Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
Phase: NA
Conditions: HIV
Sponsor: University of North Carolina, Chapel Hill

 
Title: Promoting Viral Suppression Among Transgender Women Living With HIV in Santo 
Domingo 
NCT #: NCT06316102 
Date: October 8, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Clinical Trial Protocol 
Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender 
Women Living with HIV in Santo Domingo 
Principal Investigator: Dr. Clare Barrington, PhD, University of North Carolina at Chapel Hill 
Sponsor/Collaborators: University of North Carolina, The George Washington University, 
Instituto Dermatológico y Cirugía de Piel (IDCP), National Institute of Mental Health 
 
 
 

1. Administrative Information 
Protocol Title: Piloting a Multilevel Intervention to Promote Viral Suppression Among 
Transgender Women Living with HIV in Santo Domingo 
Principal Investigator: Dr. Clare Barrington, PhD, University of North Carolina at Chapel 
Hill 
Sponsor/Collaborators: The University of North Carolina at Chapel Hill, The George 
Washington University, Instituto Dermatológico y Cirugía de Piel (IDCP), National 
Institute of Mental Health 
2. Background and Rationale 
Transgender (trans) women across the globe experience a disproportionate burden of 
HIV with an estimated global HIV prevalence of 19%.(1,2) In Latin America and the 
Caribbean, HIV prevalence among trans women is estimated between 18% and 38%, 
magnitudes of power higher than cisgender adult prevalence.(3,4) Trans women also 
experience worse HIV care and treatment outcomes than cisgender adults, including 
lower rates of viral suppression.(5-11) Despite the implications of this for individual and 
population-level health, few interventions address the multiple social determinants of 
HIV outcomes among trans women.(4, 7, 12-14)  
Stigma is a key social determinant of HIV outcomes.(14,15) Trans women experience 
intersectional stigma due gender identity, HIV status, and sex work.(15,16) This 
intersectional stigma occurs  in several forms: internalized stigma in the form of 
endorsing or applying negative beliefs; anticipated stigma in the form of fear that you 
will be discriminated or mistreated due to your identity; and enacted stigma in the form 
of actual mistreatment, exclusion, and discrimination.(17-19) These multiple types and 
forms of stigma can negatively affect health among trans women, including HIV care and 
treatment outcomes.(15, 20-22) Multilevel responses are needed to improve HIV outcomes 
among trans women by simultaneously and synergistically addressing individual, 
provider, and community dynamics.  
3. Study Objectives 
The purpose of the proposed study is to conduct a pilot randomized trial of the 
multilevel intervention GAP, or Gender-affirming Abriendo Puertas. 
3.1 Primary Objective 
Assess preliminary efficacy of GAP on viral suppression at 12 months. 

3.2 Secondary Objectives 
Examine pathways of influence (e.g. decreased stigma, increased cohesion) and 
experiences with the intervention to identify specific areas for improvement and scale 
up. 
 
4. Study Design 
This is a randomized control trial of the GAP intervention (Gender Affirming Abriendo 
Puertas (Opening Doors)). The GAP intervention includes four components that will be 
implemented over a 12-month period: 1) individual counseling; 2) peer navigation; 3) 
provider training and 4) community building. Upon consenting to enter the study, 
participants will be randomly assigned to the intervention arm (n=60) or the control arm 
(n=60). The assessment of the GAP intervention will be guided by a mixed methods 
design, including quantitative surveys, biological assessments, and qualitative 
interviews.  
 
Both intervention and control participants will complete a baseline socio-behavioral 
survey and blood draw for viral load testing. These assessments will be repeated at 
midline (6 months) and endline (12 months). A sub-group of intervention participants 
(n=20) will be invited to participate in qualitative interviews at baseline, midline, and 
endline.  
 
Intervention participants will be assigned a navigator upon completing baseline 
assessments. Navigators will maintain monthly communication (at a minimum) with 
intervention participants during the 12-month intervention period. Intervention 
participants will be scheduled for their first individual counseling session within two 
weeks following enrollment. During the second half of the intervention period (months 
6-12), intervention participants will be invited to participate in community building 
activities hosted at two local trans organizations.   
 
Control group participants will be contacted monthly by a member of the study team to 
facilitate retention and maintain contact information. They will not receive any other 
intervention. However, if a control group member attends a community building activity 
during months 6-12, they will not be turned away.  
 
The study team will facilitate training in gender affirmative care with providers and staff 
at the HIV clinics where study participants receive care during the 12-month 
intervention period. 

 
At midline and endline, intervention staff and HIV care providers will be invited to 
participate in focus groups to document their experiences with the intervention and 
recommendations for improvement.  
5. Study Population 
5.1 Inclusion Criteria 
- Age ≥ 18 years 
- Assigned male at birth and self-identify as trans woman (using locally appropriate 
terminology) 
- HIV-positive (confirmed by rapid test) 
5.2 Exclusion Criteria 
- Participation in the GAP adaptation study  
 
5.3 Recruitment 
Peer navigators will lead recruitment through social networks, referrals, and HIV clinics. 
The target sample size is 120 participants. 
6. Intervention 
The GAP intervention includes 4 intervention components:  
1) Individual counseling and health education includes 4 sessions facilitated by a 
trained psychologist. Sessions address internalized stigma through reflective exercises, 
active listening, relaxation and stress management, information provision and, as 
needed, referrals to other services such as substance use and violence support. We also 
aim to promote key concepts from healthcare empowerment including being informed, 
committed, collaborative and engaged in healthcare. Self-esteem is a cross-cutting 
theme addressed in all sessions through critical reflection exercises.  
Each session is structured around a topical focus and guided by objectives: 
• Session 1: Gender identity and sexual health 
• Session 2: Managing life with HIV 
• Session 3: HIV care and treatment 
• Session 4: Life plan 

Each session concludes with a relaxation exercise intended to provide a set of tools for 
participants to use beyond the intervention. 
All content will be delivered with sensitivity to the lived experience of trans women. 
Within each session, the content is flexible and tailored to the needs and interests of the 
specific participant.  Screening for substance use and violence is integrated into sessions 
1 and 2 to facilitate tailoring of content and referral to appropriate services as needed. 
Participants will be asked about their engagement with the trans community to assess 
their level of connection and identify opportunities to promote engagement or address 
concerns with engagement, in preparation for the community building component of 
GAP.  
Sessions will be scheduled at one to two-week intervals to facilitate cumulative progression in 
stigma reduction and self-esteem building. Participants will have the option to do the sessions at 
IDCP or TRANSSA.  
2) Peer navigation is a strengths-based model to address both internalized and enacted 
stigma. Navigators will provide informational, instrumental, and emotional support for 
HIV-related and other life concerns through in-person and virtual (e.g. text, WhatsApp) 
interactions. Examples of activities that navigators carry out include: appointment 
reminders; accompaniment to HIV and other medical appointments; supporting 
disclosure to family, friends and partners; and referral to services as needed. Navigators 
will also work with participants to address barriers to accessing care, develop strategies 
to use their existing resources and cultivate additional resources to maintain health and 
well-being, and, when needed, advocate for their rights.  
As noted earlier, we will offer the option of having a trans or cisgender peer navigator. 
We will have a team of 3-4 navigators with approximately 15-20 intervention 
participants and 15-20 control participants assigned to each navigator. Navigators will 
be trained in HIV care and treatment and strengths-based approaches and will meet 
weekly as a team to exchange experiences and address challenges. While the actual 
intervention strategy of navigation will serve as a tool for retention with intervention 
participants, navigators will also support retention among control-group participants 
through regular check ins and reminders about study visits. As navigation can be 
initiated by either the navigator or client, there will be variation in the number of 
navigation interactions per participant. Navigators will be trained to initiate at least one 
interaction per month with each client, leading to a minimum of 12 interactions during 
the intervention period.  

3) Provider capacity building will focus on enacted stigma in HIV clinics through training 
in gender affirmative care (GAC). GAC in HIV clinics includes both social and medical 
affirmation. We will focus on both, though medical gender affirmative care is not 
currently available in the 8 HIV clinics that we will work with. We will facilitate a two-day 
participatory workshop informed by evidence-based models of GAC14 with 4-5 
participants from each clinic including providers (n=2), phlebotomist (n=1) and other 
staff who engage with trans participants (n=2). We will raise awareness, identify biases 
and misconceptions, and work with participants to develop individual and clinic-level 
plans to improve the overall quality of the clinic experience for trans women. During the 
training, each clinic will also do a self-assessment of readiness to integrate hormone 
therapy.  
Study staff will facilitate a one-day booster session to assess application of the 
workshop content. Pre and post-assessments will be conducted at both workshops to 
document changes in attitudes and practices related to GAC and participants will be 
asked to provide updates to their readiness assessment at the booster session. Study 
staff will document clinic context during site visits to contextualize study findings on 
enacted stigma in HIV clinics. As noted earlier, provider capacity building will potentially 
affect both intervention and control groups as we will train providers from clinics 
attended by control and intervention groups.  
4) Community Support Building will focus on developing trust through a series of small 
group sessions. These sessions will begin at midline. This will be done through a 
combination of structured content, participatory exercises, and social interaction. Each 
month will have a topical focus, which will be decided upon in response to feedback 
from the psychologists facilitating individual sessions, navigators, and participants 
themselves, to make the sessions highly responsive to gaps in other intervention 
components and participant interest. Expected topics include sustaining ART adherence, 
relationships, employment, and family dynamics. Sessions focused on the monthly topic 
will be repeated three times each month with the goal that each intervention arm 
participant (n=60) will attend at least one group session per month for a total of 6 
sessions during the intervention period.  
Control Arm: Standard HIV care, with potential indirect exposure to provider training. 
7. Outcome Measures 
7.1 Primary Outcome 
Viral suppression (<400 copies/mL)  

7.2 Secondary Outcomes 
HIV care and treatment outcomes: Retention in HIV care, ART adherence , ART 
interruption 
 
Mental health and wellbeing outcomes: Depression, anxiety, drug use, binge drinking, 
self-esteem 
8. Study Procedures 
Participants will complete assessments at baseline, midline, and endline. Data collection 
includes completion of a survey and blood draw for viral load measurement. Qualitative 
data collection will involve in-depth interviews with 20 participants from the 
intervention group at baseline, midline, and endline. 
9. Statistical Considerations 
To estimate the initial effects of GAP, we will use survey, viral load, and monitoring data. 
We will first examine if randomization succeeded by conducting balance tests with 
baseline data, which will also inform the specification of the effects estimation model. 
Second, we will examine loss-to-follow-up (LTF) (expected not to be >10%) and 
determine if those LTF have different characteristics of those retained and if there is any 
variation between intervention and control groups. Third, we will estimate initial effects 
of the intervention. We will first estimate the intention-to-treat (ITT) effect using linear 
probability (or logistic) model with a GAP intervention indicator as the only explanatory 
variable and using endline data only. The ITT model will be  𝑌𝑖= 𝛼0 + 𝛼1𝑃𝑖+ 𝜀𝑖 , where 
𝑌𝑖 is the outcome of individual 𝑖, 𝑃𝑖 is a dummy indicator variable for being in the 
treatment group or not, and 𝜀𝑖 is the standard error term. The coefficient 𝛼1 will be our 
ITT effect estimate. Although the GAP intervention will be randomly allocated across 
participants, it is possible that some differences in baseline characteristics and 
outcomes between the groups will be observed. To correct for those imbalances, we will 
use difference-in-differences (DID) models that include baseline covariates; the DID 
model estimates intervention effects by taking the difference between the changes 
observed in the outcome in the intervention group and the changes in the control 
group, adjusting for baseline differences. The DID model will be estimated using 
baseline, midline, and endline data and will be specified as:  𝑌𝑖𝑡= 𝛼0 + 𝛼1𝑃𝑖+ 𝛼2𝑇1𝑡+
𝛼3𝑃𝑖∗𝑇1𝑡+ 𝛼4𝑇2𝑡+ 𝛼5𝑃𝑖∗𝑇2𝑡+ 𝛼6𝑋𝑖+ 𝜀𝑖𝑡 , where 𝑌𝑖𝑡 is the outcome of individual 𝑖 
at time 𝑡, 𝑃𝑖 is an indicator variable for being in the intervention group or not, 𝑇1𝑡 is an 
indicator variable for the observation from midline, 𝑇2𝑡 is an indicator variable for the 
observation from endline, 𝑋𝑖 represents characteristics of the individual at baseline, and 
𝜀𝑖𝑡 is the standard error term. The coefficient 𝛼3 will be our DID intervention effect at 

midline, and 𝛼5 at endline. This DID model allows us to examine the evolution of the 
intervention effects over time.  
A second set of analyses will examine the effect of each component of the intervention 
on the main outcome at midline and endline. We will estimate the following model: 𝑌𝑖=
𝛼0 + 𝛼1𝑃1𝑖+ 𝛼2𝑃2𝑖+ 𝛼3𝑃3𝑖+ 𝛼4𝑋𝑖+ 𝜀𝑖  where 𝑃1𝑖 is a measure of individual 
counseling (e.g. # of counseling sessions individual 𝑖 received); 𝑃2𝑖 is a measure of 
navigation (e.g. # of interactions with individual 𝑖); and 𝑃3𝑖 is a measure of community 
support building (e.g. # of group sessions attended by individual 𝑖). We will further 
extend this model to examine if different levels of intensity of exposure have different 
effects on the outcome. We will define three levels of intensity (low, medium, high) 
depending on the number of navigation interactions to estimate the following model: 
𝑌𝑖= 𝛼0 + 𝛼1𝑃1𝑖+ 𝛼2𝑀𝑒𝑑𝑃2𝑀𝑒𝑑𝑖+ 𝛼2𝐻𝑖𝑔ℎ𝑃2𝐻𝑖𝑔ℎ𝑖+ 𝛼3𝑃3𝑖+ 𝛼4𝑋𝑖+ 𝜀𝑖  where, 
𝑃2𝑀𝑒𝑑𝑖 is a dummy variable indicating that individual 𝑖 had medium exposure to 
navigation and 𝑃2𝐻𝑖𝑔ℎ𝑖 is high intensity exposure to navigation sessions. In this model, 
𝛼2𝑀𝑒𝑑 is the effect of medium exposure to navigation on the outcome and 𝛼2𝐻𝑖𝑔ℎ is the 
effect of high exposure to navigation on the outcome. The reference category is low 
exposure. 
The minimum detectable effect for a power of 80%, a significant level of 5%, and a 
50/50 split of the 120 individuals in the sample between the treatment and control 
group is of +13.3 percentage points, assuming an expected loss to follow up of 10%, and 
expected baseline prevalence of viral suppression to be 64%.  
 
10. Data Management and Monitoring 
Confidentiality of all study participants will be strictly maintained across all study 
activities. Interviewers, intervention staff, lab staff, support services staff, and all other 
relevant project staff will be trained on procedures for maintaining confidentiality. 
Interviewers assigned to conduct the survey assessments and qualitative interviews and 
focus groups will be hired by IDCP, which has a longstanding history of conducting 
confidential and respectful HIV-related research activities with key populations. All 
study data, laboratory specimens, and forms will be identified by a coded participant ID 
number only, to maintain participant confidentiality.  
 
After study completion, identifying information for participants not required for analysis 
will be destroyed. Forms, lists, logbooks, appointment books, and any other listings that 
link participant ID numbers to other identifying information will be stored on a secure, 
password protected computer in a locked study office at IDCP in the DR, in an area 
accessible only to authorized study personnel. 

11. Ethical Considerations 
This study does not raise major safety concerns. However, we will continually monitor 
wellbeing of both intervention and control group participants. Safety analyses will be 
included as part of the regular reports to the safety team, composed of all of the key 
investigators and chaired by the study PI. The safety team will review all social harms 
reported at their monthly meetings. However, the PI will review the reports in real-time, 
and should any worrisome pattern or serious harm occur to a study participant as a 
result of their participation, she will call an ad hoc meeting of the safety team. We will 
query specifically for known social harms, including stigma, rejection by family and 
friends, or other adverse events. Intervention participants will meet with study 
counselors during the first part of the study and will have continuous contact with peer 
navigators. These interactions will permit monitoring of overall health and wellbeing. 
Control group participants will be contacted on a monthly basis by a study team 
member.  
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