NCT02395328

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
481

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable hiv

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

March 5, 2015

Last Update Submit

March 10, 2017

Conditions

Keywords

Orphans and vulnerable children (OVC)Home visiting interventionSouth AfricaProgram evaluation

Outcome Measures

Primary Outcomes (5)

  • Change in access to HIV testing services indicator

    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

    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

    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

    Percent of school-age children attending school regularly.

    Baseline, 12 months post-intervention

  • Change in access to social services indicators

    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 Outcomes (3)

  • Change in household economics indicator

    Baseline, 12 months post-intervention

  • Change in health status indicator

    Baseline, 12 months post-intervention

  • Change in harsh punishment practices indicator

    Baseline, 12 months post-intervention

Other Outcomes (1)

  • Demographics and Background indicator

    Baseline, 12 months post-intervention

Study Arms (2)

Care worker home visitation

EXPERIMENTAL

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.

Behavioral: Care Worker Home Visitation

Wait List

NO INTERVENTION

Access to homework classes are made available to all participants' children at schools supported by the implementing organization.

Interventions

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.

Care worker home visitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Are not able to give informed consent due to known or recognizable cognitive or psychiatric impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tonya R Thurman, PhD MPH

    Tulane University School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Associate Professor

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 23, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 13, 2017

Record last verified: 2017-03