ALR) approach implemented in SAS PROC GENMOD will be used to address the 3-level 
clustering of observations within participants and participants assigned to Guerreiras group leaders. This 
analysis will follow an intent-to-treat (ITT) approach by including all randomized participants. Further detail on 
the analytic model and secondary analyses, including secondary outcomes, intervention persistence, and 
intervention replicability, are included in Form E, Statistical Design and Power. 
Primary Analyses for Aim 3. GEE will be used to test Aim 3 hypotheses that, following the intervention, relative 
to the control arm, intervention arm participants will have: 1) higher mean levels of resilience to anticipated 
stigma, 2) higher mean levels of resilience to enacted stigma, and 3) lower mean levels of internalized stigma. 
Analyses will follow the same ITT modeling approach as described above for Aims 1 and 2, except that a 
normal distribution and identity link will be employed to analyze continuous, normally-distributed stigma scores. 
These hypotheses will be tested via planned time-averaged comparisons of post-baseline measurements of 
the two arms in the main trial phase. These comparisons will be tested at α=.05 per comparison.  
We will also explore whether stigma measures at interim (six-months) surveys mediate the relationship 
between intervention assignment and subsequent outcomes as well as whether combinations of stigmas 
measures at baseline and six-months act synergistically (interact) and moderate the exposure-outcome 
associations in order to assess intersectional stigma. We will also assess whether measures of gender 
affirmation and transgender group identity increase over the course of the intervention and mediate the 
relationship between intervention arm and subsequent outcomes. Further detail on Aim 3 secondary analyses, 
including mediation and moderation, are in Form E, Statistical Design and Power. 
Statistical power. We computed minimum detectable effect sizes for primary outcomes using the two-group 
repeated proportions module in NCSS PASS 16127. The study will begin with 400 participants equally allocated 
to two study groups. Assuming 25% attrition, data from 300 participants will be available for analysis at all time 
points. We further lowered the effective sample size (ESS) to account for correlations between participants 
receiving the intervention from the same Guerreiras PN pairs, using a range of plausible intraclass correlations 
(ICC)s within PN pairs. Assuming α=.05 and power=.80, with four post-baseline measurements and assuming 
control group proportions P0=.50 for HIV testing and P0=.05 for PrEP use, we will have sufficient power to 
detect small to medium effects. This includes effects as low as 13% and 8% difference in proportion in HIV 
testing and persistent PrEP use, respectively, in the intervention arm compared to control. Effect size 
estimates for primary analyses (all Aims 1, 2, and 3) fall between cutoffs of .20 and .50 for small and medium 
standardized effect sizes128. Statistical power is fully elaborated in Form E, Statistical Design and Power.  
Qualitative data analysis:  We will optimize the longitudinal qualitative data we are collecting through best 
practices for analysis of this type of data, including tracking coding and analysis decisions over an extended 
analysis period, establishing clear coding and review processes, and using concept mapping to track codes, 
relationships between codes, and thematic groupings129. Audio-recordings will be transcribed; transcriptions 
will be managed using Atlas.ti, software designed to assist with textual datasets130. Functions include assisting 
with indexing, coding, searching, and mapping. Guided by gender affirmation theory and the lens of 
intersectional stigma, we will approach the qualitative analyses with the aim of elucidating how relationships of 
power or disadvantage based on stigma related to gender, race, social position (e.g. sex work, substance use), 
and stigma-related barriers (e.g. HIV and PrEP stigma) operate as mutually reinforcing rather than distinct 
systems of oppression, how these social and structural processes evolve over time and within the context of 
the intervention131. MPI Sevelius and Co-I Saggese will independently review the transcripts, beginning with 
analyzing cross-sectional baseline data separately and then grouping interviews by participant at endline to 
reflect temporality of experiences within each participant. Investigators will identify prospective codes with 
particular attention to interactions between and nesting within codes, highlighting intersections of identities and 
social processes over time. We will draft evolving summaries, including key insights and supporting data, and 
will convene weekly to discuss interpretations and arrive at consensus on key themes, navigating evolving 
interpretations over time through concept mapping with periodic coding review129.  
Conclusion. The proposed multi-level intervention is the culmination of years of our collaborative work in 
trans-specific HIV prevention interventions and a novel conceptual framework unique to trans women. Trans 
women in Brazil suffer an HIV burden over 50 times that of other groups9. Agencies and community leaders 
are rightfully demanding efficacious interventions to curb the devastating impact of HIV on trans communities. 
This application balances this impassioned outcry for urgent action with the measured, scientific rigor 
necessary to confidently and ethically evaluate the efficacy of this highly promising approach to reducing 
intersectional stigma to improve the HIV prevention continuum among transgender women in Brazil. 

 
 
References  
 
1. 
Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in 
transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013;13(3):214-222. 
2. 
Sevelius J, Murray LR, Martinez Fernandes N, Veras MA, Grinsztejn B, Lippman SA. Optimising HIV 
programming for transgender women in Brazil. Cult Health Sex. 2018:1-15. 
3. 
Perez-Brumer AG, Reisner SL, McLean SA, et al. Leveraging social capital: multilevel stigma, 
associated HIV vulnerabilities, and social resilience strategies among transgender women in Lima, 
Peru. J Int AIDS Soc. 2017;20(1):1-8. 
4. 
Bauer GR. Incorporating intersectionality theory into population health research methodology: 
Challenges and the potential to advance health equity. Social Science & Medicine. 2014;110:10-17. 
5. 
Poteat T, Wirtz AL, Radix A, et al. HIV risk and preventive interventions in transgender women sex 
workers. Lancet. 2015;385(9964):274-286. 
6. 
Avila MM, Dos Ramos Farias MS, Fazzi L, et al. High Frequency of Illegal Drug Use Influences 
Condom Use Among Female Transgender Sex Workers in Argentina: Impact on HIV and Syphilis 
Infections. AIDS Behav. 2017;21(7):2059-2068. 
7. 
Parsons JT, Antebi-Gruszka N, Millar BM, Cain D, Gurung S. Syndemic Conditions, HIV Transmission 
Risk Behavior, and Transactional Sex Among Transgender Women. AIDS and Behavior. 2018. 
8. 
De Boni R, Veloso Vg Fau - Grinsztejn B, Grinsztejn B. Epidemiology of HIV in Latin America and the 
Caribbean. Current Opinion in HIV and AIDS. 2014;9(2):192-198. 
9. 
Costa AB, Fontanari AMV, Jacinto MM, et al. Population-Based HIV Prevalence and Associated 
Factors in Male-to-Female Transsexuals from Southern Brazil. Archives of Sexual Behavior. 
2015;44(2):521-524. 
10. 
Poteat T, Wirtz AL. HIV in transgender women in Brazil. The Lancet HIV. 2017;Epub before print. 
11. 
Grinsztejn B, Jalil EM, Monteiro L, et al. Unveiling of HIV dynamics among transgender women: a 
respondent-driven sampling study in Rio de Janeiro, Brazil. The Lancet HIV. 2017;4(4):e169-e176. 
12. 
Sevelius J. Gender affirmation: A framework for conceptualizing risk behavior among transgender 
women of color. Sex Roles. 2013;68(11-12):675-689. 
13. 
Lippman SA, Moran L, Sevelius J, et al. Acceptability and Feasibility of HIV Self-Testing Among 
Transgender Women in San Francisco: A Mixed Methods Pilot Study. AIDS and Behavior. 
2015;20(4):928-938. 
14. 
Lippman SA, Veloso VG, Buchbinder S, et al. Over-the-counter human immunodeficiency virus self-test 
kits: time to explore their use for men who have sex with men in Brazil. Braz J Infect Dis. 
2014;18(3):239-244. 
15. 
Lippman SA PA, Veloso VG, et al. . Acceptability of self-conducted home-based HIV testing among 
men who have sex with men in Brazil: data from an on-line survey. Cad Saude Publica. 
2014;30(4):724-734. 
16. 
Lightfoot MA, Campbell CK, Moss N, et al. Using a Social Network Strategy to Distribute HIV Self-Test 
Kits to African American and Latino MSM. Journal of acquired immune deficiency syndromes. 
2018;79(1):38-45. 
17. 
Lippman SA LT, Rabede O, Gilmore H, Chen Y-H, Mlotshwa N, Maleke K, Marr A, McIntyre JA. High 
Acceptability and Increased HIV Testing Frequency Following Introduction of HIV Self-Testing and 
Network Distribution among South African MSM JAIDS. 2018;77(3):279-287. 
18. 
Volk JE, Lippman SA, Grinsztejn B, et al. Acceptability and feasibility of HIV self-testing among men 
who have sex with men in Peru and Brazil. International journal of STD & AIDS. 2016;27(7):531-536. 
19. 
Sevelius JM, Keatley J, Calma N, Arnold E. “I am not a man”: Trans-specific barriers and facilitators to 
PrEP acceptability among transgender women. Global Public Health. 2016(Special issue, The Trouble 
with ‘Categories’: Rethinking MSM, Trans and their Equivalents in HIV Prevention and Health 
Promotion). 
20. 
Sevelius JM, Deutsch MB, Grant R. The future of PrEP among transgender women: the critical role of 
gender affirmation in research and clinical practices. Journal of the International AIDS Society. 
2016;19(7Suppl 6):21105. 
21. 
Deutsch M, Glidden D, Sevelius J, et al. Preexposure chemoprophylaxis for HIV prevention in 
transgender women: A subgroup analysis of the iPrEx trial. The Lancet HIV. 2015;2(12):512-519. 

 
 
22. 
Sevelius J, Neilands T, Dilworth S, Castro D, Johnson M. Sheroes: Feasibility and acceptability of a 
community-driven, group-level HIV intervention program for transgender women. 22nd International 
AIDS Conference; 2018; Amsterdam, Netherlands. 
23. 
Steward WT, Agnew E, DeKadt J, et al. Peer navigation enhances HIV care retention: an RCT in South 
African primary clinics. Conference on Retroviruses and Opportunistic Infections (CROI); 2017; Seattle, 
WA. 
24. 
Silva-Santisteban A, Raymond H, Salazar X, et al. Understanding the HIV/AIDS Epidemic in 
Transgender Women of Lima, Peru: Results from a Sero-Epidemiologic Study Using Respondent 
Driven Sampling. AIDS and Behavior. 2011;16:872-881. 
25. 
Grinsztejn B, Jalil EM, Monteiro L, et al. Unveiling of HIV dynamics among transgender women: a 
respondent-driven sampling study in Rio de Janeiro, Brazil. The Lancet HIV. 2017. 
26. 
Herbst J, Jacobs E, Finlayson T, McKleroy V, Neumann M, Crepaz N. Estimating HIV prevalence and 
risk behaviors of transgender persons in the United States: A systematic review. AIDS and Behavior. 
2008;12(1):1-17  
27. 
Hill SC, Daniel J, Benzie A, Ayres J, King G, Smith A. Sexual health of transgender sex workers 
attending an inner-city genitourinary medicine clinic. Int J STD AIDS 2011 22(11):686-687  
28. 
Nuttbrock L, Hwahng S, Bockting W, et al. Lifetime risk factors for HIV/sexually transmitted infections 
among male-to-female transgender persons. JAIDS Journal of Acquired Immune Deficiency 
Syndromes. 2009;52(3):417-421. 
29. 
Nemoto T, Operario D, Keatley J, Han L, Soma T. HIV risk behaviors among male-to-female 
transgender persons of color in San Francisco. American Journal of Public Health. 2004; 94(7):1193-
1199. 
30. 
Prado Cortez F, Boer D, Baltieri D. A Psychosocial Study of Male-to-Female Transgendered and Male 
Hustler Sex Workers in São Paulo, Brazil. Archives of Sexual Behavior. 2011;40(6):1223-1231. 
31. 
Garcia M, Lehman Y. Issues Concerning the Informality and Outdoor Sex Work Performed by Travestis 
in São Paulo, Brazil. Archives of Sexual Behavior. 2011. 
32. 
Schulden J, Song B, Barros A, et al. Rapid HIV testing in transgender comunities by community-based 
organizations in three cities. Public Health Reports. 2008;123(Supplement 3):101-114. 
33. 
Grant RM, Anderson PL, McMahan V, et al. Uptake of pre-exposure prophylaxis, sexual practices, and 
HIV incidence in men and transgender women who have sex with men: a cohort study. 2014(1474-
4457 (Electronic)). 
34. 
Wilson EC, Jalil EM, Castro C, Martinez Fernandez N, Kamel L, Grinsztejn B. Barriers and facilitators to 
PrEP for transwomen in Brazil. Global Public Health. 2019;14(2):300-308. 
35. 
Jalil EM, Grinsztejn B, Velasque L, et al. Awareness, Willingness, and PrEP Eligibility Among 
Transgender Women in Rio de Janeiro, Brazil. JAIDS Journal of Acquired Immune Deficiency 
Syndromes. 2018;79(4). 
36. 
Ministério da Saúde. Situação atual da implantação da PrEP no Brasil – sucessos e desafios. 
Ministério da Saúde; Secretaria de Vigilância em Saúde; Departamento de Vigilância Prevenção e 
Controle das IST, do HIV/Aids e das Hepatites Virais;  Brasilia, Brasil. Agosto, 2018. 
37. 
Secretaria de Estado da Saúde. Relatório: Reunião de Monitoramento da Implantação e Início da 
segunda onda – expansão da PREP no estado de São Paulo. Secretaria de Estado da Saúde, 
Coordenadoria de Controle de Doenças, Centro de Referência e Treinamento DST/Aids;August 2018. 
38. 
Herek GM. A Nuanced View of Stigma for Understanding and Addressing Sexual and Gender Minority 
Health Disparities. LGBT Health. 2016(2325-8306 (Electronic)). 
39. 
Hatzenbuehler ML, Phelan JC, Link BG. Stigma as a Fundamental Cause of Population Health 
Inequalities. American Journal of Public Health. 2013;103(5):813-821. 
40. 
Golub SA. PrEP Stigma: Implicit and Explicit Drivers of Disparity. Current HIV/AIDS Reports. 
2018;15(2):190-197. 
41. 
Poteat T, Malik M, Scheim A, Elliott A. HIV Prevention Among Transgender Populations: Knowledge 
Gaps and Evidence for Action. Current HIV/AIDS Reports. 2017;14(4):141-152. 
42. 
White Hughto JM, Reisner SL, Pachankis JE. Transgender stigma and health: A critical review of 
stigma determinants, mechanisms, and interventions. Social Science & Medicine. 2015;147:222-231. 
43. 
Bockting WO, Miner MH, Swinburne Romine RE, Hamilton A, Coleman E. Stigma, Mental Health, and 
Resilience in an Online Sample of the US Transgender Population. American Journal of Public Health. 
2013;103(5):943-951. 

 
 
44. 
Bockting W. Transgender identity and HIV: Resilience in the face of stigma. Focus: A Guide to AIDS 
Research and Counseling. 2008;23(2):1-4. 
45. 
Johnson MO. The Shifting Landscape of Health Care: Toward a Model of Health Care Empowerment. 
American Journal of Public Health. 2011;101(2):265-270. 
46. 
Grant J, Mottet L, Tanis J, Harrison J, Herman J, Keisling M. Injustice at every turn: A report of the 
National Transgender Discrimination Survey. Washington: National Center for Transgender Equality 
and National Gay and Lesbian Task Force;2011. 
47. 
Bones Rocha K, Rubim Barbosa LH, Zambom Barboza C, et al. Attitudes and Perceptions of the 
Brazilian Public Health System by Transgender Individuals. Forum Qualitative Sozialforschung / Forum: 
Qualitative Social Research,. 2009;10(2). 
48. 
Poteat T, German D, Kerrigan D. Managing uncertainty: a grounded theory of stigma in transgender 
health care encounters. Soc Sci Med. 2013;84:22-29. 
49. 
Cazarré M. Com 600 mortes em seis anos, Brasil é o que mais mata travestis e transexuais. Direitos 
Humanos. 2015;http://agenciabrasil.ebc.com.br/direitos-humanos/noticia/2015-11/com-600-mortes-em-
seis-anos-brasil-e-o-que-mais-mata-travestis-e. http://agenciabrasil.ebc.com.br/direitos-
humanos/noticia/2015-11/com-600-mortes-em-seis-anos-brasil-e-o-que-mais-mata-travestis-e. 
50. 
Sevelius JM. Gender Affirmation: A Framework for Conceptualizing Risk Behavior among Transgender 
Women of Color. Sex Roles. 2013;68(11-12):675-689. 
51. 
Moradi B. Addressing gender and cultural diversity in body image: Objectification theory as a 
framework for integrating theories and grounding research. Sex Roles. 2010;63(1):138-148. 
doi:110.1007/s11199-11010-19824-11190. 
52. 
Fredrickson B, Roberts T. Objectification theory. Psychology of Women Quarterly. 1997;21(2):173-206. 
doi:110.1111/j.1471-6402.1997.tb00108.x. 
53. 
Major B, O'Brien L. The social psychology of stigma. Annual Review of Psychology. 2005;56:393-421. 
54. 
Diaz R, Ayala G, Bein E. Sexual risk as an outcome of social oppression: Data from a probability 
sample of Latino gay men in three US cities. Cultural Diversity and Ethnic Minority Psychology. 
2004;10(3):255-267. 
55. 
Sevelius J. Gender Affirmation: A Framework for Conceptualizing Risk Behavior among Transgender 
Women of Color. Sex Roles. 2012:1-15. 
56. 
Crosby RA, Salazar LF, Hill BJ. Gender Affirmation and Resiliency Among Black Transgender Women 
With and Without HIV Infection. Transgender health. 2016;1(1):86-93. 
57. 
Sevelius J, Johnson M. Preliminary support for transgender-specific predictors of uptake and 
adherence to ART and viral load among HIV+ transgender women. 8th International Conference on 
HIV Treatment and Prevention Adherence; June, 2013. 
58. 
Sevelius J, Johnson M. A Qualitative Investigation of Barriers to Treatment Initiation and Engagement 
among Transgender Women Living with HIV. 8th International Conference on HIV Treatment and 
Prevention Adherence; June, 2013; Miami Beach, FL. 
59. 
Garcia J, Parker C, Parker RG, Wilson PA, Philbin M, Hirsch JS. Psychosocial Implications of 
Homophobia and HIV Stigma in Social Support Networks: Insights for High-Impact HIV Prevention 
Among Black Men Who Have Sex With Men. Health education & behavior : the official publication of 
the Society for Public Health Education. 2016;43(2):217-225. 
60. 
Kelly JA, St Lawrence JS, Diaz YE, et al. HIV risk behavior reduction following intervention with key 
opinion leaders of population: an experimental analysis. American journal of public health. 
1991;81(2):168-171. 
61. 
ClinicalTrials.gov. ClinicalTrials.gov Identifier: NCT03525340, Improving Health Outcomes for Women 
Living With HIV.  Principal Investigator: Sheri Lippman  2018.  
https://clinicaltrials.gov/ct2/show/NCT03525340?term=NCT03525340&rank=1. 
62. 
Sevelius JM, Castro D, Olem D, Ventura A, Johnson MO. Healthy Divas: A culturally relevant 
intervention to improve engagement in care among transgender women living with HIV. International 
Association for Providers in AIDS Care; 2014; Miami, FL. 
63. 
Sevelius J, Deutsch M, Gutierrez-Mock L, Hudson B, Welborn L, Grant R. TRIUMPH: Trans Research 
Informed communities United in Mobilization for the Prevention of HIV. United States Professional 
Association for Transgender Health; 2017; Los Angeles, CA. 
64. 
ClinicalTrials.gov. ClinicalTrials.gov Identifier: NCT03483857, Peer Navigation to Improve Engagement 
in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa.  Principal 

 
 
Investigators: Tim Lane & Sheri Lippman  2018.  
https://clinicaltrials.gov/ct2/show/NCT03483857?term=NCT03483857&fund=0&rank=1. 
65. 
Pettifor A, Kahn K, Kimaru L, et al. HIV Self-testing Increases Testing in Young South African Women: 
Results of an RCT Conference on Retroviruses and Opportunistic Infections (CROI). Conference on 
Retroviruses and Opportunistic Infections (CROI); March, 2018; Boston, Massachusetts. 
66. 
Midwest Prevention Intervention Center. SISTA Implementation Manual. In: Network AAPI, ed: Centers 
for Disease Control and Prevention; 2008. 
67. 
Lippman SA, Shade SB, Sumitani J, et al. Evaluation of short message service and peer navigation to 
improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized 
controlled trial. Trials. 2016;17(1):68. 
68. 
Bandura A. Social cognitive theory: An agentic perspective. Annual Review of Psychology. 2001;52:1-
26. 
69. 
Steward WT, Sumitani J, Moran ME, et al. Engaging HIV-positive clients in care: acceptability and 
mechanisms of action of a peer navigation program in South Africa. AIDS care. 2018;30(3):330-337. 
70. 
Maiorana A, Sevelius J, Patouhas E, et al. Best practices and key elements of feasible and acceptable 
interventions to engage Transgender Women of Color in HIV Care. National HIV Prevention 
Conference, Dec 2015.; 2015; Atlanta, GA, USA. 
71. 
World Health Organization. Guidelines on HIV Testing Services and Partner Notification: Supplement to 
Consolidated Guidelines on HIV Testing Services Geneva, Switzerland: World Health Organization; 
December 2016. 
72. 
Ministerio da Saude, Departamento de Vigilância Prevenção e Controle das IST do HIV/Aids e das 
Hepatites Virais.  O autoteste de HIV no SUS.  http://www.aids.gov.br/pt-br/autoteste/o-autoteste-de-
hiv-no-mundo. Accessed January 15, 2019. 
73. 
De Boni RB, Lentini N, Santelli AC, et al. Self-testing, communication and information technology to 
promote HIV diagnosis among young gay and other men who have sex with men (MSM) in Brazil. J Int 
AIDS Soc. 2018;21 Suppl 5:e25116. 
74. 
Ortblad KF, Chanda MM, Musoke DK, et al. Acceptability of HIV self-testing to support pre-exposure 
prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled 
trials. BMC Infectious Diseases. 2018;18(1):503. 
75. 
Sevelius J, Patouhas E, Keatley J, Johnson M. Barriers and facilitators to engagement and retention in 
care among transgender women living with human immunodeficiency virus. Annals of Behavioral 
Medicine. 2014;47(1):5-16. 
76. 
Sevelius J, dickey l, Singh A. Affirmative Research with Transgender and Gender Nonconforming 
Communities. Handbook of Trans-Affirmative Counseling & Psychological Practice. Washington DC: 
American Psychological Association; 2016. 
77. 
Kaplan RL, Sevelius J, Ribeiro K. In the name of brevity: The problem with binary HIV risk categories. 
Global Public Health. 2016;11(7-8):824-834. 
78. 
Heckathorn DD. Snowball Versus Respondent-Driven Sampling. Sociological methodology. 
2011;41(1):355-366. 
79. 
Vianna AR, Carrara S. Tá lá o copro estendido no chão…” a Violência Letal contra Travestis no 
Municipio do Rio de Janeiro. Revista de Saúde Coletiva. 2006;16(2):233-249. 
80. 
Muller M, Knauth D. Desigualdades no SUS: o caso do atendimento às travestis é ‘babado! . Cadernos 
EBAPE.BR. 2008;6(2):1-14. 
81. 
Pelucio L. Abjeção e Desejo - uma etnografia travesti sobre o modelo preventivo de aids. São Paulo: 
Editora Annablume; 2009. 
82. 
Grandi JL, Goihman S, Ueda M, Rutherford GW. HIV Infection, Syphilis, and Behavioral Risks in 
Brazilian Male Sex Workers. AIDS and Behavior. 2000;4(1):129-135. 
83. 
Cortez F, Boer DP, Baltieri DA. A Psychosocial Study of Male-to-Female Transgendered and Male 
Hustler Sex Workers in São Paulo, Brazil. Archives of Sexual Behavior. 2010. 
84. 
Inciardi JA. Sex, Drugs, and HIV/AIDS in Brazil. Boulder: Westview Press; 2000. 
85. 
Tanser F, de Oliveira T, Maheu-Giroux M, Barnighausen T. Concentrated HIV subepidemics in 
generalized epidemic settings. Curr Opin HIV AIDS. 2014;9(2):115-125. 
86. 
Johnson C, Baggaley R, Forsythe S, et al. Realizing the potential for HIV self-testing. AIDS Behav. 
2014;18 Suppl 4:S391-395. 
87. 
Johnson CC, Kennedy C, Fonner V, et al. Examining the effects of HIV self-testing compared to 
standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc. 2017;20(1):1-10. 

 
 
88. 
Haberer JE. Current concepts for PrEP adherence in the PrEP revolution: from clinical trials to routine 
practice. Current Opinion in HIV and AIDS. 2016;11(1). 
89. 
Sidebottom D, Ekström AM, Strömdahl S. A systematic review of adherence to oral pre-exposure 
prophylaxis for HIV – how can we improve uptake and adherence? BMC Infectious Diseases. 
2018;18(1):581. 
90. 
Castillo-Mancilla JR, Zheng J-H, Rower JE, et al. Tenofovir, Emtricitabine, and Tenofovir Diphosphate 
in Dried Blood Spots for Determining Recent and Cumulative Drug Exposure. AIDS Research and 
Human Retroviruses. 2013;29(2):384-390. 
91. 
Hoagland B, Moreira RI, De Boni RB, et al. High pre-exposure prophylaxis uptake and early adherence 
among men who have sex with men and transgender women at risk for HIV Infection: the PrEP Brasil 
demonstration project. J Int AIDS Soc. 2017;20(1):1-14. 
92. 
Jefferson K, Neilands T, Sevelius J. Transgender women of color: discrimination and depression 
symptoms. Ethnicity and Inequalities in Health and Social Care. 2014;6(4):121-136. 
93. 
Landrine H, Klonoff E. The schedule of racist events: A measure of racial discrimination and a study of 
its negative physical and mental health consequences. Journal of Black Psychology. 1996;22:144-168. 
94. 
Liu S-H, Srikrishnan AK, Zelaya CE, Solomon S, Celentano DD, Sherman SG. Measuring perceived 
stigma in female sex workers in Chennai, India. AIDS Care. 2011;23(5):619-627. 
95. 
Genberg BL, Kawichai S, Chingono A, et al. Assessing HIV/AIDS stigma and discrimination in 
developing countries. AIDS Behav. 2008;12(5):772-780. 
96. 
Mustanski B, Ryan DT, Hayford C, Phillips G, Newcomb ME, Smith JD. Geographic and Individual 
Associations with PrEP Stigma: Results from the RADAR Cohort of Diverse Young Men Who have Sex 
with Men and Transgender Women. AIDS and Behavior. 2018;22(9):3044-3056. 
97. 
Kamau TM, Olson VG, Zipp GP, Clark M. Coping self-efficacy as a predictor of adherence to 
antiretroviral therapy in men and women living with HIV in Kenya. AIDS Patient Care and STDs. 
2011;25(9):557-561. 
98. 
Kerrigan D, Ellen JM, Moreno L, et al. Environmental-structural factors significantly associated with 
consistent condom use among female sex workers in the Dominican Republic. AIDS (London, 
England). 2003;17(3):415-423. 
99. 
Parcesepe AM, L'Engle KL, Martin SL, Green S, Suchindran C, Mwarogo P. Early sex work initiation 
and condom use among alcohol-using female sex workers in Mombasa, Kenya: a cross-sectional 
analysis. Sexually transmitted infections. 2016;92(8):593-598. 
100. 
Johnson MO, Rose CD, Dilworth SE, Neilands TB. Advances in the conceptualization and 
measurement of Health Care Empowerment: development and validation of the Health Care 
Empowerment inventory. PLoS ONE. 2012;7(9):e45692. 
101. 
Andresen E, Malmgren J, Carter W, Patrick D. Screening for depression in well older adults: evaluation 
of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). American Journal of 
Preventive Medicine. 1994;10:77-84. 
102. 
Nduna M, Jewkes RK, Dunkle KL, Jama Shai NP, Colman I. Prevalence and factors associated with 
depressive symptoms among young women and men in the Eastern Cape Province, South Africa. 
Journal of Child and Adolescent Mental Health. 2013;25:43-54. 
103. 
Smit J, Myer L, Middelkoop K, et al. Mental health and sexual risk behaviours in a South African 
township: a community-based cross-sectional study. Public Health. 2006;120:534-542. 
104. 
Peltzer K, Simbayi L, Kalichman S, Jooste S, Cloete A, Mbelle N. Alcohol Use in Three Different Inner 
Cities in South Africa: AUDIT-C and CAGE. Journal of Psychology in Africa. 2007;17. 
105. 
Sherbourne CD, L. SA. The MOS social support survey. Social Science and Medicine. 1991;32(6):705-
714. 
106. 
Drain PK, Losina E, Coleman SM, et al. Social support and mental health among adults prior to HIV 
counseling and testing in Durban, South Africa. AIDS Care. 2015;27(10):1231-1240. 
107. 
Lippman SA, Donini A, Diaz J, Chinaglia M, Reingold A, Kerrigan D. Social-environmental factors and 
protective sexual behavior among sex workers: the Encontros intervention in Brazil. Am J Public 
Health. 2010;100 Suppl 1:S216-223. 
108. 
Lippman SA, Neilands TB, Leslie HH, et al. Development, validation, and performance of a scale to 
measure community mobilization. Soc Sci Med. 2016;157:127-137. 
109. 
Dunkle KL, Jewkes RK, Brown HC, et al. Prevalence and patterns of gender-based violence and 
revictimization among women attending antenatal clinics in Soweto, South Africa. American Journal of 
Epidemiology. 2004;160(3):230-239. 

 
 
110. 
Closson K, Dietrich JJ, Nkala B, et al. Prevalence, type, and correlates of trauma exposure among 
adolescent men and women in Soweto, South Africa: implications for HIV prevention. BMC Public 
Health. 2016;16(1):1191. 
111. 
Coates J, Swindale A, Bilinsky P. Household Food Insecurity Access Scale (HFIAS) for measurement 
of food access: Indicator guide. Washington, DD: Food and Nutrition Technical Support, USAID; 2007. 
112. 
Eaton LA, Cain DN, Pitpitan EV, et al. Exploring the relationships among food insecurity, alcohol use, 
and sexual risk taking among men and women living in South African townships. Journal of Primary 
Prevention. 2014;35(4):255-265. 
113. 
Luellen JK, Shadish WR, Clark M. Propensity scores an introduction and experimental test. Evaluation 
Review. 2005;29(6):530-558. 
114. 
Rubin DB. On principles for modeling propensity scores in medical research. Pharmacoepidemiology 
and Drug Safety. 2004;13(12):855-857. 
115. 
Seaman S, Copas A. Doubly robust generalized estimating equations for longitudinal data. Statistics in 
medicine. 2009;28(6):937-955. 
116. 
Shadish WR, Luellen JK, Clark M. Propensity Scores and Quasi-Experiments: A Testimony to the 
Practical Side of Lee Sechrest. 2006. 
117. 
Weitzen S, Lapane KL, Toledano AY, Hume AL, Mor V. Principles for modeling propensity scores in 
medical research: a systematic literature review. Pharmacoepidemiology and Drug Safety. 
2004;13(12):841-853. 
118. 
Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychological Methods. 
2002;7(2):147. 
119. 
Little RJ, Rubin DB. Statistical analysis with missing data. New York: John Wiley & Sons; 2014. 
120. 
Collins LM, Schafer JL, Kam C. A comparison of inclusive and restrictive strategies in modern missing 
data procedures. Psychological Methods. 2001;6(4):330-351. 
121. 
Graham JW. Adding missing-data-relevant variables to FIML-based structural equation models. 
Structural Equation Modeling. 2003;10(1):80-100. 
122. 
Carpenter JR, Kenward MG, White IR. Sensitivity analysis after multiple imputation under missing at 
random: a weighting approach. Statistical Methods in Medical Research. 2007;16(3):259-275. 
123. 
Hedeker D, Gibbons RD. Application of random-effects pattern-mixture models for missing data in 
longitudinal studies. Psychological Methods. 1997;2(1):64-78. 
124. 
SAS Institute. SAS On-Line Doc, Version 9.0. Cary, NC: SAS Institute, Inc.; 2002. 
125. 
Muthén LK, Muthén BO. Mplus User's Guide: Eigth Edition. Los Angeles, CA: Muthén and Muthén; 
1998-2017. 
126. 
Young ML, Preisser JS, Qaqish BF, Wolfson M. Comparison of subject-specific and population 
averaged models for count data from cluster-unit intervention trials. Statistical Methods in Medical 
Research. 2007;16(2):167-184. 
127. 
NCSS PASS 16 [computer program]. Version 16. Kaysville, Utah: NCSS Statistical Software; 2018. 
128. 
Crosby RA, Rothenberg R. In STI interventions, size matters. Sexually Transmitted Infections. 
2004;80(2):82-85. 
129. 
Fadyl JK, Channon A, Theadom A, McPherson KM. Optimising qualitative longitudinal analysis: 
Insights from a study of traumatic brain injury recovery and adaptation. Nursing Inquiry. 
2017;24(2):e12170. 
130. 
Muhr T. User's Manual for ATLAS.ti 5.0. GmbH, Berlin: ATLAS.ti Scientific Software Development; 
2004. 
131. 
Warner L. A best practices guide to intersectional approaches in psychological research. Sex Roles. 
2008;59(5):454-463.