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1.
Int J Tuberc Lung Dis ; 23(7): 844-849, 2019 07 01.
Article in English | MEDLINE | ID: mdl-31439117

ABSTRACT

SETTING: Efficient tuberculosis (TB) active case-finding strategies are important in settings with high TB burdens and limited resources, such as those in western Kenya.OBJECTIVE: To guide efforts to optimize screening efficiency, we identified the predictors of TB among people screened in health facilities and communities.DESIGN: During February 2015-June 2016, adults aged ≥15 years reporting any TB symptom were identified in health facilities and community mobile screening units, and evaluated for TB. We assessed the predictors of TB using a modified Poisson regression with generalized estimating equations to account for clustering according to screening site.RESULTS: TB was diagnosed in 484 (20.3%) of 2394 symptomatic adults in health facilities and 39 (3.4%) of 1424 in communities. In health facilities, >10% of symptomatic adults in all demographic groups had TB, and no predictors were associated with a ≥2-fold increased risk. In communities, the independent predictors of TB were male sex (adjusted prevalence ratio [aPR] = 4.26, 95%CI 2.43-7.45), HIV infection (aPR 2.37, 95%CI 1.18-4.77), and household TB contact in the last 2 years (aPR 2.84, 95%CI 1.62-4.96).CONCLUSION: Our findings support the notion of general TB screening in health facilities and evaluation of the adult household contacts of TB patients.


Subject(s)
Health Services Accessibility , Mass Screening/standards , Tuberculosis, Pulmonary/prevention & control , Adolescent , Adult , Community Health Services/standards , Comorbidity , Female , HIV Infections , Health Facilities/standards , Humans , Kenya/epidemiology , Male , Middle Aged , Regression Analysis , Sex Factors , Tuberculosis, Pulmonary/epidemiology , Tuberculosis, Pulmonary/microbiology , Young Adult
2.
J Clin Microbiol ; 54(12): 3028-3033, 2016 12.
Article in English | MEDLINE | ID: mdl-27733634

ABSTRACT

The Xpert MTB/RIF assay is both sensitive and specific as a diagnostic test. Xpert also reports quantitative output in cycle threshold (CT) values, which may provide a dynamic measure of sputum bacillary burden when used longitudinally. We evaluated the relationship between Xpert CT trajectory and drug exposure during tuberculosis (TB) treatment to assess the potential utility of Xpert CT for treatment monitoring. We obtained serial sputum samples from patients with smear-positive pulmonary TB who were consecutively enrolled at 10 international clinical trial sites participating in study 29X, a CDC-sponsored Tuberculosis Trials Consortium study evaluating the tolerability, safety, and antimicrobial activity of rifapentine at daily doses of up to 20 mg/kg of body weight. Xpert was performed at weeks 0, 2, 4, 6, 8, and 12. Longitudinal CT data were modeled using a nonlinear mixed effects model in relation to rifapentine exposure (area under the concentration-time curve [AUC]). The rate of change of CT was higher in subjects receiving rifapentine than in subjects receiving standard-dose rifampin. Moreover, rifapentine exposure, but not assigned dose, was significantly associated with rate of change in CT (P = 0.02). The estimated increase in CT slope for every additional 100 µg · h/ml of rifapentine drug exposure (as measured by AUC) was 0.11 CT/week (95% confidence interval [CI], 0.05 to 0.17). Increasing rifapentine exposure is associated with a higher rate of change of Xpert CT, indicating faster clearance of Mycobacterium tuberculosis DNA. These data suggest that the quantitative outputs of the Xpert MTB/RIF assay may be useful as a dynamic measure of TB treatment response.


Subject(s)
DNA, Bacterial/genetics , Mycobacterium tuberculosis/drug effects , Rifampin/analogs & derivatives , Sputum/microbiology , Tuberculosis, Pulmonary/diagnosis , Tuberculosis, Pulmonary/drug therapy , Adolescent , Adult , Female , Humans , Male , Middle Aged , Mycobacterium tuberculosis/genetics , Rifampin/adverse effects , Rifampin/therapeutic use , Sensitivity and Specificity , Young Adult
3.
Int J Tuberc Lung Dis ; 20(1): 49-56, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26688528

ABSTRACT

SETTING: Even among persons who have completed a course of treatment for their first tuberculosis (TB) episode, patients with a history of TB are at higher risk for having TB. OBJECTIVE: To describe factors from the initial TB episode associated with recurrent TB among patients who completed treatment and remained free of TB for at least 12 months. DESIGN: During 1993-2006, US TB cases stratified by birth origin were examined. Cox proportional hazards regression was used to assess the association of factors during the initial episode with recurrence at least 12 months after treatment completion. RESULTS: Among 632 US-born patients, TB recurrence was associated with age 25-44 years (adjusted hazard ratio [aHR] 1.77, 99% confidence interval [CI] 1.02-3.09, attributable fraction [AF] 1-34%), substance use (aHR 1.57, 99%CI 1.23-2.02, AF 8-22%), and treatment supervised by health departments (aHR 1.42, 99%CI 1.03-1.97, AF 2-28%). Among 211 foreign-born patients, recurrence was associated with human immunodeficiency virus infection (aHR 2.24, 99%CI 1.27-3.98, AF 2-9%) and smear-positive TB (aHR 1.56, 99%CI 1.06-2.30, AF 3-33%). CONCLUSION: Factors associated with recurrence differed by origin of birth, and might be useful for anticipating greater risk for recurrent TB among certain patients with a history of TB.


Subject(s)
Antitubercular Agents/therapeutic use , Tuberculosis, Pulmonary/epidemiology , Adolescent , Adult , Aged , Child , Child, Preschool , Cohort Studies , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Proportional Hazards Models , Recurrence , Retrospective Studies , Risk Factors , Treatment Outcome , Tuberculosis, Pulmonary/drug therapy , Tuberculosis, Pulmonary/etiology , United States/epidemiology , Young Adult
4.
Int J Tuberc Lung Dis ; 19(11): 1348-53, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26467587

ABSTRACT

SETTING: Drug susceptibility testing (DST) is recommended in Kenya to identify multidrug-resistant tuberculosis (MDR-TB) in persons registered for tuberculosis (TB) retreatment. DST is performed at a central laboratory with a two-step growth-based process and a regional laboratory with a simultaneous molecular- and growth-based process. OBJECTIVE: To compare proportions of retreatment cases who underwent DST and turnaround times for hospitals referring to the central vs. regional laboratory. DESIGN: Cases were persons registered for TB retreatment from 1 January 2012 to 31 December 2013. Records of 11 hospitals and 7 hospitals referring patients to the regional and central laboratories, respectively, were reviewed. RESULTS: Respectively 238/432 (55%) and 88/355 (25%) cases from hospitals referring to the regional and central laboratories underwent DST. The mean time from case registration to receipt of DST results and initiation of MDR-TB treatment was quicker in hospitals referring to the regional laboratory. The time required for the transportation of specimens, specimen testing and receipt of DST results at hospitals was shorter for the regional laboratory (P < 0.05). CONCLUSION: Testing was faster and more complete at hospitals referring to the regional laboratory. A comprehensive review of MDR-TB detection in Kenya is required to increase the proportion of cases receiving DST.


Subject(s)
Laboratories/standards , Referral and Consultation/statistics & numerical data , Tuberculosis, Multidrug-Resistant/diagnosis , Drug Resistance, Multiple, Bacterial , Humans , Kenya , Microbial Sensitivity Tests , Retreatment , Tuberculosis, Multidrug-Resistant/drug therapy
5.
Int J Tuberc Lung Dis ; 18(5): 571-80, 2014 May.
Article in English | MEDLINE | ID: mdl-24903795

ABSTRACT

SETTING: Twenty tuberculosis (TB) clinics in the United States and Canada. OBJECTIVE: To evaluate the efficacy and safety of a 6-month intermittent regimen of rifampin (RMP), pyrazinamide (PZA) and ethambutol (EMB) in human immunodeficiency virus (HIV) negative patients with culture-confirmed pulmonary or extra-pulmonary tuberculosis and either isoniazid (INH) resistance or INH intolerance. DESIGN: Patients were enrolled in a single-arm clinical trial to receive intermittent dosing after at least 14 initial daily doses of RMP+PZA+EMB. Treatment was continued twice (BIW) or thrice weekly (TIW) per physician/patient preference for a total of 6 months, with 2 years of follow-up for relapse after treatment. RESULTS: From 1999 to 2004, 98 patients were enrolled, 78 with reported INH resistance and 20 with INH intolerance. BIW dosing was used in 77 and TIW in 21. Study treatment was completed in 73 (74%). Reasons for discontinuation were hepatic adverse events (n= 12), other adverse effects (n= 3) and other reasons (n= 10). Failure (n= 1) and relapse (n= 2) occurred in 3 (3.5%, 95%CI 1.2-9.8) of 86 patients eligible for efficacy analysis, all occurring in patients with cavitary, acid-fast bacilli smear-positive pulmonary TB. CONCLUSIONS: Intermittent RMP+PZA+EMB appears to be effective in HIV-negative patients, but the regimen is poorly tolerated, possibly due to the prolonged use of PZA. Alternative regimens of lower toxicity are needed.


Subject(s)
Antitubercular Agents/administration & dosage , Antitubercular Agents/adverse effects , Drug Resistance, Bacterial , Ethambutol/administration & dosage , Isoniazid/adverse effects , Pyrazinamide/administration & dosage , Rifampin/administration & dosage , Tuberculosis/drug therapy , Adult , Ambulatory Care Facilities , Canada , Directly Observed Therapy , Drug Administration Schedule , Drug Therapy, Combination , Ethambutol/adverse effects , Female , Humans , Male , Middle Aged , Prospective Studies , Pyrazinamide/adverse effects , Rifampin/adverse effects , Time Factors , Treatment Outcome , Tuberculosis/diagnosis , United States
6.
Int J Tuberc Lung Dis ; 17(12): 1531-7, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24200264

ABSTRACT

SETTING: A large randomized controlled trial recently showed that for treating latent tuberculous infection (LTBI) in persons at high risk of progression to tuberculosis (TB) disease, a 12-dose regimen of weekly rifapentine plus isoniazid (3HP) administered as directly observed treatment (DOT) can be as effective as 9 months of daily self-administered isoniazid (9H). OBJECTIVES: To assess the cost-effectiveness of 3HP compared to 9H. DESIGN: A computational model was designed to simulate individuals with LTBI treated with 9H or 3HP. Costs and health outcomes were estimated to determine the incremental costs per active TB case prevented and per quality-adjusted life year (QALY) gained by 3HP compared to 9H. RESULTS: Over a 20-year period, treatment of LTBI with 3HP rather than 9H resulted in 5.2 fewer cases of TB and 25 fewer lost QALYs per 1000 individuals treated. From the health system and societal perspectives, 3HP would cost respectively US$21,525 and $4294 more per TB case prevented, and respectively $4565 and $911 more per QALY gained. CONCLUSIONS: 3HP may be a cost-effective alternative to 9H, particularly if the cost of rifapentine decreases, the effectiveness of 3HP can be maintained without DOT, and 3HP treatment is limited to those with a high risk of progression to TB disease.


Subject(s)
Antitubercular Agents/administration & dosage , Antitubercular Agents/economics , Drug Costs , Isoniazid/administration & dosage , Isoniazid/economics , Latent Tuberculosis/drug therapy , Latent Tuberculosis/economics , Rifampin/analogs & derivatives , Antitubercular Agents/adverse effects , Computer Simulation , Cost-Benefit Analysis , Directly Observed Therapy/economics , Drug Administration Schedule , Drug Therapy, Combination , Hospital Costs , Humans , Isoniazid/adverse effects , Latent Tuberculosis/diagnosis , Models, Economic , Quality-Adjusted Life Years , Rifampin/administration & dosage , Rifampin/adverse effects , Rifampin/economics , Time Factors , Treatment Outcome , United States
7.
Int J Tuberc Lung Dis ; 17(8): 1023-8, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23827025

ABSTRACT

BACKGROUND: Delayed diagnosis of tuberculosis (TB) increases mortality. OBJECTIVE: To evaluate whether stool culture improves the diagnosis of TB in people living with the human immunodeficiency virus (PLHIV). DESIGN: We analysed cross-sectional data of TB diagnosis in PLHIV in Cambodia, Thailand and Viet Nam. Logistic regression was used to assess the association between positive stool culture and TB, and to calculate the incremental yield of stool culture. RESULTS: A total of 1693 PLHIV were enrolled with a stool culture result. Of 228 PLHIV with culture-confirmed TB from any site, 101 (44%) had a positive stool culture; of these, 91 (90%) had pulmonary TB (PTB). After adjusting for confounding factors, a positive stool culture was associated with smear-negative (odds ratio [OR] 26, 95% confidence interval [CI] 12-58), moderately smear-positive (OR 60, 95%CI 23-159) and highly smear-positive (OR 179, 95%CI 59-546) PTB compared with no PTB. No statistically significant association existed with extra-pulmonary TB compared with no extra-pulmonary TB (OR 2, 95%CI 1-5). The incremental yield of one stool culture above two sputum cultures (5%, 95%CI 3-8) was comparable to an additional sputum culture (7%, 95%CI 4-11). CONCLUSION: Nearly half of the PLHIV with TB had a positive stool culture that was strongly associated with PTB. Stool cultures may be used to diagnose TB in PLHIV.


Subject(s)
Feces/microbiology , HIV Infections/epidemiology , Tuberculosis, Pulmonary/diagnosis , Tuberculosis/diagnosis , Adult , Cross-Sectional Studies , Delayed Diagnosis , Female , Humans , Logistic Models , Male , Sputum/microbiology , Thailand/epidemiology , Tuberculosis/epidemiology , Tuberculosis, Pulmonary/epidemiology , Vietnam/epidemiology
8.
Int J Tuberc Lung Dis ; 16(12): 1582-7, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23131255

ABSTRACT

BACKGROUND: The treatment of multidrug-resistant tuberculosis (MDR-TB) is currently based upon expert opinion and findings from case series, rather than upon randomised clinical trials (RCTs). OBJECTIVE: To describe the challenges encountered during an RCT for the treatment of MDR-TB. METHODS: Tuberculosis Trials Consortium Study 30 was a pilot, Phase I/II, double-blind, placebo-controlled, RCT of the safety and tolerability of 16 weeks of daily, low-dose linezolid treatment for MDR-TB. RESULTS: A total of 36 patients, 56% of the target of 64 patients, consented to participate, for an average of 0.69 enrolments per week. Of the 36 patients enrolled, only 25 (69%) completed at least 90 doses of study treatment. Among the 12 (33%) patients who did not complete all 112 doses of the study treatment, the median time to study withdrawal was 15 days (range 0-92). After the study, we discovered discordance between treatment assignment and study drug for at least 9 (25%) of the 36 patients. CONCLUSIONS: Recruitment and retention in this MDR-TB clinical trial posed substantial challenges, suggesting the need for a large, multidisciplinary group of study staff to support the participants. Withdrawal tended to occur early in study treatment. The discrepancy in assigned study medication reflects the need for stronger administrative controls for study drugs.


Subject(s)
Acetamides/administration & dosage , Antitubercular Agents/administration & dosage , Oxazolidinones/administration & dosage , Tuberculosis, Multidrug-Resistant/drug therapy , Tuberculosis, Pulmonary/drug therapy , Acetamides/adverse effects , Acetamides/blood , Acetamides/pharmacokinetics , Antitubercular Agents/adverse effects , Antitubercular Agents/blood , Antitubercular Agents/pharmacokinetics , Directly Observed Therapy , Double-Blind Method , Drug Monitoring , Female , Humans , Linezolid , Male , Mycobacterium tuberculosis/isolation & purification , Oxazolidinones/adverse effects , Oxazolidinones/blood , Oxazolidinones/pharmacokinetics , Patient Dropouts , Pilot Projects , Research Design , South Africa , Sputum/microbiology , Treatment Outcome , Tuberculosis, Multidrug-Resistant/diagnosis , Tuberculosis, Multidrug-Resistant/microbiology , Tuberculosis, Pulmonary/diagnosis , Tuberculosis, Pulmonary/microbiology
9.
Int J Epidemiol ; 34(3): 577-84, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15737969

ABSTRACT

BACKGROUND: In the continuing effort to introduce antiretroviral therapy in resource-limited settings, there is a need to understand differences between natural history of HIV in different populations and to identify feasible clinical measures predictive of survival. METHODS: We examined predictors of survival among 836 heterosexuals who were infected with HIV subtype CRF01_AE in Thailand. RESULTS: From 1993 to 1999, 269 (49.4%) men and 65 (25.7%) women died. The median time from the estimated seroconversion to death was 7.8 years (95% confidence interval 7.0-9.1). Men and women with enrolment CD4 counts <200 cells/microl had about 2 and 11 times greater risk of death than those with CD4 counts of 200-500 and >500, respectively. Measurements available in resource-limited settings, including total lymphocyte count (TLC), anaemia, and low body mass index (BMI), also predicted survival. Men with two or more of these predictors had a median survival of 0.8 (0.5-1.8) years, compared with 2.7 (1.9-3.3) years for one predictor and 4.9 (4.1-5.2) years for no predictors. CONCLUSIONS: The time from HIV infection to death appears shorter among this Thai population than among antiretroviral naive Western populations. CD4 count and viral load (VL) were strong, independent predictors of survival. When CD4 count and VL are unavailable, individuals at high risk for shortened HIV survival may be identified by a combination of low TLC, anaemia, and low BMI. This combination of accessible clinical measures of the disease stage may be useful for medical management in resource-limited settings.


Subject(s)
HIV Infections/mortality , HIV-1 , Adolescent , Adult , Age Distribution , Anemia/complications , Anemia/epidemiology , Anti-Retroviral Agents/therapeutic use , Body Mass Index , CD4 Lymphocyte Count/methods , Cohort Studies , Disease Progression , Female , HIV Infections/drug therapy , Heterosexuality , Humans , Lymphocyte Count/methods , Male , Middle Aged , Risk Factors , Sex Distribution , Thailand/epidemiology
10.
Int J Cancer ; 94(5): 753-7, 2001 Dec 01.
Article in English | MEDLINE | ID: mdl-11745473

ABSTRACT

The purpose of our study was to identify the types and rates of cancers seen in high-risk human immunodeficiency virus (HIV)-infected and HIV-uninfected women. From 1993 to 1995, 1,310 women enrolled at four urban U.S. research sites in the HIV Epidemiology Research Study and were interviewed biannually to identify interval diagnoses and hospitalizations until study closure in March 2000. Cancer incidence data were collected through abstraction of medical records and death certificates. Of 871 HIV-infected and 439 HIV-uninfected women, 85% had a history of smoking and 50% a history of injection drug use. For our analysis, 4,180 person-years were contributed by HIV-infected women, and 2,308 person-years by HIV-uninfected women. HIV-infected women had 8 non-Hodgkin's lymphomas, 5 invasive cervical cancers (ICC), 1 Kaposi's sarcoma and 12 non-AIDS defining cancers, including 4 lung cancers, compared with 4 cancers in HIV-uninfected women including 1 lung cancer (all cancers, 6.22/1000 person-years vs. 1.73/1000 person-years, p = 0.01). CD4+ cell counts were above 200/mm3 in all women with ICC. HIV-infected women with lung cancer were young smokers (mean age, 40 years), and all died within 6 months of diagnosis. Lung cancer occurred at twice the rate in HIV-infected vs. uninfected women in the cohort and severalfold above expected in age- and race-matched women in U.S. national data (incidence relative risk 6.39; 95% confidence interval 3.71, 11.02; p < 10(-7)). The frequent occurrence of cervical and lung cancers have important implications for the counseling (cigarette cessation), screening (PAP smears) and care of women with HIV infection, as they live longer because of current antiretroviral therapies.


Subject(s)
HIV Infections/complications , Neoplasms/epidemiology , Adolescent , Adult , CD4 Lymphocyte Count , Female , Humans , Incidence , Lung Neoplasms/epidemiology , Middle Aged , Prospective Studies , Uterine Cervical Neoplasms/epidemiology
11.
Public Health Rep ; 116 Suppl 1: 103-19, 2001.
Article in English | MEDLINE | ID: mdl-11889279

ABSTRACT

OBJECTIVE: The authors used data from a larger study to evaluate the long-term effects of a peer advocate intervention on condom and contraceptive use among HIV-infected women and women at high risk for HIV infection. METHODS: HIV-infected women in one study and women at high risk for HIV infection in a second study were selected from the Women and Infants Demonstration Project and assigned to a standard or an enhanced HIV prevention treatment group. The enhanced intervention included support groups and one-on-one contacts with peer advocates tailored to clients' needs. The authors interviewed women at baseline and at 6-, 12- and 18-months, and measured changes in consistency of condom and contraceptive use and in self-efficacy and perceived advantages and disadvantages of condom and contraceptive use. RESULTS: Of HIV-infected women, the enhanced group had improved consistency in condom use, increased perceived advantages of condom use, and increased level of self-efficacy compared with the standard group. Of women at risk, the enhanced intervention group at six months maintained consistent condom use with a main partner and perceived more benefit of condom use compared with the standard group. These differences diminished at 12 months. CONCLUSIONS: The enhanced intervention was generally effective in the HIV+ study. In the at-risk study, however, intervention effects were minimal and short-lived. Factors related to the theory, intervention design, and sample characteristics help explain these differences.


Subject(s)
HIV Infections/prevention & control , Health Promotion/organization & administration , Peer Group , Safe Sex/statistics & numerical data , Self-Help Groups , Women's Health , Adolescent , Adult , Baltimore/epidemiology , Community Health Planning , Condoms/statistics & numerical data , Contraceptive Agents/therapeutic use , Female , HIV Infections/epidemiology , Health Behavior , Humans , Incidence , Logistic Models , Philadelphia/epidemiology , Primary Prevention , Risk Assessment , Risk-Taking , Safe Sex/psychology , Self Efficacy , Time
12.
J Air Waste Manag Assoc ; 50(7): 1215-22, 2000 Jul.
Article in English | MEDLINE | ID: mdl-10939214

ABSTRACT

In 1996, Schwartz, Dockery, and Neas reported that daily mortality was more strongly associated with concentrations of PM2.5 than with concentrations of larger particles (coarse mass [CM]) in six U.S. cities ("original paper"/"original analyses"). Because of the public policy implications of the findings and the uniqueness of the concentration data, we undertook a reanalysis of these results. This paper presents results of the reconstruction of these data and replication of the original analyses using the reconstructed data. The original investigators provided particulate air pollution data for this paper. Daily weather and daily counts of total and cause-specific deaths were reconstructed from original public records. The reconstructed particulate air pollution and weather data were consistent with the summaries presented in the original paper. Daily counts of deaths in the reconstructed data set were lower than in the original paper because of restrictions on residence and place of death. The reconstruction process identified an administrative change in county codes that led to higher numbers of deaths in St. Louis. Despite these differences in daily counts of deaths, the estimated effects of particulate air pollution from the reconstructed dataset, using analytic methods as described in the original paper, produced combined effect estimates essentially equivalent to the originally published results. For example, the estimated association of a 10 micrograms/m3 increase in 2-day mean particulate air pollution on total mortality was 1.3% (95% confidence interval [CI] 0.9-1.7%, t = 6.53) for PM2.5 based on the reconstructed dataset, compared to the originally reported association of 1.5% (95% CI 1.1-1.9%, t = 7.41). For coarse particles, the estimated association from the reconstructed dataset was 0.4% (95% CI -0.2-0.9%, t = 1.43) compared to the originally reported association of 0.4% (95% CI -0.1-1.0%, t = 1.48). These results from the reconstructed data suggest that the original results reported by Schwartz, Dockery, and Neas were essentially replicated.


Subject(s)
Air Pollution/adverse effects , Mortality , Adolescent , Adult , Aged , Child , Child, Preschool , Epidemiologic Studies , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Particle Size , Reproducibility of Results
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