NCT03536286

Brief Summary

The South Kivu province of DRC has experience continuous armed conflict over the last several decades; as a result, livelihoods and health metrics are uniformly poor. Thus, the objective of this study is to determine if an integrated set of social enterprises can improve child health while offering viable and scalable new business opportunities for the community. Specific research questions include the impact of the individual enterprises on (1) child health, (2) access to clean water, and (3) economic opportunities in the region.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9,999

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

April 23, 2018

Last Update Submit

October 16, 2019

Conditions

DiarrheaCoughFeverMalnutrition, Child

Outcome Measures

Primary Outcomes (1)

  • Under-5 child health

    incidence of diarrhea, fever (as a proxy for malaria), and cough/short, rapid breathing (as a proxy for pneumonia)

    up to 15 months

Secondary Outcomes (3)

  • Enhanced economic activity

    up to 15 months

  • Food security

    up to 15 months

  • Vaccination rates

    up to 15 months

Study Arms (4)

Encouragement Zone 3

EXPERIMENTAL

Encouragement households will be randomly sampled based on location, and a team of 2 local community champions/data collectors (hired from within the community) will visit each of the encouragement arm homes. Community champions will be responsible for visiting each home, going door-to-door and speaking with each family individually in order to avoid contamination/cross-over with control households. The Asili intervention involves membership into a program; households have the option to opt in or out at any time, without consequence to themselves or the study. The intervention itself involves access to clean water and health clinics. No drugs or medication are administered to individuals through this intervention.

Behavioral: Encouragement

Control Zone 3

NO INTERVENTION

Control households will still have equal access to the Asili intervention and can gain membership into a program at any time. Regardless of membership status, households have the option to opt in or out at any time, without consequence to themselves or the study. The intervention itself involves access to clean water and health clinics. No drugs or medication are administered to individuals through this intervention.

Encouragement Zone 4

EXPERIMENTAL

Encouragement households will be randomly sampled based on location, and a team of 2 local community champions/data collectors (hired from within the community) will visit each of the encouragement arm homes. Community champions will be responsible for visiting each home, going door-to-door and speaking with each family individually in order to avoid contamination/cross-over with control households. The Asili intervention involves membership into a program; households have the option to opt in or out at any time, without consequence to themselves or the study. The intervention itself involves access to clean water and health clinics. No drugs or medication are administered to individuals through this intervention.

Behavioral: Encouragement

Control Zone 4

NO INTERVENTION

Control households will still have equal access to the Asili intervention and can gain membership into a program at any time. Regardless of membership status, households have the option to opt in or out at any time, without consequence to themselves or the study. The intervention itself involves access to clean water and health clinics. No drugs or medication are administered to individuals through this intervention.

Interventions

EncouragementBEHAVIORAL

Households will be visited and encouraged to enroll in Asili

Encouragement Zone 3Encouragement Zone 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in an Asili catchment area
  • Between the age of 18 and 65
  • Have at least one child under 5 living at home at baseline
  • Able to communicate in the study languages: French, Kiswahili, or Mashi

You may not qualify if:

  • Suffering from a significant mental deficit, including mental illness, learning difficulties, or substance abuse, which would impair their ability to consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Behl R, Ali S, Altamirano J, Leno A, Maldonado Y, Sarnquist C. Rebuilding child health in South Kivu, Democratic Republic of Congo (DRC): evaluating the Asili social enterprise program. Confl Health. 2022 May 7;16(1):21. doi: 10.1186/s13031-022-00454-0.

    PMID: 35526031DERIVED

MeSH Terms

Conditions

DiarrheaCoughFeverChild Nutrition Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryBody Temperature ChangesNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: As part of the encouragement intervention, participants (households) will be randomly assigned to the "opportunity" or encouragement arm, where they will be incentivized to participate in the Asili intervention, but are allowed to choose whether or not they actually participate. Families will be randomly sampled based on location, and a team of 2 local community champions/data collectors (hired from within the community) will visit each of the encouragement arm homes, supervised by a community outreach liaison. Control households will not receive an individualized home visit. Due to numerous factors, including political instability and program implementation delays, our local research team was unable to deploy encouragement as planned.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pediatric Infectious Diseases

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 24, 2018

Study Start

August 4, 2016

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

October 18, 2019

Record last verified: 2019-10