NCT06275867

Brief Summary

This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 8, 2024

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Underuse

    number of days of illness where care-seeking is recommended by guidelines but not sought by the child's parent or guardian

    12 weeks

  • Overuse

    proportion of primary health care visits that are considered unnecessary

    12 weeks

Secondary Outcomes (3)

  • Illness duration

    12 weeks

  • Out-of-pocket expenditures

    12 weeks

  • Health knowledge

    Endline survey (i.e. 12 weeks approximately after the start of the intervention)

Study Arms (3)

Control group

NO INTERVENTION

In this group, participants will have free access to government facilities (usual care)

Convenient group

EXPERIMENTAL

In this group, for the duration of the study, participants will be given free access to a small number of private providers located relatively close by (less than 30 minutes).

Other: Free high-quality careOther: Close distance

Inconvenient group

EXPERIMENTAL

In this group, for the duration of the study, participants will be given free access to a small number of private providers located relatively far (about one hour).

Other: Free high-quality careOther: Far distance

Interventions

Participants are able to take their child to receive free consultations and treatment in a network of contracted private healthcare providers.

Convenient groupInconvenient group

The network of contracted providers is located close to where participants live.

Convenient group

The network of contracted providers is located far to where participants live.

Inconvenient group

Eligibility Criteria

Age2 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • parent has a child aged under 6 years old and over 2 months old

You may not qualify if:

  • is planning to move out of the area in the next 3 months
  • has private medical aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HDSS Soweto clusters

Soweto, Gauteng, South Africa

Location

MeSH Terms

Conditions

Patient Acceptance of Health CareBehavior

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth Behavior

Study Officials

  • Mylene Lagarde, PhD

    London School of Economics and Political Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 23, 2024

Study Start

January 20, 2024

Primary Completion

June 10, 2024

Study Completion

August 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-02

Locations