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Linguistic and Cultural Adaptation of a Computer-Based Counseling Program (CARE+ Spanish) to Support HIV Treatment Adherence and Risk Reduction for People Living With HIV/AIDS: A Randomized Controlled Trial

Kurth, Ann E; Chhun, Nok; Cleland, Charles M; Crespo-Fierro, Michele; Pares-Avila, Jose A; Lizcano, John A; Norman, Robert G; Shedlin, Michele G; Johnston, Barbara E; Sharp, Victoria L
BACKGROUND: Human immunodeficiency virus (HIV) disease in the United States disproportionately affects minorities, including Latinos. Barriers including language are associated with lower antiretroviral therapy (ART) adherence seen among Latinos, yet ART and interventions for clinic visit adherence are rarely developed or delivered in Spanish. OBJECTIVE: The aim was to adapt a computer-based counseling tool, demonstrated to reduce HIV-1 viral load and sexual risk transmission in a population of English-speaking adults, for use during routine clinical visits for an HIV-positive Spanish-speaking population (CARE+ Spanish); the Technology Acceptance Model (TAM) was the theoretical framework guiding program development. METHODS: A longitudinal randomized controlled trial was conducted from June 4, 2010 to March 29, 2012. Participants were recruited from a comprehensive HIV treatment center comprising three clinics in New York City. Eligibility criteria were (1) adults (age >/=18 years), (2) Latino birth or ancestry, (3) speaks Spanish (mono- or multilingual), and (4) on antiretrovirals. Linear and generalized mixed linear effects models were used to analyze primary outcomes, which included ART adherence, sexual transmission risk behaviors, and HIV-1 viral loads. Exit interviews were offered to purposively selected intervention participants to explore cultural acceptability of the tool among participants, and focus groups explored the acceptability and system efficiency issues among clinic providers, using the TAM framework. RESULTS: A total of 494 Spanish-speaking HIV clinic attendees were enrolled and randomly assigned to the intervention (arm A: n=253) or risk assessment-only control (arm B, n=241) group and followed up at 3-month intervals for one year. Gender distribution was 296 (68.4%) male, 110 (25.4%) female, and 10 (2.3%) transgender. By study end, 433 of 494 (87.7%) participants were retained. Although intervention participants had reduced viral loads, increased ART adherence and decreased sexual transmission risk behaviors over time, these findings were not statistically significant. We also conducted 61 qualitative exit interviews with participants and two focus groups with a total of 16 providers. CONCLUSIONS: A computer-based counseling tool grounded in the TAM theoretical model and delivered in Spanish was acceptable and feasible to implement in a high-volume HIV clinic setting. It was able to provide evidence-based, linguistically appropriate ART adherence support without requiring additional staff time, bilingual status, or translation services. We found that language preferences and cultural acceptability of a computer-based counseling tool exist on a continuum in our urban Spanish-speaking population. Theoretical frameworks of technology's usefulness for behavioral modification need further exploration in other languages and cultures. TRIAL REGISTRATION: ClinicalTrials.gov NCT01013935; https://clinicaltrials.gov/ct2/show/NCT01013935 (Archived by WebCite at http://www.webcitation.org/6ikaD3MT7).
PMCID:4963608
PMID: 27417531
ISSN: 1438-8871
CID: 2179802

Toothbrush efficacy for plaque removal

Nightingale, Kj; Chinta, Sk; Agarwal, P; Nemelivsky, M; Frisina, Ac; Cao, Z; Norman, Rg; Fisch, Gs; Corby, P
OBJECTIVES: To determine the effectiveness of a novel sonic toothbrush in reducing plaque and in maintenance of gingival health when compared to a standard manual brush. METHODS: This study was a block-randomized, examiner-blind, two-treatment, parallel group, single centre clinical investigation. A total of 84 subjects were enrolled and randomly assigned to receive either the Panasonic EW-DL90 or an American Dental Association-endorsed manual toothbrush. Subjects were instructed to follow a twice-daily brushing regimen without flossing. Plaque levels and gingival health were assessed at baseline and after 1 and 3 weeks of treatment using the Turesky Modification of the Quigley-Hein Plaque Index and the Papillary Bleeding Score. RESULTS: Subjects assigned to the EW-DL90 group had significantly lower plaque levels after 1 and 3 weeks of treatment than those in the manual group (P = 0.003 and 0.0035, respectively). Both groups showed a reduction in plaque levels at Week 3 relative to baseline. The EW-DL90 group had significantly lower gingival inflammation scores after 1 week of treatment (P = 0.0293), but there was no difference between groups after 3 weeks of treatment. CONCLUSION: The EW-DL90 toothbrush safely and effectively removes more plaque than a standard manual toothbrush. Improvement in gingival inflammation was observed after 1 week of treatment. There was no difference in Papillary Bleeding Score between the two groups after 3 weeks of treatment. CLINICAL SIGNIFICANCE: The newly developed sonic brush (Panasonic EW-DL90) tested in this study was found to be more effective than a manual toothbrush at plaque removal. The papillary bleeding scores were significantly lower in the sonic brush group after 1 week of product use. After 3 weeks of product use, both treatment groups had similar papillary bleeding scores almost returning to baseline values.
PMID: 24738786
ISSN: 1601-5029
CID: 882812

Physical Work Environment: Testing an Expanded Model of Job Satisfaction in a Sample of Registered Nurses (vol 59, pg 441, 2010) [Correction]

Djukic, M.; Kovner, C.; Budin, W. C.; Norman, R.
ISI:000339754200004
ISSN: 0029-6562
CID: 3305452

Examining factors associated with oral health-related quality of life for youth with cleft

Broder, Hillary L; Wilson-Genderson, Maureen; Sischo, Lacey; Norman, Robert G
BACKGROUND: Patient-reported quality-of-life outcomes in cleft lip-cleft palate treatment are critical for evidence-based care. Scant data exist analyzing treatment from the patient's perspective. The authors examined the interrelationship among variables associated with oral health-related quality of life among youth with cleft. METHODS: As part of an ongoing longitudinal study, clinical evaluations and research questionnaire packets were completed before surgical recommendations were made (baseline). Participants completed the Child Oral Health Impact Profile, a validated oral health-related quality-of-life measure for children with cleft. During the baseline clinical evaluations, plastic surgeons determined whether surgical interventions were recommended within the year (expert determination represents a greater degree of current clinical need). General linear models incorporating surgical recommendation, gender, and age were fit for each subscale of and for the total Child Oral Health Impact Profile. Significant interaction terms were evaluated for their effect on the subscale. RESULTS: Baseline assessments were obtained from 1200 participants (mean, 11.8 years; 57 percent male). Participants with a surgical recommendation had lower quality of life on all but the self-esteem subscale compared with those without a surgical recommendation (p < 0.002). Two subscales had statistically significant age-sex interactions (p < 0.003), whereas another subscale had a statistically significant surgery by sex interaction term (p = 0.027). CONCLUSIONS: Overall, youth for whom surgery is currently recommended had lower oral health-related quality-of-life scores on the Child Oral Health Impact Profile Total scale than those with no surgical recommendation; older female subjects had lower quality-of-life scores than male subjects. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.
PMCID:4120869
PMID: 24867742
ISSN: 1529-4242
CID: 1018702

HIV Infection and Microbial Diversity in Saliva

Li, Yihong; Saxena, Deepak; Chen, Zhou; Liu, Gaoxia; Abrams, Willam R; Phelan, Joan A; Norman, Robert G; Fisch, Gene S; Corby, Patricia M; Dewhirst, Floyd; Paster, Bruce J; Kokaras, Alexis S; Malamud, Daniel
Limited information is available about the effect of human immunodeficiency virus (HIV) and subsequent antiretroviral treatment on host-microbe interaction. This study aimed to determine the salivary microbial composition in 10 HIV-seropositive subjects, before and 6 months after highly active antiretroviral therapy (HAART), compared with that of 10 HIV-seronegative subjects. Both a conventional culture and two culture-independent analyses were used and consistently demonstrated differences in microbial composition among the three sets of samples. HIV+ subjects had higher levels of total cultivable microbes, including oral streptococci, lactobacilli, S. mutans, and Candida, in saliva as compared to HIV- subjects. The total cultivable microbial level was significantly correlated with CD4+ T cell counts. Denaturing gradient gel electrophoresis (DGGE), which compared the overall microbial profiles, showed distinct fingerprinting profiles for each group. Human oral microbe identification microarray (HOMIM), which compared the 16S rRNA genes, showed a clear separation among the three sample groups. Veillonella, Synergistetes, and Streptococcus, were present in all 30 saliva samples. Only minor changes or no changes were observed in the prevalence of Neisseria, Haemophilus, Gemella, Leptotrichia, Solobacterium, Parvimonas and RothiaI. Severn genera were detected only in HIV- samples, including Capnocytophaga, Slackia, Porphyromonas, Kingella, Peptostreptococcaceae, Lactobacillus, and Atopobium. The prevalence of Fusobacterium, Campylobacter, Prevotella, Capnocytophaga, Selenomonas, Actinomyces, and Atopobium was increased after therapy with HAART. In contrast, the prevalence of Aggregatibacter was significantly decreased after HAART. Findings of this study suggest that HIV infection and therapy with HAART could have a significant effect on salivary microbial colonization and composition.
PMCID:3993673
PMID: 24523469
ISSN: 0095-1137
CID: 807452

"Computerized Counseling Reduces HIV-1 Viral Load and Sexual Transmission Risk: Findings from a Randomized Controlled Trial"

Kurth, Ann E; Spielberg, Freya; Cleland, Charles M; Lambdin, Barrot; Bangsberg, David R; Frick, Pamela A; Severynen, Anneleen O; Clausen, Marc; Norman, Robert G; Lockhart, David; Simoni, Jane M; Holmes, King K
OBJECTIVE:: Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. DESIGN:: Longitudinal RCT. SETTINGS:: An academic HIV clinic and a community-based organization in Seattle. SUBJECTS:: 240 HIV-positive adults on ART; 209 completed nine-month follow-up (87% retention). INTERVENTION:: Randomization to computerized counseling or assessment-only, 4 sessions over 9 months. MAIN OUTCOME MEASURES:: HIV-1 viral suppression, and self-reported ART adherence, and transmission risks, compared using generalized estimating equations. RESULTS:: Overall, intervention participants had reduced viral load (VL): mean 0.17 log10 decline, versus 0.13 increase in controls, p = 0.053, and significant difference in ART adherence baseline to 9 months (p = 0.046). Their sexual transmission risk behaviors decreased (OR = 0.55, p = 0.020), a reduction not seen among controls (OR = 1.1, p = 0.664), and a significant difference in change (p = 0.040). Intervention effect was driven by those most in need: among those with detectable virus at baseline (>30 copies/milliliter, n=89), intervention effect was mean 0.60 log10 VL decline versus 0.15 increase in controls, p=0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, p = 0.038. CONCLUSIONS:: Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.
PMCID:3999203
PMID: 24384803
ISSN: 1525-4135
CID: 801402

Evaluation of the similarities and differences in response patterns to the Pediatric Quality of Life Inventory and the Child Oral Health Impact Scores among youth with cleft

Broder, Hillary L; Norman, Robert G; Sischo, Lacey; Wilson-Genderson, Maureen
PURPOSE: To examine (a) the pattern of responses to a generic health-related quality of life (HRQL) measure (Pediatric Quality of Life Inventory-PedsQL) and an oral health-related quality of life (OHRQoL) measure (Child Oral Health Impact Profile-COHIP), and (b) the associations of these scores with surgical recommendation status among youth with cleft. METHODS: Cross-sectional data (baseline) regarding clinicians' surgical recommendations and quality of life (QoL) measures were examined from an ongoing observational study on treatment outcomes. Approximately one-third of the racially and geographically diverse sample (N = 1,200; [Formula: see text] = 11.6 years) received surgical recommendations to correct either visible (aesthetic) or invisible (functional) defects. Effect sizes were used to quantify differences in QoL based on surgical recommendation and to compare the sensitivity of the PedsQL and COHIP subscales. Using Pearson coefficients, the scores of those recommended for surgery were compared with those without a surgical recommendation. RESULTS: A moderate correlation (0.52) was found between the total scores on the PedsQL and COHIP (p < 0.0001). Subscale correlations between the QoL measures ranged from 0.19 to 0.48 with the strongest correlation between the PedsQL Emotional (r = 0.47) and COHIP Socioemotional Well-being subscale. The effect size for the COHIP Socioemotional Well-being (0.39) was larger than the PedsQL Social/Emotional (0.07/0.11) subscale (Z = 5.30/Z = 4.64, p < 0.0001, respectively), and the total COHIP (0.31) was significantly greater than the total PedsQL scale (0.15, z = 2.65, p = 0.008). CONCLUSIONS: A significant relationship was found between generic HRQL, OHRQoL, and surgical needs among youth with cleft with the COHIP having larger effect sizes than the PedsQL among surgical groups.
PMCID:3834226
PMID: 23760529
ISSN: 0962-9343
CID: 381152

HIV-induced immunosuppression is associated with colonization by plant pathogens in the gut [Meeting Abstract]

Yang, Liying; Poles, Michael A; Fisch, Gene S; Ma, Yingfei; Nossa, Carlos; Norman, Robert G; Phelan, Joan A; Pei, Zhiheng
ISI:000341276000195
ISSN: 1791-244x
CID: 1267922

Design Aspects of a Case-Control Clinical Investigation of the Effect of HIV on Oral and Gastrointestinal Soluble Innate Factors and Microbes

Phelan, Joan A; Abrams, William R; Norman, Robert G; Li, Yihong; Laverty, Maura; Corby, Patricia M; Nembhard, Jason; Neri, Dinah; Barber, Cheryl A; Aberg, Judith A; Fisch, Gene S; Poles, Michael A; Malamud, Daniel
INTRODUCTION: The impaired host defense system in HIV infection impacts the oral and gastrointestinal microbiota and associated opportunistic infections. Antiretroviral treatment is predicted to partially restore host defenses and decrease the oral manifestation of HIV/AIDS. Well-designed longitudinal studies are needed to better understand the interactions of soluble host defense proteins with bacteria and virus in HIV/AIDS. "Crosstalk" was designed as a longitudinal study of host responses along the gastrointestinal (GI) tract and interactions between defense molecules and bacteria in HIV infection and subsequent therapy. PURPOSE: The clinical core formed the infrastructure for the study of the interactions between the proteome, microbiome and innate immune system. The core recruited and retained study subjects, scheduled visits, obtained demographic and medical data, assessed oral health status, collected samples, and guided analysis of the hypotheses. This manuscript presents a well-designed clinical core that may serve as a model for studies that combine clinical and laboratory data. METHODS: Crosstalk was a case-control longitudinal clinical study an initial planned enrollment of 170 subjects. HIV+ antiretroviral naive subjects were followed for 9 visits over 96 weeks and HIV uninfected subjects for 3 visits over 24 weeks. Clinical prevalence of oral mucosal lesions, dental caries and periodontal disease were assessed. RESULTS: During the study, 116 subjects (47 HIV+, 69 HIV-) were enrolled. Cohorts of HIV+ and HIV- were demographically similar except for a larger proportion of women in the HIV- group. The most prevalent oral mucosal lesions were oral candidiasis and hairy leukoplakia in the HIV+ group. DISCUSSION: The clinical core was essential to enable the links between clinical and laboratory data. The study aims to determine specific differences between oral and GI tissues that account for unique patterns of opportunistic infections and to delineate the differences in their susceptibility to infection by HIV and their responses post-HAART.
PMCID:4237510
PMID: 25409430
ISSN: 1932-6203
CID: 1355192

Mortality, ethnicity, and education in an occupational cohort

Jonas, Saran; Grieco, Giacinto; Norman, Robert; Grumet, Surah; Kedan, Ilan
Purpose: The purpose of this paper is to investigate the relationship between occupational degree requirement and mortality between ethnic groups in a cohort of urban workers. Design/methodology/approach: The study included 118,606 health-insured full-time workers from the New York City Health and Hospitals Corporation (HHC). Mortality rates (MR) and mortality rate ratios (MRR) were calculated for major ethnic categories. Estimates were adjusted for age, sex, and occupational degree requirement. Findings: Prior to adjustment for degree requirement, mortality rates (MRs) by ethnic groups in the Health and Hospitals Corporation were in line with national estimates: highest for blacks, followed by whites, Hispanics, and Asian/Pacific Islander (APIs). After adjustment, the MR for blacks became comparable to whites (mortality rate ratio (MRR) = 1.02). The low-Hispanic MR did not change; the Hispanic advantage persisted (MRR = 0.66), as did the API advantage (MRR = 0.50). Research limitations/implications: Higher education may not substantially change the MR for Hispanics, and it may only account for a portion of the survival advantage among APIs. The findings also suggest that without reducing the disparity in higher education attainment between blacks and whites, equality in other socioeconomic factors may not abolish the disparity in mortality between these groups. Originality/value: This study bypassed common limitations of ethnic mortality studies, with intrinsic parity for certain socio-economic status factors (full-time employment and health care access) across cohort members and consistent ethnic classification across time-points. This includes a cohort of API workers with complete self-identification of ethnicity, which has not been accomplished by previous investigations.
PSYCH:2014-45500-003
ISSN: 2042-8367
CID: 1422422