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

This study has been completed.
Sponsor:
Collaborators:
University of Toronto
Ministry of Health and Population, Malawi
Information provided by (Responsible Party):
Dignitas International
ClinicalTrials.gov Identifier:
NCT01356095
First received: May 17, 2011
Last updated: August 28, 2012
Last verified: May 2011
  Purpose

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 Intervention
Tuberculosis
Other: Knowledge translation intervention
Other: Palm-Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi

Resource links provided by NLM:


Further study details as provided by Dignitas International:

Primary Outcome Measures:
  • Proportion of patients classified as successfully treated. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).


Enrollment: 28
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All health centers in Zomba District
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356095

Locations
Malawi
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
  More Information

No publications provided

Responsible Party: Dignitas International
ClinicalTrials.gov Identifier: NCT01356095     History of Changes
Other Study ID Numbers: DI807
Study First Received: May 17, 2011
Last Updated: August 28, 2012
Health Authority: Malawi: National Health Sciences Research Committee

Keywords provided by Dignitas International:
Tuberculosis
Treatment Adherence
knowledge translation
Educational outreach

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 28, 2014