MalariaNCT05123378
Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality
A study testing Liberia National Community Health Assistant Program in people with Malaria and Diarrhea, run by Last Mile Health at 1 site in Liberia.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria, Diarrhea, Acute Respiratory Infection
- What is being tested?
- Liberia National Community Health Assistant Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,702 participants
- Where
- 1 siteLiberia
- Study dates
- 1 May 2018to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Communities >5 km from a health facility
- Within a household all women 18-49 were interviewed (if possible).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of the Liberia National Community Health Assistant (NCHA) Program on Under-five Mortality: A Study Protocol
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.
Read the 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.
- Conditions
- Malaria, Diarrhea, Acute Respiratory Infection, Malnutrition, Child
- Being tested
- Liberia National Community Health Assistant Program
- Keywords
- Community Health, Mortality, Health Care Utilization, Child Illness Prevalence, Experiential Quality
- Medical subject headings
- Malaria, Diarrhea, Child Nutrition Disorders, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberia National Community Health Assistant ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Implementation | Experimental | Campwood District and District 3C begin NCHAP implementation in May 2018. Receives: Behavioral: Liberia National Community Health Assistant Program |
| Phase 2 Implementation | Experimental | District 3AB and District 2 begin NCHAP implementation in November 2018. Receives: Behavioral: Liberia National Community Health Assistant Program |
| Phase 3 Implementation | Experimental | District 4 begins NCHAP implementation in September 2020. Receives: Behavioral: Liberia National Community Health Assistant Program |
| Phase 4 Implementation | Experimental | Owensgrove District and Commonwealth District begin NCHAP implementation in April 2021. Receives: Behavioral: Liberia National Community Health Assistant Program |
| Phase 5 Implementation | Experimental | District 1 begins NCHAP implementation in January 2022. Receives: Behavioral: Liberia National Community Health Assistant Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in children under 5
Assess the impact of the NCHA program on under-5 mortality
Measured: Cross-sectional household surveys administered at endline in 2022
Secondary outcomes (3)
Health care utilization
Determine effects of the NCHA program on health care utilization
Measured: Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Child illness prevalence
Determine effects of the NCHA program on child illness prevalence
Measured: 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
Determine effects of the NCHA program on experiential quality and trust in the health care system
Measured: Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 May 2018
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 23,702 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Last Mile Health
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Northwestern University, Georgetown University, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Marion Subah, Principal investigator, marionsubah@lastmilehealth.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123378
- Sponsor's protocol ID
- Pro00048901
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests can be made of the PI.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of the Liberia National Community Health Assistant (NCHA) Program on Under-five Mortality: A Study Protocol
- ClinicalTrials.gov ID
- NCT05123378
- Acronym / sponsor ID
- Pro00048901
- Conditions
- Malaria, Diarrhea, Acute Respiratory Infection, Malnutrition, Child
- Keywords
- Community Health, Mortality, Health Care Utilization, Child Illness Prevalence, Experiential Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23,702 participants (estimated)
- Lead sponsor
- Last Mile HealthUniversity, hospital or other
- Collaborators
- Heidelberg University, Northwestern University, Georgetown University, Massachusetts General Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Implementation | Experimental | Behavioral: Liberia National Community Health Assistant ProgramCampwood District and District 3C begin NCHAP implementation in May 2018. |
| Phase 2 Implementation | Experimental | Behavioral: Liberia National Community Health Assistant ProgramDistrict 3AB and District 2 begin NCHAP implementation in November 2018. |
| Phase 3 Implementation | Experimental | Behavioral: Liberia National Community Health Assistant ProgramDistrict 4 begins NCHAP implementation in September 2020. |
| Phase 4 Implementation | Experimental | Behavioral: Liberia National Community Health Assistant ProgramOwensgrove District and Commonwealth District begin NCHAP implementation in April 2021. |
| Phase 5 Implementation | Experimental | Behavioral: Liberia National Community Health Assistant ProgramDistrict 1 begins NCHAP implementation in January 2022. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Communities >5 km from a health facility
- Within a household all women 18-49 were interviewed (if possible).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberia National Community Health Assistant ProgramThrough 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. | Behavioural | Phase 1 Implementation, Phase 2 Implementation, Phase 3 Implementation, Phase 4 Implementation, Phase 5 Implementation |
Primary outcome
Mortality in children under 5
Time frame: Cross-sectional household surveys administered at endline in 2022
Assess the impact of the NCHA program on under-5 mortality
3 secondary outcomes
Health care utilization
Time frame: Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Child illness prevalence
Time frame: 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
Time frame: Cross-sectional household surveys administered at baseline in 2018, midline 2019 and 2021, and endline in 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No. Requests can be made of the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Subah principal investigator
marionsubah@lastmilehealth.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberia National Community Health Assistant Program in people with Malaria and Diarrhea, run by Last Mile Health at 1 site in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality in children under 5 (time frame: Cross-sectional household surveys administered at endline in 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.