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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Knowledge translation intervention
Palm-Plus
Sponsored by
Dignitas International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis focused on measuring Tuberculosis, Treatment Adherence, knowledge translation, Educational outreach

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All health centers in Zomba District

Sites / Locations

  • Zomba District Health Centers, Dignitas International

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

PALM-Plus control

Adherence intervention

Control

Arm Description

Health centers randomized to Palm-Plus intervention in larger trial this trial is embedded in, but not receiving the adherence intervention.

Intervention arm.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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)
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).

Full Information

First Posted
May 17, 2011
Last Updated
August 28, 2012
Sponsor
Dignitas International
Collaborators
University of Toronto, Ministry of Health and Population, Malawi
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1. Study Identification

Unique Protocol Identification Number
NCT01356095
Brief Title
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi
Official Title
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dignitas International
Collaborators
University of Toronto, Ministry of Health and Population, Malawi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis, Treatment Adherence, knowledge translation, Educational outreach

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PALM-Plus control
Arm Type
Active Comparator
Arm Description
Health centers randomized to Palm-Plus intervention in larger trial this trial is embedded in, but not receiving the adherence intervention.
Arm Title
Adherence intervention
Arm Type
Experimental
Arm Description
Intervention arm.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Knowledge translation intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Palm-Plus
Intervention Description
Clinical guideline and training approach, designed for mid-level healthworkers.
Primary Outcome Measure Information:
Title
Proportion of patients classified as successfully treated.
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of patients defaulting from treatment.
Description
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).
Time Frame
1 year
Title
Proportion of successfully treated and default cases among patients treated for tuberculosis only and those on both tuberculosis and antiretroviral treatment
Description
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)
Time Frame
1 year
Title
Weight change.
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All health centers in Zomba District
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Puchalski Ritchie
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zomba District Health Centers, Dignitas International
City
Zomba
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
25890186
Citation
Puchalski Ritchie LM, Schull MJ, Martiniuk AL, Barnsley J, Arenovich T, van Lettow M, Chan AK, Mills EJ, Makwakwa A, Zwarenstein M. A knowledge translation intervention to improve tuberculosis care and outcomes in Malawi: a pragmatic cluster randomized controlled trial. Implement Sci. 2015 Mar 28;10:38. doi: 10.1186/s13012-015-0228-y.
Results Reference
derived

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

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