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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05123378
Other study ID # Pro00048901
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date August 1, 2022

Study information

Verified date November 2021
Source Last Mile Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 23702
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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: -

Study Design


Intervention

Behavioral:
Liberia National Community Health Assistant Program
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.

Locations

Country Name City State
Liberia Last Mile Health Monrovia Montserrado

Sponsors (5)

Lead Sponsor Collaborator
Last Mile Health Georgetown University, Heidelberg University, Massachusetts General Hospital, Northwestern University

Country where clinical trial is conducted

Liberia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Health care utilization Determine effects of the NCHA program on health care utilization Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Secondary Child illness prevalence Determine effects of the NCHA program on child illness prevalence Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Secondary 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 Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
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