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Microfinance Intervention to Improve Health of Trauma Survivors in DRC

Primary Purpose

Mental Disorders, Multiple Trauma

Status
Completed
Phase
Not Applicable
Locations
Congo
Study Type
Interventional
Intervention
Livestock Microfinance
Delayed Control Group
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Disorders focused on measuring Health, Microfinance

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • household in participating 10 villages with at least one member:

    • 16 years or older,
    • male or female
    • interest in animal husbandry microfinance,
    • vulnerable, including survivor of sexual violence, widow, single mother
    • children under age 18 in the home.

Exclusion Criteria:

  • do not live in villages included in study

Sites / Locations

  • PAIDEK Microfinance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Livestock microfinance

Delayed Control Group

Arm Description

Participants randomized to the microfinance intervention receive a female pig loan with ongoing support to manage health and care of the pig by trained agents.

Participants randomized to delayed control group receives pig loan 12 months after the intervention group

Outcomes

Primary Outcome Measures

Change from baseline Mental health distress at 18 months
10 villages in rural South Kivu province of DRC will be selected for participation. Sixty-100 households in each village will then be randomized to intervention (receive 1st loan pig) and delayed control (receive offspring from loan pig) groups. Outcome will be measured in both intervention and control villages. Measurement of outcome will use self-report by participating household member. An eligible participant is an adult head of household at least 16 years or older.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2013
Last Updated
March 2, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02008708
Brief Title
Microfinance Intervention to Improve Health of Trauma Survivors in DRC
Official Title
Microfinance Intervention to Improve Health of Trauma Survivors in DRC
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective is to test the effectiveness of a village-led microfinance program, Pigs for Peace, on health, household economic stability, and reintegration of trauma survivors to family and community. The five-year experimental trial will use mixed-methods to address the following aims: Determine the effectiveness of a village-led microfinance program on participants health and reintegration in intervention households compared to participants in delayed control households. Health and reintegration will be measured at baseline and six, twelve, and 18-months post-baseline using self-report in both intervention and delayed control groups. We hypothesize that at six, twelve and 18 months post-baseline participants in intervention households will have improved health and increased reintegration to families in comparison to participants in control households. Determine the effectiveness of a village-led microfinance program on household economic stability in intervention households compared to delayed control villages. Household economic stability will be measured at baseline and six, twelve and 18 months post- baseline using self-report in both intervention and control households. We hypothesize that at six, twelve and 18-months post-baseline the intervention households will have improved household economic stability in comparison to control households. Examine the role of a village-led microfinance program on village-level health, economics, stigma and reintegration of survivors and their families in intervention and delayed control villages. Village members (n=5 in each village, n=50 total) will complete a baseline and 18 month post-baseline qualitative interview to examine the role of microfinance on village-level health, economics, stigma and reintegration in both intervention and control households.
Detailed Description
Mobutu Sese Seko's government of "Kleptocracy" collapsed in 1997 after 30 years of oppression. The new nation that emerged, the Democratic Republic of Congo (DRC), remains an all-to-potent reminder of how human rights violations, and their related health and economic impacts, can devastate individuals, families and communities. The genocide in neighboring Rwanda, coupled with the collapse of the Mobutu government, has spawned two wars and over a decade of warfare throughout the region, resulting in millions of deaths in what is the deadliest conflict since World War II 1. The last decade has seen the use of rape as a weapon of war in the DRC, where rebels and soldiers subject women, men and children to brutalizing attacks, rape, torture, and mutilation. Survivors of the assault are often further traumatized by infections, disease, poverty, stigma and social isolation. The US plays a significant role in global health. It is both the largest funder of innovation in global health and the largest donor to care and support programs in sub-Saharan Africa-notably through The US President's Emergency Plan for AIDS Relief (PEPFAR) and responses to humanitarian crisis, such as USAID funded programs in DRC. The effectiveness and sustainability of these efforts are limited by gaps in knowledge of the role of social determinants, such as poverty, social isolation, chronic stress and trauma, and limited access to health care services has on the health of women and families. To begin to address these gaps, our overall goal is to build the science base for large-scale implementation of economic programs to improve the health of survivors of trauma living in man-made and natural disaster settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Multiple Trauma
Keywords
Health, Microfinance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
878 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Livestock microfinance
Arm Type
Experimental
Arm Description
Participants randomized to the microfinance intervention receive a female pig loan with ongoing support to manage health and care of the pig by trained agents.
Arm Title
Delayed Control Group
Arm Type
Active Comparator
Arm Description
Participants randomized to delayed control group receives pig loan 12 months after the intervention group
Intervention Type
Behavioral
Intervention Name(s)
Livestock Microfinance
Intervention Description
Participants randomized to the microfinance group receive the pig loan.
Intervention Type
Other
Intervention Name(s)
Delayed Control Group
Intervention Description
Participants enrolled in delayed control receive their pig loan 12 months after the intervention group.
Primary Outcome Measure Information:
Title
Change from baseline Mental health distress at 18 months
Description
10 villages in rural South Kivu province of DRC will be selected for participation. Sixty-100 households in each village will then be randomized to intervention (receive 1st loan pig) and delayed control (receive offspring from loan pig) groups. Outcome will be measured in both intervention and control villages. Measurement of outcome will use self-report by participating household member. An eligible participant is an adult head of household at least 16 years or older.
Time Frame
Baseline and 18 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: household in participating 10 villages with at least one member: 16 years or older, male or female interest in animal husbandry microfinance, vulnerable, including survivor of sexual violence, widow, single mother children under age 18 in the home. Exclusion Criteria: do not live in villages included in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Glass, PhD, MPH, RN
Organizational Affiliation
Johns Hopkins University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAIDEK Microfinance
City
Bukavu
State/Province
South Kivu
ZIP/Postal Code
2375
Country
Congo

12. IPD Sharing Statement

Citations:
PubMed Identifier
28589002
Citation
Glass N, Perrin NA, Kohli A, Campbell J, Remy MM. Randomised controlled trial of a livestock productive asset transfer programme to improve economic and health outcomes and reduce intimate partner violence in a postconflict setting. BMJ Glob Health. 2017 Feb 28;2(1):e000165. doi: 10.1136/bmjgh-2016-000165. eCollection 2017.
Results Reference
derived
PubMed Identifier
28292764
Citation
Kohli A, Perrin NA, Remy MM, Alfred MB, Arsene KB, Nadine MB, Heri BJ, Clovis MM, Glass N. Adult and adolescent livestock productive asset transfer programmes to improve mental health, economic stability and family and community relationships in rural South Kivu Province, Democratic Republic of Congo: a protocol of a randomised controlled trial. BMJ Open. 2017 Mar 14;7(3):e013612. doi: 10.1136/bmjopen-2016-013612.
Results Reference
derived
PubMed Identifier
25419743
Citation
Glass N, Perrin NA, Kohli A, Remy MM. Livestock/animal assets buffer the impact of conflict-related traumatic events on mental health symptoms for rural women. PLoS One. 2014 Nov 24;9(11):e111708. doi: 10.1371/journal.pone.0111708. eCollection 2014.
Results Reference
derived

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Microfinance Intervention to Improve Health of Trauma Survivors in DRC

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