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Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality

Primary Purpose

Malaria, Diarrhea, Acute Respiratory Infection

Status
Active
Phase
Not Applicable
Locations
Liberia
Study Type
Interventional
Intervention
Liberia National Community Health Assistant Program
Sponsored by
Last Mile Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Community Health, Mortality, Health Care Utilization, Child Illness Prevalence, Experiential Quality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

The intervention will be accessable for everyone in the target communities without eligbilty criteria.

The impact assessment survey will be a full census. All remote target communities in Grand Bassa will be selected and all households within selected communities will be surveyed with the child mortality module and for other core indicators. Within each household the survey population will consist of all women of reproductive age who are at least 15 years old (15-49). We will select all 1,733 remote communities in the study area of Grand Bassa covering 23,702 households.

Inclusion Criteria:

  • Communities >5 km from a health facility
  • Within a household all women 18-49 were interviewed (if possible).

Exclusion Criteria:

-

Sites / Locations

  • Last Mile Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1 Implementation

Phase 2 Implementation

Phase 3 Implementation

Phase 4 Implementation

Phase 5 Implementation

Arm Description

Campwood District and District 3C begin NCHAP implementation in May 2018.

District 3AB and District 2 begin NCHAP implementation in November 2018.

District 4 begins NCHAP implementation in September 2020.

Owensgrove District and Commonwealth District begin NCHAP implementation in April 2021.

District 1 begins NCHAP implementation in January 2022.

Outcomes

Primary Outcome Measures

Mortality in children under 5
Assess the impact of the NCHA program on under-5 mortality

Secondary Outcome Measures

Health care utilization
Determine effects of the NCHA program on health care utilization
Child illness prevalence
Determine effects of the NCHA program on child illness prevalence
Experiential quality and trust in the health care system
Determine effects of the NCHA program on experiential quality and trust in the health care system

Full Information

First Posted
November 5, 2021
Last Updated
November 5, 2021
Sponsor
Last Mile Health
Collaborators
Heidelberg University, Northwestern University, Georgetown University, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05123378
Brief Title
Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality
Official Title
Assessing the Impact of the Liberia National Community Health Assistant (NCHA) Program on Under-five Mortality: A Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Last Mile Health
Collaborators
Heidelberg University, Northwestern University, Georgetown University, Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Last Mile Health (LMH) has partnered with the Liberian Ministry of Health (MOH) to support the design and implementation of the National Community Health Assistant Program (NCHAP). In collaboration with MOH, LMH is planning to conduct an impact evaluation in Grand Bassa to assess the effect of the National Community Health Assistant Program (NCHAP) on health outcomes, as well as to learn lessons around program operations and implementation. Our central hypothesis is that Community Health Assistants (CHAs) within the NCHAP will reduce under 5 mortality, as a result of expanding access to and uptake of health care utilization in remote communities. We will use a mixed effects discrete survival model, taking advantage of the staggered program implementation in Grand Bassa districts over a period of 4 years to compare the incidence of under-5 child mortality between the pre- and post-CHW program implementation periods.
Detailed Description
Previous evaluations of the NCHAP in Rivercess and Grand Gedeh counties found significant increases in uptake of child and maternal health-care services from qualified providers. We will expand upon those studies to assess the impact of the CHA program after a phased implementation in an additional county. The Liberian NCHAP is being rolled out staggered across the eight districts of Grand Bassa County by the government of Liberia. The practical program implementation is accompanied and supported by LMH. Starting with program implementation in March 2018, the last district will be covered by the NCHAP by January 2022. At baseline, midline, and endline LMH will conduct representative household surveys to assess the interventions uptake and effectiveness on population health. This programmatic strategy allows us to apply a effectiveness-implementation hybrid design, where we are using quasi experimental methods on the intervention's impact on relevant outcomes and program utilization and mixed methods to assess the implementation process. The program implementation and data collection takes place in the Grand Bassa county of Liberia between 2018 and 2022. Measuring an area of 7,936 square kilometres and an overall population of 224,839 in 2008, the county is predominantly rural. For program roll out the five administrative districts were subdivided in eight study districts (see Figure 1). The target population of the NCHA are households in communities with a distance of more than 5 km from the nearest health facility. According to the 2018 LMH Grand Bassa household survey, 1,733 communities were identified as remote with 23,702 households. The long-term objective of the NCHA program is to provide community-based health care that substantially improves population health and is desirable and respectful to the clients it serves. In pursuit of this objective, our specific research aims for the Grand Bassa causal impact evaluation is to assess the impact of the NCHA program on under-5 mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Diarrhea, Acute Respiratory Infection, Malnutrition, Child
Keywords
Community Health, Mortality, Health Care Utilization, Child Illness Prevalence, Experiential Quality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The NCHAP is being implemented in Grand Bassa county on a staggered schedule across eight study districts between 2018 and 2022. In order to serve most indigent districts first, the order is not randomized. Districts with more need for health interventions have been prioritized in the implementation roll out. All program implementations are preceded by community engagement activities, especially in getting the involvement of political and traditional leaders in the community and a training period for CHWs of a few months. Within this time CHWs are recruited and trained in a modular approach with in class training followed by practice in the community for mastery before the next module. The implementation process is still ongoing and the NCHA program will continue after the end of the study in 2022.
Masking
None (Open Label)
Masking Description
All participants, care providers, investigators, and outcome assessors are aware of where and when the intervention is being delivered in each community in Grand Bassa.
Allocation
Non-Randomized
Enrollment
23702 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Implementation
Arm Type
Experimental
Arm Description
Campwood District and District 3C begin NCHAP implementation in May 2018.
Arm Title
Phase 2 Implementation
Arm Type
Experimental
Arm Description
District 3AB and District 2 begin NCHAP implementation in November 2018.
Arm Title
Phase 3 Implementation
Arm Type
Experimental
Arm Description
District 4 begins NCHAP implementation in September 2020.
Arm Title
Phase 4 Implementation
Arm Type
Experimental
Arm Description
Owensgrove District and Commonwealth District begin NCHAP implementation in April 2021.
Arm Title
Phase 5 Implementation
Arm Type
Experimental
Arm Description
District 1 begins NCHAP implementation in January 2022.
Intervention Type
Behavioral
Intervention Name(s)
Liberia National Community Health Assistant Program
Intervention Description
Through the National Community Health Assistant Program (NCHAP), members of remote communities select Community Health Assistants (CHAs). Once selected, CHAs are trained to deliver direct services which include; treatment of diarrhea, ARI, and malaria following Integrated Community Case Management (iCCM) protocols, referrals for patients with clinical danger signs, family planning for women of childbearing age and birth preparedness and education for pregnant women. CHAs are also trained to deliver indirect services which include; health education, active surveillance, referral for mental health and other special conditions for all age groups. Since 2020 COVID-education has also been included in the CHAs work.
Primary Outcome Measure Information:
Title
Mortality in children under 5
Description
Assess the impact of the NCHA program on under-5 mortality
Time Frame
Cross-sectional household surveys administered at endline in 2022
Secondary Outcome Measure Information:
Title
Health care utilization
Description
Determine effects of the NCHA program on health care utilization
Time Frame
Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Title
Child illness prevalence
Description
Determine effects of the NCHA program on child illness prevalence
Time Frame
Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Title
Experiential quality and trust in the health care system
Description
Determine effects of the NCHA program on experiential quality and trust in the health care system
Time Frame
Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The intervention will be accessable for everyone in the target communities without eligbilty criteria. The impact assessment survey will be a full census. All remote target communities in Grand Bassa will be selected and all households within selected communities will be surveyed with the child mortality module and for other core indicators. Within each household the survey population will consist of all women of reproductive age who are at least 15 years old (15-49). We will select all 1,733 remote communities in the study area of Grand Bassa covering 23,702 households. Inclusion Criteria: Communities >5 km from a health facility Within a household all women 18-49 were interviewed (if possible). Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Subah
Organizational Affiliation
marionsubah@lastmilehealth.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
Last Mile Health
City
Monrovia
State/Province
Montserrado
Country
Liberia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Requests can be made of the PI.

Learn more about this trial

Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality

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