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

NCT03106727 | Completed

• 1 other identifier: 16/11/1694
• Study Type: interventional
• Target: 122,395
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Hypertension; Asthma; Diabetes; Epilepsy; Mental Health Disorder; Malnutrition; Tuberculosis; Antenatal Care; Family Planning

Keywords

Community Health Workers; Maternal and Child Health; Integrated Care; Malawi; NCD

Outcome Measures

Primary Outcomes (10)

• HIV

  Percentage of enrolled patients with a visit to integrated care clinic

  Last 3 months

• Hypertension

  Percentage of enrolled patients with a visit to integrated care clinic

  Last 3 months

• Asthma

  Percentage of enrolled patients with a visit to integrated care clinic

  Last 3 months

• Diabetes

  Percentage of enrolled patients with a visit to integrated care clinic

  Last 3 months

• Epilepsy

  Percentage of enrolled patients with a visit to integrated care clinic

  Last 3 months

• Mental Health

  Percentage of enrolled patients with a visit to integrated care clinic

  Last 3 months

• Malnutrition

  Percentage of children under five enrolled in care for moderate and severe paediatric malnutrition

  Last 3 months

• Tuberculosis

  Percentage of total population diagnosed with new confirmed TB cases

  Last 3 months

• Family Planning

  Percentage of women of childbearing age on long-term family planning methods

  Last 3 months

• Antenatal Care

  Percentage of women starting ANC within first trimester

  Last 3 months

Secondary Outcomes (10)

• ART Initiation

  Last year

• EID

  Last 3 months

• HTC

  Last 3 months

• Malnutrition - Cured

  Last 3 months

• Tuberculosis Treatment

  Last 3 months

Study Arms (6)

Zalewa

ACTIVE COMPARATOR

Household Model Intervention introduced first - March 2017

Behavioral: Household model

Ligowe and Magaleta

ACTIVE COMPARATOR

Household Model Intervention to be introduced in June 2017

Behavioral: Household model

Neno District Hospital and Neno Parish

ACTIVE COMPARATOR

Household Model Intervention to be introduced in September 2017

Behavioral: Household model

Matope

ACTIVE COMPARATOR

Household Model Intervention to be introduced in December 2017

Behavioral: Household model

Matandani and Nsambe

ACTIVE COMPARATOR

Household Model Intervention to be introduced in March 2018

Behavioral: Household model

Luwani, Nkula, and Midzemba

ACTIVE COMPARATOR

Household Model Intervention to be introduced in June 2018

Behavioral: Household model

Interventions

Household model BEHAVIORAL

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.

Ligowe and Magaleta; Luwani, Nkula, and Midzemba; Matandani and Nsambe; Matope; Neno District Hospital and Neno Parish; Zalewa

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Partners in Health: lead
• University of Warwick: collaborator

Study Sites (1)

Partners In Health / Abwenzi Pa Za Umoyo

Neno, Malawi

Location

Related Publications (1)

• Dunbar EL, Wroe EB, Nhlema B, Kachimanga C, Gupta R, Taylor C, Michaelis A, Cundale K, Dullie L, Jumbe A, Nazimera L, McBain R, Lilford RJ, Watson SI. Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial. BMJ Open. 2018 Jul 13;8(7):e019473. doi: 10.1136/bmjopen-2017-019473.

  PMID: 30007924 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hypertension; Asthma; Diabetes Mellitus; Epilepsy; Mental Disorders; Malnutrition; Tuberculosis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Nutrition Disorders; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Luckson Dullie, MBBS, M Fam Med

  Partners in Health

  PRINCIPAL INVESTIGATOR

• Elizabeth Dunbar, MPH

  Partners in Health

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 10, 2017
• Study Start: March 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)