HIV-related stigma, depression, and social support are associated with health-related quality of life among patients newly entering HIV care.

Entering HIV care is a vulnerable time for newly diagnosed individuals often exacerbating psychosocial difficulties, which may contribute to poor health-related quality of life (HRQOL) ultimately influencing health behaviors including ART adherence, the driver of viral load suppression. Understanding HRQOL in people newly entering HIV care is critical and has the potential to guide practice and research. This exploratory cross-sectional study examined demographic, clinical, and psychosocial factors associated with limitations in four specific domains of HRQOL among persons initially entering outpatient HIV care at four sites in the United States (n = 335). In the unadjusted analysis, female gender was significantly associated with sub-optimal HRQOL with women having increased odds of reporting HRQOL challenges with pain, mood, mobility, and usual activity when compared to men. The adjusted models demonstrated attenuation of parameter estimates and loss of statistical significance for the associations with impaired HRQOL observed among women in unadjusted analyses, suggesting psychosocial factors related to HRQOL are complex and interrelated. Findings are consistent with a robust literature documenting gender-related health disparities. Programs aimed at improving HRQOL for persons initially entering HIV care are warranted generally, and specifically for women, and must address modifiable psychosocial factors via mechanisms including coping and social support.

Lost to Care and Back Again: Patient and Navigator Perspectives on HIV Care Re-engagement.

Engagement in HIV care is critical to achieve viral suppression and ultimately improve health outcomes for people living with HIV (PLWH). However, maintaining their engagement in care is often a challenging goal. Utilizing patient navigators, trained in an adapted ARTAS intervention, to help re-engage out-of-care PLWH has proven to be a valuable resource. This qualitative study describes the encounters between PLWH (n = 11) and their care re-engagement navigators (n = 9). Participants were interviewed in-person; interviews were transcribed and analyzed using the strengths model of case management. PLWH shared how working with navigators increased their motivation to return to HIV care and assisted them to overcome barriers that were a hindrance to care engagement. Navigators described a strengths-based approach to working with their clients, thus helping facilitate PLWH care re-engagement goals and successes. Results from this study may inform the development of effective HIV navigation programs to re-engage out-of-care PLWH, often the hardest-to-engage.

Characteristics of Out-of-Care Patients Who Required a Referral for Re-engagement Services by Public Health Bridge Counselors Following a Brief Clinic-Based Retention Intervention.

The NC-LINK Project initiated both clinic-based retention services and state public health bridge counselor-based (SBCs) re-engagement services to retain and re-engage people living with HIV infection (PLWH) in care. The goal of this project is to compare efforts between clinic-based retention and SBC re-engagement services to determine whether patients are more or less likely to remain in HIV care services. Clinic appointment data were used to identify patients who were last seen more than 6-9 months prior. Patients either received clinic-based retention services only or were subsequently referred to the SBC re-engagement intervention if the retention services were unsuccessful. The frequency of re-engagement in care (180 days) and HIV suppression (VLS, within 1 year) was examined for patients in these two groups. The SBC group was less likely to have VLS at the visit prior to referral (adjusted OR 2.04, 95% CI 1.53, 2.72). Patients who were referred to the SBC were less likely to re-engage in care within 180 days as compared to those who received clinic-based retention services only (adjusted OR 0.29, 95% CI 0.21, 0.41).

Results of a Social Network Testing Intervention for HIV in Infectious Disease Clinics.

Social networks can be leveraged to identify undiagnosed HIV-infected individuals. The NC-LINK clinic-based testing initiative utilized these networks to achieve a 5% (95% CI 1.1-8.9%) positivity rate by providing free HIV testing to anyone who accompanied an HIV-infected patient to their clinic appointment. During 2013-2015, 120 individuals were tested at two clinics (N > 1000 patients each) in North Carolina, with 5 new and 6 total positive results. Of these, three linked to care within 30 days and all within 365 days. If expanded further, this initiative could significantly increase the number of HIV-infected individuals aware of their status.

Lessons Learned from Applying a Modified Learning Collaborative Model to Promote Change in Regional and Statewide HIV Care Systems.

The Health Resources and Services Administration Special Projects of National Significance launched the Systems Linkage and Access to Care for Populations at High Risk of HIV Infection Initiative in 2011. Six state departments of health were funded to utilize a modified Learning Collaborative model to develop and/or adapt HIV testing, linkage to care and retention in care system-level interventions. More than 60 Learning Sessions were held over the course of the Learning Collaborative. A total of 22 unique interventions were tested with 18 interventions selected and scaled up. All interventions were created to impact services at a systems level, with standardized protocols developed to ensure fidelity. Our findings provide key lessons and present considerations for replication for use of a modified Learning Collaborative to achieve state-level systems change.

"I don't have to do this all by myself": Systems Navigation to Ensure Continuity of HIV Care for Persons Leaving Prison.

Ensuring continuity of and retention in care after release from prison is critical for optimizing health outcomes among people living with HIV. As part of a large federal initiative, we conducted qualitative interviews (n = 24) with individuals living with HIV and recently released from prison in four states to understand their experiences in different navigation interventions to improve access to HIV care post-release. Interventions were delivered only in prison, only in the community, or in both settings. While the interventions varied by design, overall, participants appreciated the breadth of support received from interventionists, including health system navigation, case management and social support. Even when individuals leaving prison were returning to clinics that they were familiar with, systems navigation supported continuity of care. Our findings elucidate why navigational support was instrumental, and underscore the value of a variety of types of navigation programs in facilitating continuity of care and reintegration post-prison.

"Closing the Loop" Developing State-Level Data Sharing Interventions to Promote Optimum Outcomes Along the HIV Continuum of Care.

This manuscript describes the experiences of three state departments of health (SDoH) that successfully launched data sharing interventions involving surveillance and/or patient data collected in clinics to improve care outcomes among people living with HIV. We examined 58 key informant interviews, gathered at two time points, to describe the development and implementation of data sharing interventions. We identified three common themes across states' experiences: creating standard practices, fostering interoperability, and negotiating the policy environment. Projects were successful when state teams adapted to changing circumstances and were committed to a consistent communication process. Once implemented, the interventions streamlined processes to promote linkage and retention in care among low-income populations living with HIV. Despite using routinely collected data, key informants emphasized the labor-intensive process to develop and sustain the interventions. Lessons learned from these three state experiences can help inform best practices for other SDoH that are considering launching similar interventions.

HIV Standard of Care for ART Adherence and Retention in Care Among HIV Medical Care Providers Across Four CNICS Clinics in the US.

Despite the issuance of evidence-based and evidence-informed guidelines to improve engagement in HIV care and adherence-related outcomes, few studies have assessed contemporary adherence or engagement support practices of HIV care providers in US clinics. As a result, the standard of HIV care in the US and globally remains poorly understood. This programmatic assessment approach aimed to identify the strengths and gaps in the current standard of HIV care from the perspective of HIV care providers. A self-administered Standard of Care measure was developed and delivered through Qualtrics to HIV care providers at four different HIV care sites as a part of a multisite intervention study to improve engagement in HIV care and ART adherence. Providers were asked to provide demographic and clinic specific information, identify practices/strategies applied during typical initial visits with HIV-positive patients and visits prior to and at ART initiation, as well as their perceptions of patient behaviors and adequacy of HIV care services at their clinics. Of the 75 surveys which were completed, the majority of respondents were physicians, and on average, providers have worked in HIV care for 13.5 years. Across the sites, 91% of the providers' patient panels consist of HIV-positive patients, the majority of whom are virally suppressed and 1/5 are considered "out of care." Few resources were routinely available to providers by other staff related to monitoring patient adherence and engagement in care. During typical initial visits with HIV positive patients, the majority of providers report discussing topics focused on behavioral/life contexts such as sexual partnerships, sexual orientation, disclosure, and other sources of social support. Nearly all providers emphasize the importance of adherence to treatment recommendations and nearly 90% discuss outcomes of good adherence and managing common side effects during ART start visits. Overall, providers do not report often implementing practices to improve retention in care. Survey results point to opportunities to enhance engagement in HIV care and improve ART adherence through systematic data monitoring and increased collaboration across providers and other clinic staff, specifically when identifying patients defined as "in need" or "out of care." Trial Registration: Clinicaltrials.gov NCT01900236.

Past Care Predicts Future Care in Out-of-Care People Living with HIV: Results of a Clinic-Based Retention-in-Care Intervention in North Carolina.

Poor retention in care is associated with higher viral load (VL) results and decreased rates of viral load suppression (VS) in people living with HIV (PLWH). Therefore, improving retention in HIV care is a priority of national significance. The NC-LINK Retention Project utilized a systematic approach to identify, locate, and attempt to return to care patients who did not attend a clinic appointment for 6-9 months. Clinical and surveillance data were used to evaluate associations between patient characteristics and VL outcomes. Between January 1, 2013 and December 31, 2014, 1118 patients at participating clinics were identified as out-of-care and referred to retention staff. Of these, 712 (64%) were located in North Carolina. Patients with recent prior medical care (aPR 1.43, 95% CI 1.25, 1.66) and recent VS (aPR 1.28, 95% CI 1.16, 1.41) were more likely to be located. Of located patients, 58% re-engaged in care within 90 days of retention referral. Patients who achieved VS within 180 days were more likely to be 40-49 years (aPR 1.19 95% CI 1.01-1.40; compared with 18-29 age group), had insurance at their last visit (aPR 1.19 95% CI 1.01-1.77), had a care visit in the prior year (aPR 1.37 95% CI 1.05-1.77), and had VS at the prior care visit (aPR 2.54 95% CI 1.98-3.25). Clinic-based retention efforts may be effective at helping PLWH decrease out-of-care periods, but prior patterns of care usage persist.

HIV patient retention: the implementation of a North Carolina clinic-based protocol.

Decreased visit attendance leads to poor health outcomes, decreased viral suppression, and higher mortality rates for persons living with HIV. Retention in care is an important factor in improving health status for people living with HIV but continues to be a challenge in clinical settings. This paper details the development and implementation of the NC-LINK Retention Protocol, a clinic-based protocol to locate and reengage out-of-care patients, as part of overall clinic retention efforts. The protocol was implemented as one of four interventions of the NC-LINK Systems and Linkages Project, a multi-site initiative funded by the HIV/AIDS Bureau and the Special Projects of National Significance. Lists of out-of-care patients who had not received HIV medical care in over nine months and did not have a future appointment were created each month. Patient navigators, case managers, and other staff then followed a standardized protocol to locate and reengage these patients in care. A total of 452 patients were identified for reengagement services. Of those, 194 (43%) returned to care, 108 (24%) had another definitive outcome (incarcerated, deceased, or relocated) and 150 (33%) were referred for additional follow-up to locate and reengage in care. In summary, 67% of patients were located through the efforts of the clinic staff. The results of this intervention indicate that it is possible to successfully integrate a protocol into the existing infrastructure of a clinic and reengage a majority of out-of-care patients into medical care.

Improvements in Depression and Changes in Fatigue: Results from the SLAM DUNC Depression Treatment Trial.

Fatigue and depression are common co-morbid conditions among people with HIV infection. We analyzed a population of HIV-infected adults with depression, who were enrolled in a depression treatment trial, to examine the extent to which improvements in depression over time were associated with improvements in HIV-related fatigue. Data for this analysis come from a randomized controlled trial to evaluate the effectiveness of improved depression treatment on antiretroviral adherence. Fatigue was measured using the HIV-Related Fatigue Scale, and depressive symptoms were measured with the Hamilton Depression Rating Scale. Participants (n = 234) were on average nearly 44 years of age and predominantly male, black or African American, and unemployed. Individuals who experienced stronger depression response (i.e., greater improvement in depression score) had larger decreases in fatigue. However, even among those who demonstrated a full depression response, nearly three-quarters continued to have either moderate or severe fatigue at 6 and 12 months.

Balancing Contamination and Referral Bias in a Randomized Clinical Trial: An Application of Pseudo-Cluster Randomization.

In randomized trials of provider-focused clinical interventions, treatment allocation often cannot be blinded to participants, study staff, or providers. The choice of unit of randomization (patient, provider, or clinic) entails tradeoffs in cost, power, and bias. Provider- or clinic-level randomization can minimize contamination, but it incurs the equally problematic potential for referral bias; that is, because arm assignment of future participants generally cannot be concealed, differences between arms may arise in the types of patients enrolled. Pseudo-cluster randomization is a novel study design that balances these competing validity threats. Providers are randomly assigned to an imbalanced proportion of intervention-arm participants (e.g., 80% or 20%). Providers can be masked to the imbalance, avoiding referral bias. Contamination is reduced because only a minority of control-arm participants are treated by majority-intervention providers. Pseudo-cluster randomization was implemented in a randomized trial of a decision support intervention to manage depression among patients receiving human immunodeficiency virus care in the southern United States in 2010-2014. The design appears successful in avoiding referral bias (participants were comparable between arms on important characteristics) and contamination (key depression treatment indicators were comparable between usual care participants managed by majority-intervention and majority-usual care providers and were markedly different compared with intervention participants).

Detecting HIV among persons accompanying patients to an infectious diseases clinic.

BACKGROUND: Infectious diseases (ID) clinics are locations where members of at risk social networks, including sex partners of HIV-infected patients, make contact with a medical care setting when they accompany HIV-positive patients to appointments. METHODS: We implemented a free point-of-care rapid HIV testing program for anyone accompanying a patient to the University of North Carolina ID clinic. Acceptability of the program among the general clinic population was assessed via an anonymous survey 1 year after program implementation. Basic frequencies of those who underwent and received results of rapid HIV testing, the proportion of positive rapid tests and confirmatory HIV tests performed, and the level of University of North Carolina ID clinic patient satisfaction with the HIV testing program were calculated. RESULTS: Between October 2007 and June 2013, 450 (99.6%) of 452 individuals tested in the program received their results on the same day as testing. Twenty-two individuals (4.9%) tested HIV positive, of which 16 (72.7%) were newly positive, including 3 never previously tested. Excluding previously diagnosed individuals, HIV prevalence was 3.6% (16/446). Among those testing positive by rapid testing, 19 (86.4%) had confirmatory testing and immediately entered into HIV care at the clinic. CONCLUSIONS: The high positivity and confirmatory HIV rates in our program confirm that the provision of rapid HIV testing in an ID clinic capitalizes on missed opportunities among an at-risk population and allows immediate linkage to care.

Patterns of HIV service use and HIV viral suppression among patients treated in an academic infectious diseases clinic in North Carolina.

Irregular participation in HIV medical care hinders HIV RNA suppression and impacts health among people living with HIV. Cluster analysis of clinical data from 1,748 patients attending a large academic medical center yielded three HIV service usage patterns, namely: 'engaged in care', 'sporadic care', and 'frequent use'. Patients 'engaged in care' exhibited most consistent retention (on average, >88 % of each patient's observation years had ≥2 visits 90 days apart), annualized visit use (2.9 mean visits/year) and viral suppression (>73 % HIV RNA tests <400 c/mL). Patients in 'sporadic care' demonstrated lower retention (46-52 %), visit use (1.7 visits/year) and viral suppression (56 % <400 c/mL). Patients with 'frequent use' (5.2 visits/year) had more inpatient and emergency visits. Female, out-of-state residence, low attendance during the first observation year and detectable first-observed HIV RNA were early predictors of subsequent service usage. Patients 'engaged in care' were more likely to have HIV RNA <400 than those receiving sporadic care. Results confirm earlier findings that under-utilization of services predicts poorer viral suppression and health outcomes and support recommendations for 2-3 visits/year.

Modeling the impact of Trichomonas vaginalis infection on HIV transmission in HIV-infected individuals in medical care.

BACKGROUND: To assess factors associated with having a Trichomonas vaginalis (TV) infection among persons receiving care for human immunodeficiency virus (HIV) and estimate the number of transmitted HIV infections attributable to TV. METHODS: HIV clinic patients were recruited from 2 secondary prevention studies, screened by urine nucleic-acid amplification tests for sexually transmitted infections, and interviewed about risk factors (baseline, 6, and 12 months). We conducted mathematical modeling of the results to estimate the number of transmitted HIV infections attributable to TV among a cohort of HIV-infected patients receiving medical care in North Carolina. RESULTS: TV was prevalent in 7.4%, and incident in 2% to 3% of subjects at follow-up. Individuals with HIV RNA <400 copies/mL (odds ratio, 0.32; 95% CI: 0.14-0.73) and at least 13 years of education (odds ratio, 0.24; 95% CI: 0.08-0.70) were less likely to have TV. Mathematical modeling predicted that 0.062 HIV transmission events occur per 100 HIV-infected women in the absence of TV infection and 0.076 HIV infections per 100 HIV- and TV-infected women (estimate range: 0.070-0.079), indicating that 23% of the HIV transmission events from HIV-infected women may be attributable to TV infection when 22% of women are coinfected with TV. CONCLUSIONS: The data suggest the need for improved diagnosis of TV infection and suggest that HIV-infected women in medical care may be appropriate targets for enhanced testing and treatment.

Integrase Inhibitor-Based Antiretroviral Therapy Among Women Living with HIV: Data from the OPERA Cohort.

BACKGROUND: Women face unique complexities in HIV treatment yet are underrepresented in antiretroviral therapy (ART) studies. OBJECTIVE: This analysis assessed the one-year durability of the first integrase strand transfer inhibitor (INSTI)-based regimens prescribed to women in a large cohort of patients living with HIV in care. METHODS: Women with HIV who initiated their first INSTI-containing regimen between 08/12/2013 and 11/30/2015 were identified in the OPERA cohort, a collaboration of 79 US outpatient clinics. Discontinuation within the first year of treatment with an INSTI was compared between dolutegravir (DTG), raltegravir (RAL) and elvitegravir (EVG), using multivariable Cox regression and Kaplan- Meier estimates. Virologic response and regimen modifications were described and compared across INSTIs. RESULTS: A total of 537 treatment-naïve (DTG: 39%, EVG: 48%, RAL: 13%) and 878 treatmentexperienced (DTG: 57%, EVG: 29%, RAL: 13%) women were analyzed. In the first twelve months after initiation, women taking EVG or RAL were more likely to discontinue their initial INSTI than those taking DTG among both treatment-naïve (adjusted hazard ratio EVG vs. DTG: 1.59 (95% CI: 1.09, 2.39); RAL vs. DTG: 2.46 (1.49, 4.05)) and treatment-experienced women (EVG vs. DTG: 1.39 (1.02, 1.88); RAL vs. DTG: 2.17 (1.51, 3.12)). Following discontinuation of the initial INSTI, women commonly switched to a regimen containing a different drug from the INSTI class (treatment-naïve DTG: 34%, RAL: 33% EVG: 41%; treatment-experienced DTG: 23%, RAL: 19% EVG: 41%). CONCLUSION: In treatment-naïve and treatment-experienced women living with HIV, women taking DTG had the lowest risk for early (≤1 year) discontinuation.

Integrating a Statewide HIV Call Line: An Innovative and Tailored Approach for Rapid Linkage to HIV Care.

Only 80% of people living with HIV (PLWH) in the United States are linked to care, 40% are engaged in care, and 30% have achieved viral load suppression. We addressed linkage to care with a pilot program of a statewide referral call center to connect PLWH and their non-HIV specialty providers to HIV care. Callers received tailored referrals from nurses trained to work in an existing call center, using an electronic assessment tool and a comprehensive HIV provider list. Of 122 calls, 85% were from PLWH and 15% from providers calling about a patient. Overall, 88 of 104 (84.6%) PLWH and 16 of 18 (88.9%) providers accepted care referral, including 13% of PLWH callers without prior HIV care. Results indicated that the call center was an acceptable strategy for HIV care referral; the use of an existing call center facilitated feasibility of the program and improved linkage to HIV care.

The North Carolina HIV Bridge Counselor Program: Outcomes From a Statewide Level Intervention to Link and Reengage HIV-Infected Persons in Care in the South.

BACKGROUND: To improve the HIV continuum of care, a team of field service interventionists (State Bridge Counselors, SBC) was developed through a state public health system and provided brief (1-2) contacts for linkage of newly diagnosed persons with HIV and reengagement of persons living with HIV (PLWH) who were not in care. SETTING: North Carolina, United States. METHODS: Service data from January 2013 to June 2015 were analyzed to determine characteristics of clients referred to SBCs, proportions linked or reengaged in care, and/or achieved viral load suppression (VLs). We evaluated associations between client characteristics and outcomes using multivariable analyses and estimated odds ratios (OR) with 95% confidence intervals (CI). RESULTS: SBCs provided linkage services to 299 newly diagnosed individuals and reengagement services to 606 PLWH throughout North Carolina. Among persons who received linkage services, 189 (63%) had evidence of care within 90 days of referral and 205 (69%) had VLs within a year. Among PLWH who received reengagement services, 278 (46%) had care within 90 days and 308 (51%) had VLs within a year. Persons aged 30-39 years (OR, 2.1; 95% CI, 1.1 to 3.9) and 40-49 years had an increased likelihood (OR, 2.4; 95% CI, 1.1 to 5.2) of linkage within 90 days compared with persons aged 18-29 years. Non-white PLWH had an increased OR of 1.7; (95% CI, 1.2 to 2.5) of reengagement compared with whites. CONCLUSIONS: Our SBC program successfully implemented a "low-touch" approach to provision of linkage and reengagement services, demonstrating that public health resources can be used to address the HIV care continuum on a statewide level.

A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

BACKGROUND: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. OBJECTIVE: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. METHODS: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). RESULTS: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. CONCLUSIONS: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. TRIAL REGISTRATION: Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v).

Barriers and Facilitators to Retaining and Reengaging HIV Clients in Care: A Case Study of North Carolina.

Retention in HIV care is critical to decrease disease-related mortality and morbidity and achieve national benchmarks. However, a myriad of barriers and facilitators impact retention in care; these can be understood within the social-ecological model. To elucidate the unique factors that impact consistent HIV care engagement, a qualitative case study was conducted in North Carolina to examine the barriers and facilitators to retain and reengage HIV clients in care. HIV professionals (n = 21) from a variety of health care settings across the state participated in interviews that were transcribed and analyzed for emergent themes. Respondents described barriers to care at all levels within the HIV prevention and care system including intrapersonal, interpersonal, institutional, community, and public policy. Participants also described recent statewide initiatives with the potential to improve care engagement. Results from this study may assist other states with similar challenges to identify needed programs and priorities to optimize client retention in HIV care.