NCT01945905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

4.7 years

First QC Date

September 9, 2013

Last Update Submit

August 10, 2015

Conditions

Tuberculosis, Pulmonary

Keywords

TuberculosisAdherence, medicationPatient compliance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cured patients

    Participants will be followed for the duration of the treatment, an expected average of six months

Study Arms (2)

Extramural

EXPERIMENTAL

Extramural medication delivery and supervision

Other: Extramural

Intramural

ACTIVE COMPARATOR

Intramural medication delivery and supervision

Other: Intramural

Interventions

IntramuralOTHER

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

Intramural
ExtramuralOTHER

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

Extramural

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female (non-pregnant)
  • 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

You may not qualify if:

  • Not written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Secretaria de Salud Publica Municipal de Cali

Cali, Valle del Cauca Department, 76001000, Colombia

Location

Related Publications (13)

  • 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. No abstract available.

    PMID: 19275807BACKGROUND

  • Pablos-Mendez 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. doi: 10.1016/s0002-9343(96)00402-0.

    PMID: 9217566BACKGROUND

  • 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. doi: 10.1378/chest.111.5.1168.

    PMID: 9149565BACKGROUND

  • 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.

    PMID: 11936739BACKGROUND

  • 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. doi: 10.1046/j.1365-3156.2003.01061.x.

    PMID: 12828545BACKGROUND

  • 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. doi: 10.1080/14034940510032220.

    PMID: 16449048BACKGROUND

  • 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.

    PMID: 12132000BACKGROUND

  • 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.

    PMID: 12971655BACKGROUND

  • 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. doi: 10.1046/j.1365-3156.2003.00999.x.

    PMID: 12631309BACKGROUND

  • 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. doi: 10.1093/heapol/17.2.178.

    PMID: 12000778BACKGROUND

  • 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.

    PMID: 12971657BACKGROUND

  • 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. doi: 10.1186/1478-7547-3-6.

    PMID: 16018806BACKGROUND

  • 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.

    PMID: 18204974BACKGROUND

MeSH Terms

Conditions

Tuberculosis, PulmonaryTuberculosisMedication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sandra L Giron, Msc Epi

    Fundación FES

    PRINCIPAL INVESTIGATOR

  • Julio C Mateus, Msc Epi

    Fundación FES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc Epidemiologist

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 19, 2013

Study Start

December 1, 2009

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

CO(1)