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Home Visiting for OVC in Tshwane Townships of South Africa

10. března 2017 aktualizováno: Tonya Renee Thurman, Tulane University School of Social Work

The Impact of Future's Families Orphans and Vulnerable Children Home Visiting Program in Tshwane Townships of South Africa

This study consists of a one-year randomized controlled trial investigating the impact of mobilized care workers trained and supported by Futures Families, a South African non-profit organization, that provide biweekly home visits to families with orphans and vulnerable children (OVC) in Tshwane (aka Pretoria) townships, South Africa. Future Families takes a family-based approach to addressing the needs of OVC by providing caregivers with information, psychosocial support, and access to external services. Caregivers will participate in a survey providing information on their personal wellbeing as well as key indicators reflecting the wellbeing of each child under their care. Newly enrolled caregivers will be randomly assigned to either program participation beginning in late 2014 or to delayed participation following the impact survey about one year later. The data will be used to test for changes in a set of key program indicators pertaining to child protection, HIV prevention, psychosocial wellbeing, education and early childhood development. This study aims to strengthen the evidence base for effective family centered programming to address the needs of HIV-affected children and their caregivers.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

481

Fáze

  • Nelze použít

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Žádný zásah: Wait List
Access to homework classes are made available to all participants' children at schools supported by the implementing organization.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in access to HIV testing services indicator
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in household economics indicator
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Demographics and Background indicator
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Tonya R Thurman, PhD MPH, Tulane University School of Social Work

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2014

Primární dokončení (Aktuální)

1. prosince 2015

Dokončení studie (Aktuální)

1. prosince 2015

Termíny zápisu do studia

První předloženo

5. března 2015

První předloženo, které splnilo kritéria kontroly kvality

16. března 2015

První zveřejněno (Odhad)

23. března 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. března 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. března 2017

Naposledy ověřeno

1. března 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • AID-674-A-12-00002-FFGS

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