How access to higher-quality care services affect the use of medical care for young children in urban South Africa
| ISRCTN | ISRCTN15792062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15792062 |
| ClinicalTrials.gov number | NCT06275867 |
| Secondary identifying numbers | SOPRIMA//T023635 |
- Submission date
- 24/02/2025
- Registration date
- 26/02/2025
- Last edited
- 25/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In many low-income areas, public healthcare services often suffer from poor quality and low accountability, leading people to delay using these services even when they are free. In South Africa, most people rely on free government healthcare, which is often of low quality and involves long waiting times. The South African government is considering a national health insurance scheme to provide free access to higher-quality private healthcare. This study aims to find out if access to free private care reduces under-use of services for children, if it increases overuse, and if the distance to private providers affects these outcomes.
Who can participate?
The study will include about 1,500 primary caregivers of at least one child aged six or under who do not have medical insurance.
What does the study involve?
Participants will be randomly assigned to one of three groups: a control group with free access to government facilities, or one of two treatment groups with free access to private providers located either relatively close or far away. Participants will complete two surveys at the start and end of the 12-week study period, keep a daily diary of their child's symptoms and healthcare use, and have weekly 10-minute visits from a researcher to collect data from the diary.
What are the possible benefits and risks of participating?
There are no direct risks for participants. Those in the treatment groups will get subsidised access to private care for one of their children. All participants will continue to have access to free public healthcare services. Participants' confidentiality will be protected, and results will be reported only at the group level.
Where is the study run from?
Centre for Health Policy (CHP) at the University of the Witwatersrand (South Africa)
When is the study starting and how long is it expected to run for?
March 2022 to August 2024
Who is funding the study?
Medical Research Council, UKRI Reference MR/T023635/1 (UK)
Who is the main contact?
Dr Duane Blaauw, duane.blaauw@wits.ac.za
Contact information
Public, Scientific, Principal Investigator
London School of Economics and Political Science, Houghton Street
London
WC2A 2AE
United Kingdom
 ORCID ID |
0000-0002-5713-2659 |
|---|---|
| Phone | +44 (0)7595 911011 |
| m.lagarde@lse.ac.uk |
Public, Scientific, Principal Investigator
1 Jan Smuts Avenue
Johannesburg
Braamfontein 2000
South Africa
| ORCID ID |
0000-0002-0605-7134 |
|---|---|
| Phone | +27 (0)117173422 |
| duane.blaauw@wits.ac.za |
Study information
| Study design | Multicentre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The impact of access to higher-quality care services on healthcare utilization for children aged under 5 years: a randomized controlled trial in urban South Africa |
| Study acronym | SOPRIMA |
| Study objectives | 1. Free private care reduces underuse of services for children 2. Free private care increases overuse of services for children 3. These effects are mitigated by the distance between households and private providers |
| Ethics approval(s) |
1. Approved 18/03/2022, University of the Witswatersrand, Human Research Ethics Committee (non-medical) (1 Jan Smuts Avenue, Braamfontein, Johannesburg, 2000, South Africa; +27(0) 11 717 1408; hrecnon-medical@wits.ac.za), ref: H22/03/32 2. Approved 17/03/2024, London School of Economics Research Ethics Committee (Houghton Street, London, WC2A 2AE, United Kingdom; +44 (0)20 7852 3629; research.ethics@lse.ac.uk), ref: 57203 |
| Health condition(s) or problem(s) studied | Common conditions in children under-5 |
| Intervention | Participants are the primary caregivers of at least one child aged five years or under. Participants are randomly allocated to one of three groups in equal proportions: a control group (CONTROL) with default free access to government facilities; a treatment group with free access to government facilities and to a network of private providers located close by (CONVENIENT); or a treatment group with free access to government facilities and to a network of private providers located far away (INCONVENIENT). In treatment groups, participants have unlimited access for one of their children (chosen at random) to private providers for 12 weeks. Randomisation is done after recruitment using a computer. |
| Intervention type | Other |
| Primary outcome measure | 1. Underuse: the proportion of caregivers who do not seek 'recommended' care for their child at least once , measured over 12 weeks with health diaries (recommended care is defined against community-IMCI guidelines). 2. Overuse : the proportion of caregivers who seek unnecessary care for their child at least once , measured over 12 weeks with health diaries (unnecessary care is defined against community-IMCI guidelines: care is unnecessary if it does not meet the threshold of recommended care). |
| Secondary outcome measures | 1. Appropriate, timely use: the proportion of caregivers who seek care for their child exactly when 'recommended' at least once, measured over 12 weeks with health diaries (recommended care is defined against community-IMCI guidelines). 2. Number of appropriate, timely visits: the number of timely visits made by a caregiver for their child, measured over 12 weeks with health diaries (a timely visit is done exactly when care is 'recommended' accoridng to the community-IMCI guidelines). 3. Appropriate, delayed use: the proportion of caregivers who seek care for their child after it is 'recommended' at least once, measured over 12 weeks with health diaries (recommended care is defined against community-IMCI guidelines). 4. Number of appropriate, delayed visits: the number of delayed visits made by a caregiver for their child, measured over 12 weeks with health diaries (a delayed visit is done after care is 'recommended' accoridng to the community-IMCI guidelines). 5. Underuse of care: the number of days of illness where care-seeking is recommended but not sought by the child's parent or guardian measured through daily symptoms and health-seeking data collected over 12 weeks. 6. Overuse : the proportion of primary health care visits made by the household that are considered unnecessary measured through daily symptoms and health-seeking data collected over 12 weeks (unnecessary care is defined against community-IMCI guidelines: care is unnecessary if it does not meet the threshold of recommended care). 7. Public care use: the proportion of caregivers who seek care for their child at least once at a government health care facility, measured over 12 weeks with health diaries. 8. Private care use: the proportion of caregivers who seek care for their child at least once at a private GP, measured over 12 weeks with health diaries. 9. Pharmacy use: the proportion of caregivers who seek care for their child at least once in a pharmacy, measured over 12 weeks with health diaries. 10. Out-of-pocket expenditures: the total direct (consultations, drugs) and indirect (transport) expenditures spent on health care, measured over 12 weeks with health diaries. 11. Waiting time: time spent by caregivers on transport and at facilities waiting to seek care, measured over 12 weeks with health diaries. 12. 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 computed 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. Captured in the endline survey at 12 weeks after the start of the intervention. |
| Overall study start date | 18/03/2022 |
| Completion date | 30/08/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Total final enrolment | 1415 |
| Key inclusion criteria | 1. The parent or primary caregiver who has a child aged under 5 years old and over 2 months old 2. Resident in selected clusters of the Soweto Health and Demographic Surveillance site (HDSS) that are part of the Child Health and Mortality Prevention Surveillance (CHAMPS) study. |
| Key exclusion criteria | 1. Is planning to move out of the area in the next 3 months 2. Has private medical aid |
| Date of first enrolment | 19/01/2024 |
| Date of final enrolment | 16/02/2024 |
Locations
Countries of recruitment
- South Africa
Study participating centres
Johannesburg
1818
South Africa
Johannesburg
1852
South Africa
Johannesburg
1852
South Africa
Johannesburg
1801
South Africa
Johannesburg
1818
South Africa
Sponsor information
University/education
Houghton Street
London
WC2A 2AE
England
United Kingdom
| Phone | +44 (0)20 7405 7686 |
|---|---|
| L.grove@lse.ac.uk | |
| Website | http://www.lse.ac.uk/home.aspx |
"ROR" |
https://ror.org/0090zs177 |
University/education
1 Jan Smuts Avenue, Braamfontein
Johannesburg
2017
South Africa
| Phone | +27 11 717 2226 |
|---|---|
| chandre.fisher@wits.ac.za | |
| Website | https://www.wits.ac.za/ |
|
"ROR" |
https://ror.org/03rp50x72 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
25/02/2025: Trial's existence confirmed by London School of Economics Research Ethics Committee.
