A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi

Tuberculosis Clinical Trial

Official title:

A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356095
• Other study ID #: DI807
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: August 28, 2012
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2011
• Source: Dignitas International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research Committee
• Study type: Interventional

Clinical Trial Summary

Despite increased emphasis on evidence based practice in recent years a gap remains between evidence and practice, particularly in resource poor countries. Few studies to date have examined the use of knowledge translation strategies to improve health care outcomes in low income countries. However, given that the majority of health care in these settings is provided by workers with less training and limited resources, the theoretical potential for knowledge translation strategies to improve health care delivery and outcomes by integrating best evidence into routine practice may be greatest in these settings.

Knowledge translation (KT) is an approach to changing health care provider behavior to reduce the gap between evidence and practice in health care delivery. There has been a tendency for knowledge translation interventions to employ generic, "off the shelf", strategies, and apply them to deal with specific issues. This generic approach, fails to recognize the variability in the specific characteristics of health care settings, in terms of their patient populations, health care systems, and health care providers. These characteristics, whether they function as barriers or facilitators to change, make a generalized approach to KT ineffective, where a tailored strategy, which specifically adjusts its approach to measured local barriers and facilitators may achieve better alignment of practice to evidence. This is likely to be particularly true in low income countries where the majority of health care is provided by non-physician health care workers, working within a wider range of health care systems, with variable and unique patient populations and resource constraints. Given the potential to significantly impact health care outcomes at relatively low cost, further research is needed both to develop methods for identifying potential barriers and facilitators to KT strategies in specific resource poor settings, and to evaluate the effectiveness of KT strategies tailored to address the identified barriers.

This study will assess the effectiveness of a two part knowledge translation intervention tailored to address factors identified in a previous study as functioning as barriers and facilitators to treatment adherence among patients on treatment for tuberculosis or combined tuberculosis and antiretroviral treatment, targeting improved patient adherence and health outcomes, in a specific low income country.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All health centers in Zomba District

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Knowledge translation intervention
Two part intervention includes an educational outreach intervention for health care workers and a point of care patient education/counselling tool, delivered to providers within health centers randomized to the intervention arm, using a train the trainer on-site training model.
• Palm-Plus
Clinical guideline and training approach, designed for mid-level healthworkers.

Locations

Country	Name	City	State
Malawi	Zomba District Health Centers, Dignitas International	Zomba

Sponsors (3)

Lead Sponsor	Collaborator
Dignitas International	Ministry of Health and Population, Malawi, University of Toronto

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients classified as successfully treated.	Treatment success is defined as cure or treatment completion. Outcomes measured at patient level at end of treatment (6 months), and at 1 year at health center level (randomized at level of health center)	1 year	No
Secondary	Proportion of patients defaulting from treatment.	Default defined as missing greater than or equal 2 consecutive months of treatment. Outcome measured at patient level at end of treatment (6 months), and 1 year at level of health center (randomized at level of health center).	1 year	No
Secondary	Proportion of successfully treated and default cases among patients treated for tuberculosis only and those on both tuberculosis and antiretroviral treatment	Treatment success defined as cure or treatment completion. Outcome measured at patient level at end of treatment (6 months), and at 1 year for the the health center (randomized at level of health center)	1 year	No
Secondary	Weight change.	Weight change from start to end of treatment. Outcome measured at patient level throughout treatment (6 months) and at 1 year at the health center level (randomized at level of health center).	1 year	No