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| ID | Type | Description | Link |
|---|---|---|---|
| D43TW009127 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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Ethiopia is one of the high burden Tuberculosis countries and Tuberculosis is still the leading cause of mortality due to communicable diseases in the country. Nutritional status is one of the predictors of TB treatment outcomes. Thus, the current practices need integration of nutritional intervention in the DOT using Mobile health intervention. However, to investigator's knowledge, there is no sufficient evidence on the effect SMS text Messaging Mobile Health intervention on nutritional status and TB treatment outcomes in Ethiopia.
To ensure the quality of SMS intervention, nutritional related SMS text message will be developed systematically through reviewing literature, systematic reviews and guidelines and appropriate behavioral theories by involving experts and patients. Automated SMS will be sent from one computer database at the scheduled date and time. A validated questionnaire will be adapted and pre-tested to check for any error. Adequate sample size is calculated for both arms with the ratio of 1:1 allocation. Standardized Anthropometric measurement, FANTA Household Dietary Diversity Score and WHO TB treatment outcome classification will be used for assessing the outcome variables. The data collectors will be trained on the objective, screening of eligible participants, the procedure of data collection, and how to assure the quality and security of the data based on the protocol. Continuous supervision will be employed throughout the data collection and intervention period. The data will be collected electronically and will be exported to STATA for analysis. Intention to treat analysis and regression analysis model will be employed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMS group | Experimental | Nutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy |
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| Control group | No Intervention | Standard care of TB treatment with directly observed therapy alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS-based Mobile Health intervention | Behavioral | Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status change | The nutritional status of the patient will be assessed by Body Mass Index (BMI) that calculated through measuring the body weight and height of the patients using an electronic platform weight scale to the nearest 0.1 kg and height to the nearest centimeter using standardized meter. | Change from baseline BMI at end of 2 months and 6 months treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary practice change | Patient's dietary diversity practice will be assessed through a standardized tool adapted from FANTA Household Dietary Diversity Score | Change from baseline dietary practice at end of 6 months treatment |
| Treatment outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zekariyas Sa Nezenega | Contact | 911072963 | +251 | zekitiru@gmail.com |
| Damen Haile Mariam | Contact | 929438641 | +251 | damengoog@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Damen Haile Mariam | Addis Ababa University School of Public Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addis Ababa Health Bureau | Addis Ababa | Ethiopia |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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A Cluster Randomized Trial (CRT) with parallel design will be employed.
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Participants and providers will not be blind to the study intervention. Nutrition and tuberculosis treatment outcomes will be assessed by two independent reviewers without knowledge of each participant's treatment allocation.
Treatment outcomes will be classified as per WHO Tuberculosis treatment guideline. The classification is made based on the smear sputum examination result at second, five and end of six months treatment and/or treatment completion status.
| End of six months TB treatment |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |