Preliminary Outcomes from PrEP Well: A Community-led, Multicomponent HIV Prevention Strategy Implemented in a Transgender Community Health Center

Abstract

Transgender and nonbinary (TGNB) individuals are disproportionately impacted by HIV, particularly those who identify as racial/ethnic minorities and those who are socioeconomically disadvantaged. Pre-exposure prophylaxis (PrEP) is a highly effective medication to prevent HIV infection, but many TGNB individuals encounter barriers to PrEP uptake and adherence that limit fully realized preventive benefits. We developed PrEP Well, a multicomponent community-led program, to scale and sustain comprehensive PrEP services from a TGNB-led community organization that provides gender-affirming healthcare and social services. We used implementation science frameworks to evaluate initial program outcomes and contextual influences on program implementation. Preliminary data from August 2022 through January 2024 showed promising implementation and effectiveness outcomes. During that time, 113 primarily low-resourced TGNB clients were educated about PrEP and received an HIV test, of whom 60 (53%) attended a visit with a provider and received a PrEP prescription. At 30-day follow-up, urinalysis confirmed uptake of PrEP among 50 (83%) of the clients prescribed PrEP. At 90-day follow-up, 43 (72%) demonstrated continued use of PrEP and 40 (67%) showed protective levels of PrEP adherence. Qualitative interviews and surveys indicated that clients, staff, and leadership viewed the PrEP Well program as highly acceptable, feasible, and sustainable (including willingness to address persistent implementation barriers). Referral patterns and rates of PrEP uptake suggested increasing integration of PrEP Well into the TGNB community center over time. The PrEP Well program demonstrates the potential for TGNB communities to address HIV inequities by integrating community-led HIV prevention services with gender-affirming healthcare in TGNB-specific health centers.

Introduction

Despite facing disproportionately high HIV prevalence, transgender and nonbinary (TGNB) communities in the U.S. have consistently fostered an ethos of mutual support and inclusivity while continuing to advocate for access to affirming healthcare [1–4]. Racial and ethnic minority and socioeconomically disadvantaged TGNB persons encounter an especially high burden, with HIV prevalence of 24–52% in some jurisdictions [1, 2]. This highlights the urgent need for inclusive public health responses. The HIV burden is compounded by socio-structural challenges such as intersectional stigma, discrimination, exposure to violence, and systemic barriers including poverty, unemployment, and lack of access to affirming educational and healthcare resources, all of which profoundly affect TGNB communities [5–11]. These multifaceted factors not only contribute to higher HIV prevalence but also create significant barriers to engagement in HIV prevention efforts [12–14]. To address these issues, prior work has emphasized the importance of ethical, community-engaged practices that avoid further alienating or re-traumatizing TGNB community members [15].

Pre-exposure prophylaxis (PrEP) medication has proven to be a highly effective method for preventing HIV infection when adhered to as prescribed [16–21]. The Centers for Disease Control and Prevention’s Ending the HIV Epidemic initiative [22] underscores the critical role of PrEP use among individuals at elevated risk for HIV, including TGNB individuals [23, 24]. Despite this, PrEP uptake remains markedly low in TGNB communities [25–29]. This is in part due to the multiple steps required to move along the PrEP care continuum, including initial outreach and education to increase knowledge and acceptability, HIV and lab testing to assess eligibility, provider visits and prescriptions, pharmacy fill, uptake of medication, and maintenance on the regimen including routine STI testing [30, 31]. For TGNB persons who have initiated PrEP, challenges with maintaining consistent, long-term adherence are also significant [25–27, 32]. This is largely due to the same socio-structural and systemic challenges mentioned above, challenges that are particularly notable for trans women of color [33–35]. Research indicates similar barriers among trans men, highlighting that although many transmasculine individuals meet the eligibility criteria for PrEP, access to and utilization of these services remain limited [34, 36–38]. These findings underscore the urgent need for multicomponent community-led PrEP interventions that effectively address the myriad barriers to PrEP uptake and persistence within these communities.

In response, our TGNB community-academic partnership developed and implemented PrEP Well—an ongoing community-led, multicomponent PrEP strategy designed to support the implementation and sustainment of community-led, trans-affirming PrEP services—in a TGNB community-led health and wellness center in Los Angeles called the Trans Wellness Center (TWC). Implementation is the adoption and integration of an evidence-based practice, in this case comprehensive PrEP services, into routine clinical and/or social services [39]. Sustainment is the ongoing delivery of that evidence-based practice over time [40].

Central to PrEP Well is a partnership between the clients, staff, and Trans Community Advisory Board (TCAB) of the TWC; staff of our implementing partners, the Los Angeles LGBT Center (“the Center”); and a team of community-engaged academic researchers. The initial conceptualization for PrEP Well came from TWC staff, community members, and implementing partners at the Center, who proposed a partnership to the academic researchers based on formative work previously completed together, investigating the barriers to PrEP uptake among the local TGNB community [32, 37, 41]. During the initial proposal generation phase, it became increasingly evident that the key to breaking down barriers to accessing HIV prevention services was to bring as many of the necessary PrEP services onsite to TWC as possible, rather than referring TWC clients out to another setting for PrEP. However, because TWC had limited clinical services and no onsite pharmacy, flexibility was required in terms of initial scheduling of appointments for PrEP visits, laboratory testing, and pharmacy services off-site. The primary goal of PrEP Well was to increase access to affordable, affirming, and comprehensive PrEP services that celebrate sexual health as part of whole-person TGNB health and wellness. This approach, with the aim of eventually bringing PrEP services to scale onsite at TWC as part of a “one-stop shop” model—or a healthcare approach that provides multiple medical and social support services in a single location, aiming to improve patient convenience, care coordination, and health outcomes—would then serve as a potential blueprint for overcoming barriers to implementing a one-stop shop model with key populations in other priority jurisdictions of the United States.

This paper provides an overview of the PrEP Well implementation and sustainment strategies that we selected as well as the implementation and clinical outcomes observed throughout the implementation process. The current study addressed four research questions: (1) Was it feasible to implement and sustain trans-led HIV testing and PrEP services in a TGNB community-led health and wellness center? (2) What were the contextual influences of implementing a one-stop shop model of HIV testing and PrEP services in a TGNB community-led health and wellness center? (3) What implementation strategies were used to support the implementation and sustainment of trans-led HIV testing and PrEP services? and (4) How acceptable were trans-led HIV testing and PrEP services to the staff and clients of the TGNB community-led health and wellness center?

Methods

Study Design

The PrEP Well pilot utilized a single-group, longitudinal observational study design. This design was selected based on community preferences for making the program available to all clients of the community center who met eligibility criteria for PrEP. The community is well connected, and community members shared that it was likely that clients receiving different versions of the program would become aware of these differences, which might cause distress, feelings of inequity, or reduce the ability to detect differences between conditions. Our team then selected two implementation science frameworks. First, the Exploration, Preparation, Implementation, Sustainment (EPIS) process framework [42–45] guided our implementation process, including our selection of implementation strategies through an iterative process of collecting community, staff, and participant feedback through regular meetings and rapid qualitative analysis of interviews [46–50], and tailoring implementation strategies [51] to a dynamic TGNB community health center context. EPIS also includes four domains that helped us characterize multilevel determinants influencing implementation to inform our strategy selection, such as characteristics of the intervention (e.g., safety labs and STI testing required for PrEP provision), intra-organizational context (e.g., provider training and knowledge about PrEP, physical space, other services provided), extra-organizational context (e.g., pharmacy/medical board regulations, client needs and experiences in local communities), and bridging factors that span and connect the intra- and extra-organizational contexts (e.g., academic-community partnership that developed and secured funding for PrEP, Federally Qualified Health Center [FQHC] “in scope” designation for the TGNB community center).

Second, for the evaluation of key PrEP Well implementation and effectiveness outcomes, we used the RE-AIM framework [52] to comprehensively assess impacts on Reach (proportion of the eligible population participating in the intervention), Effectiveness (impact of intervention on outcomes), Adoption (proportion of staff willing to facilitate intervention), Implementation (extent to which intervention is consistently delivered as intended), and Maintenance (extent to which intervention becomes part of ongoing routine practice) [52]. Figure 1 presents our implementation logic model, which outlines the determinants (across EPIS domains), implementation strategies (across EPIS phases), intervention components, and outcomes (using RE-AIM domains).

Fig. 1.

PrEP Well Implementation logic model

Study Setting

The TWC is a TGNB-led community center offering social and health services to the TGNB community. The TWC opened in April 2018 with the express goal of reducing structural and other barriers to accessing trans healthcare and social services. The creation of a welcoming, safe, dedicated, and affirming physical space was the culmination of a decade of collaboration between the Los Angeles Department of Public Health and numerous TGNB-led community-based organizations and community activists in Los Angeles. The TWC currently provides services and resources specifically for the TGNB community, including housing, workforce development, financial literacy, economic empowerment, legal services, self-defense classes, clothing and meals, gender-affirming hormone therapy, mental health services, and primary care medical services. The provision of services at TWC is overseen by the TCAB, which meets monthly to review current programming, provide feedback, and discuss new proposals and initiatives for TWC. The community-driven and informed model of service provision is empowering to TGNB clients and ensures that healthcare and social service providers prioritize client-centered care.

PrEP Well Implementation Process

During the preparation phase, our team sought input through multiple meetings and interviews with TWC clients, the TCAB, TWC staff, leadership, and medical providers from the Center. We solicited feedback through semi-structured interviews with representatives from each group to inform the selection of initial strategies and the implementation process; the results of these interviews were previously published [53]. Two primary implementation strategies were identified: (1) a one-stop shop model, where all steps in the PrEP care continuum (e.g., HIV testing, medical visits, lab testing, and pharmacy) would be provided onsite at the TWC, and (2) having a bilingual, TGNB-identified PrEP coordinator onsite to help promote, educate, and navigate community members along the PrEP care continuum. We identified three additional community-centered implementation strategies from our meetings and interviews, which included (3) developing TGNB-specific PrEP Well educational materials offered in both English and Spanish, (4) providing transportation vouchers and additional economic incentives, and (5) conducting community outreach through both online and at local events [53]. Together, these priorities then became the overarching strategies for the PrEP Well program.

Implementation, defined as actively delivering PrEP Well services at TWC, was divided into two, 6-month phases. During Phase I, PrEP outreach and education, HIV testing, and navigation (benefits enrollment, appointment scheduling) were offered in both English and Spanish at TWC. Due to limited clinical capacity, wherein providers were onsite to prescribe PrEP only one day a week, clients were then linked via telehealth for a virtual appointment and provided with rideshare vouchers for laboratory appointments and pharmacy services, which were offered at either the Center (~5 miles away from the TWC) or with the providers of the clients’ choosing. During Phase 2, all Phase I activities continued, and in addition, providers began offering PrEP visits onsite at TWC two days per week. Additional lab and visit room space was also acquired onsite at TWC during Phase II, increasing capacity and ability to collect labs onsite. During Phase II, PrEP prescriptions began to be filled at a local pharmacy (~1 block from TWC), eliminating the need to travel via rideshare to another clinic location. After the two 6-month implementation phases concluded, we transitioned into Phase III, a sustainment phase focused on maintaining PrEP Well at TWC. During Phase III, all activities from Phase I and Phase II continued, and onsite prescribing of PrEP increased to five days per week. Data collected during the first 6 months of the sustainment period are also presented in this paper. Dividing implementation and sustainment across three phases allows us to compare differences in PrEP outcomes across the phases of implementation, as we selected alternate strategies and moved closer to the one-stop shop model.

PrEP Well Program and Study Procedures

Figure 2 presents a flow diagram that details the schedule of services and research visits offered to each PrEP Well participant. The diagram outlines a comprehensive ordering of PrE-related services offered as part of the PrEP Well program. These services include peer outreach and PrEP education, HIV testing, peer navigation (benefits enrollment, appointment scheduling), medical appointment with a provider where PrEP is prescribed, pharmacy fill and pick-up, a 30-day return visit with PrEP Well coordinator to assess PrEP uptake and provide adherence support, and a 90-day return visit with PrEP Well coordinator to assess continued PrEP use and provide additional adherence support. TWC clients who were educated about PrEP and the PrEP Well program and expressed interest in participating were first tested for HIV. Those who tested negative and were determined to be eligible were informed that study participation was voluntary and that their participation would have no impact on their ability to access PrEP and/or any other services at TWC. Clients who consented to participate in the study were then enrolled and sociodemographic data were collected by the study coordinator and entered into a baseline Qualtrics survey. Additional data was collected by the study coordinator via follow-up Qualtrics surveys at 30- and 90-day visits to track progress, collect feedback on the program, and document any barriers/facilitators that came up along the way. Twenty-five participants, who were demographically diverse and characterized as being along a continuum of engagement with the PrEP Well program, were also invited to participate in semi-structured interviews to gain a deeper understanding of experiences and suggestions for improvement of the PrEP Well program.

Fig. 2.

PrEP Well program flow diagram

Monitoring and the Need for Alternate Implementation Strategies

The community-academic project team monitored PrEP Well implementation processes and responded to obstacles and opportunities continuously throughout the implementation phase. The team met regularly with organizational leadership, the TCAB, and staff at TWC and the Center to keep all team members apprised of PrEP Well implementation and to discuss specific implementation strategies. If a strategy was not demonstrating benefits or unexpected barriers arose, the team was able to incorporate additional strategies as needed, with real-time input from community partners and participants. For example, we continually assessed the most feasible ways to connect clients to PrEP under extant conditions (e.g., local COVID-19 infection levels during the pandemic, TWC capacity for on-site services) and updated those strategies as conditions changed over time.

Implementation and Effectiveness Outcome Measures

Table 1 provides study outcome measures, data sources, and collection timepoints. The outcome variables reflect the five RE-AIM outcome domains [52].

Table 1.

RE-AIM domains, measures, and data sources

RE-AIM Domain	Measure	Data source	Assessment timepoint
Reach	Proportion of TGNB clients who receive outreach and education, HIV testing, start PrEP and are maintained on PrEP out of the total number of eligible clients at Trans Wellness Center	Qualtrics survey and TWC electronic medical records	Baseline, 30-day follow up, 90-day follow up
	Representativeness of PrEP Well participants’ sociodemographic characteristics (age, race, ethnicity, education level, and relationship status) as compared to eligible clients at Trans Wellness Center	Qualtrics survey and TWC electronic medical records	Baseline
Effectiveness	Number of TGNB clients who received all the following services: peer outreach, HIV testing, and peer navigation (benefits enrollment if needed, PrEP visit scheduled)	Qualtrics survey	Baseline
	Number of TGNB clients attended PrEP visit with provider, labs provided, and PrEP prescription written	TWC electronic medical records	30-day follow up
	Number of TGNB clients demonstrating biologically confirmed PrEP uptake at 30-day follow-up visit	UrSure test*	30-day follow up
	Number of TGNB clients that return for 90-day follow-up visit demonstrating biologically confirmed PrEP uptake.	UrSure test*	90-day follow up
	Number of TGNB clients return for 90-day follow-up visit demonstrating biologically confirmed PrEP uptake.	UrSure test*, DBS**	90-day follow up
Adoption	Proportion of staff members who were willing to refer clients to the PrEP Well program coordinator.	Qualtrics Provider/staff survey	September 2024
Implementation	Training and support provided to PrEP Well coordinator and other TWC staff	Implementation log	April – August 2022
	Acceptability, appropriateness, fit, and feasibility of the PrEP Well intervention among staff	Qualtrics Provider/staff survey	September 2024
	Acceptability, appropriateness of the PrEP Well intervention among clients	Participant exit interviews	90-day follow up
Maintenance	The degree to which PrEP Well continues to be delivered	Qualtrics survey, TWC electronic medical records	Baseline, 30-day follow up, 90-day follow up
	The degree to which the effects of PrEP Well continue to be sustained over time	UrSure test*, DBS**	30-day follow up, 90-day follow up

^*PrEP uptake and persistence was verified via UrSure SureQuick^® test, a rapid diagnostic tool used to detect the presence of Tenofovir Diphosphate (TFV-DP) in urine, providing quick and reliable results that confirm PrEP has been taken. Participants verified to be on long-acting injectable cabotegravir were classified to be on PrEP if their PrEP Well visit was within 60-days of their last injection

^**PrEP Adherence was verified via a Dried Blood Spot (DBS) test, a laboratory method used for the quantitative assessment of long-term levels of Tenofovir Diphosphate (TFV-DP) in the blood, helping to monitor and confirm adherence to PrEP medications such as Descovy^® or Truvada^®. DBS levels consistent with 4 or more doses/week were considered adherent. Participants verified to be on long-acting injectable cabotegravir were classified as adherent to PrEP if their PrEP Well visit was within 60-days of their last injection

Reach refers to the extent to which program or intervention is reaching its target population, including whether the receipients are representative of the broader population. We defined reach as the proportion and representativeness of PrEP Well clients as compared to TWC clients. To assess overall reach, we measured the number of TWC clients enrolled in PrEP Well compared to the number of TWC clients who accessed services at TWC during the 6 months prior to implementation of PrEP Well. To assess the representativeness of participants, we examined the sociodemographic characteristics of PrEP Well participants including age, race, ethnicity, education level, and relationship status (collected from all participants at enrollment), as compared to the overall TWC client sociodemographic characteristics (as recorded in the TWC client database).

Effectiveness refers to the impact of a program or intervention on important health-related outcomes. We defined effectiveness as receipt of services along the PrEP care continuum [30] including PrEP education, HIV testing, starting PrEP, and adherence to PrEP at adequate levels to protect against HIV infection. These were measured from the total number of participants who received peer outreach, HIV testing, and peer navigation; the number of participants who attended a PrEP visit with a provider; the number of 30-day follow-up visits where PrEP uptake was biologically confirmed; and the proportion of participants demonstrating uptake who remained on PrEP at 90-day follow-up and were biologically confirmed to be at protective levels of adherence (i.e., consistent with four or more doses taken per week). Adherence was confirmed either via dried blood spot assay for daily oral PrEP or by electronic medical record verification that the client had received long-acting injectable cabotegravir PrEP within the past 60 days.

Adoption refers to the proportion of staff who start engaging with a program or intervention as part of routine practice. Adoption of PrEP Well was measured as the extent to which the TWC staff were willing to routinely refer clients to the PrEP Well program as indicated by anonymous provider and staff surveys using a 5-point Likert-type scale.

Implementation refers to the extent to which a program or intervention is delivered as intended. Implementation was assessed by factors such as the availability of resources to support PrEP Well, such as the training and support provided to PrEP Well project staff, which was routinely recorded in a program implementation log. Implementation was also assessed by provider and staff surveys, which measured overall acceptability, feasibility, and the perceived fit of PrEP Well within the existing practices and workflows of TWC. We also assessed the perceived acceptability and appropriateness of the PrEP Well intervention for PrEP Well participants through exit interviews; we asked participants to rate the quality of information they received from PrEP Well, the perceived usefulness, their overall satisfaction, their comfort participating, and the cultural sensitivity of PrEP Well on a 5-point Likert-type scale.

Maintenance refers to the long-term sustainability of a program or intervention. Maintenance was measured by evaluating the extent to which PrEP Well has continued to be delivered beyond the initial grant funding period, the degree to which it continues to be delivered (i.e., PrEP Well enrollment), and the degree to which the effects of PrEP Well (e.g., rates of HIV testing, PrEP visit attendance, PrEP uptake, and adherence) continue to be sustained over time.

Data Analysis

We used descriptive statistics to summarize the demographic characteristics of the sample, including age, gender identity, race/ethnicity, and relationship status. To test for associations between demographic factors and PrEP Well outcomes (e.g., HIV testing, PrEP visits, PrEP uptake, persistence, and adherence) across the implementation and maintenance phases, we conducted bivariate analyses using chi-square tests for categorical variables and t-tests for continuous variables. All analyses were conducted using IBM SPSS Statistics (version 27.0) [54]. The significance level was set at p <.05 to assess statistical significance.

Pre-implementation interviews were analyzed using the Rigorous and Accelerated Data Reduction “RADaR” technique, which has been used in implementation science where findings must inform implementation decisions in a timely manner, including research that has informed scale-up of PrEP-related interventions [46, 55–59]. In this process, researchers wrote reflective memos immediately following data collection on preliminary ideas, patterns, and analyses. These were presented weekly to the rest of the research team as well as to the TCAB to inform planning for program implementation [55, 60–62]. Following presentation of the preliminary memos, segments of the transcripts were organized into a table by interview guide topic, which was then further synthesized to include key segments from the transcript text. These were compared to ensure consistency and resolve any discrepancies [59]. The key ideas in this table were identified, and themes were discussed and confirmed with the TGNB community members and TGNB-serving providers.

Post-implementation interviews were analyzed using conventional content analysis methods [63–66]. In this process, researchers read through and open-coded a subset of transcripts and developed an initial codebook. This codebook was iteratively tested and revised through double coding of the same transcripts by two researchers until they reached an inter-rater reliability Kappa ≥ .80. After that, the two researchers independently coded the remaining transcripts [67, 68]. Once all transcripts were coded, the study team identified key themes around the positive experiences, negative experiences, and strategies for intervention improvement through group discussions about coding patterns [65, 69, 70]. All data analysis was performed using the computer-assisted qualitative data analysis software NVivo [71].

Results

Reach

During the 6-month pre-implementation period, 662 TGNB clients visited TWC for services. Most clients were socioeconomically disadvantaged, with 254 (38.4%) seeking housing services through TWC. We estimated that approximately one-third (n = 220) of TWC clients would be eligible for PrEP during any 6-month period. However, during the 6-month period pre-implementation (February 2022 – July 2022), use of PrEP by TWC clients was low with only 18 clients prescribed PrEP across all gender identity, age, and race/ethnicity groups. During the first 6 months of the implementation phase (August 2022 – January 2023), 27 TWC clients received PrEP education, HIV testing, and navigation, and 13 were linked to a PrEP visit. During the second 6 months of the implementation phase (February 2023 – July 2023), 36 TWC clients received PrEP education, HIV testing, and navigation, and 18 were linked to a PrEP visit. Finally, during the initial 6 months of the sustainment phase (August 2023 – January 2024), 50 TWC clients received PrEP education, HIV testing, and navigation, and 29 were linked to a PrEP visit.

Table 2 presents the demographic breakdown of PrEP Well participants enrolled from 8/1/22 through 1/31/24 compared to the demographics of all TWC clients during the 6-month period pre-implementation. The demographics that we could directly compare (age, gender, race/ethnicity) did not significantly differ between PrEP Well participants and TWC clients. This suggests that the reach of the PrEP Well program accurately reflects the age, racial, ethnic, and gender diversity of TWC clients.

Table 2.

Sociodemographic characteristics of TWC clients and PrEP Well participants

Sociodemographic variable	Trans Wellness Center clients*	PrEP Well participants	Statistic, p-value
	N = 662	N = 113
	N (%)	N (%)
Age, mean (SD)	29.8 (10.7)	29.8 (9.6)	t = 1, p = 1
Gender identity			X2(2) = 3.38, p >.10
Trans female or feminine	467 (70.5)	73 (64.6)
Trans male or masculine	104 (15.7)	17 (15.0)
Nonbinary/genderqueer/other	91 (13.7)	23 (20.4)
Race/ethnicity			X2(5) = 8.75, p >.10
Native American or	5 (0.8)	3 (2.7)
Alaska Native
Black or African American	110 (16.6)	16 (14.2)
Asian/Pacific Islander	29 (4.4)	8 (7.1)
White	123 (18.6)	14 (12.4)
Hispanic or Latinx	315 (47.6)	55 (48.7)
Multiracial/other	60 (9.1)	9 (8.0)
Assigned sex at birth			Unable to calculate
Male	–	89 (78.8)
Female	–	22 (19.5)
Intersex	–	2 (1.8)
Sexual orientation			Unable to calculate
Gay or lesbian	–	6 (5.3)
Bisexual/pansexual	–	32 (28.3)
Straight	–	50 (44.3)
Queer/questioning/other	–	25 (22.1)
Highest level of education			Unable to calculate
Some high school	–	8 (7.1)
High school/GED	–	49 (43.4)
Associate’s, technical degree, or some college	–	29 (25.7)
College graduate	–	22 (19.5)
More than bachelor’s degree	–	5 (4.4)
Relationship status			Unable to calculate
Single	–	72 (63.7)
In relationship	–	41 (30.7)

^*Sociodemographic data of unique clients who visited TWC for services during 6-month period prior to PrEP Well Implementation

Effectiveness

Table 3 provides the participant-level outcomes used to evaluate the effectiveness of the PrEP Well program, by implementation phase. During that time, 113 TWC clients were educated about PrEP, received an HIV test, and were provided navigation, of whom 60 (53.1%) attended a visit with a PrEP provider and received a PrEP prescription. At 30-day follow-up, point-of-care urinalysis confirmed uptake of PrEP among 50 (83.3%) of the clients prescribed PrEP. At 90-day follow-up, 44 (73.3%) demonstrated continued use of PrEP via point-of-care urinalysis, with 40 (66.7%) showing protective levels of PrEP adherence. Importantly, the clinical benefits seen at 90-day follow-up improved from the first 6-months of implementation (Phase I) to the second 6-months of implementation (Phase II) of implementation, with sustained PrEP use increasing from 46.2 to 100% via urinalysis (X²(1) = 9.75, p <.001) and PrEP adherence increasing from 46.2 to 83.3% via dried blood spot assay (X²(1) = 4.70, p <.05). During Phase II, implementation strategies were modified to move closer to a one-stop shop model of PrEP care at TWC.

Table 3.

Stage of PrEP use continuum reached by PrEP Well participants across each phase

Participant-level Efficacy Outcomes	All Phases 8/1/22 – 1/31/24	Implementation Phase I 8/1/22 – 1/31/23	Implementation Phase II 2/1/23 – 7/31/23	Sustainment Phase III 8/1/23 – 1/31/24	X2 statistic, p-value
	n (%)	n (%)	n (%)	n (%)
Received peer outreach, HIV testing, and peer navigation (baseline visit).	N = 113	n = 27	n = 36	n = 50
Attended PrEP visit with provider, labs provided, and PrEP prescription written	60 (53.1)	13 (48.2)	18 (50.0)	29 (58.0)	X2(2) = 0.88, p =.64
Returned for 30-day visit and urinalysis showed PrEP uptake	50 (83.3)	10 (76.9)	15 (83.3)	25 (86.2)	X2(2) = 0.55, p =.76
Returned for 90-day visit and urinalysis showed sustained PrEP use	44 (73.3)	6 (46.2)*	18 (100.0)+*	20 (70.0)	X2(2) = 11.73, p <.01
Returned for 90-day visit and dried blood spots showed PrEP adherence	40 (66.7)	6 (46.2)**	15 (83.3)**	19 (65.5)	X2(2) = 4.74, p <.05

Note: Rates of clients who demonstrated PrEP uptake, sustained use, and adherence are compared against the number of clients who attended PrEP visit and received a PrEP prescription (denominator)

⁺3 clients missed their 30-day return visits but returned for 90-day visit and demonstrated PrEP uptake

^*Phase I and Phase II post hoc tests were significantly different at 90-day visit for sustained PrEP use via urinalysis X²(1) = 9.75, p <.001

^**Phase I and Phase II post hoc tests were significantly different at 90-day visit for PrEP adherence use via dried blood spot assay X²(1) = 4.70, p <.05

Adoption

All staff who responded to the survey (n = 11) supported the PrEP Well program at the TWC, actively promoting the program and referring clients (Fig. 3). On survey items about the acceptability and feasibility of the PrEP Well program, 11 (100%) indicated that they refer clients to PrEP Well services as much as possible when appropriate to a great or very great extent. When asked about referring clients to PrEP Well under a variety of circumstances, 11 (100%) said they do to a great or very great extent. Finally, 11 (100%) indicated that they consider referring clients to PrEP Well services a routine part of their activities to a great or very great extent.

Fig. 3.

Adoption of the PrEP Well program among TWC staff (N = 11) measured through survey responses about client referrals

Implementation

The PrEP Well program implementation activities spanned the EPIS preparation phase and the two 6-month implementation phases, during which strategies were explicitly selected and applied in response to key contextual barriers as they arose. These decisions were systematically documented in an implementation log throughout the study, as detailed below by EPIS phase:

Preparation Phase

During the preparation phase, several key activities laid the groundwork for the implementation of the PrEP Well program, including obtaining Federally Qualified Health Center (FQHC) designation [72], developing program support materials, workflow and logistics planning, hiring a PrEP Well coordinator/study coordinator, and providing training. First, the implementing partner organization (the Center), which is the administrative lead agency for TWC, worked to extend its FQHC designation to TWC, setting the stage for the gradual onboarding of select medical services on-site, enabling services such as gender-affirming care, expanded primary care, and eventually, PrEP prescribing onsite at TWC.

Second, the PrEP Well team identified and contracted with a local TGNB-identified artist to design PrEP Well advertisements and flyers (see Supplemental Materials for flyer examples), addressing the need for culturally relevant promotional materials. Third, incorporation of PrEP Well into the organizational framework of TWC was achieved through multiple meetings with TWC staff and leadership. Workflows and logistics were developed to support staff engagement, client referral, and the allocation of space for PrEP Well visits. Finally, a dedicated TGNB-identified PrEP Well coordinator was hired and worked iteratively with TWC staff, through shadowing and consultation, to create a seamless integration of PrEP Well into the TWC setting. TWC staff trained the coordinator on PrEP benefits enrollment, client navigation, use of the electronic medical record system for scheduling, and referral resources for other social services. The coordinator also received human subjects training and completed an HIV testing certification course. To establish credibility, the PrEP Well coordinator was fully incorporated into the TWC staff and team. This integration required the coordinator to take on multiple responsibilities beyond their primary role, including covering for other staff, assisting during understaffed periods, participating in staff meetings, and fulfilling various roles within TWC as needed. This comprehensive involvement ensured the coordinator became an integral part of the TWC ecosystem.

Implementation Phase I

The first 6-month implementation phase focused on launching the program and establishing its presence within TWC. While the overarching goal for PrEP Well was to establish a one-stop shop approach for PrEP services, the team initially faced challenges due to resource and funding limitations at TWC. These included limited capacity for clinical services (e.g., laboratory services, PrEP provider visits) onsite at TWC. These obstacles were exacerbated by service interruptions caused by the COVID-19 pandemic. To address this, the team developed multiple pathways for PrEP Well engagement, including arranging rideshare vouchers to nearby providers, setting up telehealth visits, and utilizing community laboratory and pharmacy services.

The PrEP Well program was advertised through various channels, including flyers at TWC, social media, and outreach at TGNB community events and spaces (e.g., Los Angeles Trans Pride festival, the Center’s Youth Center programs). Clients were also referred directly by TWC staff or through the Center’s providers. For potentially interested TGNB community members, the PrEP Well coordinator reached out to educate them about PrEP, offered an HIV test, and if HIV-negative, discussed whether PrEP might be right for them (if HIV-positive, they were linked immediately to HIV care). The PrEP Well coordinator then assisted those who were interested with PrEP benefits enrollment and scheduled them for an appointment with a PrEP provider at either the Center or with a provider of their choosing.

Implementation Phase II

The second implementation phase focused on expanding services onsite at TWC, refining PrEP Well processes, and providing additional economic support in response to community feedback, to further enhance participant engagement and program effectiveness. TWC staff and clients continued to advocate for a one-stop shop model, prompting ongoing modifications to the workflow as primary care capacity gradually increased from 1 to 5 onsite days at TWC per week. An onsite laboratory was built out through additional service grants, further enhancing TWC’s capacity. This expansion allowed for more on-site PrEP services, moving closer to the initially envisioned one-stop shop model.

Throughout both implementation phases, the team adapted to contextual factors such as funding constraints and evolving organizational capabilities by identifying alternative approaches and resources. The PrEP Well team worked collaboratively, centering community input and continuing to address challenges by selecting appropriate strategies. Especially impactful, additional behavioral economic incentives were introduced during Phase II, in response to community feedback, further enhancing participant engagement and program effectiveness.

At the end of the implementation phases, PrEP Well’s acceptability and feasibility were assessed by TWC providers and staff through a survey. All 11 of the providers and staff members (100%) surveyed agreed or completely agreed that PrEP Well met their approval, was appealing, and that they liked and welcomed the program. Everyone agreed or completely agreed that PrEP Well seemed fitting, suitable, and applicable, and a good match for the TWC. All providers and staff agreed or completely agreed that PrEP Well seemed doable, possible, and implementable at the TWC. Nine (82%) of the participants agreed or completely agreed that PrEP Well seemed easy to implement at the TWC.

TWC clients also described PrEP Well as highly acceptable and appropriate in exit interviews and surveys. Of the 25 PrEP Well participants who completed exit surveys, all 25 (100%) agreed or completely agreed that the quality of information they received from PrEP Well was accurate, valuable, and easy to comprehend. All 25 (100%) agreed or completely agreed that the PrEP Well program was useful, 23 (92%) agreed or completely agreed that they were satisfied overall with the services offered as part of PrEP Well, 24 (96%) agreed or completely agreed that they felt comfortable participating, and 22 (88%) agreed or completely agreed that the PrEP Well program was sensitive to the needs of TWC clients. Example quotes from participant exit interviews include the following:

“I think it’s a good program, it’s actually very helpful and informative; and basically it’s-it helped me and I also had fun doing it.”

Latinx, nonbinary client in their 20s.

“I think just knowing that someone cares to find [PrEP for me] made a big difference. It’s what drew me to the program to begin with. And then, I also think just the environment here. Just keep doing what you guys are doing, and it’ll be good. People will want to be here. The environment is really… comforting. It’s welcoming. So that’s a big part of it…Just knowing where you’re going to be is safe while you’re waiting for your appointment, that matters a lot, especially since it’s something we have to think about on a daily basis.”

Multiracial, nonbinary client in their 20s.

“[PrEP Well] is also good because it helps to buy food or something you need, clothes or pay for something, the telephone.”

Black, trans female client in their 20s.

“[The program coordinator] speaks Spanish too, and I speak only Spanish, you understand it, you convey it to me that way, and you break down the information that I want to hear. So, it’s very good to have that understanding with-you in this case.”

Latinx, trans female client in their 30s.

Maintenance

The Sustainment column of Table 3 illustrates the degree to which PrEP Well continued to be delivered, and clinical outcomes were maintained over time as we moved closer to the one-stop shop model of PrEP delivery. The number of TWC clients receiving PrEP education and HIV testing (n = 50) and the proportion of those attending PrEP medical visits (n = 29, 58%) increased in number during the sustainment phase III. The proportion demonstrating PrEP uptake at their 30-day follow up visit during phase III (n = 25, 86%) was similar to that observed at the 30-day follow up visit during implementation phase II (n = 15, 83%). The proportion sustained on PrEP at 90-days during phase III (n = 20, 70%), and the proportion shown to be adherent to PrEP at 90 days during phase III (n = 19, 66%) dropped slightly from implementation phase II, however, this change was not statistically significant.

The maintenance phase of the PrEP Well program underscores its long-term sustainability and continued impact. The program has successfully transcended the initial grant funding period, bolstered by additional grants and the continued commitment of the community and staff to sustaining the program. Additional service grants have facilitated the expansion of physical space, including a new lab space. During the EPIS sustainment phase, primary care continued to be offered onsite five days per week, maintaining the operational capacity for PrEP appointments at TWC. PrEP prescriptions were either filled at the Center’s pharmacy and picked up or mailed to clients, or prescriptions were sent across the street to a local pharmacy for convenient pickup. Efforts to enable onsite dispensation of PrEP starter packs onsite continued. Despite Board of Pharmacy restrictions regarding an onsite dispensary and dispensation of PrEP starter packs, the program continues to move closer to full realization of the one-stop shop model. As of the writing of this manuscript, the PrEP Well program has been sustained for a total of 30 months, 18 months longer than originally planned.

Discussion

Our evaluation of the PrEP Well program reveals several key findings that underlie the successful implementation and potential for sustaining this community-led, multicomponent HIV-prevention strategy. The program’s reach and effectiveness were demonstrated by the continued increases in engagement along the PrEP care continuum, during the implementation and sustainment phases of the project, among clients that reflect the sociodemographic diversity of the TWC community. Consistent with recommendations from prior PrEP implementation projects with TGNB communities [73], several strategies were shown to be helpful in increasing the reach of the PrEP Well program, such as staff trainings on PrEP Well to support client referral. The PrEP Well team cohosted community events (e.g., holiday parties, wellness events) at TWC where PrEP was celebrated as a part of overall trans health and wellness. Additional outreach was conducted to the local TGNB community through social media and advertisements on the Center’s webpages, tabling at local events (e.g., Trans Pride), and in other trans community spaces (e.g., youth drop-in center). These activities served the dual purpose of increasing knowledge, awareness, and demand for PrEP among clients and community members, while also increasing knowledge and fostering interprofessional collaboration among providers and staff of the TWC, the Center, and the PrEP Well team. To further enhance the reach of PrEP Well, several additional strategies will be implemented as we continue to move closer to the one-stop shop model. These include leveraging social networks to engage in additional peer-led outreach, developing comprehensive digital outreach strategies, collaborating with other LGBTQ+ organizations and healthcare providers across the region, addressing structural barriers through the integration of PrEP Well with housing, legal, economic, and telehealth services, and further culturally tailoring of PrEP messaging for different subgroups within the transgender community.

A recent systematic review of implementation strategies and adjunctive interventions to improve delivery and uptake of PrEP, found that the majority of studies in the United States have focused intervention efforts on the individual recipient (client) level rather than targeting necessary changes within the health system to increase reach, adoption, implementation and sustainment of PrEP services [74]. PrEP Well sought to promote change at the health system level by moving PrEP services onsite to a TGNB community center where TGNB-identified staff could provide PrEP education, coordination, and PrEP services to TGNB clients in a safe, welcoming environment where clients receive gender-affirming medical care and other supportive services. This overall vision of a one-stop shop model of care for TGNB clients aligns well with equitable implementation science frameworks that underscore the importance of centering community input and leadership throughout the process of identifying implementation determinants and selecting (and adapting, as needed) appropriate strategies to maximize responsiveness of intervention delivery to community needs [75–79].

Our work with community members during the Exploration and Preparation phases of this project suggested, consistent with multiple prior PrEP linkage and navigation interventions for TGNB persons, that a significant number of TGNB clients would not progress along the PrEP care continuum if they were required to attend multiple visits [28, 32, 37, 41, 80]. In addition to the time and cost of attending multiple PrEP-related appointments, often with multiple providers and requiring travel to different physical locations, TGNB persons have the added barrier of encountering extraordinarily high rates of stigma and discrimination in healthcare settings [81–84]. Locating as much of the PrEP service delivery experience as possible onsite at TWC where it could be delivered by TGNB-identified staff and providers was our best attempt at centering the needs of the local TGNB community to overcome some of these persistent barriers.

TWC provides care to a client population that is also experiencing significant socioeconomic hardship, with a sizeable proportion reporting houselessness, housing insecurity, and living in poverty. Community members voiced concerns that an exclusive focus on PrEP would overlook basic needs such as food, safety, and shelter. Our team sought to address those concerns by embedding the PrEP Well program within the broader menu of social and structural services offered at TWC. We did this by training all TWC service providers about PrEP so that they could integrate PrEP into conversations with clients when seeking housing, economic, or legal services, when appropriate to do so. Our PrEP Well coordinator was also trained on the other services being provided at TWC so that she could link clients to other appropriate services and assist with the delivery of other social and structural services as needed. TWC offers a comprehensive suite of support services, including housing assistance, a clothing closet, financial literacy, and legal services. These structural supports play a crucial role in addressing the holistic health and wellness needs of TGNB community members. By situating PrEP Well within this supportive environment, the TWC’s trans-led team has been able to address multiple determinants of health, thereby creating a more enabling context for linking participants to PrEP and keeping them engaged in the program. The provision of these additional services not only removes barriers to care (e.g., through transportation services) but also fosters a sense of community and safety, essential for the engagement of TGNB individuals in PrEP care.

There is strong preliminary evidence to suggest that these strategies also led to increased adoption of PrEP Well among the TWC staff and providers. PrEP Well has made substantial progress towards implementation and sustainment of a one-stop shop model of PrEP services in an affirming trans community center. The effectiveness of this model of PrEP delivery is further evident from the increase in sustained PrEP use across the implementation phases and maintained during the sustainment phase. Moving toward a one-stop shop model has been particularly responsive to the needs and preferences of TWC staff and clients, increasing adoption by reducing barriers to access and simplifying the PrEP care continuum. To further enhance adoption, future efforts could focus on ongoing staff training, fostering a culture of continuous quality improvement, and sharing success stories and outcome data. These strategies could help maintain high levels of adoption over time and reinforce the program’s value within the TGNB community.

The implementation and sustainment outcomes from the PrEP Well program reveal several salient insights about successfully integrating PrEP services within a TGNB community-based setting. The program’s evolution throughout the implementation and sustainment phases demonstrates the importance of flexibility and adaptability in achieving program goals. The COVID-19 pandemic and organizational capacity constraints limited the ability to fully integrate all PrEP-related services at TWC from the start of the project. As a result, we worked closely with our community and implementing partners to develop multiple alternative pathways for connecting clients to PrEP while continuing to improve capacity to move closer to the one-stop shop model. This highlights the need for an ongoing and iterative problem-solving throughout the implementation process that continues to center community input and advocate for longer-term system-level changes, while flexibly employing additional “workaround” strategies in the immediate-term. This adaptive approach allowed the program to overcome barriers and continuously improve service delivery, underscoring the importance of responsive program design in meeting the unique needs of the TGNB community.

The high levels of acceptability and feasibility reported by TWC providers, staff, and clients indicate that, over time, PrEP Well received strong organizational buy-in and successful alignment with the community’s needs. The emphasis on continuous training and support for staff, particularly the PrEP Well program coordinator, demonstrates a commitment to building internal capacity, crucial for ensuring continued program fidelity and sustainability. This investment in TGNB community members as PrEP service providers and the TWC’s organizational infrastructure to offer PrEP onsite lays a solid foundation for long-term sustainment of the program. The positive feedback regarding cultural sensitivity and overall satisfaction suggests that the integration of PrEP Well with other services offered at TWC helps to overcome barriers through programming that addresses the often-competing structural needs TGNB community members. Taken together, the RE-AIM outcomes collectively indicate that PrEP Well is effectively navigating the complexities of introducing a complex multifaceted healthcare service within a community-based organization. Moreover, the program’s ability to transition from implementation to a sustainment phase while maintaining its core objectives and adapting to ongoing challenges bodes well for its long-term viability. This successful transition to a focus on sustainment is particularly noteworthy, as it suggests that the program has become “institutionalized,” or integrated into the TWC’s regular operations, increasing the likelihood of continued growth and positive impacts on PrEP uptake and persistence among TGNB individuals beyond the initial study period.

One key finding from this implementation science project was the differences observed in attrition rates at each stage of the PrEP care continuum across implementation and sustainment phases. Notably, the majority of those lost to follow-up were not successfully linked to a PrEP visit with a provider, nor did they ever receive a prescription. These data reinforce and amplify qualitative interview findings from the preparation phase in which TGNB community members advocated for a one-stop shop model of providing PrEP services at TWC [85]. This underscores the need for centering the lived experiences of the community members we aim to reach in the design and delivery of healthcare interventions. The challenges faced in linking participants to external healthcare providers highlight the importance of having all components of PrEP care, including medical visits and prescriptions, readily accessible within a familiar and supportive environment. The feedback we received was that the number of additional appointments and providers required for PrEP delivery was inversely related to individual-level PrEP outcomes. The one-stop model aims to simplify care coordination by reducing the number of potentially stigmatizing interactions clients must have but also reduces the likelihood of participants “falling through the cracks” at crucial stages of the PrEP care continuum.

Limitations

As previously discussed, ongoing capacity constraints for an onsite pharmacy at TWC limited our ability to analyze the implementation outcomes of a fully one-stop shop model of PrEP service delivery in a TGNB community center. Future work is needed to evaluate the impact of a fully integrated one-stop shop model of PrEP care, including pharmacy services, in TGNB spaces. Another limitation was the lack of randomization in this pilot implementation project. Because the PrEP Well strategies were implemented across the entire TWC community center, it was important to both staff and community members that the PrEP Well program be offered to all TGNB clients who were interested in PrEP. Because of this, it was not considered appropriate to randomize clients to a standard-of-care or waitlist condition. As such, this design lacks a controlled comparison group, and it is not possible to determine how the observed outcomes differ from what would have occurred without the PrEP Well program.

Suggestions for Future Research

Future research should focus on several key areas to build upon the insights gained from the PrEP Well program. First, studies should explore the full integration of pharmacy and lab services onsite within TGNB community spaces to assess the impact of a complete one-stop shop model of PrEP care. Implementation research should also identify sustainable funding models and evaluate the long-term effects of ongoing staff training and community engagement on program fidelity (i.e., adherence to and quality of program components) and effectiveness. Additionally, investigations into the scalability and adaptability of the TGNB-led PrEP Well one-stop shop implementation model in other jurisdictions, with differing policies and funding structures for TGNB healthcare, particularly in rural or underserved areas, will be important for reducing HIV inequities among TGNB persons.

Further areas of study should include the integration and evaluation of comprehensive digital outreach strategies, the potential of social network interventions to increase demand for PrEP and provide additional peer-led support, and the integration of telehealth and home-based PrEP services to enhance accessibility. Implementation scientists and public health practitioners should also consider intersectional approaches to tailor PrEP messaging and services for different subgroups within the TGNB community. Moreover, longitudinal studies assessing long-term health outcomes, cost-effectiveness analyses comparing the one-stop shop model to traditional PrEP delivery methods, and the application of equitable implementation science frameworks will contribute to a more comprehensive understanding of effective PrEP implementation strategies for TGNB communities.

Conclusion

The PrEP Well program represents a significant advancement in community-led, trans-affirming HIV prevention services. By leveraging equitable implementation science frameworks and a holistic, community-driven approach, the program has successfully enhanced access, effectiveness, adoption, implementation, and maintenance of PrEP services within a TGNB-centered environment. The integration of PrEP Well with the extensive social and structural services available at TWC underscores the importance of addressing the full spectrum of TGNB needs—structural, health-related, and wellness-focused.

While challenges remain, the program’s adaptability and community-driven approach offer a robust model for similar initiatives in other jurisdictions. Continued efforts to expand the reach and services of PrEP Well, to include additional economic and mental health support, are currently underway. Future work to identify long-term funding mechanisms and to increase demand through innovative digital outreach, social network and peer-support interventions, and intersectional approaches, will be key to sustaining PrEP Well’s positive impact on TGNB health outcomes. The insights from this study can inform future HIV prevention strategies, contributing to the broader goal of ending the HIV epidemic while celebrating and supporting TGNB identities and communities. The PrEP Well model demonstrates the power of embedding inclusive, empowering, and trans-affirming healthcare within a comprehensive framework of social support and structural interventions.

Supplementary Material

Supplementary Information The online version contains supplementary material available at https://doi.org/10.1007/s10900-025-01468-4.