Microfinance Intervention to Improve Health of Trauma Survivors in DRC

Study Overview
=================
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.

Official Title
-----------------
Microfinance Intervention to Improve Health of Trauma Survivors in DRC

Conditions
-----------------
Mental Disorders, Multiple Trauma

Intervention / Treatment
-----------------
* Behavioral: Livestock Microfinance
* Other: Delayed Control Group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Livestock microfinance<br>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<br>* Participants randomized to the microfinance group receive the pig loan.<br>|
| Active Comparator: Delayed Control Group<br>Participants randomized to delayed control group receives pig loan 12 months after the intervention group | Other: Delayed Control Group<br>* Participants enrolled in delayed control receive their pig loan 12 months after the intervention group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health, Microfinance