- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01447615
Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rakai And Masaka Districts
-
Masaka, Rakai And Masaka Districts, Uganda
- International Center for Child Health and Asset Development
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 Names:
|
|
Experimental: 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 Names:
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 Names:
|
|
Experimental: Bridges PLUS
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Savings and Asset Accumulation
Time Frame: 12-month post-intervention follow-up assessment
|
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
|
|
Educational Achievement
Time Frame: 12-month post-intervention follow-up assessment
|
School enrollment and attendance.
Educational attainment, plans, and aspirations.
Performance on National Primary Leaving Examinations.
|
12-month post-intervention follow-up assessment
|
|
Mental Health Functioning
Time Frame: 12-month post-intervention follow-up assessment
|
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
|
|
Sexual Risk-Taking Behavior
Time Frame: 12-month post-intervention follow-up assessment
|
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
|
|
Savings and Asset Accumulation
Time Frame: 24-month post-intervention follow-up assessment
|
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
|
|
Educational Achievement
Time Frame: 24-month post-intervention follow-up assessment
|
School enrollment and attendance.
Educational attainment, plans, and aspirations.
Performance on National Primary Leaving Examinations.
|
24-month post-intervention follow-up assessment
|
|
Mental Health Functioning
Time Frame: 24-month post-intervention follow-up assessment
|
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
|
|
Sexual Risk-Taking Behavior
Time Frame: 24-month post-intervention follow-up assessment
|
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
|
|
Savings and Asset Accumulation
Time Frame: 36-month post-intervention follow-up assessment
|
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
|
|
Educational Achievement
Time Frame: 36-month post-intervention follow-up assessment
|
School enrollment and attendance.
Educational attainment, plans, and aspirations.
Performance on National Primary Leaving Examinations.
|
36-month post-intervention follow-up assessment
|
|
Mental Health Functioning
Time Frame: 36-month post-intervention follow-up assessment
|
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
|
|
Sexual Risk-Taking Behavior
Time Frame: 36-month post-intervention follow-up assessment
|
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
|
|
Savings and Asset Accumulation
Time Frame: 48-month post-intervention follow-up assessment
|
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
|
|
Educational Achievement
Time Frame: 48-month post-intervention follow-up assessment
|
School enrollment and attendance.
Educational attainment, plans, and aspirations.
Performance on National Primary Leaving Examinations.
|
48-month post-intervention follow-up assessment
|
|
Mental Health Functioning
Time Frame: 48-month post-intervention follow-up assessment
|
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
|
|
Sexual Risk-Taking Behavior
Time Frame: 48-month post-intervention follow-up assessment
|
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
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ssewamala FM, Shu-Huah Wang J, Brathwaite R, Sun S, Mayo-Wilson LJ, Neilands TB, Brooks-Gunn J. Impact of a Family Economic Intervention (Bridges) on Health Functioning of Adolescents Orphaned by HIV/AIDS: A 5-Year (2012-2017) Cluster Randomized Controlled Trial in Uganda. Am J Public Health. 2021 Mar;111(3):504-513. doi: 10.2105/AJPH.2020.306044. Epub 2021 Jan 21.
- Nabunya P, Padgett D, Ssewamala FM, Courtney ME, Neilands T. Examining the nonkin support networks of orphaned adolescents participating in a family-based economic-strengthening intervention in Uganda. J Community Psychol. 2019 Apr;47(3):579-593. doi: 10.1002/jcop.22139. Epub 2018 Nov 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAA11950
- 1R01HD070727-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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