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

August 10, 2015 updated by: Sandra Lorena Girón Vargas, Fundación FES

Cost-effectiveness of Two Forms of Delivery of Directly Observed Treatment in a Demonstration Area of the DOTS Strategy in Colombia

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle
      • Cali, Valle, Colombia, 76001000
        • Secretaria de Salud Publica Municipal de Cali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extramural
Extramural medication delivery and supervision
Other: Extramural
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
Active Comparator: Intramural
Intramural medication delivery and supervision
Other: Intramural
Under this alternative, the patients will receive treatment with direct observation from health team. Treatment will be provided for free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with treatment
Time Frame: Participants will be followed for the duration of the treatment, an expected average of six months
Total of patients who completed de treatment
Participants will be followed for the duration of the treatment, an expected average of six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cured patients
Time Frame: 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
Participants will be followed for the duration of the treatment, an expected average of six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación FES

Collaborators

Instituto Nacional de Salud Publica, Mexico
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Investigators

  • Principal Investigator: Sandra L Giron, Msc Epi, Fundación FES
  • Principal Investigator: Julio C Mateus, Msc Epi, Fundación FES

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FES02013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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