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Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia (DOTS)

Primary Purpose

Tuberculosis, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Intramural
Extramural
Sponsored by
Fundación FES
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis, Pulmonary focused on measuring Tuberculosis, Adherence, medication, Patient compliance

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female (non-pregnant)
  • 15 years of age and older
  • Living in urban area (Cali)
  • New diagnosed patients (TB)
  • In conditions to give survey information
  • Patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, HIV/AIDS and negative test for pulmonary tuberculosis

Exclusion Criteria:

  • Not written informed consent

Sites / Locations

  • Secretaria de Salud Publica Municipal de Cali

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extramural

Intramural

Arm Description

Extramural medication delivery and supervision

Intramural medication delivery and supervision

Outcomes

Primary Outcome Measures

Compliance with treatment
Total of patients who completed de treatment

Secondary Outcome Measures

Cured patients
Total number of patients who completed the treatment and had the last or the two last smear negative and had negative cultures at the end of the treatment

Full Information

First Posted
September 9, 2013
Last Updated
August 10, 2015
Sponsor
Fundación FES
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Salud Publica, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01945905
Brief Title
Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia
Acronym
DOTS
Official Title
Cost-effectiveness of Two Forms of Delivery of Directly Observed Treatment in a Demonstration Area of the DOTS Strategy in Colombia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación FES
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Salud Publica, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Tuberculosis ( TB ) remains a major global public health problems and actions to ensure the diagnosis and complete treatment of all cases is the priority for the control of this disease. Despite the availability of effective anti-tuberculosis medications, there are still high levels of nonadherence to treatment. The nonadherence increases the morbidity and mortality of patients, decreases the cure rate, increases the community transmission and the increase of chronically ill patients enables the emergence of multi - drug resistant and increases treatment costs. Despite the knowledge about different forms of cost-effective delivery of DOT (directly observed treatment), recognition of the need to establish the DOT strategy related to the context from local studies, in Colombia and in Cali we hadn't had made studies similar than this one that establish the cost and results of the current DOT delivery strategy and to identify other ways to improve adherence and cure rate for the TB patients at reasonable cost for both: health services and families Therefore, this research aims to compare the cost -effectiveness of current DOT delivery method with an alternative extra- institutional delivery of anti -TB treatment in urban areas of Cali. A cost-effectiveness study was conducted from the institutional and familiar perspective with prospective information collection.
Detailed Description
We compared two strategies for anti- TB treatment delivery: one institutional in which patients went to health institutions to receive treatment and other extra- institutional in which the medication was delivered in the place of choice for treating patients. Measuring the effectiveness ( compliance and cure ) was made from a controlled clinical trial , randomized , partially blinded . The measurement of family and institutional costs , direct and indirect , will be based on the activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
Keywords
Tuberculosis, Adherence, medication, Patient compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extramural
Arm Type
Experimental
Arm Description
Extramural medication delivery and supervision
Arm Title
Intramural
Arm Type
Active Comparator
Arm Description
Intramural medication delivery and supervision
Intervention Type
Other
Intervention Name(s)
Intramural
Intervention Description
Under this alternative, the patients will receive treatment with direct observation from health team. Treatment will be provided for free
Intervention Type
Other
Intervention Name(s)
Extramural
Intervention Description
In this form the medication will be given by a health worker in the place chosen by patients. This option will be delivered to patients with newly diagnosed pulmonary TB without hospitalization criteria
Primary Outcome Measure Information:
Title
Compliance with treatment
Description
Total of patients who completed de treatment
Time Frame
Participants will be followed for the duration of the treatment, an expected average of six months
Secondary Outcome Measure Information:
Title
Cured patients
Description
Total number of patients who completed the treatment and had the last or the two last smear negative and had negative cultures at the end of the treatment
Time Frame
Participants will be followed for the duration of the treatment, an expected average of six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female (non-pregnant) 15 years of age and older Living in urban area (Cali) New diagnosed patients (TB) In conditions to give survey information Patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, HIV/AIDS and negative test for pulmonary tuberculosis Exclusion Criteria: Not written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra L Giron, Msc Epi
Organizational Affiliation
Fundación FES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio C Mateus, Msc Epi
Organizational Affiliation
Fundación FES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Secretaria de Salud Publica Municipal de Cali
City
Cali
State/Province
Valle
ZIP/Postal Code
76001000
Country
Colombia

12. IPD Sharing Statement

Citations:
PubMed Identifier
19275807
Citation
Moulding T, Mateus-Solarte JC, Carvajal-Barona R. Factors predictive of adherence to tuberculosis treatment, Valle del Cauca, Colombia. Int J Tuberc Lung Dis. 2009 Mar;13(3):416-7; author reply 417-8. No abstract available.
Results Reference
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PubMed Identifier
9217566
Citation
Pablos-Mendez A, Knirsch CA, Barr RG, Lerner BH, Frieden TR. Nonadherence in tuberculosis treatment: predictors and consequences in New York City. Am J Med. 1997 Feb;102(2):164-70. doi: 10.1016/s0002-9343(96)00402-0.
Results Reference
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PubMed Identifier
9149565
Citation
Burman WJ, Cohn DL, Rietmeijer CA, Judson FN, Sbarbaro JA, Reves RR. Noncompliance with directly observed therapy for tuberculosis. Epidemiology and effect on the outcome of treatment. Chest. 1997 May;111(5):1168-73. doi: 10.1378/chest.111.5.1168.
Results Reference
background
PubMed Identifier
11936739
Citation
O'Boyle SJ, Power JJ, Ibrahim MY, Watson JP. Factors affecting patient compliance with anti-tuberculosis chemotherapy using the directly observed treatment, short-course strategy (DOTS). Int J Tuberc Lung Dis. 2002 Apr;6(4):307-12.
Results Reference
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PubMed Identifier
12828545
Citation
Jaiswal A, Singh V, Ogden JA, Porter JD, Sharma PP, Sarin R, Arora VK, Jain RC. Adherence to tuberculosis treatment: lessons from the urban setting of Delhi, India. Trop Med Int Health. 2003 Jul;8(7):625-33. doi: 10.1046/j.1365-3156.2003.01061.x.
Results Reference
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PubMed Identifier
16449048
Citation
Clarke M, Dick J, Bogg L. Cost-effectiveness analysis of an alternative tuberculosis management strategy for permanent farm dwellers in South Africa amidst health service contraction. Scand J Public Health. 2006;34(1):83-91. doi: 10.1080/14034940510032220.
Results Reference
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PubMed Identifier
12132000
Citation
Islam MA, Wakai S, Ishikawa N, Chowdhury AM, Vaughan JP. Cost-effectiveness of community health workers in tuberculosis control in Bangladesh. Bull World Health Organ. 2002;80(6):445-50.
Results Reference
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PubMed Identifier
12971655
Citation
Sinanovic E, Floyd K, Dudley L, Azevedo V, Grant R, Maher D. Cost and cost-effectiveness of community-based care for tuberculosis in Cape Town, South Africa. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S56-62.
Results Reference
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PubMed Identifier
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Citation
Lwilla F, Schellenberg D, Masanja H, Acosta C, Galindo C, Aponte J, Egwaga S, Njako B, Ascaso C, Tanner M, Alonso P. Evaluation of efficacy of community-based vs. institutional-based direct observed short-course treatment for the control of tuberculosis in Kilombero district, Tanzania. Trop Med Int Health. 2003 Mar;8(3):204-10. doi: 10.1046/j.1365-3156.2003.00999.x.
Results Reference
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PubMed Identifier
12000778
Citation
Khan MA, Walley JD, Witter SN, Imran A, Safdar N. Costs and cost-effectiveness of different DOT strategies for the treatment of tuberculosis in Pakistan. Directly Observed Treatment. Health Policy Plan. 2002 Jun;17(2):178-86. doi: 10.1093/heapol/17.2.178.
Results Reference
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PubMed Identifier
12971657
Citation
Okello D, Floyd K, Adatu F, Odeke R, Gargioni G. Cost and cost-effectiveness of community-based care for tuberculosis patients in rural Uganda. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S72-9.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia

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