Evaluating the Impact of a Community Health Worker Program in Neno, Malawi
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ClinicalTrials.gov Identifier: NCT03106727 |
Recruitment Status :
Completed
First Posted : April 10, 2017
Last Update Posted : September 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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HIV/AIDS Hypertension Asthma Diabetes Epilepsy Mental Health Disorder Malnutrition Tuberculosis Antenatal Care Family Planning | Behavioral: Household model | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | July 31, 2019 |
Actual Study Completion Date : | July 31, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Zalewa
Household Model Intervention introduced first - March 2017
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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. |
- HIV [ Time Frame: Last 3 months ]Percentage of enrolled patients with a visit to integrated care clinic
- Hypertension [ Time Frame: Last 3 months ]Percentage of enrolled patients with a visit to integrated care clinic
- Asthma [ Time Frame: Last 3 months ]Percentage of enrolled patients with a visit to integrated care clinic
- Diabetes [ Time Frame: Last 3 months ]Percentage of enrolled patients with a visit to integrated care clinic
- Epilepsy [ Time Frame: Last 3 months ]Percentage of enrolled patients with a visit to integrated care clinic
- Mental Health [ Time Frame: Last 3 months ]Percentage of enrolled patients with a visit to integrated care clinic
- Malnutrition [ Time Frame: Last 3 months ]Percentage of children under five enrolled in care for moderate and severe paediatric malnutrition
- Tuberculosis [ Time Frame: Last 3 months ]Percentage of total population diagnosed with new confirmed TB cases
- Family Planning [ Time Frame: Last 3 months ]Percentage of women of childbearing age on long-term family planning methods
- Antenatal Care [ Time Frame: Last 3 months ]Percentage of women starting ANC within first trimester
- ART Initiation [ Time Frame: Last year ]Percentage of clients initiated on ART with visit in last 3 months
- EID [ Time Frame: Last 3 months ]Percentage of infants who attend 10 week EID visit
- HTC [ Time Frame: Last 3 months ]Percentage of population tested for HIV
- Malnutrition - Cured [ Time Frame: Last 3 months ]Percentage of children aged 6-59m who were discharged as cured in SFP or OTP (cure rate)
- Tuberculosis Treatment [ Time Frame: Last 3 months ]Percentage of TB cases completing treatment successfully (no loss to follow up or death)
- Modern Family Planning Methods [ Time Frame: Last 3 months ]Percentage of WCBA receiving modern family planning methods
- Newly Initiated Family Planning [ Time Frame: Last 3 months ]Percentage of WCBA newly initiating family planning
- ANC Coverage [ Time Frame: Last 3 months ]Percentage of expected pregnant women in ANC care
- 4+ ANC Visits [ Time Frame: Last 3 months ]Percentage of in cohort attending 4+ ANC visits
- CHW Retention [ Time Frame: Last 2 years ]Percentage of CHWs retained during the entire intervention period

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

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
Malawi | |
Partners In Health / Abwenzi Pa Za Umoyo | |
Neno, Malawi |
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 |
Responsible Party: | Partners in Health |
ClinicalTrials.gov Identifier: | NCT03106727 |
Other Study ID Numbers: |
16/11/1694 |
First Posted: | April 10, 2017 Key Record Dates |
Last Update Posted: | September 23, 2019 |
Last Verified: | September 2019 |
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 |
Community Health Workers Maternal and Child Health Integrated Care Malawi NCD |
Tuberculosis Malnutrition Mental Disorders Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Nutrition Disorders |