Microfinance Intervention to Improve Health of Trauma Survivors in DRC

Mental Disorders Clinical Trial

Official title:

Microfinance Intervention to Improve Health of Trauma Survivors in DRC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008708
• Other study ID #: R01MD006075
• Secondary ID: R01MD006075
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: March 2, 2017
• Start date: January 2011
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 878
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Multiple Trauma
• Psychotic Disorders
• Wounds and Injuries

Intervention

Behavioral:
• Livestock Microfinance
Participants randomized to the microfinance group receive the pig loan.

Other:
• Delayed Control Group
Participants enrolled in delayed control receive their pig loan 12 months after the intervention group.

Locations

Country	Name	City	State
Congo	PAIDEK Microfinance	Bukavu	South Kivu

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 18 months post baseline