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

October 10, 2018 updated by: Fred Ssewamala, PhD, Columbia University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
    • Rakai And Masaka Districts
      • Masaka, Rakai And Masaka Districts, Uganda
        • International Center for Child Health and Asset Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • Usual Services
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 Names:
  • 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 Names:
  • Usual Services
Experimental: Bridges PLUS
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:
  • Usual Services
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 Names:
  • Child Development Account

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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