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

NCT01356095 | Completed

• 1 other identifier: DI807
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Treatment Adherence; knowledge translation; Educational outreach

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Proportion of patients defaulting from treatment.

  1 year

• Proportion of successfully treated and default cases among patients treated for tuberculosis only and those on both tuberculosis and antiretroviral treatment

  1 year

• Weight change.

  1 year

Study Arms (3)

PALM-Plus control

ACTIVE COMPARATOR

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

Other: Palm-Plus

Adherence intervention

EXPERIMENTAL

Intervention arm.

Other: Knowledge translation intervention

Control

NO INTERVENTION

Interventions

Knowledge translation intervention OTHER

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.

Adherence intervention

Palm-Plus OTHER

Clinical guideline and training approach, designed for mid-level healthworkers.

PALM-Plus control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All health centers in Zomba District

Sponsors & Collaborators

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

Study Sites (1)

Zomba District Health Centers, Dignitas International

Zomba, Malawi

Location

Related Publications (1)

• 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.

  PMID: 25890186 DERIVED

MeSH Terms

Conditions

Tuberculosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Health Behavior; Behavior

Study Officials

• Lisa Puchalski Ritchie

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 19, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 29, 2012

Record last verified: 2011-05

Locations

MA (1)