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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06275867
Other study ID # SOPRIMA//T023635
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2024
Est. completion date August 30, 2024

Study information

Verified date February 2024
Source London School of Economics and Political Science
Contact Mylene Lagarde, PhD
Phone +447595911011
Email M.Lagarde@lse.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

In many low-income settings, provision of social services by the public sector is plagued by problems of quality and low accountability to users. As a result, low expected benefits or fear of neglect by service providers may delay the use of needed services, even when those are free. In South Africa, the health system is characterised by stark inequalities, with most of the population only able to seek care in free government facilities. The low quality of the public sector, where patients wait long times to be seen by nurses, is believed to lead many to delay needed care and prevent health outcome improvement. The government of South Africa is developing proposals to introduce a national health insurance scheme that would provide free access to private providers who deliver higher care quality. However, concerns about the unequal geographical distribution of private providers raise questions about the potential benefits of the reform. This study asks several questions to inform this reform: 1. Does access to higher-quality care reduce under-use of services for children but also increase overuse? 2. Does access to higher-quality care lead to improved health knowledge of parents and better health outcomes for children? 3. Are these effects mitigated by the distance to the contracted providers? A randomised controlled trial is used to answer these questions. The study will recruit about 1,500 individuals who are the primary caregiver of at least one child aged six or under. and randomly allocate them 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 will be the proportion of visits that are considered unnecessary (overuse) and the number of days of illness where care-seeking is recommended by guidelines but not sought by the child's parent or guardian. Secondary outcomes will include (1) the number of days with ill-health symptoms; (2) out-of-pocket expenditures; (3) health knowledge of parents; (4) subjective and (5) objective measures of child's health.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date August 30, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 6 Years
Eligibility Inclusion Criteria: - parent has a child aged under 6 years old and over 2 months old Exclusion Criteria: - is planning to move out of the area in the next 3 months - has private medical aid

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Free high-quality care
Participants are able to take their child to receive free consultations and treatment in a network of contracted private healthcare providers.
Close distance
The network of contracted providers is located close to where participants live.
Far distance
The network of contracted providers is located far to where participants live.

Locations

Country Name City State
South Africa HDSS Soweto clusters Soweto Gauteng

Sponsors (2)

Lead Sponsor Collaborator
London School of Economics and Political Science University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Overuse proportion of primary health care visits that are considered unnecessary 12 weeks
Secondary Illness duration number of days with ill-health symptoms 12 weeks
Secondary Out-of-pocket expenditures Direct (consultations, drugs) and indirect (transport) expenditures spent on health care 12 weeks
Secondary Health knowledge Index of knowledge of parents in relation to preventive and curative care. Parents will answer as series of knowledge questions relative to care-seeking patterns for children (with correct and incorrect responses). For each individual, a score will be computing by adding up all of the correct responses (1 point per correct response, 0 for incorrect), so a higher score will reflect a better knowledge. Endline survey (i.e. 12 weeks approximately after the start of the intervention)
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