Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda

Poverty Clinical Trial

Official title:

Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447615
• Other study ID #: AAA11950
• Secondary ID: 1R01HD070727-01
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: January 15, 2018

Study information

• Verified date: October 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda, represents the first study that measures medium-term efficacy and cost-effectiveness of a family economic empowerment intervention for AIDS-orphaned children. The usual care provided to AIDS orphans in sub-Saharan Africa consists mainly of informal counseling as well as limited material support (e.g., specifically school lunches, textbooks for the required subjects, and note-books). Given the challenges facing these children and their caregivers, further supports are needed in order to help them successfully make the transition from primary school to secondary school and into adolescence. In the context of resource-poor countries, interventions that improve families' economic capabilities are likely to be particularly consequential. Both theory and prior research indicate that economic instability (including poverty) constitutes one of the primary risk factors for AIDS-orphaned children's risk-taking behaviors (including sexual risk-taking), poor mental health functioning, and poor educational outcomes. Thus, the lack of economic security constitutes an important risk factor for AIDS-orphaned children. Yet, to-date, few interventions aimed at care and support of AIDS-orphaned children have incorporated components to address family-level poverty/economic instability of the children and their caregiving families. Within this context, there is a need for innovative interventions that promote sustainable (more than short-term) economic and behavior change among AIDS-orphaned children and create the supports necessary to sustain these changes.

Description:

The overall goal of the proposed research is to evaluate the efficacy and cost-effectiveness of an innovative family-based economic empowerment intervention for AIDS-orphaned children. This will be accomplished via a three-group cluster randomized control trial (RCT). The three groups are: Bridges, Bridges PLUS, and usual care for AIDS-orphaned children. There will be five assessment points: baseline (pretest), 12, 24, 36, and 48-months post-intervention initiation.

The intervention, "Bridges to the Future" (Bridges) will be guided by asset-theory and both Bridges and Bridges PLUS will include the following intervention components tested in the two earlier pilot studies, SEED-Uganda and SUUBI-Uganda: 1) workshops focused on asset building, future planning, and protection from risks; 2) mentors to reinforce learning and build optimism; 3) a Child Development Account (CDA) that can be used for secondary education by the AIDS-orphaned child; and 4) a family income generating/micro-enterprise promotion component for children enrolled in Bridges and Bridges PLUS, and their families.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1410
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• An HIV/AIDS-orphaned child (a child who has lost one or both parents to HIV/AIDS)

• Enrolled in grade 5 or 6 of primary school

• Living within a family

Exclusion Criteria:

• Any child who does not self-identify as an HIV/AIDS-orphan

• Any child who is not enrolled in grade 5 or 6 of primary school

• Any child who is not living within a family at the time of enrollment

Related Conditions & MeSH terms

• AIDS Orphans
• Orphaned Children
• Poverty

Intervention

Behavioral:
• Bridges
Each child participant in the Bridges Arm will receive the usual care in addition to a Child Development Account (CDA) to be used for secondary education by the AIDS-orphaned child. The CDA will be a matched savings account held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda). The account will be matched with money from the program at a match rate of 1:1. Additionally, participants will receive: 1) twelve 1-2 hour workshops focused on asset building, future planning, and protection from risks; 2) mentorship sessions to reinforce learning and build optimism; and 3) a family income-generating /micro-enterprise promotion component for children enrolled in Bridges and their families.
• Bridges PLUS
Each child participant in the Bridges PLUS Arm will receive the usual care in addition to a Child Development Account (CDA) to be used for secondary education by the AIDS-orphaned child. The CDA will be a matched savings account held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda). The account will be matched with money from the program at a match rate of 2:1. Additionally, participants will receive: 1) twelve 1-2 hour workshops focused on asset building, future planning, and protection from risks; 2) mentorship sessions to reinforce learning and build optimism; and 3) a family income-generating /micro-enterprise promotion component for children enrolled in Bridges PLUS and their families.

Other:
• Usual Care
Participants in the usual care condition will receive usual care for AIDS-orphaned children in the study area. This includes: counseling, school lunches, and scholastic materials (textbooks and notebooks). Counseling will be provided by priests in the community (as is currently done).

Locations

Country	Name	City	State
Uganda	International Center for Child Health and Asset Development	Masaka	Rakai And Masaka Districts

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Savings and Asset Accumulation	Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.	12-month post-intervention follow-up assessment
Primary	Educational Achievement	School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.	12-month post-intervention follow-up assessment
Primary	Mental Health Functioning	Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.	12-month post-intervention follow-up assessment
Primary	Sexual Risk-Taking Behavior	Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.	12-month post-intervention follow-up assessment
Primary	Savings and Asset Accumulation	Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.	24-month post-intervention follow-up assessment
Primary	Educational Achievement	School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.	24-month post-intervention follow-up assessment
Primary	Mental Health Functioning	Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.	24-month post-intervention follow-up assessment
Primary	Sexual Risk-Taking Behavior	Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.	24-month post-intervention follow-up assessment
Primary	Savings and Asset Accumulation	Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.	36-month post-intervention follow-up assessment
Primary	Educational Achievement	School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.	36-month post-intervention follow-up assessment
Primary	Mental Health Functioning	Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.	36-month post-intervention follow-up assessment
Primary	Sexual Risk-Taking Behavior	Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.	36-month post-intervention follow-up assessment
Primary	Savings and Asset Accumulation	Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.	48-month post-intervention follow-up assessment
Primary	Educational Achievement	School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.	48-month post-intervention follow-up assessment
Primary	Mental Health Functioning	Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.	48-month post-intervention follow-up assessment
Primary	Sexual Risk-Taking Behavior	Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.	48-month post-intervention follow-up assessment