ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Impact of a Community Health Worker Program in Neno, Malawi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03106727
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
University of Warwick
Information provided by (Responsible Party):
Partners in Health

Brief Summary:
This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of Community Health Workers (CHW) in Neno District, Malawi to better support the care needs of the clients they serve. The proposed intervention is a 'Household Model' where CHWs will be assigned to households, rather than HIV or TB specific patients, and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes, and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program. Eleven sites (health centres and hospitals) were arranged into six clusters by estimated size of the catchment area populations, with a population range of 11,680 to 26,260 and an average population of 20,400. The order in which the intervention will be rolled out across the sites will be randomized so that the intervention can be evaluated in a stepped-wedge cluster randomized controlled trial. These clusters were grouped based mostly on geographic location but also on catchment area sizes, in order to maximize feasibility of training for the CHW team and not overload CHW training sessions with too many trainees.

Condition or disease Intervention/treatment Phase
HIV/AIDS Hypertension Asthma Diabetes Epilepsy Mental Health Disorder Malnutrition Tuberculosis Antenatal Care Family Planning Behavioral: Household model Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122395 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The roll-out of this study is designed as a stepped wedge cluster randomised controlled trial. The study consists of six clusters: the first cluster will receive the intervention in March 2017, with a new cluster receiving the intervention every three months thereafter.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the Impact of a Community Health Worker Program in Neno, Malawi: A Stepped-Wedge Cluster Randomized Controlled Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zalewa
Household Model Intervention introduced first - March 2017
Behavioral: Household model
The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.

Active Comparator: Ligowe and Magaleta
Household Model Intervention to be introduced in June 2017
Behavioral: Household model
The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.

Active Comparator: Neno District Hospital and Neno Parish
Household Model Intervention to be introduced in September 2017
Behavioral: Household model
The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.

Active Comparator: Matope
Household Model Intervention to be introduced in December 2017
Behavioral: Household model
The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.

Active Comparator: Matandani and Nsambe
Household Model Intervention to be introduced in March 2018
Behavioral: Household model
The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.

Active Comparator: Luwani, Nkula, and Midzemba
Household Model Intervention to be introduced in June 2018
Behavioral: Household model
The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.




Primary Outcome Measures :
  1. HIV [ Time Frame: Last 3 months ]
    Percentage of enrolled patients with a visit to integrated care clinic

  2. Hypertension [ Time Frame: Last 3 months ]
    Percentage of enrolled patients with a visit to integrated care clinic

  3. Asthma [ Time Frame: Last 3 months ]
    Percentage of enrolled patients with a visit to integrated care clinic

  4. Diabetes [ Time Frame: Last 3 months ]
    Percentage of enrolled patients with a visit to integrated care clinic

  5. Epilepsy [ Time Frame: Last 3 months ]
    Percentage of enrolled patients with a visit to integrated care clinic

  6. Mental Health [ Time Frame: Last 3 months ]
    Percentage of enrolled patients with a visit to integrated care clinic

  7. Malnutrition [ Time Frame: Last 3 months ]
    Percentage of children under five enrolled in care for moderate and severe paediatric malnutrition

  8. Tuberculosis [ Time Frame: Last 3 months ]
    Percentage of total population diagnosed with new confirmed TB cases

  9. Family Planning [ Time Frame: Last 3 months ]
    Percentage of women of childbearing age on long-term family planning methods

  10. Antenatal Care [ Time Frame: Last 3 months ]
    Percentage of women starting ANC within first trimester


Secondary Outcome Measures :
  1. ART Initiation [ Time Frame: Last year ]
    Percentage of clients initiated on ART with visit in last 3 months

  2. EID [ Time Frame: Last 3 months ]
    Percentage of infants who attend 10 week EID visit

  3. HTC [ Time Frame: Last 3 months ]
    Percentage of population tested for HIV

  4. Malnutrition - Cured [ Time Frame: Last 3 months ]
    Percentage of children aged 6-59m who were discharged as cured in SFP or OTP (cure rate)

  5. Tuberculosis Treatment [ Time Frame: Last 3 months ]
    Percentage of TB cases completing treatment successfully (no loss to follow up or death)

  6. Modern Family Planning Methods [ Time Frame: Last 3 months ]
    Percentage of WCBA receiving modern family planning methods

  7. Newly Initiated Family Planning [ Time Frame: Last 3 months ]
    Percentage of WCBA newly initiating family planning

  8. ANC Coverage [ Time Frame: Last 3 months ]
    Percentage of expected pregnant women in ANC care

  9. 4+ ANC Visits [ Time Frame: Last 3 months ]
    Percentage of in cohort attending 4+ ANC visits

  10. CHW Retention [ Time Frame: Last 2 years ]
    Percentage of CHWs retained during the entire intervention period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of one of the 11 catchment areas
  • Seeks routine health care from a health facility in Neno District

Exclusion Criteria:

  • Not a resident and/or does not reside predominantly in Neno District

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106727


Contacts
Contact: Emily Wroe, MD, MPH +265882825535 ewroe@pih.org
Contact: Elizabeth Dunbar, MPH +265881767946 edunbar@pih.org

Locations
Malawi
Partners In Health / Abwenzi Pa Za Umoyo Recruiting
Neno, Malawi
Contact: Emily Wroe, MD    +265882825535    ewroe@pih.org   
Contact: Elizabth Dunbar, MPH    +265881767946    edunbar@pih.org   
Principal Investigator: Luckson Dullie, MD         
Sub-Investigator: Elizabeth Dunbar, MPH         
Sponsors and Collaborators
Partners in Health
University of Warwick
Investigators
Principal Investigator: Luckson Dullie, MBBS, M Fam Med Partners in Health
Principal Investigator: Elizabeth Dunbar, MPH Partners in Health
Study Chair: Emily Wroe, MD, MPH Partners in Health
Study Chair: Richard Lilford, Dsc, PhD, FRCOG, FRCP, FFPH University of Warwick
Study Chair: Celia Taylor, BSocSc (Hons), PhD, QTS, FHEA University of Warwick
Study Chair: Samuel Watson, PhD, MPH University of Warwick

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Partners in Health
ClinicalTrials.gov Identifier: NCT03106727     History of Changes
Other Study ID Numbers: 16/11/1694
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Partners in Health:
Community Health Workers
Maternal and Child Health
Integrated Care
Malawi
NCD

Additional relevant MeSH terms:
Tuberculosis
Malnutrition
Mental Disorders
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Nutrition Disorders