High Acceptability but Persistent Barriers to Implementation of Long-acting Injectable Antiretrovirals: A Nationwide Cross-sectional Survey of Ryan White Clinics in the United States

Abstract

Background

The first long-acting injectable antiretroviral therapy (LAI ART) for HIV was approved for commercial use in the United States in January 2021. Assessment of clinic characteristics and their associations with implementation outcomes and barriers is essential to developing strategies for equitable access to LAI ART.

Methods

Using validated implementation measures—acceptability of intervention measure (AIM), intervention appropriateness measure (IAM), and feasibility of intervention measure (FIM)—we conducted a cross-sectional survey of Ryan White clinics in the United States. Additionally, we gathered information on the clinics’ population, LAI ART implementation status, and barriers to implementation. Data were analyzed using STATA, version 17. Open-ended responses were analyzed using an inductive thematic approach.

Results

Forty-two clinics completed the survey, with 73% in an urban setting. Most clinics identified as either federally qualified health centers (39%) or academic medical centers (27%). The mean (SD) for each measure (maximum of 20) reflected higher AIM (17.7 [2.3]) and IAM (17.6 [2.4]) compared with FIM (16.4 [3.0]). There was a positive correlation between the percentage of patients on Medicaid and summative AIM and IAM scores. The greatest barriers were prior authorizations, drug procurement, and clinic cost of implementation.

Conclusions

Despite high acceptability and appropriateness, clinics’ perceived feasibility of LAI ART implementation was low. Barriers to implementation include nonstandardization of prior authorizations, obtaining the medication, and cost of implementation. Clinics with a larger Medicaid-insured population reported higher acceptability and appropriateness of LAI ART, suggesting that public insurance might promote equitable access. Interventions that address structural barriers are needed to improve uptake.

HIV treatment has been complicated by nonadherence for decades, leading to immunocompromised states, viral transmission, and viral resistance [1]. Cabotegravir/rilpivirine long-acting injectable antiretroviral therapy (LAI ART) was approved by the US Food and Drug Administration (FDA) in January 2021, making it the first commercially available LAI ART [2]. This FDA approval was a breakthrough advancement in HIV treatment, as patients on LAI medications for other conditions, such as antipsychotics and contraception, have demonstrated increased adherence compared with oral medications [3]. Many issues of ART adherence are related to their oral formulation; for example, the daily reminder of one's diagnosis and the potential for unwanted disclosure can contribute to missed doses [4–6]. LAI ART may reduce some of these barriers [6].

Moreover, LAI ART shows promise as a new means of HIV treatment for patients negatively impacted by social determinants of health (SDoH). A program in San Francisco provided patients experiencing homelessness with access to LAI ART and reported 94% sustained virologic suppression at 24 months, despite many of these patients having viremia initially [7]. However, the monthly clinic visits pose new challenges on both patient and systems levels [8], leading to slow uptake of these therapies. Requirements for successful implementation of LAI ART include adequate staffing, private administration spaces, training on injectable administration and side effects, in-clinic refrigerated storage, navigation of insurance coverage and prior authorization, and tracking patient visits to ensure adherence [8]. Current data have shown slow uptake of LAI ART in the United States despite high levels of acceptability by patients, providers, and clinics [5, 6, 9]. Studies investigating individual clinic barriers have been conducted [10]; however, limited data exist on nationwide clinics’ perceived barriers and ability to implement this therapy post–FDA approval.

To examine the reasons behind the slow scalability, we conducted a survey of Ryan White clinics in the United States. The objectives of this study were to assess clinics’ LAI ART implementation status, clinics’ perceptions of acceptability, feasibility, and appropriateness of implementation, and any encountered barriers. We had previously conducted a similar survey in 2021 that assessed the LAI ART pre-implementation readiness in Ryan White clinics [9]. This survey assessed the same domains 2 years after FDA approval of LAI ART.

METHODS

Study Population

We reached out to 274 Ryan White Part C Clinics using the medical directors’ email addresses available on Target HIV.

Study Design

The survey was an anonymous web-based questionnaire modeled after the initial 2021 survey with revisions to reduce redundancy and update the questionnaire to reflect postimplementation challenges, specifically for cabotegravir/rilpivirine treatment (Supplementary Data). These revisions were discussed and implemented with input from the physicians and Ryan White grant director who contributed to the initial survey. The survey items included information on clinic characteristics, patient populations, current practices, barriers to LAI ART, and the clinic's perception regarding the acceptability, appropriateness, and feasibility of implementing LAI ART. The survey was created and managed using Research Electronic Data Capture (REDCap) hosted at the University of Nebraska Medical Center [11, 12]. The 274 potential participants were sent an email invitation in March 2023, with 4 reminder emails sent at weekly intervals. Each invitation link was specific to the intended recipient. The recipient could forward the survey to another clinic staff member; for example, the medical director could send the survey to a staff member more directly involved in LAI ART implementation. The survey could not be submitted more than once per invitation link. Survey data were anonymously and securely stored in REDCap for further analysis.

Measures

The survey included the acceptability of intervention measure (AIM), the intervention appropriateness measure (IAM), and the feasibility of intervention measure (FIM) [13]. Acceptability is related to the perception of an intervention as agreeable, palatable, and satisfactory [13]. Appropriateness pertains to the perceived pertinence and fit of an intervention [13]. Feasibility is the extent to which a new intervention can be successfully implemented [13]. These 3 measures are validated tools often used to gauge the success of novel, early-stage interventions, and each scale has a high degree of validity and reliability [13].

The AIM, IAM, and FIM items containing subdomains of each measure were presented with a Likert scale response. Each item's response options included 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree. Responses with higher numbers reflected a more favorable view of LAI ART implementation. Additionally, an item was added to the survey to gauge the clinics’ tendency toward innovation in a broader sense, in accordance with Roger's Diffusion of Innovation Theory [14]. Responses from this item aided in describing each clinic on a spectrum from change-resistant to innovation-seeking [14].

Participants were presented with items describing various barriers to LAI ART implementation, including insurance coverage, patient tracking, and patient/provider buy-in. These items were selected based on what was reported in our previous survey and the literature [3, 8, 9, 15]. Each item had responses presented on a Likert scale; the options ranged from 1 = not a barrier at all to 5 = an extreme barrier. General information about each clinic was gathered, including geographic location, institution type, and patient population size. Additionally, the characteristics of each clinic's patient population were included in the survey, including race, gender, income, insurance coverage, and viral suppression rate.

This survey addressed clinics’ perceptions of LAI ART 2 years after FDA approval. This allowed for investigation into clinics’ practical implementation of the therapy. Three items were added to assess the extent of clinics’ status in implementing LAI ART, the development of processes for implementation, and access to resources regarding implementation. Participants were also asked whether their clinic participated in LAI ART clinical trials and the number of patients currently using LAI ART. An item was included to assess the amount of time it takes for a provider to prescribe LAI ART until the patient receives the treatment. Participants were asked which groups of patients were using LAI ART in their clinic, including patients who were adherent, were nonadherent, had disclosure concerns, or had experienced pill fatigue. Respondents were also asked an open-ended question regarding their experiences in implementing LAI ART within their clinics.

Data Analysis

Quantitative continuous data were analyzed using means and standard deviations, while categorical measures were analyzed with frequencies and percentages. The 4 subdomains of AIM, IAM, and FIM were summed to create a representative summary of each measure. The Likert scale responses ranged from 1 to 5, resulting in possible final ranges of 4–20 for each measure. Additionally, means and standard deviations were recorded for each of the subdomains. AIM, IAM, FIM, and all subdomains of the measures were compared with or across clinic characteristics. For clinic characteristics that were continuous measures (eg, proportion of patient populations falling into each race, sex, and poverty level), comparisons were made using Spearman correlations. Clinic characteristics that were categorical (eg, clinic location, whether a resource covered LAI ART in their state, and current implementation status) were assessed with rank-sum tests to compare AIM, IAM, and FIM values across categories. Some comparisons were complicated by clinics affiliating with multiple responses per item in categorical measures, so these were not formally evaluated. The means and standard deviations of these measures alone provide utility in understanding differences across categories. The items regarding barriers to implementation are also reported as their means, with higher scores indicating greater perception of the item as a barrier. Additional comparisons between barrier ratings and feasibility scores (FIM) were made using Spearman rank correlations. The statistical software STATA, version 17, was used for statistical analysis.

Respondents’ answers to a single open-ended question soliciting any additional comments on the subject were analyzed via an inductive thematic analysis approach. One coder (A.T.) conducted primary coding, and another coder (N.F.) reviewed the coding to ensure coherence and alignment with question objective. Given the short nature of responses, formal intercoder reliability was not assessed; however, coders discussed and refined initial codes iteratively to ensure coherence. As the coding process progressed, we discussed initial codes and grouped the open-ended responses into 2 broad categories of barriers to and facilitators of implementation.

RESULTS

Respondents and Clinic Characteristics

Of the 274 Ryan White clinics invited to participate, 42 (15%) completed the survey. The respondents’ mean clinic characteristics are summarized in Table 1. The most common professional category of respondents was medical providers (17, 40%). Clinic types were federally qualified health centers (16, 39%), academic medical centers (11, 27%), hospital outpatient clinics (10, 24%), AIDS service organizations or community-based organizations (5, 12%), nonprofit private clinics (5, 12%), and “other” (3, 7%). The largest US region represented by respondents was the Southeast (15, 38%), with most respondents identifying their clinics as being in an urban setting (30, 73%).

Table 1.

Respondents’ Clinic and Patient Population Characteristics

Respondent's Clinic Role	No. (%)
Medical provider	17 (40)
Medical director	13 (32)
Program manager	12 (29)
Nurse	7 (17)
Fiscal manager	3 (7)
Social worker	1 (2)
Pharmacist	1 (2)
Other	7 (17)
Type of clinic
Federally qualified health center	16 (39)
Academic medical center	11 (27)
Hospital outpatient clinic	10 (24)
AIDS service organization or community-based organization	5 (12)
Nonprofit private clinic	5 (12)
Other	3 (7)
US geographic location of clinic
Southeast	15 (38)
Northeast	10 (25)
Midwest	5 (12)
Southwest	4 (11)
West	4 (11)
Puerto Rico	1 (3)
Clinic setting
Urban	30 (73)
Suburban	6 (15)
Rural	5 (12)
LAI ART implementation status
Providing with no barriers	15 (36)
Providing with some barriers	23 (53)
In implementation process	2 (5)
Neither providing nor implementing	1 (2)
No response	1 (2)

Abbreviation: LAI ART, long-acting injectable antiretroviral therapy.

The respondents’ mean patient population characteristics are displayed in Table 2. The most common racial groups of patients were Black/African American (46.7%) and White (41.7%), and most patients were cisgender males (mean of 64.9%). Most of the patients were within 300% of the poverty level (mean of 76.1%). The largest source of insurance coverage was Medicaid (mean of 43.5%), and a mean of 21.6% of patients within clinics were uninsured. Clinic respondents reported a mean viral suppression rate of 87.9% in their patient populations.

Table 2.

Respondents’ Mean Patient Population Characteristics

Clinic Population Race Distribution	Mean, % (SD)
Black or African American	46.7 (26)
White	41.7 (25)
Asian	1.4 (2)
American Indian or Alaska Native	0.5 (1)
Native Hawaiian or other Pacific Islander	0.3 (1)
Other	9.9 (21)
Clinic population gender distribution
Cisgender male	64.9 (18)
Cisgender female	32.6 (18)
Transgender person	2.9 (4)
Clinic population poverty level distribution
≤100%	52.70 (26)
100–300%	23.40 (18)
301–500%	16.90 (24)
>500%	6.10 (13)
Clinic population insurance coverage distribution
Medicaid	43.50 (26)
Uninsured	21.60 (22)
Medicare/Tricare/other federal insurance	15.80 (16)
Private/employer insurance	15.10 (15)
ADAP sponsored insurance	13.50 (14)
Other	2.90 (3)

Abbreviation: ADAP, AIDS Drug Assistance Program.

Perceptions of LAI ART Acceptability, Appropriateness, and Feasibility of Implementation

The means (SDs) for each measure were as follows: AIM 17.7 (2.3), IAM 17.6 (2.4), FIM 16.4 (3.0). Figure 1 presents proportions of respondents who selected “agree” or “strongly agree” to statements describing LAI ART as acceptable, appropriate, and feasible to implement. Of note, 98% of respondents said they welcome LAI ART; however, only 68% agreed that it is implementable or seems easy to use, reflecting higher acceptability than feasibility.

Figure 1.

Respondents’ agreement with AIM, IAM, and FIM statements. Abbreviations: AIM, acceptability of intervention measure; ART, antiretroviral therapy; FIM, feasibility of intervention measure; IAM, intervention appropriateness measure.

Clinics’ Status of Implementation and Prescribing Patterns of LAI ART

The survey included an item measuring clinic status of implementation; respondents were able to select whether their clinic was providing LAI ART without barriers, providing LAI ART with some barriers, in the process of LAI ART implementation, or not providing LAI ART. At the time of the survey, only 15 clinics (37%) were providing LAI ART without barriers; 23 clinics (56%) were providing LAI ART with some barriers to implementation. The clinics that had not implemented LAI ART were either in the process of implementation (2 clinics, 5%) or expressed interest in offering LAI ART in the future (1 clinic, 2%). One participant did not answer this question. None of the respondents denied interest in LAI ART.

Respondents reported the mean time from the prescription of LAI ART to administration as 36 days. When asked which patient groups were prescribed LAI ART in their clinics (multiple selections were allowed), 35 (85%) respondents reported that they prescribe it to patients who express interest in LAI ART, 33 (80%) reported that they prescribe it to patients who are adherent to daily oral ART, 28 (68%) reported that they prescribe it to patients who experience pill fatigue or aversion, 26 (63%) reported that they prescribe it to patients who are concerned about HIV disclosure, and 18 (44%) reported that they prescribe it to patients with medical conditions that affect absorption of oral ART.

Barriers to and Recommendations for Implementing LAI ART

The most cited barriers were obtaining prior authorization from insurance, procuring the medication from local pharmacies, and implementation costs (Supplementary Figure 1). Correlational comparisons between barrier ratings and FIM showed that concerns about patient adherence, the availability of trained staff, the ease of obtaining mediation from pharmacies, and being able to obtain prior authorization were the barriers with the largest negative correlations with feasibility (data not shown). Respondents were prompted to select resources that may improve their clinics’ implementation of LAI ART. Thirty-three (80%) respondents selected standardization for insurance coverage, and 22 (54%) selected shared experiences from other clinics that have had implementation success. Other resources needed by respondents included additional staff to assist with the implementation process (20, 49%), implementation guides and resources (19, 46%), online training/workshops (19, 46%), and in-person training/workshops (13, 32%).

In the open-ended questions, 22 respondents shared their experiences of implementing LAI ART within their clinics, which were divided into themes of barriers and facilitators (Table 3). They highlighted additional barriers such as patient adherence, staffing issues, and facilitators, including pharmacists and nurses, to support the implementation process. Insurance was identified as a major barrier that limits implementation in different ways, including nonstandardization of coverage, prior authorizations, insurance denials, and low reimbursement rates. Respondents’ recommendations for improving LAI ART included multidisciplinary approaches, educational resources for clinics, and shared experiences from clinics with successful implementation.

Table 3.

Thematic Analysis of Open-ended Question Responses

Category	Themes	Respondents’ Quotes
Barriers to implementation	Insurance and cost	“Unable to prescribe here if it is covered as a Medical Benefit. We cannot prepurchase medication and then bill. If it is covered as a pharmacy benefit, then this barrier goes away.”—Respondent 13 “Every insurance has a different process for authorization and some have made it impossible to even order this drug.”—Respondent 3
	Staffing	“We unfortunately continue to be short staffed. We have created the procedure and are waiting to build up the staff.”—Respondent 19 “Labor intensive process to review eligibility criteria and document in EMR. Need for additional trained personnel to administer injections.”—Respondent 4 “We do not have a fulltime, permanent adult provider. Once this provider is identified and on board, we will then be able to implement long acting injectables.”—Respondent 8
	Patient adherence	“It [LAI ART] is useful for some patients but has not had a big impact. Some patients improved their oral adherence to become eligible, and then stuck with oral meds having achieved virologic control! Some patients just couldn’t get their viral loads down and we did not initiate injectables with those patients.”—Respondent 1
	Clinic infrastructure	“Not having a pharmacy in our clinic or a place to store the medication is a major barrier.”—Respondent 12
Facilitators to implementation	Patient preference	“Some patients improved their oral adherence to become eligible, and then stuck with oral meds having achieved virologic control!”—Respondent 1
	Protocols and procedures	“We have instituted a large program [name of program] to give long-acting ART to even viremic patients who can’t take oral ART. We have a rigorous protocol to do this.”—Respondent 17
	Interdisciplinary teams	“We have been successful using a team approach and using the leadership of our clinical practice pharmacists.”—Respondent 16
	Training and education	“Educational materials/flyers for patients & trainings for nurses would be helpful.”—Respondent 4

Abbreviation: ART, antiretroviral therapy; EMR, electronic medical record; LAI ART, long-acting injectable antiretroviral therapy.

Associations Between Clinic Characteristics and Acceptability, Appropriateness, and Feasibility of Implementing LAI ART

The associations between clinic characteristics and AIM, IAM, and FIM are reported in Table 4. There was a positive correlation between the percentage of patients covered by Medicaid and the summative acceptability score (P < .05). Positive correlations with appropriateness of implementation included the percentage of patients with Medicaid coverage (P < .05), the percentage of Asian patients (P < .05), coverage of LAI ART by Medicaid (P < .05), and clinic participation in LAI ART clinical trials (P < .05). Feasibility also showed a trend toward a positive correlation with the percentage of patients covered by Medicaid (P = .060) and was negatively correlated with having a high percentage of patients >500% of the poverty level (P < .05). Additionally, the clinics’ status in implementing LAI ART had a positive correlation with the FIM composite score, indicating that clinics that were already providing LAI ART viewed the therapy as more feasible than those that were not yet providing LAI ART or were in the process of implementation.

Table 4.

AIM, IAM, and FIM Measured Against Clinic Characteristics

	AIM	IAM	FIM
Clinic population race distribution	Spearman correlation
Black or African American	0.187	0.013	−0.031
White	−0.118	0.020	−0.026
Asian	0.242	0.357	0.149
American Indian or Alaska Native	0.111	0.122	0.013
Native Hawaiian or other Pacific Islander	0.311	0.312	0.150
Other	0.141	0.195	0.236
Clinic population gender distribution
Cisgender male	−0.008	−0.025	0.184
Cisgender female	0.022	0.002	−0.237
Transgender person	0.152	0.126	0.204
Clinic population poverty level distribution
≤100%	0.112	0.001	0.372
100–300%	0.046	0.085	−0.214
301–500%	−0.049	−0.040	−0.343
>500%	−0.165	−0.106	−0.464
Clinic population insurance coverage distribution
Medicaid	0.371	0.349	0.321
Uninsured	−0.147	−0.184	−0.144
Medicare/Tricare/other federal insurance	−0.104	−0.097	−0.200
Private/employer insurance	−0.178	−0.028	−0.119
ADAP sponsored insurance	−0.05	−0.026	0.170
Other	−0.12	−0.178	−0.330

Bold formatting indicates P < .05.

Abbreviations: ADAP, AIDS Drug Assistance Program; AIM, acceptability of intervention measure; FIM, feasibility of intervention measure; IAM, intervention appropriateness measure.

Each subdomain of AIM, IAM, and FIM was also analyzed against clinic characteristics. One of the AIM subdomains, “Long-acting injectable ART is implementable,” had a positive correlation with the percentage of patients covered by Medicaid and the clinic status of implementation (P < .05). A subdomain of FIM, “Long-acting injectable ART seems doable,” had a positive correlation with clinics that prescribe LAI ART to patients who are nonadherent to daily oral ART (P < .05). There was a positive correlation between clinics that reported “access to resources for LAI ART” and the percentage of patients covered by private/employer insurance and coverage of LAI ART by Medicaid (P < .05).

DISCUSSION

In this study, we evaluated the acceptability, appropriateness, and feasibility of long-acting injectable antiretroviral therapy across Ryan White Clinics in the United States 2 years post–FDA approval. We found that while LAI ART has been widely accepted by both patients and providers, significant barriers to implementation remain at the systems level, hindering its scalability. Our findings indicate that while most respondents view LAI ART as acceptable and appropriate for their patient populations, fewer clinics find it feasible to implement without substantial obstacles, such as prior authorization and medication procurement issues. Most respondents were medical providers working in a Federally Qualified Health Center (FQHC) in urban settings, with a majority of Black cisgender male patients. Through open-ended responses, they identified additional barriers to implementation, such as insurance and cost, staffing, and concerns about patient adherence. Facilitators to implementation were identified as patient preference, having an interdisciplinary team, and training and education of clinics’ staff.

A previous pre-implementation survey of Ryan White clinics conducted before FDA approval of LAI ART revealed high levels of perceived acceptability and appropriateness of implementation [9]. Following LAI ART's approval, our current survey showed similar results in the acceptability and appropriateness domains. However, there was a significant drop in agreement with FIM measures compared with the survey before FDA approval (Supplementary Figure 2).

The lower feasibility scores, especially compared with our pre-approval survey, highlight the real-world challenges clinics face as they transition from theoretical readiness to practical implementation. Clinics with a higher proportion of Medicaid-insured patients reported greater acceptability and appropriateness of LAI ART, possibly reflecting Medicaid's comprehensive HIV care coverage, although this varies by state. In contrast, there was a trend toward a negative correlation between IAM and clinics with a larger percentage of patients covered by Medicare/Tricare/other federal insurance coverage (P = .058). This may suggest that federal insurance programs are less likely to view LAI ART as an appropriate alternative to oral ART, possibly due to hesitance in adopting new treatments. Additionally, clinics may perceive that older patients on Medicare prefer to continue with long-established oral regimens. A trend toward a negative correlation was identified between clinics with higher patient population poverty level >500% and FIM (P = .060). This may be influenced by the limited amount of Ryan White resources available to patients with higher incomes. There is a positive correlation between the percentage of Asian patients and higher IAM scores; however, the sample size was small, with Asian patients representing a mean of 1.4% of the clinics’ populations.

Insurance-related barriers, particularly around prior authorizations and drug procurement, were the most frequently cited challenges in our study. These findings are supported by recent studies, such as Cooper et al., which identified similar systems-level hurdles in adopting LAI ART in high-income countries [8]. Standardizing insurance coverage for LAI ART may significantly improve access, particularly for clinics serving marginalized populations. Additionally, the cost of implementation (eg, drug pricing, required infrastructure) remains a major hurdle for many clinics.

People with HIV nationwide have welcomed the idea of LAI ART [16]. Despite patient interest, clinic implementation has lagged. Approximately 11 000 prescriptions for LAI ART have been written in the United States since its FDA approval [15]. A study conducted by Collins et al., focused on an HIV clinic in Atlanta, described barriers to LAI ART, including lack of clinic staff, insurance denials, patient ineligibility due to resistance concerns, and difficulty obtaining the medication [10]. Of the clinics surveyed in our study, 93% currently provide LAI ART; however, 56% of respondents reported similar barriers to implementation, including difficulties with prior authorizations and obtaining the medication. Additional barriers reported in our survey included implementation costs, patient transportation, and tracking patients with missed doses. Respondents overwhelmingly reported systems-level issues as significant barriers, while patient buy-in was not viewed as a barrier to implementation.

The challenges surrounding LAI ART implementation are multifaceted, and several approaches are needed to establish it as a treatment option in many clinics. Conducting hybrid effectiveness–implementation trials would be helpful in gathering data on implementation outcomes while simultaneously assessing clinical outcomes. Specifically, a type 3 hybrid trial would be ideal as it primarily focuses on implementation while including effectiveness data as a secondary outcome [17]. There is a need to focus on different clinic populations, with the greatest need for focus on clinics who serve marginalized groups. Future studies should synthesize input from clinics, community partners, and patients to identify barriers and potential solutions from multiple perspectives. Clinics with successful implementation reported that having concrete protocols and procedures has streamlined the process, and those that had difficulty with implementation noted that shared experiences from clinics with established LAI ART would be helpful. Recruiting clinics with successful LAI ART programs to produce educational materials could be useful in guiding other clinics through this process. There are many interacting systems in the implementation of LAI ART, including pharmacy, communication, scheduling, care, and billing [15]. One potential workflow solution is to have a full-time coordinator to manage these integrated systems [15]. To address adherence concerns, implementing a multidisciplinary team including a medical provider, pharmacist, and outreach worker may streamline treatment and help patients reach their goal of virologic suppression [18]. A generic LAI ART is expected to arrive within the next few years, and this may ameliorate issues related to accessibility by making the cost more palatable to insurance providers [15, 19]. The invention of LAI ART is a pivotal advancement in HIV treatment; however, the barriers to implementation are significant and must be addressed to improve accessibility to all clinics. Additionally, focusing on different populations and integrating input from clinics, community partners, and patients are essential in ensuring equitable access to LAI ART.

Limitations

This study has several limitations. The response rate was 15%, and the sample was skewed toward urban clinics, potentially limiting the generalizability of the findings to rural settings, where barriers such as patient transportation may be more pronounced. Additionally, clinics undergoing the most barriers to implementation might not have had the time or human resources to participate in the survey, potentially introducing a response bias. Future studies could address this by extending the survey deadline, increasing follow-up efforts, or offering targeted support to encourage participation from clinics with significant implementation challenges.

CONCLUSIONS

Despite high levels of acceptability, the implementation of LAI ART in Ryan White clinics in the United States has lagged due to significant systems-level barriers, such as insurance authorization, drug procurement and storage, and staffing. Potential solutions such as standardizing insurance coverage, sharing best practices among clinics, and establishing multidisciplinary teams may help overcome these challenges. Introducing a generic version of LAI ART in the future could improve access by reducing costs and simplifying the procurement process. More implementation science research examining the outcomes of LAI ART implementation and strategies to address barriers will be critical to providing equitable access to this promising HIV therapy.

Supplementary Data

Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author.