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Home Visiting for OVC in Tshwane Townships of South Africa

10 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

481

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: Wait List
Access to homework classes are made available to all participants' children at schools supported by the implementing organization.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in access to HIV testing services indicator
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in household economics indicator
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Demographics and Background indicator
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Tonya R Thurman, PhD MPH, Tulane University School of Social Work

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2014

Completamento primario (Effettivo)

1 dicembre 2015

Completamento dello studio (Effettivo)

1 dicembre 2015

Date di iscrizione allo studio

Primo inviato

5 marzo 2015

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2015

Primo Inserito (Stima)

23 marzo 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • AID-674-A-12-00002-FFGS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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