Increasing antiretroviral therapy adherence and retention in care among adults living with HIV in Philadelphia: a study protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial of managed problem-solving plus (MAPS+) delivered by community health workers

Abstract

Introduction

To end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs). The adapted intervention is MAPS+. To maximise the clinical impact and reach of the intervention, evaluation of the effectiveness and implementation of MAPS+ is necessary.

Methods and analysis

This manuscript describes the protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial in 10 clinics in Philadelphia. This research incorporates innovative approaches to accomplish three objectives: (1) to evaluate the effectiveness of the CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the individual implementation period (N=390 participants), (2) to examine the effect of the menu of implementation strategies on reach and implementation cost and (3) to examine processes, mechanisms, and sustainment of the implementation strategies for MAPS+ (N=56 participants). Due to various factors (eg, COVID-19), protocol modifications have occurred.

Ethics and dissemination

The institutional review board (IRB) at the city of Philadelphia serves as the primary IRB; initial approval was granted on 21 December 2020. The University of Pennsylvania and Northwestern University executed reliance agreements. A safety monitoring committee comprised experts in implementation science, biostatistics and infectious diseases oversee this study. This research will offer insights into achieving the goals to end the HIV epidemic in Philadelphia as well as implementation efforts of MAPS+ and other behavioural interventions aimed at increasing medication adherence and retention in care. Dissemination will include deliverables (eg, peer-reviewed manuscripts and lay publications) to reach multiple constituents.

Trial registration number

NCT04560621.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This research will leverage a partnership between the Philadelphia Department of Public Health, health system and research team to foster sustainability of the work.

• This research will employ a hybrid effectiveness-implementation trial that enables the dual evaluation of clinical effectiveness and implementation outcomes.

• This research will use a combination of implementation strategies derived from preliminary data and a partner-engaged implementation mapping process, thus increasing potential success of implementation.

• This research will pragmatically assess the cost of the implementation approach and explore implementation mechanisms, two emerging topics critical for advancing the field of implementation science.

• This research will measure implementation reach against the total number of eligible individuals within the study clinic, which will limit the generalisability of the outcome.

Introduction

HIV contributes to substantial mortality and morbidity in the USA. The Department of Health and Human Services developed the ending the HIV epidemic (EHE) plan to reduce the number of new HIV infections by 90% in the USA by focusing on regions with high HIV prevalence.¹ In Philadelphia (1 of the 48 EHE prioritised counties),² HIV disproportionately affects individuals from marginalised groups, (eg, black individuals, particularly men who have sex with men).³ Multifaceted factors have created barriers to care, which has resulted in poor rates of retention in HIV care and viral suppression.³ To end the HIV epidemic in Philadelphia, the Philadelphia Department of Public Health (PDPH) established the goal of having 95% of people living with HIV (PWH) with evidence of care in the last 5 years achieve viral suppression. To achieve this goal, Philadelphia requires concentrated efforts to implement evidence-based practices.

Managed problem solving (MAPS) is a low-intensity behavioural intervention endorsed by the Centers for Disease Control and Prevention to increase viral suppression in PWH.⁴ The intervention consists of four individual sessions during the first 3 months reinforced by ongoing telephone calls during the intervention period of 1 year. Using the problem-solving framework,⁵ the facilitator and participant work together to solve adherence barriers, which empowers individuals to manage their own health. MAPS follows five steps: (1) identifying barriers to adherence, (2) brainstorming to generate potential solutions, (3) decision-making and developing an action plan, (4) implementing the plan and (5) evaluating and modifying the plan. Despite demonstrated effectiveness in increasing adherence to antiretroviral therapy and viral suppression, none of the HIV care sites in Philadelphia were implementing the intervention. To address low adoption, barriers of time and limited capacity of health professionals, the intervention was adapted to restructure the delivery model. Community health workers (CHWs) can serve as a workforce to deliver MAPS to PWH. Task-shifting from healthcare professionals to CHWs has demonstrated success across many contexts, including improving uptake of HIV services, retention in care and cost savings.⁶ In high-income countries, studies have shown an association between CHW involvement in the HIV continuum of care and improvements in viral suppression.^{7 8} Thus, CHWs can serve as trusted, effective individuals for the delivery of HIV care. The adapted intervention facilitated by CHWs that focuses on both viral suppression and retention in care is termed MAPS+ (figure 1).

Figure 1.

MAPS+intervention steps. CHWs, community-health workers; MAPS, managed problem solving.

To maximise the clinical impact and reach of MAPS+, systematic evaluation of the effectiveness and implementation of the adapted intervention is needed. Hybrid effectiveness-implementation trials facilitate the dual assessment of both clinical and implementation outcomes, thus closing the research-to-practice gap.⁹ This manuscript outlines the protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial in 10 clinics in Philadelphia. Overall, this research aims to improve retention in HIV care and viral suppression through successful implementation of MAPS+ among PWH in an EHE prioritised county. To accomplish this goal, this research will pursue the following objectives: (1) to evaluate the effectiveness of CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the implementation period, (2) to examine the effect of the implementation strategies on reach and cost and (3) to examine processes (eg, barriers and facilitators) and mechanisms of the implementation strategies for MAPS+.

Methods and analysis

The Standards for Reporting Implementation Studies Statement and Standard Protocol Items: Recommendations for Interventional Trials (online supplemental Additional file 1) guided the reporting of this protocol.¹⁰ Figure 2 provides an overview of the research.

Figure 2.

Study overview. Example determinants are listed above. This is not an exhaustive list. CHWs, community health workers.

Study team

A team with multidisciplinary content expertise (eg, implementation science, HIV care, behavioural theory, psychology, community-engaged research and economics) and methodological expertise (eg, clinical trials and mixed methods) will lead this study. The team includes the original developer of MAPS and partners from the primary public health institution in the city, PDPH. To facilitate successful partnership, leadership from each of the implementation sites will communicate directly with the study team.

Study design

This study will employ a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial design.^{9 11} The three wedges of the trial will occur over the course of four phases (September 2020–June 2024; anticipated end date), starting with CHW recruitment and training in July 2021 and participant enrolment in February 2022 (see figure 3 for full timeline). Phase 1 will focus on adaptation of MAPS+, engagement of clinics and partners, and regulatory activities. Phase 2 will involve onboarding sites for wedge one (eg, recruitment, training and onboarding of CHWs) and participant enrolment. Phase 3 will continue onboarding sites for wedge two and three (eg, recruitment, training and onboarding of CHWs), continued participant enrolment and qualitative interviews for aim 3. Phase 4 will focus on continued participant enrolment and data analysis.

Figure 3.

Study timeline. MAPS, managed problem solving.

Ten clinics in the Philadelphia metropolitan area will be randomised at 9-month intervals (ie, two cohorts comprised four clinics and one cohort comprised two clinics) to receive MAPS+ via simulated restricted randomisation by the research team. The selected clinics include sites that receive funding from the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act (ie, sites located in prioritised areas) and provide care to more than 75% of PWH in Philadelphia. The population served mirrors the local and national epidemiologic profiles of PWH. Clinic sizes include: <500 PWH (N=1), 500–1000 PWH (N=2) and >1000 PWH (N=7). Seven of the clinics are affiliated with academic institutions, while the remaining three are community-based clinics. Colocated services include medical case management (10/10 clinics), medication-assisted treatment for substance use disorders (9/10 clinics), mental health services (6/10 clinics) and nutritional services (4/10 clinics). Providers include internists, family practitioners, infectious disease specialists, physician assistants and nurse practitioners.

CHWs will be recruited from diverse sources depending on the existing structure, including referral from clinics, online job postings and a formal CHW certification programme. Eligibility criteria include: (1) share demographic characteristics of the population of PWH in Philadelphia (eg, race/ethnicity, language, socioeconomic status, sexual orientation and place of residence), (2) share life experiences regarding exposure to social determinants of health (eg, housing instability, food insecurity and incarceration), (3) possess basic trouble-shooting and communication skills, (4) hold non-stigmatising beliefs towards HIV treatment and care, (5) have prior experience working with marginalised populations or active involvement in the community and (6) have at least a high school diploma or equivalent. Criteria will be assessed through a questionnaire that includes a medical problem-solving measure, a series of interviews and letters of reference. HIV status will not influence eligibility. Selected CHWs will be employed, trained and embedded in clinics in which they will implement MAPS+.

Patient and public involvement

No patient involvement in the study design or execution.

Implementation strategies

Primary implementation strategies

This trial will deploy three primary implementation strategies informed by preliminary data (table 1): (1) initial training, (2) ongoing support and (3) integration of the CHW within the clinical team. Lay delivery of MAPS by CHWs was conceptualised as an adaption of MAPS+ rather than a core implementation strategy given delivery by CHWs is a key component of the adapted intervention.

Table 1.

Primary implementation strategies

Strategy	Definition	Example
Primary implementation strategies
Initial training	Educational strategies by providing the CHWs training	Facilitate a training including didactic and practical training for the MAPS+ intervention, foundational knowledge for HIV adherence and retention in care, and facilitation skills over 5 days in Philadelphia.
Ongoing support	Ensuring that CHWs are properly supported	Facilitate a weekly group meeting with CHWs and research team to problem solve issues that arise.
Integration of the CHW within the clinical team	Ensuring that CHWs are properly integrated within the treatment team	Define the CHW role and standard work procedures. Create standard work procedures. Community engagement and engagement of stakeholders during the preparation phase: Actively involve the Penn CFAR Community Advisory Board subcommittee for Data-to-Care in this project and provide input on the implementation of research protocols.

See online supplemental Additional file 2 for a list of additional context-specific strategies highlighted from that implementation mapping process.

CFAR, Center for AIDS Research; CHWs, community health workers; MAPS, managed problem solving.

Initial training will cover the MAPS+intervention, foundational knowledge for HIV adherence and retention in care, facilitation skills, use of the MAPS+ educational materials, practice implementing the intervention and creation of common responses to issues that may arise during implementation. The training will stress the importance of conducting the sessions with fidelity, keeping client confidentiality and practising cultural humility. In addition, the research team will hold an annual training to refresh CHWs’ skills.

Ongoing support will involve both regular meetings and ad hoc meetings with multiple constituents, as needed. CHWs will attend weekly group meetings with the research team to troubleshoot issues that arise (eg, recruitment strategies) and review data collection. In addition, ad hoc meetings may occur to address issues in delivery of care as aligned with the goals of MAPS+ or to discuss the dynamics of CHW management with supervisors.

Finally, integration of the CHW within the clinical team is key, for it contributes to work satisfaction, fosters a culture of inclusivity, and empowers the CHW, all factors that prevent turn-over.¹² The MAPS+ study will use the following approaches to foster integration of the CHW within the clinical team: (1) developing structures to support information sharing among the CHW and clinical team members, (2) defining the CHW role and standard work procedures and (3) having the CHW accompany patients that they serve to their medical appointment. Each clinic will have the autonomy to operationalise the process of accompanying patients to medical appointments based on CHW, patient and staff preferences.

Additional implementation strategies

This study will use the three primary strategies in all sites and additional context-specific strategies to enhance the uptake of MAPS+, as needed (online supplemental Additional file 2). Guided by the Consolidated Framework for Implementation Research (CFIR),¹³ the research team engaged in contextual inquiry to gain an understanding of the implementation context of MAPS+.^{14 15} Semistructured interviews with key constituents in Ryan White CARE Act-funded clinics in Philadelphia (eg, prescribing clinicians, clinic administrators and policymakers from PDPH) identified perceived barriers and facilitators to MAPS+. These determinants served as the input for the process of implementation mapping, which included two constituent meetings. Each strategy was operationalised with specific examples for clinic settings and mapped to relevant behaviour change theories to provide a mechanistic understanding of their function. This process produced a menu of 34 strategies for the implementation of MAPS+, which was supplemented with an additional five strategies through discussions with policymakers for a final list of 39 strategies.

Aim 1: effectiveness

Adaption of MAPS+ involved task-shifting delivery to CHWs and integrating a focus on retention in care. Therefore, assessment of the effectiveness of MAPS+ is needed. Aim 1 will evaluate the effectiveness of CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the implementation period. The team hypothesises that participants receiving MAPS+ will achieve a higher rate of viral suppression and a higher rate of retention in care compared with treatment as usual.

Participants and procedures

Participants will include target users (ie, PWH not virally suppressed who are in ongoing care or out-of-care). PWH will be recruited from 10 clinics in Philadelphia participating in Data-to-Care. Data-to-Care is an evidence-based approach used by many public health departments that leverages HIV public health data to identify PWH out of care and in need of intervention.¹⁶ Eligibility criteria include: (1) documented HIV diagnosis, (2) receiving care at one of the 10 study clinics and (3) not virally suppressed as defined by at least two consecutive HIV viral loads greater than 200 copies/mL. Care status will be determined from an out-of-care list generated by PDPH that includes HIV laboratory surveillance data and clinic appointment data, which is reconciled in monthly meetings at each study clinic. This list will serve as a sampling frame from which CHWs can contact individuals for potential participation.

CHWs will recruit potential participants via multiple mechanisms including ad hoc referral from HIV care providers, psychologists and medical case managers. A list of clinic patients lost to care or known to be virally unsuppressed will be used for ‘cold calls’ by CHWs. In addition, CHWs will join clinic conferences for patients lost to care and/or unsuppressed as allowed by local practice. Recruitment will emphasise that MAPS+ is offered as an additional service to all clinic patients. Recruitment will aim to enrol 390 participants. CHWs will administer MAPS+ per protocol. The intervention will consist of four in-person (ie, in clinic) or virtual sessions (ie, via telephone or videoconference), followed by weekly and then monthly check-ins via telephone calls or text messaging. The initial session lasts approximately 60–90 min, with follow-up session durations varying (range: 5–30 min). Strategies to retain participants include sending a reminder text the day before appointments, obtaining emergency contact information for participants and team meetings for CHWs. Ad hoc interactions initiated by participants for new problems that arise or lack of resolution of existing problems for which they want CHW input will be allowed.

Measures

Given the focus on the effectiveness of MAPS+, the primary outcome variable will be HIV suppression, the biomarker in PWH most strongly associated with protection from morbidity and mortality and prevention of transmission to others. HIV suppression will be defined as <200 copies/mL within 3 months of a participant’s end of enrolment in the trial.

A secondary outcome variable will include retention in care. Retention in care will be defined by the measure developed by the Health Resources and Services Administration (HRSA), which includes (at least one visit with an HIV provider in each 6-month interval of the follow-up year with 60 or more days between clinic visits). Data will be obtained from CAREWare, the electronic database that reports clinical data to PDPH, at the conclusion of a participant’s enrolment in the trial.

Multiple exposure variables will be obtained from CAREWare to allow for control of potential confounding variables in the effectiveness analyses. Measures include: age, race/ethnicity, sexual orientation, HIV history (eg, mode of acquisition and opportunistic infections), HIV treatment history, substance use, presence of comorbid mental health disorders, income and housing information.

Analysis

The primary analysis will evaluate the effectiveness of MAPS+ on achieving viral suppression. Logistic regression models will test the association between MAPS+ exposure (dichotomised as receiving MAPS+ or not) and viral suppression. A modified intention-to-treat model will define exposed as being at least one interaction between a CHW and client during which MAPS+ content was delivered. In addition, logistic regression and linear regression models will evaluate the association between MAPS+ exposure and demographic variables (eg, race, ethnicity and sexual orientation) and baseline clinical variables (eg, HIV viral load and CD4 count), respectively. To adjust for the lack of independence of observations by cluster and control for confounding by site, a dummy variable for site will be created for all models.

Multiple secondary analyses will be completed. First, to address effect modification by sex, two logistic regression models will assess the association between MAPS+ and (1) gender and (2) biological sex. Second, if the primary analysis involving demographic variables yield clinically important differences, then additional logistic regression models will be run that adjust for these variables. Third, logistic regression models will test for the association between MAPS+ exposure and retention in care.

The pattern of missingness will inform the handling of missing data.¹⁷ All analyses will be completed in R (V.3.3.3; R Core Team, 2021).

Aim 2: implementation

Given the hybrid effectiveness-implementation design, this trial will test a package of implementation strategies. Aim 2 will examine the effect of the implementation strategies on reach (primary) and cost.¹⁸ The team hypothesises that the implementation strategies will yield a high rate of reach.

Measures and procedures

Reach will be ascertained at the clinic-level. Sample size will be driven by aim 1 enrolment. Reach will be defined as the number of PWH who receive MAPS+ divided by the number of eligible PWH within the clinic referred for the intervention. CHWs will report the number of potentially eligible individuals referred to the MAPS+ programme. A secondary analysis will calculate reach as the number of PWH who received MAPS+divided by the number of eligible PWH on the clinic rolls using Data-to-Care tracking software.

Cost will be calculated using time-driven activity-based costing in implementation science.^19–21 This process will involve (1) identifying the implementation strategies and intervention activities, as well as listing the associated actions, actors and temporality; (2) determining the frequency and average duration of each implementation and intervention action by actors, as well as calculating actors’ total time spent on each action; (3) determining the price per hour of each actor; (4) determining non-personnel and their associated expenses and (5) calculating total costs. Action frequency and duration will be obtained from study documentation on the research process (eg, number of counselling sessions and duration of session). Most of the anticipated actions are standard, which will increase the feasibility of estimating precise costs for the implementation strategies. A process map will leverage the implementation protocol and operational information from key personnel most familiar with the study (eg, project managers) to outline the implementation process and produce a transparent estimation of cost.

Analysis

The primary analysis will assess the reach of MAPS+. To determine a range of estimates, 95% CIs around the proportion reached will be calculated. To compare the reach by site, χ² tests will calculate the proportion reached by clinic. If the analysis yields differences by clinic, then the association between clinic characteristics and reach will be assessed. In addition, χ² tests will evaluate the association between patient sex and reach.

Cost analyses will focus on calculating the frequency and duration of the key measures. The cost of each component of the implementation strategy (eg, training activities) will be determined per clinician and site. Calculations will include opportunity cost of clinician time to capture true costs. Analyses will calculate total hours spent, as well as associated costs by actor, action and implementation strategy for comparison to the total implementation cost. Sensitivity analyses will estimate the implementation costs under hypothetical scenarios to evaluate potential cost savings (eg, different frequencies and unit durations of actions).

Aim 3: processes, mechanisms and sustainment

This trial will deploy three primary strategies for the delivery of MAPS+. To optimise the effectiveness, efficiency and transportability, it is critical to understand the processes and mechanisms of these implementation strategies (ie, causal pathway between the strategy and outcomes).²² Further, production of an implementation blueprint requires particular attention to scalability. Thus, aim 3 will examine processes and mechanisms of the implementation strategies for MAPS+.

Participants and procedures

Interviews will occur concurrently with the trial throughout years two to four to attain better understanding of the implementation process across various stages. To elicit diverse perspectives, 56 individuals will be recruited via email from four stakeholder groups: clinic staff (N=30), CHWs (N=6), PWH (N=15) and HRSA leaders (N=5). Purposive sampling will ensure recruitment across treatment arms and time.²³ Interviews with HRSA leaders will occur in year four to understand potential scalability at the national level pending effectiveness of the implementation strategies. All participants will provide demographic information before proceeding with the interview.

The CFIR will inform the development of a semi-structured interview guide. The CFIR provides a comprehensive framework for the evaluation of implementation determinants.¹³ Interviews will include questions across all five CFIR domains as well as specific mechanisms through which implementation strategies operate (eg, self-efficacy) and sustainability (eg, clinic’s plan to sustain MAPS+ delivery and needed support). All interviews will be conducted in English via phone by a member of the research team trained in qualitative research. Interviews will be audiorecorded and transcribed. Transcripts will be uploaded into NVivo Qualitative Data Analysis Software (QSR International, V.12, 2018) for data management and analysis.

Analysis

Analysis will follow an integrated approach combining deductive and inductive methods.²⁴ Constructs from the CFIR will be selected a priori, and modified grounded theory will identify recurrent themes that emerge from the transcripts. An initial coding scheme will be applied to a subset of transcripts by two independent investigators. On achieving strong reliability (ie, kappa statistic greater than 0.80), the final coding scheme will be applied to all transcripts by one investigator. To increase rigour and ensure reliability, 20% of the transcripts will be independently double coded by an additional investigator. Disagreements will be resolved through team discussion. Analyses will evaluate all stakeholder groups together, as well as stratified to assess for differences in themes by group.

Ethics and dissemination

Ethics

This trial was registered on ClincalTrials.gov on September 23, 2020 (NCT04560621). The institutional review board (IRB) at the city of Philadelphia serves as the primary IRB (per preference of participating sites), where approval was granted on 21 December 2020 (#2020-59). The University of Pennsylvania executed a reliance agreement on 27 May 2021. Due to change of institution for one of the MPIs, Northwestern University executed a reliance agreement on 24 October 2022 and completed additional administrative review on 6 December 2022. A safety monitoring committee (SMC) comprised experts in implementation science, biostatistics, behavioural interventions and infectious diseases oversee this study. The SMC convened an introductory meeting on 10 May 2021, which will continue twice a year. All participants will provide informed consent before proceeding with enrolment (online supplemental Additional file 3). All personal information will be kept confidential by the research team. Protocol modifications and adverse events will be reported to the respective IRBs.

Dissemination

Dissemination will include deliverables to reach individuals at multiple levels. First, findings from each of the aims will be submitted to peer-reviewed journals. Given the valuable insights for both the implementation science and HIV research communities, outputs will target a diverse set of journals. Second, this research will be presented at academic conferences of varying foci. Third, to increase accessibility to the findings, dissemination will also include lay publications (eg, op-eds). Fourth, to expand the reach of this research, the research team will share the findings in multiple presentations, including meetings with leadership at PDPH and meetings with community partners. Fifth, the training manual will be made available for download on a dedicated website.

Discussion

This research includes multiple innovations. First, adaptation of MAPS+involved task-shifting the intervention to CHWs. Although common in low-income and middle-income countries, task-shifting is not common practice in the USA. Such change in delivery may decrease burden on the clinical team and increase reach of the evidence-based practice to a vulnerable population, thus overcoming the typical implementation-as-usual approach that results in failure. Second, this study will employ a hybrid effectiveness-implementation trial, a design seldomly used in HIV research.²⁵ This approach enables the dual evaluation of clinical and implementation outcomes to close the research-to-practice gap. Third, this research leverages a partnership between the PDPH, health system and research team that will foster sustainability of the work and serve as an example for other cities.²⁶ Fourth, this research will pragmatically assess the cost of the implementation approach and explore implementation mechanisms, two emerging topics critical for advancing the field of implementation science.²⁷

The original protocol contains differences from the procedures reported in this manuscript. Modifications occurred due to several reasons that emerged in the beginning stages of the study. First, the study launched during the COVID-19 pandemic. Protocols required alterations to accommodate infectious disease control procedures, such as space constraints, seating of CHWs in clinics, desire to have less non-essential staff present in clinics and patients’ comfort with telehealth technology. Second, the clinics had preferences on who would lead the process of hiring the CHWs. These different arrangements required meeting with each site individually to tailor the communication and CHW oversight process to the local needs. The process resulted in half of the CHWs being directly employed by the research team (and deployed within the site) and half of the CHWs being directly employed by the clinic (and working with the research team). These differences in implementation will be explored qualitatively. Third, participant recruitment difficulties arose. The original protocol conceptualised the research to be a pragmatic trial (ie, MAPS+ offered as part of standard of care not requiring consent), which proved difficult due to constraints including the requirement by the IRB of record to obtain written informed consent for participation. This has offered challenges in ascertaining reach. These modifications provide valuable insights for implementation research, as issues can arise in clinical trials despite well-planned procedures. Successful completion of the research will likely require additional adjustment.

This research has the potential to yield multiple public health benefits. If findings demonstrate the effectiveness of a task-shifted behavioural intervention, this work will produce an evidence-based practice that effectively targets two key measures for HIV treatment, adherence and retention in care. The evaluation of implementation processes will identify the best strategies for increasing access to MAPS+. These anticipated outcomes align with multiple EHE pillars.¹ By increasing viral suppression through improved medication adherence, the risk of HIV transmission among the population will decrease, which will reduce the incidence of HIV and contribute to EHE in Philadelphia. Insights can be applied beyond the study setting and target intervention. Future efforts can leverage these findings to scale up implementation of MAPS+ in other HRSA-funded clinics, for example. Further, Philadelphia is 1 of the 48 prioritised EHE counties, so this research can inform both local EHE efforts as well as national goals. In addition, this research may demonstrate the feasibility of implementing a task-shifted behavioural intervention, which may serve as a model for other behavior-focused evidence-based practices for HIV treatment.

Ethics statements

Patient consent for publication

Not applicable.