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

Not Applicable

Completed

• Conditions: Tuberculosis, Pulmonary
• Interventions: Other: Extramural; Other: Intramural

• Registration Number: NCT01945905
• Lead Sponsor: Fundación FES

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extramural	Extramural	Extramural medication delivery and supervision
Intramural	Intramural	Intramural medication delivery and supervision

Primary Outcome Measures

Name	Time	Method
Compliance with treatment	Participants will be followed for the duration of the treatment, an expected average of six months	Total of patients who completed de treatment

Secondary Outcome Measures

Name	Time	Method
Cured patients	Participants will be followed for the duration of the treatment, an expected average of six months	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

Trial Locations

Locations (1)

Secretaria de Salud Publica Municipal de Cali; 🇨🇴 Cali, Valle, Colombia