Clinical trial NCT01447615: Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda
Official title: Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poverty
Orphaned Children
AIDS Orphans
Keywords: Orphaned children and youth
Economic empowerment
Uganda
HIV/AIDS
Sub-Saharan Africa
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-10-06
Enrollment: 1410
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Savings and Asset Accumulation
timeFrame: 12-month post-intervention follow-up assessment
measure: Educational Achievement
timeFrame: 12-month post-intervention follow-up assessment
measure: Mental Health Functioning
timeFrame: 12-month post-intervention follow-up assessment
measure: Sexual Risk-Taking Behavior
timeFrame: 12-month post-intervention follow-up assessment
measure: Savings and Asset Accumulation
timeFrame: 24-month post-intervention follow-up assessment
measure: Educational Achievement
timeFrame: 24-month post-intervention follow-up assessment
measure: Mental Health Functioning
timeFrame: 24-month post-intervention follow-up assessment
measure: Sexual Risk-Taking Behavior
timeFrame: 24-month post-intervention follow-up assessment
measure: Savings and Asset Accumulation
timeFrame: 36-month post-intervention follow-up assessment
measure: Educational Achievement
timeFrame: 36-month post-intervention follow-up assessment
measure: Mental Health Functioning
timeFrame: 36-month post-intervention follow-up assessment
measure: Sexual Risk-Taking Behavior
timeFrame: 36-month post-intervention follow-up assessment
measure: Savings and Asset Accumulation
timeFrame: 48-month post-intervention follow-up assessment
measure: Educational Achievement
timeFrame: 48-month post-intervention follow-up assessment
measure: Mental Health Functioning
timeFrame: 48-month post-intervention follow-up assessment
measure: Sexual Risk-Taking Behavior
timeFrame: 48-month post-intervention follow-up assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Asset Development
state: Rakai And Masaka Districts
Study officials:
affiliation: Columbia University
name: Fred M Ssewamala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.