Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT04601714 - Baseline Cohort Malaria Morbidity Study
Withdrawn NCT04020653 - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria Phase 2
Terminated NCT04368910 - Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria Phase 3
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02544048 - Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Active, not recruiting NCT04704674 - Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
Completed NCT03276962 - Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age Phase 2
Completed NCT04966871 - Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults Phase 1
Completed NCT00289185 - Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants Phase 2
Recruiting NCT03937817 - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Active, not recruiting NCT06153862 - Africa Ready Malaria Screening N/A
Completed NCT04545905 - Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
Recruiting NCT06278181 - Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Completed NCT02315690 - Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland Phase 3