This study takes a qualitative descriptive approach [25,26] to identify ADAPs’ programs and policies that could help ADAP clients achieve sustained viral suppression for individual and public health benefits. Enrollment was at the state level.

Data collection involved individual semistructured interviews and was conducted via Health Insurance Portability and Accountability Act (HIPAA)–compliant videoconferencing to maintain the confidentiality of responses. Interviews were recorded and transcribed verbatim. Participants also responded to a brief survey focused on the characteristics of ADAP structures.

While the interview questions focused on ADAP structures and processes, some respondents may have offered insight into other aspects of the RWHAP and the general health infrastructure within the state, and we will incorporate these findings. Each interview consisted of open-ended questions organized into five parts covering five domains: (1) Opening questions focused on individuals and their roles and experiences in the operation and oversight of their state ADAP; this included questions about ADAP successes and challenges. (2) Operation, integration, and collaboration were discussed, which included understanding connections to other state agencies and health department personnel. We also assessed input from community stakeholders; connections to other social service providers; and interconnectedness with ADAPs in other states, the National Alliance for State and Territorial AIDS Directors (NASTAD), and other external partners, as well as how these are operationalized. (3) ADAP medication procurement and delivery policies were explored, including insurance assistance programs and processes shaping ADAP policy decisions, including questions about program eligibility, formulary design, and pharmacy network design. (4) Questions about eligibility criteria and enrollment policy, practices, and operational machinery included questions about state ADAP internal assessments of viral suppression rates and goals; differences in viral suppression among subpopulations who are disproportionately affected and/or historically underserved; and suggestions for ideal resources, policies, and programs that they think would improve viral suppression and reduce differences in outcomes for ADAP clients. (5) Concluding questions focused on innovation and implementation, which included program assessment, stakeholders involved in evaluating outcomes, data and data literacy challenges, and perceptions of the value of ADAP, as well as needed state or federal support, resources, or regulatory changes to implement best practices and improve health outcomes.

The interviews concluded with open-ended questions that invited participants to share additional thoughts. They will also be asked to identify any key stakeholders whom we should invite to participate in the study.

The study used maximum variance sampling to obtain qualitative interviews across a broad range of state ADAPs to maximize contextual insight. States will be selected based on the following key variables: (1) viral suppression rates [27] and (2) contextual variables, including region or geographic diversity [28], HIV prevalence [29], number of ADAP clients [12], state financial contributions to ADAP [12], and state Medicaid expansion status [30], as has been done by us [31] and others in previous work [22,32]. This sampling strategy will enable us to gain insight into a wide range of state ADAPs. These variables are critical as they represent external policy and resource factors (outer setting in CFIR) that constrain or enable ADAP operations.

From the 50 US states and the District of Columbia (n=51), state health department HIV leaders, including AIDS directors and ADAP directors and staff, were approached to participate in this study. The list of eligible participants (with their email addresses) is publicly available and was verified by NASTAD [33]. We used modified snowball sampling to recruit additional participants based on enrolled participants’ suggestions for key stakeholders in HIV care whom we should interview (eg, politically appointed health department personnel, community opinion leaders, and implementation team members), aligning with CFIR roles [27]. When more than 1 participant was interested in a state, we offered a joint interview or individual interviews.

The interview questions were drafted to uncover rich information about ADAP operations, policies, and practices, including eligibility criteria and re-enrollment requirements, organizational architecture and leadership, and participant and client profiles. For example, we anticipate learning about individual roles within ADAPs, staffing, and staff workloads; patterns of integration and cooperation with external partners and the wider community of actors conceptualizing and guiding ADAPs’ policies and practices; how state agencies and political and operational leadership cooperate and support ADAPs’ work; variations in program eligibility criteria and how criteria are adapted to respond to shifts in the level and character of need; and the ways in which innovations and new practices are implemented and adopted. Additionally, resources, including ADAP budget and revenue generation opportunities, are a key part of what drives operational and programmatic decisions, and these topics are covered as well. Table 1 shows the domains of qualitative interview questions and their alignment with the CFIR. The full interview guide is available in Multimedia Appendix 1.

Analyses will include descriptive statistics, conventional qualitative content analysis [34], and situational mapping [31], in which themes are inductively derived from data [34]. Data analysis will combine inductive and deductive methods of qualitative content analysis, with deductive components guided by CFIR [34]. Specifically, we will develop an initial coding dictionary using relevant CFIR domains (eg, inner setting, outer setting, innovation, and characteristics of individuals). Segments of interview data will be coded to these domains to systematically identify implementation determinants, such as leadership engagement, resource availability, interagency coordination, data infrastructure, and policy constraints. This approach ensures that analysis remains theoretically anchored and allows examination of how multilevel contextual factors influence ADAP operations.

The remaining analyses will be divided between research team members, who have in-depth experience with both forms of qualitative content analysis used in the study. Analyses will be discussed at full team meetings. These will be conducted using Dedoose (version 10.0.59; SocioCultural Research Consultants LLC). Situational mapping will be used to visualize and analyze the complex interplay between ADAP (the “what” or innovation), organizational context (inner setting), external environment (outer setting), and resultant client outcomes (viral suppression) across different states, as guided by CFIR.

Research team members will maintain reflective journal entries throughout the research process. Methods to ensure rigor and trustworthiness [35] of the data analysis will include aspects of demonstrating (1) credibility (direct observation of online communication, iterative questioning, and frequent debriefing), (2) transferability (contextual review), (3) dependability (maintaining an audit trail), and (4) confirmability (bracketing and investigator triangulation).

We will use the Consolidated Criteria for Reporting Qualitative Research reporting criteria when we publish the primary analysis [36].

This study has received ethics approval from the University of Virginia Institutional Review Board for the Social and Behavioral Sciences (Protocol #5707; modification approved on December 1, 2025). NASTAD and JSI Research and Training Institute Inc are collaborating partners supporting implementation, analysis, and dissemination activities. University of Virginia Institutional Review Board–Social and Behavioral Sciences serves as the institutional review board of record. JSI obtained a supplemental exempt determination (institutional review board #24-56E) for the participation of its staff. All participants were adults. Prior to participation, the study purpose, procedures, confidentiality protections, and potential risks and benefits were explained to each prospective participant. Verbal informed consent was obtained, and participants were informed that their participation is voluntary and that they could decline to answer questions or withdraw from the study at any point without consequences. No financial compensation was provided for participation. In the dissemination process, we will not identify individual people or states.

The overall viral suppression rate in the United States is 67% [1], which contrasts with the higher rate of 85% among people with HIV who receive services from ADAP [13]. This difference highlights an important opportunity to leverage ADAPs to improve HIV outcomes for low-income people with HIV [39]. Additionally, as ADAPs are helping people with HIV achieve higher-than-average outcomes, part of the reasoning behind focusing on ADAPs is that getting more people with HIV into ADAP could help improve viral suppression rates in the United States. It could be a key component of ending the HIV epidemic in the United States.

Our study focuses on this opportunity by studying ADAPs—a critical safety-net system that provides HIV medications for low-income people with HIV, either through direct provision of medication or assistance with premiums and medication cost sharing. Our approach is both theoretically and conceptually innovative. Specifically, we situate our analysis within the broader field of implementation science using the CFIR to guide our interview guide and subsequent analysis. This framework enables us to identify the key factors and contextual conditions that facilitate or hinder the adoption of innovations designed to improve viral suppression among people with HIV served by ADAPs.

A variety of mechanisms, organizational structures, operational practices, eligibility criteria, and related factors contribute to the success of particular ADAPs in elevating their clients’ viral suppression rates, providing continuity of care, and accomplishing broader public health aims that guide their operations. This study, given its reach across a broad range of state ADAPs representing the variety of policies and practices permitted under the RWHAP, can help identify policies, practices, approaches, and organizational structures that promote better outcomes for individual ADAP clients and public health objectives of wider health care and civic effort.

Our qualitative methodology, when used within a broader understanding of the health care needs and objectives related to people with HIV, is designed to assemble rich operational-level details about the mechanisms, policy structures, eligibility criteria, and decision-making processes that shape how effectively and responsively ADAPs serve an evolving client base in a changing policy and health care environment (Multimedia Appendix 2). The dynamic nature of the landscape in which viral suppression efforts unfold requires a better understanding of how decisions are implemented, innovations are adopted, and health care professionals and organizational and political leaders collaborate to implement best practices and ultimately improve health outcomes.

Much of HIV research overlooks the real-world barriers to achieving viral suppression among subpopulations who are disproportionately affected, historically underserved groups, and low-income populations. Despite the availability of safe and effective ART, more than one-third of people with HIV in the United States remain with detectable viral loads [1]. More work is needed to ensure that the tools available to safely and effectively treat HIV are reaching those who need them [40]. Our team’s recent quantitative work demonstrates that while state ADAPs serve less than a quarter of people with HIV, almost a third of the viral suppression in the United States can be attributed to people with HIV accessing medications through ADAPs [41]. ADAPs are essential for ending the HIV epidemic in the United States, and recent experts have declared ADAPs a model for chronic disease treatment support [42].

We anticipate that ADAPs with high rates of viral suppression will share information about programs and policies that could be disseminated to improve viral suppression and reduce differences in outcomes for subpopulations who are disproportionately affected and/or historically underserved. Because we will also have data on aspects of the states (such as Medicaid expansion status) as well as viral suppression rates, we can provide context for the environments in which these programs or policies affect ADAP clients. The Health Resources and Services Administration and state ADAPs could use these results to inform future regulatory and funding priorities. Following completion of the interviews, there were additional cost-containment measures imposed [43,44]. Therefore, these interviews will serve as a critical baseline assessment prior to the implementation and evaluation of the impacts of these cost-containment measures. In close collaboration with NASTAD, findings will be disseminated to traditional academic audiences and translated into actionable policy recommendations. Dissemination to stakeholders will include the development of brief, accessible policy reports and presentations at key national- and state-level RWHAP-ADAP convenings to facilitate shared best practices and immediate translation into operational changes.

Despite the study strengths, several challenges remain. Perspectives are drawn primarily from state health department HIV leaders, ADAP leaders and staff, and key stakeholders, which may underrepresent frontline staff and client experiences and may be influenced by institutional framing or social desirability. Although we use maximum variance sampling, participation is voluntary, and some states may differ systematically from those that did not participate. Viral suppression is shaped by many factors beyond ADAP design, including the broader HIV care infrastructure and health system navigation, Medicaid policies, and social and structural determinants. Findings also reflect a dynamic policy period (eg, the end of the COVID-19 public health emergency and the related Medicaid continuous coverage unwinding, as well as delayed funding and defunding of state public health systems), which may affect generalizability over time. Finally, we will mitigate concerns related to generalizability using team-based coding, audit trails, reflexivity, and triangulation.

We will disseminate the results of this study through traditional academic channels, including peer-reviewed manuscripts and presentations at national HIV conferences. In addition, study findings will inform the development of policy reports tailored to federal and state partners. In collaboration with NASTAD, we will share results directly with ADAP leadership and program staff to support translation of evidence into practice. We will align dissemination products with the Translational Science Benefit Model for optimal translation to impact policy and health outcomes [45].

This qualitative study will address a critical gap by characterizing the operational, organizational, and contextual factors that enable ADAPs to achieve sustained viral suppression. By identifying key mechanisms that drive success across diverse state contexts, this work is well suited to inform policy and program development aimed at improving the overall health of people living with HIV. Findings will contribute essential evidence to guide ADAPs, policymakers, and public health leaders in strengthening the nation’s HIV care safety net.