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

Tuberculosis, Pulmonary Clinical Trial

— DOTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945905
• Other study ID #: FES02013
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: August 10, 2015
• Start date: December 2009
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Fundación FES
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

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

Locations

Country	Name	City	State
Colombia	Secretaria de Salud Publica Municipal de Cali	Cali	Valle

Sponsors (3)

Lead Sponsor	Collaborator
Fundación FES	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Salud Publica, Mexico

Country where clinical trial is conducted

Colombia, 

References & Publications (13)

Burman WJ, Cohn DL, Rietmeijer CA, Judson FN, Sbarbaro JA, Reves RR. Noncompliance with directly observed therapy for tuberculosis. Epidemiology and effect on the outcome of treatment. Chest. 1997 May;111(5):1168-73. — View Citation

Clarke M, Dick J, Bogg L. Cost-effectiveness analysis of an alternative tuberculosis management strategy for permanent farm dwellers in South Africa amidst health service contraction. Scand J Public Health. 2006;34(1):83-91. — View Citation

Elamin EI, Ibrahim MI, Sulaiman SA, Muttalif AR. Cost of illness of tuberculosis in Penang, Malaysia. Pharm World Sci. 2008 Jun;30(3):281-6. doi: 10.1007/s11096-007-9185-0. Epub 2008 Jan 18. — View Citation

Islam MA, Wakai S, Ishikawa N, Chowdhury AM, Vaughan JP. Cost-effectiveness of community health workers in tuberculosis control in Bangladesh. Bull World Health Organ. 2002;80(6):445-50. — View Citation

Jaiswal A, Singh V, Ogden JA, Porter JD, Sharma PP, Sarin R, Arora VK, Jain RC. Adherence to tuberculosis treatment: lessons from the urban setting of Delhi, India. Trop Med Int Health. 2003 Jul;8(7):625-33. — View Citation

Khan MA, Walley JD, Witter SN, Imran A, Safdar N. Costs and cost-effectiveness of different DOT strategies for the treatment of tuberculosis in Pakistan. Directly Observed Treatment. Health Policy Plan. 2002 Jun;17(2):178-86. — View Citation

Lwilla F, Schellenberg D, Masanja H, Acosta C, Galindo C, Aponte J, Egwaga S, Njako B, Ascaso C, Tanner M, Alonso P. Evaluation of efficacy of community-based vs. institutional-based direct observed short-course treatment for the control of tuberculosis in Kilombero district, Tanzania. Trop Med Int Health. 2003 Mar;8(3):204-10. — View Citation

Moulding T, Mateus-Solarte JC, Carvajal-Barona R. Factors predictive of adherence to tuberculosis treatment, Valle del Cauca, Colombia. Int J Tuberc Lung Dis. 2009 Mar;13(3):416-7; author reply 417-8. — View Citation

O'Boyle SJ, Power JJ, Ibrahim MY, Watson JP. Factors affecting patient compliance with anti-tuberculosis chemotherapy using the directly observed treatment, short-course strategy (DOTS). Int J Tuberc Lung Dis. 2002 Apr;6(4):307-12. — View Citation

Okello D, Floyd K, Adatu F, Odeke R, Gargioni G. Cost and cost-effectiveness of community-based care for tuberculosis patients in rural Uganda. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S72-9. — View Citation

Pablos-Méndez A, Knirsch CA, Barr RG, Lerner BH, Frieden TR. Nonadherence in tuberculosis treatment: predictors and consequences in New York City. Am J Med. 1997 Feb;102(2):164-70. — View Citation

Sinanovic E, Floyd K, Dudley L, Azevedo V, Grant R, Maher D. Cost and cost-effectiveness of community-based care for tuberculosis in Cape Town, South Africa. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S56-62. — View Citation

Wandwalo E, Robberstad B, Morkve O. Cost and cost-effectiveness of community based and health facility based directly observed treatment of tuberculosis in Dar es Salaam, Tanzania. Cost Eff Resour Alloc. 2005 Jul 14;3:6. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with treatment	Total of patients who completed de treatment	Participants will be followed for the duration of the treatment, an expected average of six months	No
Secondary	Cured patients	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	No