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

Sponsor
Dignitas International (Other)
Overall Status
Completed
CT.gov ID
NCT01356095
Collaborator
University of Toronto (Other), Ministry of Health and Population, Malawi (Other)
28
1
3
14
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Knowledge translation intervention
  • Other: Palm-Plus
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PALM-Plus control

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

Other: Palm-Plus
Clinical guideline and training approach, designed for mid-level healthworkers.

Experimental: Adherence intervention

Intervention arm.

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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients classified as successfully treated. [1 year]

    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

  1. Proportion of patients defaulting from treatment. [1 year]

    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).

  2. Proportion of successfully treated and default cases among patients treated for tuberculosis only and those on both tuberculosis and antiretroviral treatment [1 year]

    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)

  3. Weight change. [1 year]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All health centers in Zomba District

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zomba District Health Centers, Dignitas International Zomba Malawi

Sponsors and Collaborators

  • Dignitas International
  • University of Toronto
  • Ministry of Health and Population, Malawi

Investigators

  • Principal Investigator: Lisa Puchalski Ritchie, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dignitas International
ClinicalTrials.gov Identifier:
NCT01356095
Other Study ID Numbers:
  • DI807
First Posted:
May 19, 2011
Last Update Posted:
Aug 29, 2012
Last Verified:
May 1, 2011
Keywords provided by Dignitas International
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2012