Yukari C Manabe

Johns Hopkins University, Baltimore, Maryland, United States

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Publications (95)427.81 Total impact

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    ABSTRACT: To demonstrate the feasibility of integrated screening for cryptococcal antigenemia and tuberculosis (TB) before antiretroviral therapy (ART) initiation and to assess disease specific and all-cause mortality in the first 6 months of follow-up. We enrolled a cohort of HIV-infected, ART-naive adults with CD4 counts ≤250 cells per microliter in rural Uganda who were followed for 6 months after ART initiation. All subjects underwent screening for TB; those with CD4 ≤100 cells per microliter also had cryptococcal antigen (CrAg) screening. For those who screened positive, standard treatment for TB or preemptive treatment for cryptococcal infection was initiated, followed by ART 2 weeks later. Of 540 participants enrolled, pre-ART screening detected 10.6% (57/540) with prevalent TB and 6.8% (12/177 with CD4 count ≤100 cells/μL) with positive serum CrAg. After ART initiation, 13 (2.4%) patients were diagnosed with TB and 1 patient developed cryptococcal meningitis. Overall 7.2% of participants died (incidence rate 15.6 per 100 person-years at risk). Death rates were significantly higher among subjects with TB and cryptococcal antigenemia compared with subjects without these diagnoses. In multivariate analysis, significant risk factors for mortality were male sex, baseline anemia of hemoglobin ≤10 mg/dL, wasting defined as body mass index ≤15.5 kg/m, and opportunistic infections (TB, positive serum CrAg). Pre-ART screening for opportunistic infections detects many prevalent cases of TB and cryptococcal infection. However, severely immunosuppressed and symptomatic HIV patients continue to experience high mortality after ART initiation.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 04/2015; 68(5):1. DOI:10.1097/QAI.0000000000000527 · 4.39 Impact Factor
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    ABSTRACT: Sputum smear microscopy for tuberculosis (TB) diagnosis lacks sensitivity in HIV-infected symptomatic patients and increases the likelihood that mycobacterial infections particularly disseminated TB will be missed; delays in diagnosis can be fatal. Given the duration for MTB growth in blood culture, clinical predictors of MTB bacteremia may improve early diagnosis of mycobacteremia. We describe the predictors and mortality outcome of mycobacteremia among HIV-infected sputum smear-negative presumptive TB patients in a high prevalence HIV/TB setting. Between January and November 2011, all consenting HIV-infected adults suspected to have TB (presumptive TB) were consecutively enrolled. Diagnostic assessment included sputum smear microscopy, urine Determine TB lipoarabinomannan (LAM) antigen test, mycobacterial sputum and blood cultures, chest X-ray, and CD4 cell counts in addition to clinical and socio-demographic data. Patients were followed for 12 months post-enrolment. Of 394 sputum smear-negative participants [female, 63.7%; median age (IQR) 32 (28-39) years], 41/394 (10.4%) had positive mycobacterial blood cultures (mycobacteremia); all isolates were M. tuberculosis (MTB). The median CD4 cell count was significantly lower among patients with mycobacteremia when compared with those without (CD4 31 versus 122 cells/μL, p < 0.001). In a multivariate analysis, male gender [OR 3.4, 95%CI (1.4-7.6), p = 0.005], CD4 count <100 cells/μL [OR 3.1, 95% CI (1.1-8.6), p = 0.030] and a positive lateral flow urine TB LAM antigen test [OR 15.3, 95%CI (5.7-41.1), p < 0.001] were significantly associated with mycobacteremia. At 12 months of follow-up, a trend towards increased mortality was observed in patients that were MTB blood culture positive (35.3%) compared with those that were MTB blood culture negative (23.3%) (p = 0.065). Mycobacteremia occurred in 10% of smear-negative patients and was associated with higher mortality compared with smear-negative patients without mycobacteremia. Advanced HIV disease (CD4 < 100 cells/mm(3)), male gender and positive lateral flow urine TB LAM test predicted mycobacteremia in HIV-infected smear-negative presumptive TB patients in this high prevalence TB/HIV setting.
    BMC Infectious Diseases 02/2015; 15(62). DOI:10.1186/s12879-015-0812-4 · 2.56 Impact Factor
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    BMC Infectious Diseases 02/2015; 15(62). · 2.56 Impact Factor
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    ABSTRACT: BACKGROUND: The Xpert® MTB/RIF assay permits rapid near-patient detection of Mycobacterium tuberculosis in sputum; however, test sensitivity remains suboptimal in paucibacillary specimens that are negative for acid fast bacilli using smear microscopy. Xpert testing includes dilution with Sample Reagent, and when processed sputum pellets are tested the recommended ratio of Sample Reagent:pellet is 3:1. We evaluated whether a decreased ratio of 2:1 Sample Reagent:pellet increased Xpert sensitivity compared to the recommended 3:1. METHODS: Limit of detection was determined by inoculating serial dilutions of Mycobacterium tuberculosis into sputum samples, preparing sputum pellets, and testing each pellet by Xpert at both Sample Reagent ratios. Processed sputum pellets obtained from Mycobacterium tuberculosis culture positive clinical specimens were also tested by Xpert at both ratios. RESULTS: Among spiked sputum pellets the limit of detection was 1478 CFU/ml (95% Confidence Interval [CI] 1211-1943) at 3:1 ratio and decreased to 832 CFU/ml (95% CI 671-1134) at 2:1. The proportion of specimens in which Mycobacterium tuberculosis was detected was greater at 2:1 than 3:1 for almost all CFU/mL; this difference was most prominent at lower CFU/mL. Among 134 concentrated sputum pellets from the clinical study, the sensitivity of Xpert at 2:1 was greater than at 3:1 overall (80% vs. 72%, p=0.03) and for smear-negative specimens (67% vs. 58%, p=0.12). CONCLUSIONS: For Xpert testing of sputum pellets, using a lower Sample Reagent:pellet ratio increased Mycobacterium tuberculosis detection, especially for paucibacillary specimens. Our study supports use of a 2:1 Sample Reagent:pellet dilution for Xpert testing of sputum pellets.
    Journal of Clinical Microbiology 02/2015; DOI:10.1128/JCM.03619-14 · 4.23 Impact Factor
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    ABSTRACT: Background Syphilis infection during pregnancy leads to avoidable morbidity and mortality and remains a significant problem in sub-Saharan Africa. Despite global initiatives to increase the proportion of pregnant women screened, implementation has been slow. We sought to investigate the feasibility of adding syphilis screening within an integrated antenatal HIV clinic.Methods Pregnant women attending the HIV antenatal clinic were sequentially enrolled and consenting participants answered a questionnaire on sexual behavior and previous pregnancies, provided sociodemographic data, and were tested using rapid plasmin reagin (RPR). If positive, participants were treated with benzathine penicillin. All were given a partner notification slip and were followed up after delivery to determine birth outcomes.Results584 of 606 (95.7%) women approached and consented to test for syphilis. 570 women were enrolled (median age 29 (IQR 25¿32) with a median (IQR) CD4 of 372 (257¿569) cells/¿L). Of the 5.1% (29/570) with a positive RPR, all were asymptomatic, were successfully contacted, and treated with benzathine penicillin without adverse reactions. Overall, 61 (12.1%) of the participants had an adverse birth outcome. In the bivariate analysis, only age was significantly different between those with and without a positive RPR (RR¿=¿1.15, 95% CI 1.065-1.248; p¿<¿0.001). Partners of only 10 (34.5%) participants returned for treatment.Conclusions Structural interventions such as opt-out testing for syphilis within integrated HIV-antenatal care clinics are feasible and capitalize on the excellent care programs that have already been established for HIV care. Novel approaches are required for partner notification.
    BMC Infectious Diseases 01/2015; 15(1):15. DOI:10.1186/s12879-014-0739-1 · 2.56 Impact Factor
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    ABSTRACT: Percutaneous needle autopsy can overcome a number of barriers that limit the use of complete autopsies. We performed blind-and ultrasound guided needle autopsies in HIV-infected adults in Uganda. In this study we describe in detail the methods we used, the ability of both procedures to obtain sufficient tissue for further examination and the learning curve of the operators over time. If written informed consent was granted from the next of kin, we first performed a blind needle autopsy, puncturing brain, heart, lungs, liver, spleen and kidneys using predefined surface marking points. We then performed an ultrasound guided needle autopsy puncturing heart, liver, spleen and kidneys. The number of attempts, expected success and duration of the procedure were noted. A pathologist read the slides and indicated if the target tissue was present and of sufficient quality for pathological review. We report the predicted and true success rates, compare the yield of blind to ultrasound guided needle biopsies and evaluate the failure rate over time. Two operators performed 96 blind needle autopsies and 95 ultrasound guided needle autopsies. For blind needle biopsies true success rates varied from 56-99% and predicted success rates from 89-99%. For ultrasound guided needle biopsies true success rates varied from 72-100% and predicted success rates from 84-98%. Ultrasound guidance led to a significantly higher success rate in heart and left kidney. A learning curve was observed over time with decreasing failure rates with increasing experience and a shorter duration of the needle autopsy. Needle autopsy can successfully obtain tissue for further pathological review in the vast majority of cases, with a decrease in failure rate with increasing experience of the operator. The benefit of ultrasound guidance will depend on the population, the disease and organ of interest and the local circumstances. Our results justify further evaluation of needle autopsies as a method to establish a cause of death.
    BMC Clinical Pathology 11/2014; 14(1):44. DOI:10.1186/1472-6890-14-44
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    ABSTRACT: Background: Low income, high-tuberculosis burden, countries are considering selective deployment of Xpert MTB/RIF assay (Xpert) due to high cost per test. We compared the diagnostic gain of the Xpert add-on strategy with Xpert replacement strategy for pulmonary tuberculosis diagnosis among HIV-infected adults to inform its implementation. Methods: The first diagnostic sputum sample of 424 HIV-infected adults (67% with CD4 counts <= 200/mm(3)) suspected for tuberculosis was tested by direct Ziehl-Neelsen (DZN) and direct fluorescent microscopy (DFM); concentrated fluorescent microscopy (CFM); Lowenstein-Jensen (LJ) and Mycobacterial Growth Indicator Tube (MGIT) culture; and Xpert. Overall diagnostic yield and sensitivity were calculated using MGIT as reference comparator. The sensitivity of Xpert in an add-on strategy was calculated as the number of smear negative but Xpert positive participants among MGIT positive participants. Results: A total of 123 (29.0%) participants were MGIT culture positive for Mycobacterium tuberculosis. The sensitivity (95% confidence interval) was 31.7% (23.6-40.7%) for DZN, 35.0% (26.5-44.0%) for DFM, 43.9% (34.9-53.1%) for CFM, 76.4% (67.9-83.6) for Xpert and 81.3% (73.2-87.7%) for LJ culture. Add-on strategy Xpert showed an incremental sensitivity of 44.7% (35.7-53.9%) when added to DZN, 42.3% (33.4-51.5%) to DFM and 35.0% (26.5-44.0%) to CFM. This translated to an overall sensitivity of 76.4%, 77.3% and 79.0% for add-on strategies based on DZN, DFM and CFM, respectively, compared to 76.4% for Xpert done independently. From replacement to add-on strategy, the number of Xpert cartridges needed was reduced by approximately 10%. Conclusions: Among HIV-infected TB suspects, doing smear microscopy prior to Xpert assay in add-on fashion only identifies a few additional TB cases.
    PLoS ONE 09/2014; 9(9). DOI:10.1371/journal.pone.0107595 · 3.53 Impact Factor
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    ABSTRACT: Minimal invasive but accurate methods to establish the cause of death in HIV-infected patients are needed. We studied the agreement in cause of death between blind and ultrasound-guided needle autopsy and complete autopsy in HIV-infected patients in Uganda.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 07/2014; DOI:10.1097/QAI.0000000000000290 · 4.39 Impact Factor
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    ABSTRACT: Mortality in hospitalized, febrile patients in Sub-Saharan Africa is high due to HIV-infected, severely immunosuppressed patients with opportunistic co-infection, particularly disseminated tuberculosis (TB) and cryptococcal disease. We sought to determine if a positive lateral flow assay (LFA) result for urine lipoarabinomannan (LAM) and cryptococcal antigenuria was associated with mortality.
    PLoS ONE 07/2014; 9(7):e101459. DOI:10.1371/journal.pone.0101459 · 3.53 Impact Factor
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    07/2014; 2(7):e392. DOI:10.1016/S2214-109X(14)70235-9
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    ABSTRACT: BACKGROUND: Cryptococcal meningitis accounts for 20 to 25% of acquired immunodeficiency syndrome-related deaths in Africa. Antiretroviral therapy (ART) is essential for survival; however, the question of when ART should be initiated after diagnosis of cryptococcal meningitis remains unanswered. METHODS: We assessed survival at 26 weeks among 177 human immunodeficiency virus-infected adults in Uganda and South Africa who had cryptococcal meningitis and had not previously received ART. We randomly assigned study participants to undergo either earlier ART initiation (1 to 2 weeks after diagnosis) or deferred ART initiation (5 weeks after diagnosis). Participants received amphotericin B (0.7 to 1.0 mg per kilogram of body weight per day) and fluconazole (800 mg per day) for 14 days, followed by consolidation therapy with fluconazole. RESULTS: The 26-week mortality with earlier ART initiation was significantly higher than with deferred ART initiation (45% [40 of 88 patients] vs. 30% [27 of 89 patients]; hazard ratio for death, 1.73; 95% confidence interval [CI], 1.06 to 2.82; P=0.03). The excess deaths associated with earlier ART initiation occurred 2 to 5 weeks after diagnosis (P=0.007 for the comparison between groups); mortality was similar in the two groups thereafter. Among patients with few white cells in their cerebrospinal fluid (<5 per cubic millimeter) at randomization, mortality was particularly elevated with earlier ART as compared with deferred ART (hazard ratio, 3.87; 95% CI, 1.41 to 10.58; P=0.008). The incidence of recognized cryptococcal immune reconstitution inflammatory syndrome did not differ significantly between the earlier-ART group and the deferred-ART group (20% and 13%, respectively; P=0.32). All other clinical, immunologic, virologic, and microbiologic outcomes, as well as adverse events, were similar between the groups. CONCLUSIONS: Deferring ART for 5 weeks after the diagnosis of cryptococcal meningitis was associated with significantly improved survival, as compared with initiating ART at 1 to 2 weeks, especially among patients with a paucity of white cells in cerebrospinal fluid. (Funded by the National Institute of Allergy and Infectious Diseases and others; COAT ClinicalTrials.gov number, NCT01075152.).
    New England Journal of Medicine 06/2014; 370(26):2487-98. DOI:10.1056/NEJMoa1312884 · 54.42 Impact Factor
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    ABSTRACT: Testosterone, a male reproductive hormone, affects several physiological processes, such as sperm production, energy, strength, sexual behavior, sleep and the general well being of men. Normal levels of testosterone are necessary to effect these physiological processes. The objective of this study was to study the association between testosterone levels in a sample of Ugandan men with socio-demographic characteristics, and compare the testosterone levels of Ugandan men with that of men in other countries.
    African Health Sciences 06/2014; 14(2):348-55. DOI:10.4314/ahs.v14i2.9 · 0.66 Impact Factor
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    ABSTRACT: Rationale:Smear microscopy has suboptimal sensitivity, and there is a need to improve its performance since it is commonly used to diagnose tuberculosis (TB).Objectives:We prospectively evaluated the diagnostic accuracy of the Small Membrane Filtration (SMF) method, an approach that uses a vacuum manifold and is designed to concentrate bacilli onto a filter that can be examined microscopically.Methods:We enrolled hospitalized adult pulmonary TB suspects in Kampala, Uganda. We obtained a clinical history and three spontaneously expectorated sputum specimens for smear microscopy (direct, concentrated and SMF), MGIT 960 and Lowenstein Jensen (LJ) cultures, and Xpert MRB/RIF testing. We performed per-specimen (primary) and per-patient analyses.Results:From October 2012 to June 2013 we enrolled 212 patients (579 sputum specimens). Participants were mostly female (63.2%); 81.6% were HIV-infected, with median CD4 47 cells/μL. Overall, 19.0%, 20.4%, 27.1%, 25.2% and 25.9% of specimens tested positive by direct smear, concentrated smear, MGIT, LJ and Xpert, respectively. In the per-specimen analysis, the sensitivity of the SMF method (48.5%, 95% CI 37.4% - 59.6%) was lower than that of direct smear (60.9%, 51.4% - 70.5%, p=0.0001) and concentrated smear (63.3%, 53.6% - 73.1%, p<0.0001). Sub-group analyses showed that SMF performed poorly in specimens having low volume or low bacterial load.Conclusions:The SMF method performed poorly compared to standard smear techniques, and was sensitive to sample preparation techniques. The optimal laboratory SMF protocol may require striking a fine balance between sample dilution and filtration failure rate.
    Journal of clinical microbiology 05/2014; 52(7). DOI:10.1128/JCM.00642-14 · 4.23 Impact Factor
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    ABSTRACT: Cataracts contribute 12% of visual loss among HIV-infected adults in Uganda. Immuno-pathogenesis of cataracts may differ among HIV-infected individuals; thus the need for innovative therapeutic interventions among HIV-infected adults. In a laboratory based case-control study, nested in a clinical/surgical community outreach camp, 50 adults with cataracts eligible for surgery were selected consecutively. HIV testing was done for individuals with unknown HIV sero-status. Peripheral Blood Mononuclear Cells (PBMC) were collected from all HIV-positive-adults-with-cataracts (cases) and HIV-negative-adults-with-cataracts (comparative group) and age-matched HIV-negative and HIV-positive- adults- without-cataracts (comparative group). Treg were measured as CD3+CD4+FoxP3+CD25+(bright) and immune activation as CD3+CD4+CD38+HALDR+ using a Facs Canto II flowcytometer. Mann Whitney test was used to compare expression among the four groups. Of 50 adults operated for cataracts, 24 (48%) were female, 25(50%) were HIV-positive. HIV-positive-individuals had cataracts earlier [median; Inter-quartile Range (IQR); 49(44-53) years] than HIV-negative [70 (IQR 59-75) years]; p=0.0005.Treg were lower among individuals with cataracts irrespective of HIV status; p=0.001; but comparable among younger HIV-positive and elderly HIV-negative with cataracts; p=0.301. Immune activation levels were comparable among HIV-positive and HIV-negative individuals with cataracts. However, HIV-positive-individuals with cataracts expressed higher levels of immune activation than HIV-positive-individuals without cataracts; p=0.012 and HIV-negative-individuals-with-cataracts expressed higher levels of immune activation that HIV-negative-without-cataracts; p<0.0001. CD4 T-cell activation and reduced regulatory T-cell populations were associated with cataracts among adults aging with HIV. We recommend studies on clinical relevance of immune modulation in the prevention of early development of cataracts among adults aging with HIV in Africa.
    Immunology letters 04/2014; 161(1). DOI:10.1016/j.imlet.2014.04.011 · 2.37 Impact Factor
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    ABSTRACT: In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag ('TB LAM') test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Prospective diagnostic accuracy study. Hospital and outpatient settings in Uganda and South Africa. HIV-infected adults with tuberculosis symptoms and/or signs. Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and two respiratory specimens for smear microscopy and mycobacterial culture. For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. 1013 participants were enrolled. Among culture-positive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4≤100 cells/mm. The test was specific in 559/573 (97.6%) of patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4≤100. CD4≤50 (adjusted odds ratio [AOR] 6.2, P<0.001) or 51-100 (AOR 7.1, P<0.001), mycobacteremia (AOR 6.1; P<0.01) and hospitalization (AOR 2.6, P=0.03) were independently associated with a positive TB LAM test. In HIV-positive adults with CD4≤100, the TB LAM urine test detected over half of culture-positive tuberculosis patients, in less than 30 minutes and without the need for equipment or reagents.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 03/2014; 66(3). DOI:10.1097/QAI.0000000000000151 · 4.39 Impact Factor
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    ABSTRACT: Xpert MTB/RIF ('Xpert') and urinary lipoarabinomannan (LAM) assays offer rapid tuberculosis (TB) diagnosis, but have suboptimal sensitivity when used individually in HIV-positive patients. The yield of these tests used in combination for the diagnosis of active TB among HIV-infected TB suspects is unknown. Study of comparative diagnostic accuracy nested into a prospective study of HIV-infected individuals with signs and/or symptoms of TB in Uganda. Xpert testing of archived sputum was conducted for culture-confirmed TB cases and TB suspects in whom a diagnosis of TB was excluded. Additional testing included sputum smear microscopy, sputum culture (solid and liquid media), mycobacterial blood culture, and urinary testing for LAM using a lateral flow test ('LF-LAM') and an enzyme-linked immunosorbance assay ('ELISA-LAM'). Among 103 participants with culture-confirmed TB, sensitivity of Xpert was 76% (95% confidence interval, CI 0.66-0.84), and was superior to that of LF-LAM (49%, 95% CI 0.39-0.59, P < 0.001). Specificity was greater than 97% for both tests among 105 individuals without TB. The combination of smear microscopy and LF-LAM identified 67% (95% CI 0.57-0.76) of culture-confirmed TB cases and approached sensitivity of Xpert testing alone (P = 0.15). The sensitivity of the combination of Xpert and LF-LAM was 85% (88/103 95% CI 0.77-0.92), which was superior to either test alone (P < 0.05) and approached sensitivity of sputum liquid culture testing (94%, 95% CI 0.88-0.98, P = 0.17). Sputum Xpert and urinary LAM assays were complementary for the diagnosis of active TB in HIV-infected patients, and sensitivity of the combination of these tests was superior to that of either test alone.
    AIDS (London, England) 03/2014; 28(9). DOI:10.1097/QAD.0000000000000264 · 6.56 Impact Factor
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    ABSTRACT: Infertility is a public health problem associated with devastating psychosocial consequences. In countries where infertility care is difficult to access, women turn to herbal medicines to achieve parenthood. The aim of this study was to determine the prevalence and factors associated with herbal medicine use by women attending the infertility clinic. This was a cross-sectional study of 260 women attending the infertility clinic at Mulago hospital. The interviewer administered questionnaire comprised socio-demographic characteristics, infertility-related aspects and information on herbal medicine use. The main outcome measure was herbal medicines use for infertility treatment. Determinants of herbal medicine use were assessed using multivariable logistic regression. The majority (76.2%) of respondents had used herbal medicines for infertility treatment. The mean age of the participants was 28.3 years +/- 5.5. Over 80% were married, 59.6% had secondary infertility and 2/3 of the married participants were in monogamous unions. In a multivariable model, the variables that were independently associated with increased use of herbal medicine among infertile patients were being married (OR 2.55, CI 1.24-5.24), never conceived (OR 4.08 CI 1.86-8.96) and infertility for less than 3 years (OR 3.52 CI 1.51-8.821). Factors that were associated with less use of herbal medicine among infertile women were being aged 30 years or less (OR 0.18 CI 0.07-0.46), primary and no education (OR 0.12 CI 0.05-0.46) and living with partner for less than three years (OR 0.39 CI 0.16-0.93). The prevalence of herbal medicine use among women attending the infertility clinic was 76.2%. Herbal medicine use was associated with the participants' age, level of education, marital status, infertility duration, nulliparity, and duration of marriage. Medical care was often delayed and the majority of the participants did not disclose use of herbal medicines to the attending physician. Health professionals should enquire about use of herbal medicines. This may help in educating the patients about the health risks of using herbal medicine and may reduce delays in seeking appropriate care. Collaboration of health professionals with herbal medicine practitioners would help identify the common herbal medicines used for infertility treatment, their potential benefits and harm.
    BMC Complementary and Alternative Medicine 01/2014; 14(1):27. DOI:10.1186/1472-6882-14-27 · 1.88 Impact Factor
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    ABSTRACT: Informed consent is premised on the participants' understanding the scope of the research and the associated risks and benefits. The objective was to evaluate the improvement in knowledge in a population unfamiliar with clinical trial concepts about "what it means to be part of a clinical trial" using an innovative educational tool called the 'Speaking Book'. This was a randomized controlled trial conducted at a research site in Uganda. 201 participants were randomized to: 1) clinical trials information session control arm, or 2) clinical trials information session followed by instruction in the use of the Speaking Book with a take-home copy (intervention arm). After the session, participants of both groups completed a 22-item multiple-choice test on the rights and responsibilities of participants. Participants returned after one week to complete the same test to assess knowledge retention. The mean pre- and post-test score difference was assessed according to trial arm using an unpaired t-test of proportions. Ninety-one (90%) participants completed both the initial and follow-up tests in the control arm and 100 (100%) in the intervention arm. The average age of participants was 38 years, 53% were female and 67% were employed; 20% had previously been invited to participate in a clinical trial; of these, 19% had participated. The mean difference in proportion of correct responses from test 1 to test 2 was 2.7% (95%CI 0.3%-5.0%) for the control arm and 11.6% (95%CI 9.3%-13.7%) for the intervention arm (t-score= -5.3, p-value<0.0001). Participants who had instruction in the use of the Speaking Book had a larger increase in knowledge than those who had no access to this tool. To better engage patients unfamiliar with clinical trial concepts, innovative educational techniques can assist to increase knowledge to make an informed decision about participation in a clinical trial.
    01/2014; 5:165. DOI:10.4172/2155-9627.1000165
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    ABSTRACT: In sub-Saharan Africa, a large proportion of HIV positive patients on antiretroviral therapy (ART) are lost to follow-up, some of whom are dead. The objective of this study was to validate methods used to correct mortality estimates for loss-to-follow-up using a cohort with complete death ascertainment. Routinely collected data from HIV patients initiating first line antiretroviral therapy (ART) at the Infectious Diseases Institute (IDI) (Routine Cohort) was used. Three methods to estimate mortality after initiation were: 1) standard Kaplan-Meier estimation (uncorrected method) that uses passively observed data; 2) double-sampling methods by Frangakis and Rubin (F&R) where deaths obtained from patient tracing studies are given a higher weight than those passively ascertained; 3) Nomogram proposed by Egger et al. Corrected mortality estimates in the Routine Cohort, were compared with the estimates from the IDI research observational cohort (Research Cohort), which was used as the "gold-standard". We included 5,633 patients from the Routine Cohort and 559 from the Research Cohort. Uncorrected mortality estimates (95% confidence interval [1]) in the Routine Cohort at 1, 2 and 3 years were 5.5% (4.9%-6.3%), 6.6% (5.9%-7.5%) and 7.4% (6.5%-8.5%), respectively. The F&R corrected estimates at 1, 2 and 3 years were 11.2% (5.8%-21.2%), 15.8% (9.9%-24.8%) and 18.5% (12.3% -27.2%) respectively. The estimates obtained from the Research Cohort were 15.6% (12.8%-18.9%), 17.5% (14.6%-21.0%) and 19.0% (15.3%-21.9%) at 1, 2 and 3 years respectively. Using the nomogram method in the Routine Cohort, the corrected programme-level mortality estimate in year 1 was 11.9% (8.0%-15.7%). Mortality adjustments provided by the F&R and nomogram methods are adequate and should be employed to correct mortality for loss-to-follow-up in large HIV care centres in Sub-Saharan Africa.
    PLoS ONE 12/2013; 8(12):e83524. DOI:10.1371/journal.pone.0083524 · 3.53 Impact Factor
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    ABSTRACT: Abstract Objective: Xpert MTB/RIF (‘Xpert’) and urinary lateral-flow lipoarabinomannan (LF-LAM) assays offer rapid tuberculosis (TB) diagnosis. This study evaluated the cost-effectiveness of novel diagnostic algorithms utilizing combinations of Xpert and LF-LAM for the detection of active TB among people living with HIV. Design: Cost-effectiveness analysis using data from a comparative study of LF-LAM and Xpert, with a target population of HIV-infected individuals with signs/symptoms of TB in Uganda. Methods: A decision-analysis model compared multiple strategies for rapid TB diagnosis:sputum smear-microscopy; sputum Xpert; smear-microscopy combined with LF-LAM; and Xpert combined with LF-LAM. Primary outcomes were the costs and DALY's averted for each algorithm. Cost-effectiveness was represented using incremental cost-effectiveness ratios (ICER). Results: Compared with an algorithm of Xpert testing alone, the combination of Xpert with LF-LAM was considered highly cost-effective (ICER $57/DALY-averted) at a willingness to pay threshold of Ugandan GDP per capita. Addition of urine LF-LAM testing to smear-microscopy was a less effective strategy than Xpert replacement of smear-microscopy, but was less costly and also considered highly cost-effective (ICER $33 per DALY-averted) compared with continued usage of smear-microscopy alone. Cost-effectiveness of the Xpert plus LF-LAM algorithm was most influenced by HIV/ART costs and life-expectancy of patients after TB treatment. Conclusion: The addition of urinary LF-LAM to TB diagnostic algorithms for HIV-infected individuals is highly cost-effective compared with usage of either sputum smear-microscopy or Xpert alone.
    AIDS 11/2013; 27(18):2883-2892. DOI:10.1097/QAD.0000000000000008 · 6.56 Impact Factor

Publication Stats

2k Citations
427.81 Total Impact Points

Institutions

  • 1999–2015
    • Johns Hopkins University
      • • Department of Medicine
      • • Center for Tuberculosis Research
      Baltimore, Maryland, United States
  • 2011–2014
    • Infectious Diseases Institute, Makerere University
      Kampala, Central Region, Uganda
    • American Society for Clinical Pathology
      American Fork, Utah, United States
  • 2010–2014
    • Makerere University
      • Infectious Diseases Institute
      Kampala, Central Region, Uganda
    • University Medical Center Utrecht
      • Department of Acute Medicine and Infectious Diseases
      Utrecht, Provincie Utrecht, Netherlands
  • 2002–2013
    • Johns Hopkins Medicine
      • Department of Medicine
      Baltimore, Maryland, United States
    • University of Maryland, Baltimore
      Baltimore, Maryland, United States
  • 2010–2011
    • Mulago Hospital
      Kampala, Central Region, Uganda
  • 2004
    • Johns Hopkins Bloomberg School of Public Health
      • Department of International Health
      Baltimore, MD, United States
  • 2003
    • Boston University
      Boston, Massachusetts, United States