Child MortalityREACHNCT05016895
REACH2: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire
A study testing Single-dose azithromycin in people with Child Mortality, run by FHI 360 at 1 site in Côte d’Ivoire.
Trial summary
REACH2 is a three-year implementation research study designed to examine the implementation through a mass drug administration platform of bi-annual single-dose azithromycin to reduce child mortality among children ages 1 to 11 months who reside in high child mortality settings. Read more about this study
- Who is it for?
- Ages 1 month to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Mortality
- What is being tested?
- Single-dose azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 767,535 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 27 Aug 2021to 31 Jul 2024
- 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 1 month to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 1 to 11 months
- Resident in targeted community
Who cannot join
- Children below 3.0 kg (3rd centile for healthy 1-month old infants in the WHO growth charts)
- Appears seriously ill at the time of the MDA (per the CDD's assessment)
- Unable to swallow liquid delivered through a needle-less syringe because of physical limitations
- Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide
- prior allergic reaction to medication likely to be a macrolide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Resiliency Through Azithromycin for Children Project: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire
REACH2 is a three-year implementation research study designed to examine the implementation through a mass drug administration platform of bi-annual single-dose azithromycin to reduce child mortality among children ages 1 to 11 months who reside in high child mortality settings.
Read the detailed description
The aim of the study is to provide the government of Côte d'Ivoire and other stakeholders the information needed to understand what is required to bring bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings to scale using the existing MDA platform used for trachoma and other neglected tropical diseases.
Design: The serial cross-sectional study will be carried out in 19 health districts in coordination with the trachoma MDAs over the course of three years. The intervention under study will involve a public health campaign of bi-annual distribution of single-dose azithromycin, including:
- Expanded coverage with azithromycin during annual trachoma MDAs to children 1-5 months of age when delivered at the same time as the annual trachoma MDA, which already covers children 6-11 months, followed by
- Stand-alone MDAs targeting children 1 to 11 months delivered at the approximately 6-month interval between annual trachoma MDAs, or bi-annually in areas where the annual trachoma MDAs are phased out.
To study scale up of these intervention activities, the investigators will systematically collect data, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) implementation science framework. Data collection activities will involve:
- Analyses of routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the REACH activities are being integrated
- Periodic, cross-sectional, post-MDA surveys to verify coverage and examine exposure to project information/messaging
- Qualitative data collection through in-depth interviews (IDI) and/or focus group discussions (FGD) with parents or primary caregivers of children ages 1 to 11 months in the 19 health districts, and district-level MDA implementers to explore issues of acceptability, communication, challenges and areas for improvement in implementation.
Further, after the first round of the annual trachoma MDA scheduled to take place in July 2021, a round of focus groups will be carried out with parents of children ages 1-11 months and local implementers to inform message development for the public health campaign.
- Conditions
- Child Mortality
- Being tested
- Single-dose azithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-dose azithromycinDrug
Bi-annual mass, community-based distribution of single-dose azithromycin to children ages 1 to 11 months.
| Study group | Role | What they receive |
|---|---|---|
| Bi-annual single dose azithromycin | Experimental | Mass, community-based distribution of single dose azithromycin solution (200 mg/5ml) dosed at 20 mg/kg weight to all eligible infants ages 1 to 11 months twice yearly (approximately 6 months apart) Receives: Drug: Single-dose azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of eligible population covered by intervention
coverage of the intervention's target population (reach) with azithromycin in targeted health districts
Measured: three years
Infant mortality rate
Rate of child deaths among children under 1 year of age per 1,000 population
Measured: three years
Implementation fidelity
Proportion of intervention activities are carried out as planned
Measured: three years
Secondary outcomes (3)
Cost of the program as a whole
Program costs will be calculated based on the following inputs: personnel, supplies/recurrent goods, capital goods, travel/transport, space, services, and training
Measured: three years
Cost per child treated
Program costs per child treated
Measured: three years
Cost per death averted
Program costs per death averted
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start27 Aug 2021
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MortalityStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 767,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Ivory Coast
- Responsible party
- Sponsor
- Investigators
- Lisa Dulli, PhD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016895
- Sponsor's protocol ID
- 1743615
- Acronym
- REACH
- Status last verified
- Feb 2025
- First submitted
- 3 Aug 2021
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Quantitative survey data from the study will be shared. These data contain no individually identifying data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Resiliency Through Azithromycin for Children Project: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire
- ClinicalTrials.gov ID
- NCT05016895
- Acronym / sponsor ID
- REACH / 1743615
- Conditions
- Child Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 767,535 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Ministry of Health, Ivory Coast
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 23 Aug 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.
REACH2 is a three-year implementation research study designed to examine the implementation through a mass drug administration platform of bi-annual single-dose azithromycin to reduce child mortality among children ages 1 to 11 months who reside in high child mortality settings.
Detailed description
The aim of the study is to provide the government of Côte d'Ivoire and other stakeholders the information needed to understand what is required to bring bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings to scale using the existing MDA platform used for trachoma and other neglected tropical diseases.
Design: The serial cross-sectional study will be carried out in 19 health districts in coordination with the trachoma MDAs over the course of three years. The intervention under study will involve a public health campaign of bi-annual distribution of single-dose azithromycin, including:
- Expanded coverage with azithromycin during annual trachoma MDAs to children 1-5 months of age when delivered at the same time as the annual trachoma MDA, which already covers children 6-11 months, followed by
- Stand-alone MDAs targeting children 1 to 11 months delivered at the approximately 6-month interval between annual trachoma MDAs, or bi-annually in areas where the annual trachoma MDAs are phased out.
To study scale up of these intervention activities, the investigators will systematically collect data, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) implementation science framework. Data collection activities will involve:
- Analyses of routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the REACH activities are being integrated
- Periodic, cross-sectional, post-MDA surveys to verify coverage and examine exposure to project information/messaging
- Qualitative data collection through in-depth interviews (IDI) and/or focus group discussions (FGD) with parents or primary caregivers of children ages 1 to 11 months in the 19 health districts, and district-level MDA implementers to explore issues of acceptability, communication, challenges and areas for improvement in implementation.
Further, after the first round of the annual trachoma MDA scheduled to take place in July 2021, a round of focus groups will be carried out with parents of children ages 1-11 months and local implementers to inform message development for the public health campaign.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bi-annual single dose azithromycin | Experimental | Drug: Single-dose azithromycinMass, community-based distribution of single dose azithromycin solution (200 mg/5ml) dosed at 20 mg/kg weight to all eligible infants ages 1 to 11 months twice yearly (approximately 6 months apart) |
Who may qualify
- Ages
- 1 month to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ages 1 to 11 months
- Resident in targeted community
Key exclusion criteria (5 listed)
- Children below 3.0 kg (3rd centile for healthy 1-month old infants in the WHO growth charts)
- Appears seriously ill at the time of the MDA (per the CDD's assessment)
- Unable to swallow liquid delivered through a needle-less syringe because of physical limitations
- Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide
- prior allergic reaction to medication likely to be a macrolide
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 |
|---|---|---|
| Single-dose azithromycinBi-annual mass, community-based distribution of single-dose azithromycin to children ages 1 to 11 months. | Drug | Bi-annual single dose azithromycin |
Primary outcome
% of eligible population covered by intervention
Time frame: three years
coverage of the intervention's target population (reach) with azithromycin in targeted health districts
Infant mortality rate
Time frame: three years
Rate of child deaths among children under 1 year of age per 1,000 population
Implementation fidelity
Time frame: three years
Proportion of intervention activities are carried out as planned
3 secondary outcomes
Cost of the program as a whole
Time frame: three years
Cost per child treated
Time frame: three years
Cost per death averted
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Yes. Quantitative survey data from the study will be shared. These data contain no individually identifying data.
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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.
Lisa Dulli, PhD principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-dose azithromycin in people with Child Mortality, run by FHI 360 at 1 site in Côte d’Ivoire.
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 5 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: finished, as of the sponsor's last update on 4 Mar 2025. 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 Côte d’Ivoire. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% of eligible population covered by intervention (time frame: three years). The study lists 3 primary outcomes in all. 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 4 Mar 2025.