research & publications

CO-MORBIDITIES RESEARCH

Results by County (Approx)
  • 34 results found
  • Integrating Tuberculosis and HIV Services in rural Kenya: uptake and outcomes

    Background:

    An estimated 35.3 million persons worldwide were living with the human immunodeficiency virus (HIV) in 2012, while 8.6 million people developed tuberculosis (TB), the majority of them in sub-Saharan Africa. Kenya is one of the world’s 22 high TB burden2 and high HIV burden countries.


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  • Pilot implementation of a contact tracing intervention for tuberculosis case detection in Kisumu County, Kenya

    Abstract

    Leveraging an existing community health strategy, a contact tracing intervention was piloted under routine programmatic conditions at three facilities in Kisumu County, Kenya. Data collected during a 6-month period were compared to existing programmatic data. After implementation of the intervention, we found enhanced programmatic contact tracing practices, noting an increase in the proportions of index cases traced, symptomatic contacts referred, referred contacts presenting to a facility for tuberculosis screening, and eligible contacts started on isoniazid preventive therapy. As contact tracing is scaled up, health ministries should consider the adoption of similar contact tracing interventions to improve contact tracing practices.


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  • MORTALITY AFTER CLINICAL MANAGEMENT OF AIDS-ASSOCIATED CRYPTOCOCCAL MENINGITIS IN KENYA.

    BACKGROUND:

    Cryptococcal meningitis (CM) is an increasingly prevalent infection among HIV/AIDS patients and is becoming a leading cause of morbidity and mortality in Africa. The short-term prognosis and management of patients with CM may be improved by identifying factors leading to mortality in patients with CM.


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  • Pilot implementation of a contact tracing intervention for tuberculosis case detection in Kisumu County, Kenya

    Leveraging an existing community health strategy, a contact tracing intervention was piloted under routine programmatic conditions at three facilities in Kisumu County, Kenya. Data collected during a 6-month period were compared to existing programmatic data. After implementation of the intervention, we found enhanced programmatic contact tracing practices, noting an increase in the proportions of index cases traced, symptomatic contacts referred, referred contacts presenting to a facility for tuberculosis screening, and eligible contacts started on isoniazid preventive therapy. As contact tracing is scaled up, health ministries should consider the adoption of similar contact tracing interventions to improve contact tracing practices.


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  • Incremental Yield of Including Determine-TB LAM Assay in Diagnostic Algorithms for Hospitalized and Ambulatory HIV-Positive Patients in Kenya.

    BACKGROUND:

    Determine-TB LAM assay is a urine point-of-care test useful for TB diagnosis in HIV-positive patients. We assessed the incremental diagnostic yield of adding LAM to algorithms based on clinical signs, sputum smear-microscopy, chest X-ray and Xpert MTB/RIF in HIV-positive patients with symptoms of pulmonary TB (PTB).


    METHODS:

    Prospective observational cohort of ambulatory (either severely ill or CD4<200cells/μl or with Body Mass Index<17Kg/m2) and hospitalized symptomatic HIV-positive adults in Kenya. Incremental diagnostic yield of adding LAM was the difference in the proportion of confirmed TB patients (positive Xpert or MTB culture) diagnosed by the algorithm with LAM compared to the algorithm without LAM. The multivariable mortality model was adjusted for age, sex, clinical severity, BMI, CD4, ART initiation, LAM result and TB confirmation.


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  • Incidence and correlates of tuberculosis IGRA conversion among HIV-infected postpartum women

    Abstract


    SETTING:

    Prevention of maternal-to-child transmission program at a tertiary care hospital in Nairobi, Kenya. The risk of acquiring Mycobacterium tuberculosis infection among peripartum human immunodeficiency virus (HIV) infected women is poorly defined.


    OBJECTIVE:

    To determine the incidence of and co-factors for interferon-gamma release assay (IGRA) conversion among postpartum HIV-infected women using T-SPOT.TB.


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  • Implementation and Operational Research: Feasibility of Using Tuberculin Skin Test Screening for Initiation of 36-Month Isoniazid Preventive Therapy in HIV-Infected Patients in Resource-Constrained Settings

    Introduction:

    The tuberculin skin test (TST) can be used to identify HIV-infected people who would benefit the most from long-term isoniazid preventive therapy (IPT). However, in resource-constrained settings, implementation of the TST can be challenging. The objectives of this study were to assess the feasibility of implementing the TST for IPT initiation and to estimate the proportion of TST-positive incidence among HIV-positive patients in 2 high tuberculosis and HIV burden settings

  • Community Perceptions of Community Health Workers (CHWs) and Their Roles in Management for HIV, Tuberculosis and Hypertension in Western Kenya.

    Given shortages of health care providers and a rise in the number of people living with both communicable and non-communicable diseases, Community Health Workers (CHWs) are increasingly incorporated into health care programs. We sought to explore community perceptions of CHWs including perceptions of their roles in chronic disease management as part of the Academic Model Providing Access to Healthcare Program (AMPATH) in western Kenya. In depth interviews and focus group discussions were conducted between July 2012 and August 2013. Study participants were purposively sampled from three AMPATH sites: Chulaimbo, Teso and Turbo, and included patients within the AMPATH program receiving HIV, tuberculosis (TB), and hypertension (HTN) care, as well as caregivers of children with HIV, community leaders, and health care workers. Participants were asked to describe their perceptions of AMPATH CHWs, including identifying the various roles they play in engagement in care for chronic diseases including HIV, TB and HTN.


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  • Comparative Yield of Different Diagnostic Tests for Tuberculosis among People Living with HIV in Western Kenya.

    BACKGROUND:

    Diagnosis followed by effective treatment of tuberculosis (TB) reduces transmission and saves lives in persons living with HIV (PLHIV). Sputum smear microscopy is widely used for diagnosis, despite limited sensitivity in PLHIV. Evidence is needed to determine the optimal diagnostic approach for these patients.


    METHODS:

    From May 2011 through June 2012, we recruited PLHIV from 15 HIV treatment centers in western Kenya. We collected up to three sputum specimens for Ziehl-Neelsen (ZN) and fluorescence microscopy (FM), GeneXpert MTB/RIF (Xpert), and culture, regardless of symptoms. We calculated the incremental yield of each test, stratifying results by CD4 cell count and specimen type; data were analyzed to account for complex sampling.


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  • Identifying common barriers and facilitators to linkage and retention in chronic disease care in western Kenya.

    BACKGROUND:

    Sub-Saharan Africa is increasingly being challenged in providing care and treatment for chronic diseases, both communicable and non-communicable. In order to address the challenges of linkage to and retention in chronic disease management, there is the need to understand the factors that can influence engagement in care. We conducted a qualitative study to identify barriers and facilitators to linkage and retention in chronic care for HIV, tuberculosis (TB) and Hypertension (HTN) as part of the Academic Model Providing Access to Healthcare (AMPATH) program in western Kenya.


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  • Performance of Clinical Screening Algorithms for Tuberculosis Intensified Case Finding among People Living with HIV in Western Kenya.

    OBJECTIVE:

    To assess the performance of symptom-based screening for tuberculosis (TB), alone and with chest radiography among people living with HIV (PLHIV), including pregnant women, in Western Kenya.


    DESIGN:

    Prospective cohort study.


    METHODS:

    PLHIV from 15 randomly-selected HIV clinics were screened with three clinical algorithms [World Health Organization (WHO), Ministry of Health (MOH), and "Improving Diagnosis of TB in HIV-infected persons" (ID-TB/HIV) study], underwent chest radiography (unless pregnant), and provided two or more sputum specimens for smear microscopy, liquid culture, and Xpert MTB/RIF. Performance of clinical screening was compared to laboratory results, controlling for the complex design of the survey.


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  • Using Survival Analysis to Identify Risk Factors for Treatment Interruption among New and Retreatment Tuberculosis Patients in Kenya.

    Despite high tuberculosis (TB) treatment success rate, treatment adherence is one of the major obstacles to tuberculosis control in Kenya. Our objective was to identify patient-related factors that were associated with time to TB treatment interruption and the geographic distribution of the risk of treatment interruption by county.


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  • Treatment outcomes of drug-resistant tuberculosis patients in Kenya.

    Abstract


    SETTING: Successful treatment of drug-resistant tuberculosis (DR-TB) is crucial in preventing disease transmission and reducing related morbidity and mortality. A standardised DR-TB treatment regimen is used in Kenya. Although patients on treatment are monitored, no evaluation of factors affecting treatment outcomes has yet been performed.



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  • Tuberculosis screening outcomes for newly diagnosed persons living with HIV, Nyanza Province, Kenya, 2009.

    To describe routine tuberculosis (TB) screening and diagnostic practices among newly enrolled people living with HIV (PLHIV) prior to the implementation of World Health Organization recommended TB intensified case finding.


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  • Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression (THE or PHE)

    Over 25 million HIV-1 infected individuals are currently living in Africa and as many as 50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load was significantly greater than that seen in those individuals without documented clearance of their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of CD4 cell decline in helminth infected individuals may be directly impacted by the significant immune activation seen with such co-infection. The investigators propose a randomized controlled trial examining the potential benefits of routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis and treatment will be compared to a systematic empiric scheduled de-worming program for HIV infected adults. The investigators will compare markers of disease progression including rate of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.


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  • Factors associated with herpes simplex virus type 2 incidence in a cohort of human immunodeficiency virus type 1-seronegative Kenyan men and women reporting high-risk sexual behavior.

    Background

    Herpes simplex virus type 2 (HSV-2) is an important cause of genital ulcers and can increase HIV-1 transmission risk. Our objective was to determine the incidence and correlates of HSV-2 infection in HIV-1-seronegative Kenyan men reporting high-risk sexual behaviour, compared to high-risk HIV-1-seronegative women in the same community.


    Methods Cohort participants were screened for prevalent HIV-1 infection. HIV-1-uninfected participants had regularly scheduled follow-up visits, with HIV counseling and testing and collection of demographic and behavioral data. Archived blood samples were tested for HSV-2.


    Results

    HSV-2 prevalence was 22.0% in men and 50.8% in women (p<0.001). HSV-2 incidence in men was 9.0 per 100 person-years, and was associated with incident HIV-1 infection (adjusted incidence rate ratio [aIRR] 3.9, 95% CI 1.3–12.4). Use of soap for genital washing was protective (aIRR 0.3, 95% CI 0.1–0.8). Receptive anal intercourse had a borderline association with HSV-2 acquisition in men (aIRR 2.0, 95% CI 1.0–4.1, p=0.057), and weakened the association with incident HIV-1. Among women, HSV-2 incidence was 22.1 per 100 person-years (p < 0.001 compared to incidence in men), and was associated with incident HIV-1 infection (aIRR 8.9, 95% CI 3.6–21.8) and vaginal washing with soap (aIRR 1.9, 95% CI 1.0–3.4).


    Conclusions

    HSV-2 incidence in these men and women is among the highest reported, and is associated with HIV-1 acquisition. While vaginal washing with soap may increase HSV-2 risk in women, genital hygiene may be protective in men.


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  • Diagnosing acute and prevalent HIV-1 infection in young African adults seeking care for fever: a systematic review and audit of current practice

    Fever is a common complaint in HIV-1 infected adults and may be a presenting sign of acute HIV-1 infection (AHI). We investigated the extent to which HIV-1 infection was considered in the diagnostic evaluation of febrile adults in sub-Saharan Africa (SSA) through a systematic review of published literature and guidelines in the period 2003–2014. We also performed a detailed audit of current practice for the evaluation of febrile young adults in coastal Kenya. Our review identified 43 studies investigating the aetiology of fever in adult outpatients in SSA. While the guidelines identified recommend testing for HIV-1 infection, none mentioned AHI. In our audit of current practice at nine health facilities, only 189 out of 1173 (16.1%) patients, aged 18–29 years, were tested for HIV-1. In a detailed record review, only 2 out of 39 (5.1%) young adults seeking care for fever were tested for HIV-1, and the possibility of AHI was not mentioned. Available literature on adult outpatients presenting with fever is heavily focused on diagnosing malaria and guidelines are poorly defined in terms of evaluating aetiologies other than malaria. Current practice in coastal Kenya shows poor uptake of provider-initiated HIV-1 testing and AHI is not currently considered in the differential diagnosis.

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  • Health seeking behavior, practices of TB and access to health care among TB patients in Machakos County, Kenya

    Despite efforts to implementation of the DOTS programme in Kenya since the year (1993) and achieving 100% coverage by the year 1996; new TB cases continue to emerge in communities, a significance of TB transmission. The success of the DOTS programne require total adherence to treatment for those infected with TB and appropriate control measures as stipulated in TB treatment guidelines, trained manpower to manage the infected patients and surveillance. The main objective of this study was to examine the health seeking behavior of TB patients, practices of TB and access to health care. A cross- sectional survey of TB patients was done in Athi- River, Machakos level 5 and Mutituni TB treatment health facilities in Machakos County. A pre-tested self administered questionnaire/ interviews was used to collect data. The data was analyzed by use of statistical package for social sciences (SPSS) version 16. Pearson Chi-Square analysis was used to determine the relationships between variables. Level of significance was fixed at 0.05 (p=0.05).The results of this study reveal TB is affecting more males than females (60.4%).Most of the TB patients are young below 40 years accounting for (71.8%), are poor and unemployed (65%).When the TB patient realized they were sick, most of them
    (81.4%) sought informal remedies from private practioners or self medicated. This delayed early opportunity to seek heath care for more than one month by (82%) of the respondents. Failure of the informal treatment and unbearable pains in advanced disease forced the majority (96.8%) to seek health care in designated TB treatment facilities. There is secrecy in TB status disclosure as (75.5%) declined to openly disclose. For those who disclosed (78%) was to a selected family member mainly to seek assistance (90.7%). Across age groups, educational level, marital status, disclosure of TB status was of no statistical significance p=0.462 and openness of status p=0.112 respectively as the majority remained secret. Health education received by (52.8%) in the TB clinics was observed to significantly influence clinic attendance p=0.014 and adherence to treatment p=0.008 as 78.5% attended regularly and 85.5% adhered respectively. Treatment in public facilities is free with the majority (89.9%) reporting attendance. TB patients care in the community is mainly by family members (74.8%), there is no follow up by heath workers and social support group is minimal at (11.4%).The ministry of health needs to address control measures by initiating strict surveillance of TB, initiate community education on best practices of TB and to distigmatize the disease.

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  • Effective tuberculosis control and health sector reforms in Kenya: challenges of an increasing tuberculosis burden and opportunities through reform

    During the period from 1980 to 1997, the annual number of new tuberculosis cases increased four-fold in Kenya, and had reached approximately 50 000 cases by 1998. During the same time period, the government per capita expenditure on health dropped from US$9.5 to US$3.5. Since 1983, Kenya has been decentralising financial responsibility and decision-making power to the districts. In addition, the late 1980s saw the introduction of cost-sharing schemes for most health services, excluding tuberculosis (TB)  treatment. In the midst of these changes, a dual epidemic of TB and HIV/AIDS emerged, and is presently over-burdening the traditional public health system. In response, the National Leprosy and Tuberculosis Control Programme (NLTP) is seeking
    a wider network of service providers and new approaches to the prevention and treatment of TB in the country. The history of health sector reform in Kenya is summarised and the role of the NLTP in these reforms assessed. Recent approaches taken by the NLTP to sustain effective TB control, which draw on the environment of a changing and flexible health system, are expressed. Participation of the NLTP in components of health sector reform, particularly decentralisation, integration, financing through cost-sharing and public/ private mix, are highlighted.

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  • High Prevalence of Pulmonary Tuberculosis and Inadequate Case Finding in Rural Western Kenya

    Case finding and treatment of symptomatic patients with infectious tuberculosis (TB) are the core elements of the global TB
    control strategy of the World Health Organization (WHO) (1). Estimates suggest low case finding in Africa (2), but data are
    limited (3, 4). The HIV epidemic and, more recently, improved case finding have contributed to substantial increases in the
    notification rates in Africa over the past 2 decades (5, 6). The complex interactions between HIV and TB, including the difficulty
    of diagnosing TB in HIV-infected patients, have increased the difficulties in assessing case detection (6).
    Case finding in countries with high TB burdens depends primarily on detecting TB among symptomatic patients who
    present to health services. This policy was based on results of active case-finding studies in India and Kenya in the 1970s and
    1980s (7–12), which found that most people with prevalent TB had sought care previously for their respiratory symptoms,
    suggesting that improved case detection in health facilities would effectively identify people with TB. Modeling studies suggest that the goals for TB control are unlikely to be met without continued improvements in case detection to beyond the current global target of 70% (13) and that substantial improvement in TB control can be expected from improved case finding, including in populations with high HIV prevalence (14, 15). Only a few recent studies have investigated the prevalence of pulmonary TB (PTB) in Africa to evaluate case detection of PTB, in particular in populations with high HIV prevalence (16–21). We conducted a cross-sectional study in a rural population of approximately 134,000 people in Nyanza Province in western Kenya (the Asembo area of Rarieda District and the Gem District) to determine: (1) the prevalence of bacteriologically confirmed PTB; (2) among PTB cases identified, their HIV prevalence; and (3) their contact with health providers

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  • Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults

    The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because pulmonary TB occurs frequently in these countries and age range. In addition, the safety and immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of volunteers

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  • Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

    People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it.
    This study is being done in people who are starting HIV treatment and who live in areas where the TB infection rate is high. The purpose of this study is to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach is to start TB treatment at the same time as HIV treatment, even when TB infection has not been found. The usual approach is to start TB treatment only if TB infection is found.
    In this study, half of the people will start TB treatment at the same time as they start their HIV treatment. The other half will start TB treatment only if TB infection is found.
    The study will also test how safe and effective it is to start TB treatment at about the same time as HIV treatment even when TB infection has not been found. The study will collect information about diet, whether (and when) people in the study become sicker or die, how well their HIV is controlled, how they are feeling, how they are taking their medications, whether it matters where they live or what kind of HIV and TB care is standard, how many people are diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.

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  • Do Clinical Decision-support Reminders for Medical Providers Improve the Do Clinical Decision-support Reminders for Medical Providers Improve the Prevalence of IPT Initiation Among HIV Positive Adults in Western Kenya?

    The purpose of this study is to evaluate the impact of implementing a clinical decision support reminder system for medical providers (i.e., nurses, clinical officers, medical officers, consultants) to improve tuberculosis case-finding and the use of Isoniazid preventative therapy for adults living with HIV in western Kenya.

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  • Brief Bactericidal Activity of Anti-Tuberculosis Drugs

    Multidrug-resistant (MDR) tuberculosis (TB) must be treated with second-line drugs (SLD) that are less effective, more toxic, and more expensive. Treatment requires at least 20 months with 4 or more effective drugs based on timely drug susceptibility test (DST) results. However, there are many examples of closely related drugs with differing antimicrobial activities.
    Labs have found differences in DST results among the rifamycins, Rifampin (RMP) and Rifabutin (RBT); the fluoroquinolones, ofloxacin and Moxifloxacin; and the second-line injectable agents, kanamycin, amikacin, and Capreomycin. In a related finding, isolates resistant to 0.2 mcg/ml INH may be susceptible to higher concentrations. In the Preserving Effective Tuberculosis Treatment Study (PETTS), 32% of RMP-resistant isolates were susceptible to RBT, 41% of kanamycin-resistant isolates were susceptible to Capreomycin, and 45% of isolates resistant to 0.2 mcg/ml INH were susceptible to 1.0 or 5.0 mcg/ml (1). Other studies have demonstrated differences in DST results between Moxifloxacin and ofloxacin. Whether these in vitro results translate into clinical efficacy is completely unknown. Given the severely limited treatment options in MDR TB, it would be exceedingly useful to know whether these in vitro results translate into evidence for clinically meaningful treatment decisions.
    The investigators will determine the clinical bactericidal activity of certain antibiotics against M. tab that appear to be effective in vitro even though closely related drugs from the same class are ineffective in vitro. Further, the investigators propose to determine the molecular genetic determinants of these differences.
    Specifically, we plan to determine:
    1.    The bactericidal activity of RBT in patients whose baseline DST results demonstrate susceptibility to RBT and resistance to RMP.
    2.    The bactericidal activity of high-dose INH in patients whose baseline DST results demonstrate susceptibility to high concentrations of INH and resistance to low concentrations of INH.
    3.    The bactericidal activity of RMP when an approved molecular assay demonstrates genetic mutations associated with RMP resistance, but the phenotypic testing demonstrates susceptibility to RMP.
    4.    The bactericidal activity of Moxifloxacin in patients whose baseline DST results demonstrate susceptibility to Moxifloxacin and resistance to ofloxacin.
    5.    The bactericidal activity of amikacin and Capreomycin in patients whose baseline DST results demonstrate susceptibility to either of these two drugs and resistance to kanamycin.
    6.    The genetic mutations associated with both in vivo and in vitro drug resistance and bactericidal activity.
    To achieve these objectives the investigators propose an innovative variation on early bactericidal activity (EBA) study methodology. Patients at risk for MDR TB will be screened for RMP resistance and INH resistance using molecular assays. In those with RMP-resistant or INH-resistant TB, the investigators will quickly perform phenotypic DSTs using the direct method in the BancTec Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will be available within 14-21 days. If the DST results show, for example, RMP resistance but susceptibility to RBT, consenting patients will be treated with RBT by itself for 10 days. The investigators will assess its effect with serial quantitative sputum cultures. If the concentration of viable bacteria decreases significantly, the investigators will interpret this to mean the drug is having an effect. If not, the drug is ineffective. After 10 days, the patients will resume individualized multidrug treatment based on the full set of DST results.
    In case the investigators identify drugs that are effective under these conditions, the investigators will sequence known and putative genes associated with the action of these drugs for the mycobacterium isolates from these patients.
    The results would have immediate implications for treatment of MDR TB and for diagnostic mycobacteriology.

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  • Evaluating the Safety and Effectiveness of Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection

    HIV-infected people have an increased risk of developing active tuberculosis (TB). The standard course of treatment for TB is 6 to 9 months of Isoniazid (INH). A shorter course of treatment may be as effective and potentially increase treatment adherence. This study will compare the safety and effectiveness of a 4-week regimen of Rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

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  • Feasibility and Effectiveness of Community Based Isoniazid Preventive Therapy in Kenya

    Isoniazid preventive therapy (IPT) is a well studied clinical intervention for primary and secondary prevention of active tuberculosis (TB) after infection with Mycobacterium tuberculosis. It is widely used in industrialized countries in TB outbreak management, focusing on high risk groups such as close contacts in the family, in congregate settings, and in the workplace amongst others. Individuals infected with Human Immunodeficiency Virus (HIV) have a markedly higher risk of acquiring a TB-infection and developing consequently active TB, making HIV-infected individuals a target population for IPT. Studies of IPT in HIV infected persons in the nineties demonstrated the efficacy of IPT in the prevention of active TB in Sub -Saharan Africa and more recent studies suggest that the protective effect remains present in individuals on antiretroviral therapy.
    Despite the proven efficacy of IPT this intervention has not been taken up by most HIV and TB control programmes in Africa where the burden of TB/HIV is highest. The reasons for the low uptake of IPT are many and varied but include fears of expansion of Isoniazid resistance and subsequently the development of multi -drug resistant TB with widespread use of IPT. Additionally screening protocols for excluding active TB and selecting persons for IPT have not been uniformly agreed upon. There have also been concerns that programmes designed to provide IPT may shift TB control programmes from their primary responsibility of finding and treating active TB. Finally it has been unclear as to which programme, between the HIV and the TB control programme, has the primary responsibility of managing the provision of the IPT intervention.
    The World Health Organization and other technical agencies engaged in global TB control have recently re-emphasized the need to scale up IPT. In this proposal we outline an operational research study to evaluate the introduction of IPT at community level and to measure its effectiveness at preventing TB. The study is based on the context of expansion of Community-Based Direct Observed Therapy Short Course (CB-DOTS), home-based care and the concept of HIV prevention with positives (PwPs), where there is a real opportunity to focus on the household as a source of HIV-associated tuberculosis.
    The study is designed as a cluster randomized trial. It compares the incidence of TB in household contacts including children under 5 of identified TB/HIV co-infected patients, who received IPT through proactive community intervention and those in a control group where the community was handled in the "usual way". In the intervention group household contacts of index cases of HIV positive, smear positive PTB will be visited at home and consenting contacts will be screened for active TB using a simple questionnaire. Those found to be fit will receive Isoniazid 300mg (5 mg per Kg for children) once daily for 6 months, regardless of the HIV-status. Those found not to be fit will be referred for further evaluation at the nearest TB diagnostic centre. In the control group, routine care following national guidelines will be offered. This consists of contact invitation and assessment of eligibility for IPT, especially, in children less than 5 years. Both groups will be followed up monthly through household visits. Follow up will be for a total of 24 months including the six months when IPT is provided.
    A confidential HIV screening test will be provided to all consenting contacts in both intervention and control group after appropriate counseling.
    The primary outcome is the incidence of TB in the intervention and control household contacts. The difference in incidence between the two groups is a measure of efficacy of the intervention. In addition the efficacy of the intervention will be estimated stratified by HIV status of household contacts if data allows. Secondary outcomes are the incidence of adverse events, the incidence of TB-related symptoms, measures on the uptake of IPT (proportion of contacts starting and discontinuing IPT, treatment adherence) and programmatic indicators, i.e. percentage of persons eligible for IPT and resources needed.

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  • Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis

    REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy.
    The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two Moxifloxacin-containing treatment combinations to determine whether substituting Ethambutol with Moxifloxacin in one combination, and/or substituting Isoniazid with Moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB

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  • Sustainable East Africa Research in Community Health

    The SEARCH study is a cluster randomized community trial of 32 communities each with approximately 10,000 residents. Community health campaigns will be conducted in all study communities and will offer HIV testing and multi-disease prevention and treatment services. The intervention is antiretroviral therapy (ART), independent of CD4 cell count, delivered in a streamlined approach for all HIV infected adults and children. Components of streamlined care include ongoing HIV combination prevention strategies including male circumcision. Control communities ART treatment will follow country guidelines.
    HIV incidence will be measured using an efficient community cohort design (ECCO) comprised of three key elements: A) baseline household community level census, B) community health campaigns (CHC) incorporating HIV testing that use unique identifiers to link individuals between successive waves of the intervention, and C) tracking and evaluation of individuals who do not participate in CHCs.

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