Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz

Study Overview
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Brief Summary
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The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2 (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will be assigned to either arm by convenience. One arm will receive the joint treatment strategy and another the routine treatment used in health services.

Detailed Description
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In Mexico DM2 is the main complication of patients with TB (22.2%), more so than HIV, malnutrition and chronic pulmonary obstructive disease (COPD). The World Health Organization (WHO) has proposed a framework for the joint management of TB and DM2 and one of the key points is the need for studies that evaluate the viability and efficacy of programs that manage both diseases jointly. There are social and clinical determinants that are associated to a higher mortality in patients with DM2 and TB such as poor glucose level control (glycosylated hemoglobin >7mg/dl) and immunosuppression which in turn increases the risk of developing a recurrent episode of TB, being multi drug resistant (MDR) and/or failing TB treatment. The determinants associated to TB are the lack of awareness of the disease, drug toxicity and interaction with DM2 medication and treatment default. Social determinants are low income level, living in a crowded household, living in rural areas, not having access to health care, having been in prison and living with people with TB. The strategy consists of interventions on patients, health personnel, community health workers and directors of health services. Researchers will train patients in the use of glucometers, health personnel in management of comorbidities of DM2 and TB, health workers in how to support patients and increase treatment adherence. Bidirectional screening in patients with TB or DM2 using bacilloscopies and glycosylated hemoglobin (HbA1c). During the 6 months of directly observed treatment (DOTS) study nurses will monitor levels of glucose weekly with capillary glucose, monthly with fasting glucose, in months 1, 3 and 6 with HbA1c. Patients with high glucose levels will be referred to metabolic control which will be assessed by experts. Regarding DOTs, first line TB drugs will be available and study nurses will supervise that they are taken correctly. A nutritionist will carry out home visits to guide dietary intake.

Official Title
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Evaluation of an Integral Strategy for Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz.

Conditions
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Pulmonary Tuberculosis, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Community intervention
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of active PTB, Diagnosis of DM2, Not having started TB treatment, Attend a selected health clinic, Sign a written informed consent Exclusion Criteria: Unable to provide information, Pregnancy, HIV infection

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>This arm will receive the standard of care for patients with TB and DM2 | Drug: Standard of care<br>* DOTS plus standard DM2 care<br>|
| Experimental: Intervention<br>This arm will receive the community intervention | Behavioral: Community intervention<br>* Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | Bacteriological cure using sputum smear and culture | Up to 6 months | 
| Blood glucose control | mg/dl | Up to 6 months |