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DiarrheaNCT03536286

Asili Evaluation in the Democratic Republic of Congo

A study testing Encouragement in people with Diarrhea and Cough, run by Stanford University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diarrhea, Cough, Fever
What is being tested?
Encouragement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,999 participants
Where
No sites listed yet
Study dates
4 Aug 2016to 31 Jul 2018
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Evaluation to Assess the Asili Intervention in South Kivu, Democratic Republic of Congo

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.

Read the detailed description

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.

Asili ("foundation" in Swahili) is an innovative initiative that aims to implement a suite of social enterprises to provide basic services and employment opportunities in South Kivu, DRC. Asili was co-created by the American Refugee Committee (ARC), an independent non-profit, and IDEO.org using a methodology known as human-centered design (HCD); based on the process, a model of multiple businesses to meet multiple needs was developed, linked under the Asili membership system and coordinated through a centralized database. The Asili model is unique in bringing self-sustaining social enterprises together on a common operational platform to improve both health and economic opportunity in the region. These enterprises are 1) clean water and 2) high quality healthcare clinics.

The team at Stanford University has been recruited as the external evaluator to conduct an impact evaluation of Asili in order to determine whether or not the project goals of reduced child disease as well as increased economic capacity are met. The primary outcome of this impact evaluation study is to determine the effect of the Asili intervention on improving the health of children under five from baseline. Secondary outcomes of this study are to determine the impact of the intervention on enhanced economic activity, food security, and maternal self-esteem and self-efficacy. The investigators hypothesize that under-five children in Asili households will have lower incidence of diarrhea, fever, and cough/short, rapid breathing as well as a higher incidence of vaccination rates.

There is little research on the effects of social enterprise/HCD interventions on health, child health in particular, especially in areas recovering from recent conflict. Therefore, the investigators' aim is to determine if a multi-sectoral approach that can improve livelihoods in DRC can also improve family and child health.

This study will use household surveys at two time points (baseline and endline) to collect information on key indicators from the target populations. For Zones 3 and 4, encouragement design will be used to provide an instrumental variable to analyze the difference in outcomes between the households that enroll in Asili and those that do not. 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.

Encouragement design, a variation on the more commonly known randomized control trial (RCT), is a useful alternative for interventions where it is impractical to require adherence by participants or in situations where offering the intervention to a portion of the population is not possible or ethical. Encouragement involves randomly assigning participants to the "opportunity" or encouragement arm, where efforts are made to motivate participants to take part in an intervention or receive a particular treatment, but are allowed to choose whether or not they actually participate.

Because Asili services will be offered and available to all members of the community and controlling access to services is not possible, encouragement design will be utilized to measure uptake of Asili. 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. 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.

Champions will spend between 25-45 minutes with members of each household, during which they will explain how Asili works, what the intervention encompasses, and the benefits of joining Asili. The investigators hope to foster a sense of trust in the participants randomized to the encouragement arm by engaging data collectors from the community for these one-on-one exchanges with each household. Control households will also have equal access to Asili services; however, those households will not be visited by community champions individually.

The study populations in the two Zones include families surveyed from the catchment area of the Asili project intervention site in South Kivu. Each of these zones has a population of approximately 10,000 individuals; approximately 850 households were recruited at baseline in each of Zones 3 and 4. Baseline data was completed in Zones 3 and 4 in August 2016 and July 2017, respectively, and follow-up is anticipated in April/May 2018.

Being tested
Encouragement
Medical subject headings
Diarrhea, Cough, Fever, Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EncouragementBehavioural

    Households will be visited and encouraged to enroll in Asili

Study groups in NCT03536286
Study groupRoleWhat they receive
Encouragement Zone 3ExperimentalEncouragement 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.
Receives: Behavioral: Encouragement
Control Zone 3No interventionControl 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 4ExperimentalEncouragement 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.
Receives: Behavioral: Encouragement
Control Zone 4No interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Under-5 child health

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

    Measured: up to 15 months

Secondary outcomes (3)
  1. Enhanced economic activity

    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

    Measured: up to 15 months

  2. Food security

    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.

    Measured: up to 15 months

  3. Vaccination rates

    Measured: up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start4 Aug 2016
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

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
Randomised
Intervention model
Parallel groups
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)
Enrolment
9,999 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03536286
Sponsor's protocol ID
35216
Status last verified
Oct 2019
First submitted
23 Apr 2018
Last updated
18 Oct 2019
Results posted
No

Publications

  • 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.

    PubMed 35526031

Questions about this trial

What is this clinical trial studying?

A study testing Encouragement in people with Diarrhea and Cough, run by Stanford University.

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 4 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: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Under-5 child health (time frame: up to 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03536286, which also lists 1 linked publication.

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 18 Oct 2019.

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