NCT01774136

Brief Summary

This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a Community-Integrated Management of Childhood Illness (C-IMCI) training for community caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal, newborn and child health interventions within households in rural communities in Ugu District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. The primary objectives of the proposed evaluation are to measure the effect of the intervention on key outcomes, including early uptake of antenatal care, facility based delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR testing in infants at 6 weeks. We will also examine the effects of the intervention on immunization uptake up to 12 months and knowledge and practices of CCGs and mothers pertaining to maternal, newborn and child health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

January 20, 2013

Last Update Submit

April 16, 2019

Conditions

Prevention of Mother-to-child Transmission of HIVAntenatal Health Care UtilizationPostnatal Health Care UtilizationInfant Feeding Practices

Keywords

community health workersHIVPMTCTantenatalpostnatalbreastfeedingSouth Africa

Outcome Measures

Primary Outcomes (4)

  • Prevalence of antenatal booking before 20 weeks gestation

    1 year

  • Prevalence of presentation for post-natal care within 7 days of delivery

    1 year

  • Prevalence of exclusive breast-feeding practice at 14 weeks

    1 year

  • Coverage of HIV PCR testing at 6 weeks

    1 year

Secondary Outcomes (12)

  • Proportion of women who attended for antenatal care at least 4 times in pregnancy

    1 year

  • Proportion of deliveries by skilled birth attendant at a health facility

    1 year

  • Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months

    1 year

  • Proportion of children whose growth was monitored by CCG at home

    1 year

  • Prevalence of exclusive breast-feeding practice at 6 months

    1 year

  • +7 more secondary outcomes

Study Arms (2)

Enhanced HIV and MCH training for CHW

EXPERIMENTAL

The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs.

Behavioral: Enhanced HIV and MCH training for CHW

Standard of Care

NO INTERVENTION

Interventions

Enhanced HIV and MCH training for CHWBEHAVIORAL
Enhanced HIV and MCH training for CHW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community caregivers
  • CCGs who work in Ugu District
  • age 18 years or older
  • with grade 9 education or greater
  • Mothers
  • Mothers age 18 years and older who delivered a live-born infant within the prior 12 months
  • Reside in households served by participating CCGs.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

20000+ Partnership, UKZN

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (1)

  • Horwood C, Butler L, Barker P, Phakathi S, Haskins L, Grant M, Mntambo N, Rollins N. A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa. Hum Resour Health. 2017 Jun 13;15(1):39. doi: 10.1186/s12960-017-0210-7.

    PMID: 28610590DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Jennifer Reddy, MBChB

    20,000+ Partnership, University of KwaZulu-Natal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 20, 2013

First Posted

January 23, 2013

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

ZA(1)