Harold Katner - Academia.edu (original) (raw)

Papers by Harold Katner

Open Forum Infectious Diseases, 2020

Background In the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegra... more Background In the phase 3 FLAIR study, switching to monthly injectable long-acting (LA) cabotegravir (CAB) + rilpivirine (RPV) was noninferior to continued daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) for the maintenance of virologic suppression over 96 weeks in adults with HIV-1. Key patient-reported outcomes (PROs) through Week 96 are presented. Methods In FLAIR, ART-naive adult participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA < 50 c/mL at 16 weeks were randomized (1:1) to continue DTG/ABC/3TC or receive monthly CAB + RPV LA injections after a 4-week lead-in with daily oral CAB + RPV through Week 96. Treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) and acceptability of injections (Perception of Injection [PIN] Questionnaire) up to Week 96 were secondary endpoints. Results A total of 566 participants were randomized (median age, 34 years; 22% female); baseline characteristics w...

Journal of Racial and Ethnic Health Disparities, 2022

The state of Georgia ranks first in the rate of new diagnosis of HIV/AIDS, yet studies focused on... more The state of Georgia ranks first in the rate of new diagnosis of HIV/AIDS, yet studies focused on understanding the drivers of this epidemic in the most at-risk groups outside the Atlanta Metropolitan Statistical Area (MSA) remain sparse. Among the many consequences of this is the inability to effectively design tailored intervention programs that appropriately address the reduction of HIV/AIDS and other STDS in the state. Reducing disparities in HIV/AIDS remains an important goal in the National HIV/AIDS Strategy. Given the disproportionate burden of the HIV/AIDS epidemic among Blacks in the state of Georgia, there is a significant need to focus research attention on the sexual behavior of young people that predisposes them to increased risk of HIV/AIDS infection. The current study used latent class analysis (LCA) to examine the sexual behavior patterns of Black young adults living in Georgia. LCA results revealed a two-class fit with distinct sexual behavior patterns. Gender and educational attainment emerged as significant predictors of class membership. Our findings contribute to the vast literature showing that sexual behavior patterns of Black young adults are not homogenous, and underscore the significance of socio-demographic and contextual factors in shaping sexual risk behavior.

Substance Use & Misuse, 2021

Background Lower health literacy is associated with poorer health outcomes in people living with ... more Background Lower health literacy is associated with poorer health outcomes in people living with HIV (PLWH), but the explanatory mechanisms for these associations are not well understood. Factors such as drug use and life chaos may at least in part account for the relationship between lower health literacy and poor health outcomes. The current study tested the hypothesis that lower health literacy would predict drug use, which in turn would predict life chaos, and that all three factors would be related to poorer heath, defined by higher concentrations of HIV viremia. Methods: Patients receiving HIV care (N = 251) at an HIV clinic in the southeastern United States completed computerized interviews and permission to access their medical records. Process modeling tested direct and indirect effects of all variables in a serial mediation model. Results: The direct effects of lower health literacy and drug use were significantly related to HIV viremia. In addition, the indirect effect of...

The Lancet HIV, 2021

BACKGROUND Previous work established non-inferiority of switching participants who were virologic... more BACKGROUND Previous work established non-inferiority of switching participants who were virologically suppressed from daily oral standard of care to monthly long-acting intramuscular injections of cabotegravir plus rilpivirine over 96 weeks following a cabotegravir plus rilpivirine oral lead-in. Here, we report an evaluation of switching participants from standard of care oral regimens to long-acting cabotegravir plus rilpivirine via direct-to-injection or oral lead-in pathways. METHODS This study reports the week 124 results of the FLAIR study, an ongoing phase 3, randomised, open-label, multicentre (11 countries) trial. Antiretroviral therapy (ART)-naive participants who were virologically suppressed (HIV-1 RNA <50 copies per mL) during the 20-week induction phase with standard of care were randomly assigned (1:1) to continue the standard of care oral regimen or switch to long-acting cabotegravir plus rilpivirine (283 per group) in the 100-week maintenance phase. Randomisation was stratified by sex at birth and baseline (pre-induction) HIV-1 RNA (<100 000 or ≥100 000 copies per mL). Participants randomly assigned to long-acting therapy at baseline received a cabotegravir (30 mg) plus rilpivirine (25 mg) once daily oral lead-in for at least 4 weeks before first injection and could choose to continue long-acting cabotegravir (400 mg) plus rilpivirine (600 mg) every 4 weeks from week 100 or withdraw. At week 100, participants in the oral comparator ART group, in discussion with the investigator, could elect to switch to long-acting therapy (extension switch population), either direct-to-injection or with a 4 week oral lead-in (oral lead-in group), or withdraw. Week 124 endpoints included plasma HIV-1 RNA 50 or more copies per mL and less than 50 copies per mL (US Food and Drug Administration [FDA] Snapshot), confirmed virological failure (two consecutive HIV-1 RNA ≥200 copies per mL), and safety and tolerability. The study is registered at ClinicalTrials.gov, NCT02938520. FINDINGS Screening occurred between Oct 27, 2016, and March 24, 2017. At week 100, 232 (92%) of 253 participants transitioned to long-acting cabotegravir plus rilpivirine in the extension phase (111 [48%] in the direct-to-injection group and 121 [52%] in the oral lead-in group; extension switch population). 243 (86%) of the 283 who were randomly assigned to the long-acting therapy group continued the long-acting regimen into the extension phase. One (<1%) participant in each extension switch group had 50 or more HIV-1 RNA copies per mL; 110 (99%) participants in the direct-to-injection group and 113 (93%) participants in the oral lead-in group remained suppressed (HIV-1 RNA <50 copies per mL) at the week 124 Snapshot. The lower suppression rates in the oral lead-in group were driven by non-virological reasons. For participants in the randomly assigned long-acting group, 227 (80%) of 283 participants remained suppressed; at the week 124 Snapshot, 14 (5%) participants had HIV-1 RNA 50 or more copies per mL, including five additional participants since the week 96 analysis. The remaining 42 (15%) participants in the randomly assigned long-acting group had no virological data. Adverse events leading to withdrawal were infrequent, occurring in three (1%) participants in the extension switch population (one in the direct-to-injection group and two in the oral lead-in group) after 24 weeks of cabotegravir plus rilpivirine therapy, and 15 (5%) participants in the randomly assigned long-acting group up to 124 weeks of therapy. No deaths occurred in the extension phase. Overall, cabotegravir plus rilpivirine adverse event type, severity, and frequency were similar across all groups. Injection site reactions were the most common adverse event, occurring after 914 (21%) of 4442 injections in the extension switch population and 3732 (21%) of 17 392 injections in the randomly assigned long-acting group. Injection site reactions were mostly classified as mild-to-moderate in severity and decreased in incidence over time. Four (2%) of 232 participants in the extension switch population and seven (2%) of 283 in the randomly assigned long-acting group withdrew due to injection-related reasons. INTERPRETATION After 24 weeks of follow-up, switching to long-acting treatment with or without an oral lead-in phase had similar safety, tolerability, and efficacy, supporting future evaluation of the simpler direct-to-injection approach. The week 124 results for participants randomly assigned originally to the long-acting therapy show long-acting cabotegravir plus rilpivirine remains a durable maintenance therapy with a favourable safety profile. FUNDING ViiV Healthcare and Janssen Research & Development.

The Journal of Rural Health, 2021

PurposeTo test the efficacy of a theory‐based behavioral intervention delivered via telephone ver... more PurposeTo test the efficacy of a theory‐based behavioral intervention delivered via telephone versus clinic‐based counseling to improve HIV outcomes and reduce alcohol consumption for people at‐risk for treatment failure in a rural setting.MethodsPatients receiving HIV care (N = 240) were randomized using a computer‐generated scheme to one of three conditions: (a) telephone behavioral health counseling, (b) clinic‐based behavioral health counseling, or (c) attention control nutrition education. Behavioral counseling was delivered by either a community nurse or a paraprofessional patient navigator, with differences examined. Participants were followed for 12 months to assess medication adherence using unannounced pill counts and alcohol use measured by electronic daily text message assessments, and 18 months for HIV viral load and retention in care extracted from medical records.FindingsThere was evidence for telephone and office‐based counseling demonstrating greater medication adhe...

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2020

Background: COVID-19 and its social responses threaten the health of people living with HIV. We c... more Background: COVID-19 and its social responses threaten the health of people living with HIV. We conducted a rapid-response interview to assess COVID-19 protective behaviors of people living with HIV and the impact of their responses on HIV-related health care. Method: Men and women living with HIV (N = 162) aged 20-37 years participating in a longitudinal study of HIV treatment and care completed routine study measures and an assessment of COVID-19-related experiences. Results: At baseline, most participants demonstrated HIV viremia, markers indicative of renal disorders, and biologically confirmed substance use. At follow-up, in the first month of responding to COVID-19, engaging in more social distancing behaviors was related to difficulty accessing food and medications and increased cancelation of health care appointments, both by self and providers. We observed antiretroviral therapy adherence had improved during the initial month of COVID-19 response. Conclusions: Factors that may pose added risk for COVID-19 severity were prevalent among people living with HIV, and those with greater risk factors did not practice more COVID-19 protective behaviors. Social distancing and other practices intended to mitigate the spread of COVID-19 interfered with HIV care, and impeded access to food and medications, although an immediate adverse impact on medication adherence was not evident. These results suggest social responses to COVID-19 adversely impacted the health care of people living with HIV, supporting continued monitoring to determine the long-term effects of co-occurring HIV and COVID-19 pandemics.

Social Science & Medicine, 2020

depression symptoms (22). Furthermore, behaviors aimed to avoid stigma by concealing HIV status, ... more depression symptoms (22). Furthermore, behaviors aimed to avoid stigma by concealing HIV status, such as avoiding clinic visits and hiding medications, create barriers to care and ART adherence (23). HIV-related enacted stigma, specifically social exchanges that people experience as stigma, are therefore among the most robust barriers to engaging in HIV care and adhering to ART (24). Despite decades of stigma research, there are few empirically tested mechanisms to explain how stigma impedes ART adherence. One potential mechanism by which stigma may impact adherence is stress (25, 26), which in turn can trigger alcohol use as a means of coping, with alcohol use further diminishing adherence (27). Alcohol use is associated with both stress experiences and ART nonadherence (6), and alcohol use mediates the association between emotional distress and ART adherence (28). Katz et al. (29) developed a framework for explaining the impact of enacted stigma on ART adherence. In this model, stigma operates by compromising general psychological processes, particularly impaired coping in response to stress. The current study extends the framework offered by Katz et al. (29) to examine the association between HIV-related stigma experiences and ART adherence. We specifically tested a serial mediation model, a sequential chain of direct and indirect effects of stigma on ART adherence, to test whether stress and alcohol use explain the effects of stigma on adherence. Our aim was to test a conceptual model grounded in past studies linking stigma to stress, stress to alcohol use, and all three factors to ART adherence. Our study used prospectively collected data to assess cumulative stigma experiences over the course of a year in predicting objectively measured ART adherence. We assessed HIV-related stress as it may co-occur over time with stigma experiences and alcohol use. We tested the hypothesis that the accumulation of HIV stigma experienced over a 12-month period would predict ART adherence and that the association between stigma and adherence would be explained by HIV-related stress and alcohol use. Methods Participants and Procedures Men (n = 175) and women (n =76) were recruited from a publicly funded HIV clinic in central Georgia serving a small city and surrounding rural areas between September 2015 and December 2017. Participants were referred by clinic staff if they were returning to care after having fallen out of care for at least 6-momnths or were identified by a provider as either having unsuppressed HIV or at risk for unsuppressed HIV.

Behavioral Medicine, 2020

This study tested the hypothesis that the co-occurrence of alcohol use and depressive symptoms pr... more This study tested the hypothesis that the co-occurrence of alcohol use and depressive symptoms predicts HIV suppression and antiretroviral therapy (ART) adherence among people living with HIV. Baseline cross-sectional results showed a significant interaction between depressive symptoms and alcohol use in predicting HIV suppression; individuals who drank more alcohol and had higher depressive symptoms demonstrated poorer HIV suppression relative to those who had fewer depressive symptoms. In a one-year longitudinal analysis of ART adherence, alcohol use and depressive symptoms measured in daily text-message assessments demonstrated that neither alcohol use nor depressive symptoms alone predicted ART adherence. However, the intersection of alcohol use on days when experiencing depressive symptoms did significantly predict ART non-adherence, for both moderate and heavy alcohol drinkers. Findings suggest that the co-occurrence of alcohol use and depressive symptoms is a robust predictor of poor HIV treatment outcomes.

Translational Behavioral Medicine, 2020

With the expansion of telehealth services, there is a need for evidence-based treatment adherence... more With the expansion of telehealth services, there is a need for evidence-based treatment adherence interventions that can be delivered remotely to people living with HIV. Evidence-based behavioral health counseling can be delivered via telephone, as well as in-office services. However, there is limited research on counseling delivery formats and their differential outcomes. The purpose of this study was to conduct a head-to-head comparison of behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling delivered by in-office sessions to improve HIV treatment outcomes. Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider. The trial implemented a Wennberg Randomized Preferential Design to rigorously test: (a) patient preference and (b) comparative effects on patient retention in care and treatment adherence. There was a clear patient...

Pediatric Infectious Disease Journal, 2020

A eromonas hydrophila is a Gram-negative, oxidase-positive bacillus known to inhabit freshwater l... more A eromonas hydrophila is a Gram-negative, oxidase-positive bacillus known to inhabit freshwater lakes and streams. 1 It has also been found in soil, tap water and swimming pools. 2 It is motile, fermentative and a facultative anaerobe. 2,3 Infection is most commonly associated with immunosuppressed patients with chronic disease, particularly cirrhosis. 1,2,4 While infection is rare in immunocompetent patients, A. hydrophila is usually associated with trauma in an aquatic environment and has been associated with acute gastrointestinal illness, soft tissue infections, sepsis and occasionally pneumonia, meningitis, endocarditis, septic arthritis and osteomyelitis. 3 In 1990, an increasing incidence of infection with A. hydrophila was noted. 5 In this dual case report, we highlight 2 pediatric patients with infection with A. hydrophila, who presented to the same institution within 6 months of each other.

AIDS and Behavior, 2020

The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramusc... more The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p < 0.001) and acceptance (Week 48, +8.8 vs. +2.0 ACCEPT-points; p < 0.001). The acceptability of injection site reactions (PIN) significantly improved from week 5 (2.10 points) to week 48 (1.62 points; p < 0.001). In both studies, ≥ 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results...

Journal of Medical Cases, 2019

Elizabethkingia meningoseptica is an uncommon pathogen that has been associated with nosocomial i... more Elizabethkingia meningoseptica is an uncommon pathogen that has been associated with nosocomial infections and can pose a therapeutic challenge. It is resistant to most conventional agents used in treatment of gram-negative organisms and as such use of these agents may be unfavorable. Oral therapy with the appropriate agents to address this infection in certain patients may be successful. We report a case of graft infection with E. meningoseptica causing bacteremia in a dialysis patient who responded to oral agents.

Journal of Rural Mental Health, 2020

Social capital is associated with the health of people living with HIV, and yet few studies have ... more Social capital is associated with the health of people living with HIV, and yet few studies have examined social capital in relation to the HIV continuum of care in the United States. The current study assessed individual social capital within social networks of 251 people living with HIV and residing in a rural area of the southeastern United States. Participants completed computerized self-administered measures that included markers of social capital and disclosure of HIV status to network members. We estimated individual social capital for each relationship identified in the social network interviews and tested regression models at three points along the HIV continuum of care: receiving ART, ART adherence, and HIV viral suppression. Results indicated that one in four participants had not disclosed their HIV status to at least one member of their social network and disclosure was not associated with social capital. Regression models showed that participants with larger social networks and less social capital were more likely to be receiving ART and more likely to have HIV suppressed viral loads. Alcohol use, not social capital, was related to ART non-adherence. Participant's depressive symptomatology was unrelated to any HIV care continuum metrics assessed in this study. We conclude that social capital is drawn upon at critical points along the HIV continuum of care. Interventions should focus on building social capital within social networks and provide support to key network members when patients are transitioning into care, initiating ART and experiencing HIV unsuppressed viral loads.

AIDS and Behavior, 2019

Although anticipated HIV-related stigma-the expectation that one will experience prejudice and di... more Although anticipated HIV-related stigma-the expectation that one will experience prejudice and discrimination in the future as a result of others learning his or her HIV positive status-is theorized to be a robust predictor of antiretroviral therapy (ART) non-adherence, the association between anticipated stigma and ART non-adherence has been inconsistent. It may be, however, that anticipated stigma reliably, but indirectly, contributes to poor ART adherence through other psychosocial mechanisms. In the current study, we examine whether anticipated stigma indirectly contributes to treatment non-adherence through increased medication concerns. In a cross-sectional study, 585 people living with HIV in Atlanta and Macon, Georgia completed measures of anticipated HIV-related stigma, HIV-medication concerns, and HIV-treatment adherence. A latent variable mediation analysis revealed that anticipated stigma was positively associated with increased medication concerns, which consequently contributed to treatment non-adherence. Results reveal a psychosocial mechanism by which anticipated stigma contributes to ART non-adherence.

Prevention Science, 2019

Antiretroviral therapies (ART) suppress HIV replication, thereby preventing HIV disease progressi... more Antiretroviral therapies (ART) suppress HIV replication, thereby preventing HIV disease progression and potentially preventing HIV transmission. However, there remain significant health disparities among people living with HIV, particularly for women living in impoverished rural areas. A significant contributing factor to HIV-related disparities is a stigma. And yet, the relative contributions of stigma, gender, socio-economics, and geography in relation to health outcomes are understudied. We examined the associations of internalized stigma and enacted stigma with community-level income inequality and HIV viral suppressionthe hallmark of successful ART-among 124 men and 74 women receiving care from a publicly funded HIV clinic serving rural areas with high-HIV prevalence in the southeastern US. Participants provided informed consent, completed computerized interviews, and provided access to their medical records. Gini index was collected at the census tract level to estimate community-level income inequality. Individual-level and multilevel models controlled for point distance that patients lived from the clinic and quality of life, and included participant gender as a moderator. We found that for women, income inequality, internalized stigma, and enacted stigma were significantly associated with HIV suppression. For men, there were no significant associations between viral suppression and model variables. The null findings for men are consistent with gender-based health disparities and suggest the need for gender-tailored prevention interventions to improve the health of people living with HIV in rural areas. Results confirm and help to explain previous research on the impact of HIV stigma and income inequality among people living with HIV in rural settings.

Journal of the International Association of Providers of AIDS Care (JIAPAC), 2019

Beliefs that it is harmful to mix medications with alcohol (ie, interactive toxicity beliefs) are... more Beliefs that it is harmful to mix medications with alcohol (ie, interactive toxicity beliefs) are a known source of intentional antiretroviral therapy (ART) nonadherence. This study examined a serial process model of alcohol-ART interactive toxicity beliefs, alcohol-ART avoidance behaviors, and ART adherence in the association between alcohol use and HIV viral load. Participants were 198 patients receiving ART from a community clinic in the southeastern United States; 125 reported current alcohol use. Results showed that current alcohol use was associated with detectable HIV viral load, partially accounted for by alcohol-ART interactive toxicity beliefs, alcohol-ART avoidance behaviors, and ART adherence. There was a significant indirect effect of the serial chain of interactive toxicity beliefs—avoidance behaviors—adherence, indicating the 3 intermediating variables partially accounted for the relationship between alcohol use and HIV viral load. Addressing alcohol use as a barrier ...

Journal of Behavioral Medicine, 2018

Erroneous beliefs that it is toxic to drink alcohol while taking antiretroviral therapies (ART) u... more Erroneous beliefs that it is toxic to drink alcohol while taking antiretroviral therapies (ART) used for treating HIV infection, known as alcohol interactive toxicity beliefs, may at least in part account for ART nonadherence among alcohol drinkers. This study was conducted to test a conceptual framework to explain the effects of interactive toxicity beliefs on ART adherence. Computerized surveys were administered to 124 participants receiving HIV care in the southeastern US. Serial mediation model with perceived sensitivity to medicines predicting HIV viral load through three mediating variables: alcohol-ART interactive toxicity beliefs, alcohol-ART avoidance behaviors, and ART adherence. HIV viral load extracted from medical records. Perceived sensitivity to medicines predicted HIV viral load; greater perceptions of medication sensitivity predicted lower HIV viral loads. In addition, there was a significant indirect effect of the serial chain of interactive toxicity beliefs ? avoidance behaviors ? ART adherence, indicating partial mediation of the relationship between perceived sensitivity to medicines and higher HIV viral load. Perceived sensitivity to medicines provides a conceptual basis for the effects of alcohol-medication interactive toxicity beliefs on ART adherence. Interactive toxicity beliefs are modifiable and can be altered to prevent intentional ART nonadherence.

Prevention Science, 2017

AIDS stigmas delay HIV diagnosis, interfere with health care, and contribute to mental health pro... more AIDS stigmas delay HIV diagnosis, interfere with health care, and contribute to mental health problems among people living with HIV. While there are few studies of the geographical distribution of AIDS stigma, research suggests that AIDS stigmas are differentially experienced in rural and urban areas. We conducted computerized interviews with 696 men and women living with HIV in 113 different zip code areas that were classified as large-urban, small-urban, and rural areas in a southeast US state with high-HIV prevalence. Analyses conducted at the individual level (N = 696) accounting for clustering at the zip code level showed that internalized AIDS-related stigma (e.g., the sense of being inferior to others because of HIV) was experienced with greater magnitude in less densely populated communities. Multilevel models indicated that after adjusting for potential confounding factors, rural communities reported greater internalized AIDS-related stigma compared to large-urban areas, and that small-urban areas indicated greater experiences of enacted stigma (e.g., discrimination) than large-urban areas. The associations between anticipated AIDS-related stigma (e.g., expecting discrimination) and population density at the communitylevel were not significant. Results suggest that people living in rural and small-urban settings experience greater AIDS-related internalized and enacted stigma than their counterparts living in large-urban centers. Research is needed to determine whether low-density population areas contribute to or are sought out by people who experienced greater AIDS-related stigma.