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Microfinance Intervention to Improve Health of Trauma Survivors in DRC

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008708
First Posted: December 11, 2013
Last Update Posted: March 3, 2017
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.
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Nancy Glass, Johns Hopkins University
  Purpose

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:

  1. 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.
  2. 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.
  3. 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.

Condition Intervention
Mental Disorders Multiple Trauma Behavioral: Livestock Microfinance Other: Delayed Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Microfinance Intervention to Improve Health of Trauma Survivors in DRC

Resource links provided by NLM:


Further study details as provided by Nancy Glass, Johns Hopkins University:

Primary Outcome Measures:
  • Change from baseline Mental health distress at 18 months [ Time Frame: Baseline and 18 months post baseline ]

    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.


Enrollment: 878
Study Start Date: January 2011
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Livestock microfinance
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.
Behavioral: Livestock Microfinance
Participants randomized to the microfinance group receive the pig loan.
Active Comparator: Delayed Control Group
Participants randomized to delayed control group receives pig loan 12 months after the intervention group
Other: Delayed Control Group
Participants enrolled in delayed control receive their pig loan 12 months after the intervention group.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008708


Locations
Congo
PAIDEK Microfinance
Bukavu, South Kivu, Congo, 2375
Sponsors and Collaborators
Johns Hopkins University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Nancy Glass, PhD, MPH, RN Johns Hopkins University School of Nursing
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Glass, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02008708     History of Changes
Other Study ID Numbers: R01MD006075 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2013
First Posted: December 11, 2013
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Nancy Glass, Johns Hopkins University:
Health
Microfinance

Additional relevant MeSH terms:
Wounds and Injuries
Mental Disorders
Psychotic Disorders
Multiple Trauma
Schizophrenia Spectrum and Other Psychotic Disorders