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

May 17, 2011
August 28, 2012
March 2011
March 2012   (final data collection date for primary outcome measure)
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)
Proportion of patients classified as successfully treated. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
Treatment success is defined as cure or treatment completion.
Complete list of historical versions of study NCT01356095 on ClinicalTrials.gov Archive Site
  • 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).
  • Proportion of patients defaulting from treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Default defined as missing greater than or equal 2 consecutive months of treatment.
  • Proportion of successfully treated and default cases among patients treated for tuberculosis only and those on both tuberculosis and antiretroviral treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Treatment success defined as cure or treatment completion.
  • Weight change. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight change from start to end of treatment.
Not Provided
Not Provided
 
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Tuberculosis
  • 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.
  • Other: Palm-Plus
    Clinical guideline and training approach, designed for mid-level healthworkers.
  • 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.
    Intervention: Other: Palm-Plus
  • Experimental: Adherence intervention
    Intervention arm.
    Intervention: Other: Knowledge translation intervention
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
May 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All health centers in Zomba District
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01356095
DI807
No
Dignitas International
Dignitas International
  • University of Toronto
  • Ministry of Health and Population, Malawi
Principal Investigator: Lisa Puchalski Ritchie University of Toronto
Dignitas International
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP