- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03106727
Evaluating the Impact of a Community Health Worker Program in Neno, Malawi
Evaluating the Impact of a Community Health Worker Program in Neno, Malawi: A Stepped-Wedge Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of the household model program are:
- Timely case finding through education and screening for common, treatable conditions;
- Linkage to care for symptomatic clients along with those qualifying through routine screening;
- Ongoing support and accompaniment of patients in care, including adherence support, psychosocial support, and tracking of missed patient visits (NCDs, chronic care, Antenatal care, postnatal care); and
- Health education for common health conditions and prevention and management of these conditions to optimize prevention, health services uptake, and health management behaviors in the household.
All CHWs in Neno will be reassigned and trained in the Household model in a staggered rollout over two years. The maximum number of trainees per group is capped at 60 participants, with some trainings occurring with two groups of CHWs per catchment area. CHWs will receive a 4 to 5 day foundational training, followed by half-day refresher trainings each quarter. CHW training will be evaluated through the following tools: training attendance count; CHW knowledge assessment; CHW skill assessment; CHW refresher assessment; and overall through a training dashboard.
The implementation of the new CHW model is designed so that it may be evaluated as a stepped wedge, cluster-randomized trial (SW-CRT). The stepped-wedge study design was selected for a number of reasons. First, the training of CHWs needs to be staggered due to training capacity constraints. Second, all sites in Neno will receive the intervention. And third, the stepped wedge RCT design permits estimation of the causal effects of the intervention.
Eleven intervention sites were clustered into six groups based on population size such that each group had manageable number of CHWs to train. The order of implementation for these six sites was randomized by a third party. In the SW-CRT study design, each cluster crosses over from control to intervention group until all groups receive the intervention.
The primary outcomes are:
- HIV: % of enrolled clients with a visit to IC3 in the last 3m
NCDs
- Hypertension: % of enrolled clients with a visit to IC3 in the last 3m
- Asthma: % of enrolled clients with a visit to IC3 in the last 3m
- Diabetes: % of enrolled clients with a visit to IC3 in the last 3m
- Epilepsy: % of enrolled clients with a visit to IC3 in the last 3m
- Mental Health: % of enrolled clients with a visit to IC3 in the last 3m
Malnutrition: % of children under five enrolled in care for moderate and severe pediatric malnutrition
- Hypothesis: don't expect this to change because most cases are cured
- Tuberculosis: % of total population diagnosed with new confirmed TB cases
Women's Health:
o Family Planning: % WCBA on long-term family planning methods
- Antenatal Care:
- % women starting ANC within first trimester
The secondary outcomes are:
HIV:
- % clients initiated on ART in last year with visit in last 3m
- % infants who attend 10w EID visit
- % of population tested for HIV
Malnutrition:
o % of children aged 6m-59 who were discharged as cured in SFP or OTP (cure rate)
Tuberculosis:
- % TB cases completing treatment successfully (no loss to follow up or death)
Women's Health:
- Family Planning:
- % women of child bearing age receiving modern family planning methods
% women of child bearing age newly initiating family planning
o Antenatal Care:
- % expected pregnant women in ANC care
- % number of women in cohort attending 4+ ANC visits
- CHW retention o % of CHW retained during the entire intervention period
Descriptive Statistics:
Measure of Facility Performance o % of facilities offering women's health services on a daily basis
- % months with no facilities stocking out of RUTF (ready-to-use-food for malnutrition)
- Average number of stock out days per month per facility for combination, adult TB medication. Stock outs are measured as when running balance on the facility's stock card is zero.
- Average number of stock out days per month for non-communicable disease care at the two satellite pharmacies for several key drugs
Outcomes Data
To measure the outcomes listed above, we will collect data from:
- Ministry of Health-monthly reports collected from each facility and entered into electronic database called DHIS2
- Partners In Health Medical Record capturing patient-level HIV and NCD data.
- Short, semi-structured qualitative interviews with purposively selected sample of CHW program recipients.
The study is designed as a stepped wedge randomized controlled trial. However, unlike a typical trial of this type, data will be collected at the aggregate cluster level rather than from individuals within clusters. As such, we specify a model for the cluster-time cell means. In addition, the primary outcomes are proportions of people, therefore we will specify the model in logs and control for population size to transform to the whole real line and make a linear model appropriate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Neno, Malawi
- Partners In Health / Abwenzi Pa Za Umoyo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Zalewa
Household Model Intervention introduced first - March 2017
|
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
|
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
|
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
|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV
Time Frame: Last 3 months
|
Percentage of enrolled patients with a visit to integrated care clinic
|
Last 3 months
|
Hypertension
Time Frame: Last 3 months
|
Percentage of enrolled patients with a visit to integrated care clinic
|
Last 3 months
|
Asthma
Time Frame: Last 3 months
|
Percentage of enrolled patients with a visit to integrated care clinic
|
Last 3 months
|
Diabetes
Time Frame: Last 3 months
|
Percentage of enrolled patients with a visit to integrated care clinic
|
Last 3 months
|
Epilepsy
Time Frame: Last 3 months
|
Percentage of enrolled patients with a visit to integrated care clinic
|
Last 3 months
|
Mental Health
Time Frame: Last 3 months
|
Percentage of enrolled patients with a visit to integrated care clinic
|
Last 3 months
|
Malnutrition
Time Frame: Last 3 months
|
Percentage of children under five enrolled in care for moderate and severe paediatric malnutrition
|
Last 3 months
|
Tuberculosis
Time Frame: Last 3 months
|
Percentage of total population diagnosed with new confirmed TB cases
|
Last 3 months
|
Family Planning
Time Frame: Last 3 months
|
Percentage of women of childbearing age on long-term family planning methods
|
Last 3 months
|
Antenatal Care
Time Frame: Last 3 months
|
Percentage of women starting ANC within first trimester
|
Last 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ART Initiation
Time Frame: Last year
|
Percentage of clients initiated on ART with visit in last 3 months
|
Last year
|
EID
Time Frame: Last 3 months
|
Percentage of infants who attend 10 week EID visit
|
Last 3 months
|
HTC
Time Frame: Last 3 months
|
Percentage of population tested for HIV
|
Last 3 months
|
Malnutrition - Cured
Time Frame: Last 3 months
|
Percentage of children aged 6-59m who were discharged as cured in SFP or OTP (cure rate)
|
Last 3 months
|
Tuberculosis Treatment
Time Frame: Last 3 months
|
Percentage of TB cases completing treatment successfully (no loss to follow up or death)
|
Last 3 months
|
Modern Family Planning Methods
Time Frame: Last 3 months
|
Percentage of WCBA receiving modern family planning methods
|
Last 3 months
|
Newly Initiated Family Planning
Time Frame: Last 3 months
|
Percentage of WCBA newly initiating family planning
|
Last 3 months
|
ANC Coverage
Time Frame: Last 3 months
|
Percentage of expected pregnant women in ANC care
|
Last 3 months
|
4+ ANC Visits
Time Frame: Last 3 months
|
Percentage of in cohort attending 4+ ANC visits
|
Last 3 months
|
CHW Retention
Time Frame: Last 2 years
|
Percentage of CHWs retained during the entire intervention period
|
Last 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
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 and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/11/1694
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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