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

Fundación FES

Status: Completed

Conditions: Tuberculosis, Pulmonary

Treatments: Other: Extramural; Other: Intramural

Study type: Interventional

Funder types: Other

Identifiers

NCT01945905

FES02013

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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264 participants in 2 patient groups

Extramural

Experimental group

Description:

Extramural medication delivery and supervision

Treatment:

Other: Extramural

Intramural

Active Comparator group

Description:

Intramural medication delivery and supervision

Treatment:

Other: Intramural