- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02395328
Home Visiting for OVC in Tshwane Townships of South Africa
The Impact of Future's Families Orphans and Vulnerable Children Home Visiting Program in Tshwane Townships of South Africa
Study Overview
Detailed Description
With an estimated 5.6 million people living with HIV in South Africa, the AIDS epidemic has led to a large number of orphaned or otherwise vulnerable children (OVC) and families. Both psychosocial challenges and economic hardship are disproportionately common in homes where an orphan or HIV-infected adult resides. OVC caregivers may suffer emotional distress, have limited social support and experience family discord. Research reports a heightened risk of mental health problems among OVC caregivers, including grandparents and HIV positive parents. Addressing the needs of OVC caregivers is integral to a comprehensive, family-based approach. OVC programming principles therefore emphasize the importance of interventions that endeavor to enhance the psychosocial well-being and caregiving capacity of OVC guardians.
The purpose of this study is to evaluate the impact of Future Families Care Worker home visiting program. Future Families is a South African non-government organization working in six townships located within the greater Tshwane area (also known as Pretoria) of South Africa. Future Families trains and mobilizes Care Workers from the local community to provide biweekly home visits to OVC households to offer caregivers and children information, psychosocial support, and encourage awareness and accessing of health and social services.
Future Families will identify an approximate 500 eligible beneficiaries families between May-July 2014. These families are randomly assigned to receive a Care Worker beginning in August 2014 or approximately 12 months later following the second survey. Random assignment will be accomplished using computer software designed for random allocation of subjects to groups, and interviewers will be blind to individuals' group assignments. Both groups of newly-enrolled beneficiaries will be offered homework assistance classes at a Future Families facility, to ensure that even the control group receives some benefit from enrolment.
In each of these homes, data will be collected from the adult caregiver, the adult in the home who has primary responsibility for the care of residing children in June-July 2014 and again in November 2015 (following an approximate one year of service delivery). Further, we also obtained data from 282 current adult caregiver beneficiaries from within the same communities who have been enrolled in the program for at least one year, to facilitate an immediate post-test assessment, comparing the wellbeing of these current beneficiaries with newly enrolled beneficiaries. The post-test is designed to provide insight into potential impact of past efforts as well as potential areas for improvement. This information is particularly useful at the outset of the evaluation as it can inform and direct program implementation to address gaps while bolstering areas of success.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 or over at the time of study enrollment;
- Enrolled in a selected Future Families site;
- Willing and able to consent to study participation
Exclusion Criteria:
- Are not able to give informed consent due to known or recognizable cognitive or psychiatric impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Care worker home visitation
Care Workers provide biweekly home visits and offer residing caregivers and children information and psychosocial support, and encourage their awareness and accessing of external health and social services.
|
Primary services include biweekly home visits from Care Workers trained, mobilized and supported by Futures Families, a South African non-government organization working to support OVC in six townships within the greater Tshwane area (also known as Pretoria) of South Africa.
|
No Intervention: Wait List
Access to homework classes are made available to all participants' children at schools supported by the implementing organization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in access to HIV testing services indicator
Time Frame: Baseline, 12 months post-intervention
|
Percent of children and guardians (reported separately) who have ever been tested for HIV and received most recent test results
|
Baseline, 12 months post-intervention
|
Change in psychosocial wellbeing indicator
Time Frame: Baseline, 12 months post-intervention
|
Multi-item indicator to determine the percent of guardians with basic social support and the percent of guardians with high levels of negative feelings;
|
Baseline, 12 months post-intervention
|
Change in early childhood development indicators
Time Frame: Baseline, 12 months post-intervention
|
Multi-item indicator to determine the percent of children 1-5 years who are fully immunized; Percent of children <5 years of age who recently engaged in stimulating activities with any household member over 15 years of age and percent of children age 1-5 enrolled in a crèche or other early childhood development centre.
|
Baseline, 12 months post-intervention
|
Change in school attendance indicator
Time Frame: Baseline, 12 months post-intervention
|
Percent of school-age children attending school regularly.
|
Baseline, 12 months post-intervention
|
Change in access to social services indicators
Time Frame: Baseline, 12 months post-intervention
|
Percent of children with a verified birth certificate or other identity documentation and percent of eligible children and caregivers receiving grants.
|
Baseline, 12 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in household economics indicator
Time Frame: Baseline, 12 months post-intervention
|
Multi-item indicator to determine the percent of children whose basic material needs are met; percent of children with needed school supplies; percent of households earning income (other than from grants) for the past 3 months; percent of guardians currently earning income (other than from grants); percent of households with moderate or severe hunger; and percent of households with a member in a savings group;
|
Baseline, 12 months post-intervention
|
Change in health status indicator
Time Frame: Baseline, 12 months post-intervention
|
Multi-item indicator to determine the percent of children and guardians (reported separately) too sick to participate in daily activities in past 14 days; percent of guardians with high levels of daily functioning; percent of households with a male who has been circumcised; and the percent of HIV positive children and guardians adhering to an ARV regimen.
|
Baseline, 12 months post-intervention
|
Change in harsh punishment practices indicator
Time Frame: Baseline, 12 months post-intervention
|
Percent of guardians who used corporal punishment on any child in the household in the past 3 months
|
Baseline, 12 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics and Background indicator
Time Frame: Baseline, 12 months post-intervention
|
Multi-item indicator to determine the percent of children who have been orphaned (single/double/maternal/paternal can be reported separately); percent of children living without a biological parent in the home; percent of children living with a chronic illness; percent of children living with someone who is chronically ill; percent of children living in child or youth-headed households; percent of children whose primary guardian is age 60 or older; average child-adult ratio for households; percent of guardians who are likely AIDS-sick (three or more symptoms); and percent of guardians subject to stressful experiences in the last year.
|
Baseline, 12 months post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tonya R Thurman, PhD MPH, Tulane University School of Social Work
Study record dates
Study Major Dates
Study Start
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
Keywords
Other Study ID Numbers
- AID-674-A-12-00002-FFGS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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