The Cooperative Re-Engagement Clinical Trial (Project CoRECT) protocol has been described elsewhere [9, 11]. Briefly, sites in Connecticut, Massachusetts, and Pennsylvania followed a general study protocol with site-specific variations in implementation. In Connecticut, CoRECT was implemented in 23 clinics across Bridgeport, Hartford, and New Haven counties between 2014 and 2018 through a partnership between local departments of public health and Yale School of Medicine. Participants included PWH considered to be newly out of care, defined as not having a provider visit, CD4 count, or a viral load test for at least 6 months since their last visit or measurement. We assessed engagement by reconciling surveillance records of public health departments with clinical records data. Participants were randomized either to the clinic’s standard of care or to the study intervention arm. Standard of care varied by clinic, ranging from no follow-up to routine phone calls to patients who missed appointments. In the intervention arm, the Connecticut Department of Public Health employed one DIS per county tasked with locating and re-engaging participants in care. The main outcomes of the study were re-engagement in care at 90 days, retention in care, and viral suppression at 12 months. In this mixed-methods analysis, we report the intervention fidelity, the DIS workflow, patient-reported and DIS perceptions about facilitators and barriers to re-engagement in care.

The Anti-Retroviral Treatment and Access to Services (ARTAS) is an evidence-based intervention that was designed to target newly-diagnosed PWH with the goal of linking them to HIV care [18]. ARTAS, when delivered as intended, requires 5 one-on-one individual sessions conducted between a linkage coordinator (a person conducting ARTAS sessions with PWH) and a newly diagnosed PWH over 90 days with a focus on strengths-based assessments and coordination with community resources. We tailored ARTAS not for newly diagnosed PWH, but for those who were recently out-of-care and the use of DIS to deliver the adapted ARTAS intervention (called ARTAS+). The DIS for CoReCT were trained for HIV re-engagement based on a curriculum that focused on other populations at the Connecticut Department of Public Health (CTDPH) (i.e., those in the Sexually Transmitted Diseases Partner Notification Program) [19] along with a literature review. As DIS viewed their work as an ‘acute’ linkage intervention, one important adaptation was abbreviating the original intervention to allow for rapid delivery and transition to community case managers. Within the scope of ARTAS+, DIS were tasked with implementing several semi-structured sessions over a 90-day period or until PWH were re-engaged in HIV care (i.e., based on a completed clinic visit). For those who were linked to care, the intervention was deemed concluded. ARTAS+ was designed to utilize a patient-driven approach, with DIS conducting structured individual sessions and active, community-based case management, meeting patients in their environments and coordinating linkage to available community resources when needed, including both formal (e.g., housing agencies and food banks) and informal (e.g., support groups) resources. An integral part of ARTAS+ was building a collaborative relationship between DIS and out-of-care patients. ARTAS+ was flexibly framed with carefully placed skip patterns, allowing for deviations from a linear progression through sessions and acknowledging that not all patients would complete all three sessions. The adapted intervention provided a basic framework to help DIS tailor their interactions to address unique challenges in a personalized and effective way.

DIS training encompassed ARTAS+-specific content, including a session on the intervention protocol, a workshop on sexual and injection drug use behaviors, risk reduction and treatment retention strategies, and 1-on-1 booster sessions with role plays on protocol content. The training also included a standard DPH-required 21.5-hour module titled “Passport to Partner Services.”

DIS were then trained to deliver ARTAS+ components, including conducting the Barriers to Care (B2C) survey and strengths-based assessments, encouraging PWH to use their strengths, abilities, and skills to re-engage in care. ARTAS+ prioritized conducting structured sessions with PWH in their environment as part of community-based case management, and included advocating on behalf of the PWH to link them to medical care and other needed services. DIS were instructed to use their discretion in applying all or some components of ARTAS+ as needed. The ARTAS+ intervention framework is outlined in Appendix A.

DIS were asked to enter data and maintain field notes in an internal database, HARMSWeb, housed within the Connecticut Department of Public Health. These notes enabled us to analyze how frequently DIS utilized individual ARTAS+ components and recorded communication types documented in the Fidelity Assessment Form (Appendix B). Additional information included final outcomes of DIS’s attempts to locate patients (e.g., returned to care, incarcerated, unable to locate, etc.) and visit-related details for those who returned to care (e.g., date of visit). The B2C survey captured self-reported challenges to HIV care, including attitudes and perceptions about HIV and health, issues with the medical facility and provider, time management and organizational skills, health insurance and access to medical care, social and supportive services, and other potential barriers (Appendix C). We conducted two in-depth interviews with DIS to understand their experiences working in the field. These data were used to better understand fidelity to the ARTAS+ implementation.

Descriptive statistics are reported for the ARTAS+ fidelity, communication types, B2C survey, re-engaged status of participants randomized to DIS, and retention status at 90 days using frequencies and percentages. For the ARTAS+ fidelity analysis, the numerator was the number of times the DIS reported completing the intervention element, and the denominator was the total number of completed Fidelity Assessment Forms by DIS in their respective counties for each component. In the B2C survey, the numerator was the number of completed surveys. All analyses were stratified by county. R statistical software was used for the analysis. For qualitative interviews, thematic analysis was used, looking for the barriers, facilitators, and the general workflow that the DIS experienced during the implementation process of the CoRECT study. The thematic codebook is provided in /Appendix D.

Project CoRECT activities were approved by the State of Connecticut Department of Public Health Human Investigations Committee (Protocol #823) and Yale University Institutional Review Board (#15100166172). As the study was deemed not to be Human Subjects Research by Yale University IRB, the informed consent procedures were waived.

The study is registered at www.clinicaltrials.gov as NCT02693145.

As previously reported, there were 333 PWH who were randomized to the DIS, of which 170 (51.1%) were re-engaged in care within 90 days as defined by surveillance data using intention-to-treat analysis [13]. For those randomized to the DIS arm, 44 (57.1%), 59 (46.5%), and 66 (51.9%) PWH were re-engaged in Bridgeport, Hartford, and New Haven, respectively. Regardless of the ultimate outcome of re-engagement in care at 90 days, among those randomized to DIS (N=333), 192 (57.6%) completed some component of ARTAS+ as shown in Table 1, stratified by the county. Key fidelity measures included completion of the B2C survey for 183 (95%), the strengths-based assessment for 108 (56%), and encouraging patients to use their abilities to link to care for108 (56%), conducting one or more structured sessions with the patient for 67 (35%), conducting active community-based case management for 55 (29%), and advocating on the patient’s behalf to link them to care and other needed services for 83 (43%) participants. Additionally, DIS reported that 112 (58%) of the patients were receptive to working on overcoming barriers. The completion of ARTAS+ components by county is shown in Table 1.

Field reports reflect “as treated” analysis as DIS categorized return to care based on actual completed clinic visits. We previously reported that among those randomized to DIS (n=333), 93 (27.9 %) returned to care based on completed clinic visits; 72 (21.6%) could not be located; 52 (15.6%) were located but declined to participate [13]. As shown in Table 2, even among the sample that re-engaged at 90 days (n=170 based on surveillance data), 80 (47.1%) were attributable to DIS efforts with variations observed across counties.

Of 333 patients assigned to DIS, 183 (55%) reported at least one barrier on the B2C survey. The most commonly reported barriers pertained to (a) attitudes and perceptions about health, such as I didn’t feel sick (28%) and I didn’t want to go (19%); (b) challenges with the medical facility: the clinic’s hours didn’t match times when I could get there (20%); and (c) time management and organization: I couldn’t take time off from work or school (27%), and I forgot (31%). A total of 54 (30%) participants responded that they had other reasons why they had not remained in HIV care (Table 3). These reasons included being out of state, not being aware that they were out-of-care, either having a scheduled or a recent visit or following up every 12 months with their provider. Most of the participants reported more than one barrier to HIV care access, with 121 (67%) reporting at least two barriers (Figure 1).

All three DIS were invited for the in-depth interviews, but only two were able to participate because of time constraints. During the interviews, the DIS provided a detailed description of their workflow. They also identified two general types of participants, those who according to the DIS did not perceive themselves as being out-of-care and were relatively easy to re-engage, and those with medical and social comorbidities or social determinants of health that posed additional challenges to re-engagement.

The DIS described their workflow as follows: after receiving the list of participants following the data reconciliation process [13], they delivered the names to their supervisors in the DPH for phone number and address search. DIS reported that phone numbers would often be out of service, and in those cases, DIS visited patients at home. If patients were not at home, DIS left a letter at the door with a short message and contact information. Following a two-week period, if DIS did not hear back from patients, they conducted a second home visit:

“First, I would hand over all the information to my supervisor, the patient information, she would do a LexisNexis [patient dataset] search. With that, the first thing I do is if I have a phone number, I call. Nine times out of ten they just were not in service … If they’re not there, I leave the letter at the door. I give them a couple of weeks and then, if I don’t hear back from them, I go do a second visit. If the letter’s there, I just take it with me and then there’s not much I can do at that point.”

Following communication with DIS, patients would schedule clinic visits on their own or request help from DIS. DIS reported conducting home visits for nearly half of the sample randomized to them and deemed this type of communication helpful. In a few cases, DIS provided transportation to clinic visits. The need for transportation varied across urban and rural areas, with patients in the urban areas having better access to public transportation.

DIS often had to adopt an advocacy role, accompanying patients to clinic visits for support or to help them communicate with their providers:

“If they wanted me to go in, I just sat there for some of them and for some of the cases I had to just talk for them, in a sense, or like “translate” what the doctor was saying to them because they just didn’t understand.”

Lastly, DIS reported that to be able to build rapport with participants, they often had to abandon the scripted ARTAS+ structure and adjust the way of communication with individual patients, adopting a more informal approach.

In qualitative interviews, unlike strategies reported in the original ARTAS intervention that used mostly in-person contact, text messaging was the most commonly used mode of communication, followed by phone calls. The DIS reported that they tried to call patients at least once before starting text messaging to introduce themselves and instruct them to refrain from mentioning their diagnosis, medications, and provider names in text messages for privacy. The DIS reported that they only used Facebook to visually identify patients, but rarely resorted to messaging them there.

The DIS visited approximately 50% of patients at home, and sometimes scheduled meetings in a car or chain restaurants in cases when they wished to be discreet:

“Patients who were very discreet, would not meet [me] at their home. I have cases where I met in my car, Dunkin Donuts, one at Subway.”

The DIS reported not using video calls or any other similar services and did not consider them necessary.

The DIS reported that a large proportion of PWH did not perceive themselves as being truly out of HIV care. Some of them had been scheduling clinic visits once every 12 months, others missed a visit and forgot to reschedule. Once these participants were notified that they were out of care, they frequently scheduled a visit to re-engage. These participants were often taking their medications and had achieved an undetectable viral load. In these cases, the DIS viewed their intervention as less intensive, as a reminder phone call or a text message would be sufficient to encourage the patient to schedule a clinic visit. The DIS also proposed redefining the term “out-of-care” by extending the necessary period from 6 to 12 months. This would allow the identification of out-of-care participants who need more intensive support from the DIS:

“I would probably extend the six months out of care [period]. I would probably think that extending it to 12 months would help, because then we get those patients who are truly [out of care]”

The three medical and social comorbidities recognized as most challenging for re-engagement and retention in care by DIS were mental health problems, substance use disorders, and homelessness. DIS stated that people often needed to take care of these conditions in order to be successfully retained in HIV care, and DIS were often providing support to link them to appropriate care, including mental health and substance use clinics:

“[after getting them set up with an HIV appointment] I would get them hooked up either to mental health services or substance abuse clinic. Because, at that point, if they’re not managing their mental health and their substance abuse, you can forget about getting them in care, keeping them in care.”

DIS also identified younger age as a risk factor for failure to re-engaging in care. Younger patients often stopped contacting DIS after setting up an appointment, often missing the visit. According to DIS, the most challenging reason for not re-engaging in care among younger patients was having a lower concern regarding their health, whereas for older patients, it was the perception that medications had harmful side-effects. Additionally, DIS reported that patients who were using services of private providers were typically more discreet, often did not perceive themselves to be out-of-care, and were less receptive to working with DIS.