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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Ssewamala, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01447615
First received: October 4, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Poverty
Orphaned Children
AIDS Orphans
Behavioral: Bridges
Behavioral: Bridges PLUS
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Savings and Asset Accumulation [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    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.

  • Educational Achievement [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.

  • Mental Health Functioning [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.

  • Sexual Risk-Taking Behavior [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.

  • Savings and Asset Accumulation [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    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.

  • Educational Achievement [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.

  • Mental Health Functioning [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.

  • Sexual Risk-Taking Behavior [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.

  • Savings and Asset Accumulation [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    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.

  • Educational Achievement [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.

  • Mental Health Functioning [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.

  • Sexual Risk-Taking Behavior [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.

  • Savings and Asset Accumulation [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    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.

  • Educational Achievement [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.

  • Mental Health Functioning [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.

  • Sexual Risk-Taking Behavior [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
    Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.


Estimated Enrollment: 1440
Study Start Date: February 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bridges 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.
Other Name: Child Development Account
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).
Other Name: Usual Services
Experimental: Bridges PLUS Behavioral: 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 Name: Child Development Account
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).
Other Name: Usual Services
Usual Care 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).
Other Name: Usual Services

Detailed 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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447615

Contacts
Contact: Fred M Ssewamala, PhD 212-851-2250 fs2114@columbia.edu
Contact: Vilma P Ilic, MSW 212-851-2224 vpi2101@columbia.edu

Locations
Uganda
Recruiting
Rakai and Masaka, Rakai and Masaka Districts, Uganda
Principal Investigator: Fred M Ssewamala, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Fred M Ssewamala, PhD Columbia University
  More Information

No publications provided

Responsible Party: Fred Ssewamala, PhD, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01447615     History of Changes
Other Study ID Numbers: AAA11950, 1R01HD070727-01
Study First Received: October 4, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology

Keywords provided by Columbia University:
Orphaned children and youth
Economic empowerment
Uganda
HIV/AIDS
Sub-Saharan Africa

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014