NCT04278612

Brief Summary

This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health environment, but we were unable to achieve the changes needed to provide a comprehensive package of care for mothers and children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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 18, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 14, 2020

Last Update Submit

February 18, 2020

Conditions

Maternal and Child Health

Keywords

Quality improvementIntegrated careMaternal healthChild healthHIV/AIDSSouth AfricaGrowth MonitoringChild GrowthNutrition

Outcome Measures

Primary Outcomes (1)

  • Quality of Maternal and Child Care

    Proportion of mother-baby pairs who received comprehensive care

    3 months

Secondary Outcomes (2)

  • Quality of Child Care

    3 months

  • Quality of Maternal Care

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Provision of comprehensive care including the following: Baby: Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive - * Polymerase chain reaction (PCR) test for the baby repeated at 10 weeks * Nevirapine for the baby for six weeks Mother: Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs) HIV Care: * HIV positive mothers - provide ART for the mother and adherence support * HIV negative mothers- HIV test every three months while breastfeeding

Other: Quality improvement intervention to strengthen health service provision

Control

ACTIVE COMPARATOR

Routine maternal and child care service delivery

Other: Quality improvement intervention to strengthen health service provision

Interventions

Quality improvement intervention to strengthen health service provisionOTHER

Quality improvement intervention comprising of regular improvement meetings based at clinics.

ControlIntervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who attended the clinic for maternal and child health care services.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

You may not qualify if:

  • Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haskins L, Chiliza J, Barker P, Connolly C, Phakathi S, Feeley A, Horwood C. Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa. BMC Public Health. 2020 Mar 12;20(1):318. doi: 10.1186/s12889-020-8397-2.

    PMID: 32164597DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 20, 2020

Study Start

January 18, 2016

Primary Completion

February 5, 2017

Study Completion

January 16, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

IPD will not be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Anytime
Access Criteria
We are more than happy to share our study protocol, statistical analysis plan or informed consent with anyone who is interested.