NCT02450630

Brief Summary

Uganda's under-five mortality is high, currently estimated at 90/1000 live births (Uganda Bureau of Statistics 2011). Poor referral of sick children that seek care from the private sector is one of the contributory factors. The proposed intervention aims to improve uptake of referral advice for children that seek care from private facilities (registered drug shops/private clinics). The project will be implemented in Mukono district, central Uganda selected because a recent concluded trial in the district showed that drug shop vendors (DSVs) adhere to diagnostic test results, treat appropriately and refer sick children; although uptake of referral is poor. The main reasons attributed to the observed poor referral were negative attitude towards referral forms from drugs shops by the health workers at referral facilities,perceptions of poor quality of care at referral facilities and costs involved (Hutchinson. 2012; Hutchinson et al. 2013 in press).. Thus the proposed project is a follow up to address these factors with the aim to improve uptake of referral. This project is in line with the Uganda's Health sector and USAID Mission's health priorities of strengthening the health system. Critical barriers in the implementation of child survival interventions are poor quality of care in the private sector and timely referral and uptake of referral advice at community level. These barriers may be attributed to inadequate training of providers in the private sector (in diagnosis and management of childhood illnesses); inadequate supervision and regulation; poor linkages and collaboration between the public and private sectors; and non-existent linkages between community structures and the private sector. The barriers will be addressed through an intervention with three components; i) VHTs will be trained to do community sensitization and initiate community discussions aimed at identifying community support mechanisms for financial hardship (to be community led and managed) - e.g. communities to be encouraged to establish community credit/insurance schemes for referral VHTs will register children and facilitate follow up of sick children ii) supervision of providers in the private sector to diagnose, treat and refer sick children, iii) regular meetings between the public and private providers (convened by the district health team) to discuss the referral system.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8,910

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
unknown

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

May 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

May 9, 2015

Last Update Submit

May 18, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of sick children referred from the private sector that complete the referral process (seen at higher level facilities).

    This will be measured as a proportion of referred sick children of the total number of sick children

    2 years

Secondary Outcomes (3)

  • The proportion of sick children seeking care and receiving prompt treatment at private outlets within 24 hours of onset of symptoms;

    2 years

  • The time between consultations at private outlets and uptake of referral at health facilities (referral facilities);

    2 years

  • The cost-effectiveness of the intervention

    2years

Study Arms (2)

training on diagnosis, treatment and referral of children

EXPERIMENTAL

Intervention Arm : training in diagnosis, treatment and referral of sick children

Behavioral: Strenghtened referral of children

Presumptive treament of sick children

NO INTERVENTION

Control Arm - Training of private providers in completing study tools i.e. filling in register and referral forms. No training in diagnosis, treatment and referral and no community awareness on referral

Interventions

Community awareness on referral+ trained private providers in using RDTs/ICCM to treat and refer sick children + supervision and regular meetings between the private and public sector.All health workers in the intervention arm will be trained on how to recognize and distinguish uncomplicated \& severe malaria, supplying unit-dose packaged Coartem® to customers with uncomplicated malaria, and administration of rectal artesunate pre-referral treatment and referral for sick children with severe and complicated malaria, diarrhoea and pneumonia.Private outlets in intervention arm will be trained to improve diagnosis, treatment and referral of children. The intervention will thus contribute to better health seeking practices at a community level and improved quality of care in the private sector

Also known as: Improved referral of sick children
training on diagnosis, treatment and referral of children

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A cluster is defined to be a parish or neighboring parishes if the distance between any two private outlets located in each of the parishes is\<1 km( to minimize possible spill over).
  • Any of the 63 parishes/clusters in Mukono district will be eligible if:
  • i) Contain more than 200 households to ensure a sufficient number of sick children visiting the private outlets
  • ii) Contained at least one registered drug shop/private clinic with the district drug inspector (DDI).
  • iii) Contain a health centre II, the lowest public health facility where early treatment is sought.

You may not qualify if:

  • i) Unregistered drug shop/private clinic
  • ii) No HFII government health facility located within the same parish
  • iii) Fewer than 200 households in the parish where drug shop/private clinic is located
  • iv) If the health facility does not have a qualified health worker. Some government health HCIIs in Uganda are run by nursing aides.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mbonye AK, Buregyeya E, Rutebemberwa E, Lal S, Clarke SE, Hansen KS, Magnussen P, LaRussa P. Treatment of Sick Children Seeking Care in the Private Health Sector in Uganda: A Cluster Randomized Trial. Am J Trop Med Hyg. 2020 Mar;102(3):658-666. doi: 10.4269/ajtmh.19-0367.

  • Buregyeya E, Rutebemberwa E, LaRussa P, Mbonye A. Strengthening referral of sick children from the private health sector and its impact on referral uptake in Uganda: a cluster randomized controlled trial protocol. BMC Health Serv Res. 2016 Nov 11;16(1):646. doi: 10.1186/s12913-016-1885-5.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Anthony K Mbonye, PhD

    Minstry of Health Uganda

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony K Mbonye, PhD

CONTACT

Esther Buregyeya, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Health Servces in charge of community and clinical services

Study Record Dates

First Submitted

May 9, 2015

First Posted

May 21, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

May 21, 2015

Record last verified: 2015-05