Clinical trial NCT03536286: Asili Evaluation in the Democratic Republic of Congo
Official title: Evaluation to Assess the Asili Intervention in South Kivu, Democratic Republic of Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Cough
Fever
Malnutrition, Child
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Refugee Committee
First posted: 2018-05-24
Enrollment: 9999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Under-5 child health
timeFrame: up to 15 months
Secondary outcomes:
measure: Enhanced economic activity
timeFrame: up to 15 months
measure: Food security
timeFrame: up to 15 months
measure: Vaccination rates
timeFrame: up to 15 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.