NCT05123378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23,702

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

4.3 years

First QC Date

November 5, 2021

Last Update Submit

November 5, 2021

Conditions

Keywords

Community HealthMortalityHealth Care UtilizationChild Illness PrevalenceExperiential Quality

Outcome Measures

Primary Outcomes (1)

  • Mortality in children under 5

    Assess the impact of the NCHA program on under-5 mortality

    Cross-sectional household surveys administered at endline in 2022

Secondary Outcomes (3)

  • Health care utilization

    Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022

  • Child illness prevalence

    Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022

  • Experiential quality and trust in the health care system

    Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022

Study Arms (5)

Phase 1 Implementation

EXPERIMENTAL

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

Behavioral: Liberia National Community Health Assistant Program

Phase 2 Implementation

EXPERIMENTAL

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

Behavioral: Liberia National Community Health Assistant Program

Phase 3 Implementation

EXPERIMENTAL

District 4 begins NCHAP implementation in September 2020.

Behavioral: Liberia National Community Health Assistant Program

Phase 4 Implementation

EXPERIMENTAL

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

Behavioral: Liberia National Community Health Assistant Program

Phase 5 Implementation

EXPERIMENTAL

District 1 begins NCHAP implementation in January 2022.

Behavioral: Liberia National Community Health Assistant Program

Interventions

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.

Phase 1 ImplementationPhase 2 ImplementationPhase 3 ImplementationPhase 4 ImplementationPhase 5 Implementation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Last Mile Health

Monrovia, Montserrado County, Liberia

Location

MeSH Terms

Conditions

MalariaDiarrheaChild Nutrition DisordersPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marion Subah

    marionsubah@lastmilehealth.org

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 17, 2021

Study Start

May 1, 2018

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Requests can be made of the PI.

Locations