Clinical trial NCT01945905: Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia
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
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis, Pulmonary
Keywords: Tuberculosis
Adherence, medication
Patient compliance
Lead sponsor: Fundación FES
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: Instituto Nacional de Salud Publica, Mexico
First posted: 2013-09-19
Enrollment: 264
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Compliance with treatment
timeFrame: Participants will be followed for the duration of the treatment, an expected average of six months
Secondary outcomes:
measure: Cured patients
timeFrame: Participants will be followed for the duration of the treatment, an expected average of six months
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Secretaria de Salud Publica Municipal de Cali
state: Valle
Study officials:
affiliation: Fundación FES
name: Sandra L Giron, Msc Epi
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación FES
name: Julio C Mateus, Msc Epi
role: PRINCIPAL_INVESTIGATOR
References:
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