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Asili Evaluation in the Democratic Republic of Congo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536286
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
American Refugee Committee
Information provided by (Responsible Party):
Yvonne (Bonnie) A Maldonado, Stanford University

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.

Condition or disease Intervention/treatment Phase
Diarrhea Cough Fever Malnutrition, Child Behavioral: Encouragement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation to Assess the Asili Intervention in South Kivu, Democratic Republic of Congo
Actual Study Start Date : August 4, 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
Experimental: Encouragement Zone 3

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
Households will be visited and encouraged to enroll in Asili

No Intervention: Control Zone 3
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.
Experimental: Encouragement Zone 4

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
Households will be visited and encouraged to enroll in Asili

No Intervention: Control Zone 4
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.



Primary Outcome Measures :
  1. Under-5 child health [ Time Frame: up to 15 months ]
    incidence of diarrhea, fever (as a proxy for malaria), and cough/short, rapid breathing (as a proxy for pneumonia)


Secondary Outcome Measures :
  1. Enhanced economic activity [ Time Frame: up to 15 months ]
    Measured through household surveys based on standardized DHS questionnaires; questions include employment and income-generating activities currently undertaken as well as measures of how economic activity within the household has changed after enrolling in Asili

  2. Food security [ Time Frame: up to 15 months ]
    Measured through household surveys based on standardized DHS questionnaires; questions include access to food within the household, number of meals that children have missed, and number of days children have had to go without food.

  3. Vaccination rates [ Time Frame: up to 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
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Responsible Party: Yvonne (Bonnie) A Maldonado, Chief, Division of Pediatric Infectious Diseases, Stanford University
ClinicalTrials.gov Identifier: NCT03536286    
Other Study ID Numbers: 35216
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Diarrhea
Signs and Symptoms, Digestive
Nutrition Disorders