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Completed

NCT Number: NCT01945905

Cost-effectiveness of Two Forms of DOTS 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intramural

Other

Under this alternative, the patients will receive treatment with direct observation from health team. Treatment will be provided for free

Extramural

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fundación FES

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DOTS

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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