Effectiveness of an HIV-adapted IMCI Training and Supervision Programme for Community Health Workers

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of KwaZulu
Sponsor:
Collaborators:
World Health Organization
Centre for Rural Health, University of KwaZulu-Natal
Institute for Healthcare Improvement
University of California, San Francisco
Information provided by (Responsible Party):
Dr. Jennifer Reddy, University of KwaZulu
ClinicalTrials.gov Identifier:
NCT01774136
First received: January 20, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Prevention of Mother-to-child Transmission of HIV
Antenatal Health Care Utilization
Postnatal Health Care Utilization
Infant Feeding Practices
Behavioral: Enhanced HIV and MCH training for CHW

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Effectiveness of an HIV-adapted IMCI Training and Supervision Programme of Community Caregivers to Support Interventions That Will Reduce MTCT and Improve Delivery of Other Essential Newborn and Child Survival Interventions

Resource links provided by NLM:


Further study details as provided by University of KwaZulu:

Primary Outcome Measures:
  • Prevalence of antenatal booking before 20 weeks gestation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of presentation for post-natal care within 7 days of delivery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of exclusive breast-feeding practice at 14 weeks [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Coverage of HIV PCR testing at 6 weeks [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of women who attended for antenatal care at least 4 times in pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of deliveries by skilled birth attendant at a health facility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of children whose growth was monitored by CCG at home [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of exclusive breast-feeding practice at 6 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of women without known HIV-positive status who received HIV test in pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of women without known HIV-positive status who received HIV test result in pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of HIV-positive women who received CD4 test results [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Knowledge and practices of mothers in the community regarding: infant feeding, HIV, availability of interventions to reduce HIV transmission, newborn care practices and recognition of serious illness in children and management of childhood illnesses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3840
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced HIV and MCH training for CHW
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
No Intervention: Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774136

Contacts
Contact: Jennifer Reddy, MBChD Reddyj@ukzn.ac.za

Locations
South Africa
20000+ Partnership, UKZN Recruiting
Durban, KwaZulu-Natal, South Africa
Contact: Jennifer Reddy, MBChD       Reddyj@ukzn.ac.za   
Principal Investigator: Jennifer Reddy, MBChB         
Sponsors and Collaborators
University of KwaZulu
World Health Organization
Centre for Rural Health, University of KwaZulu-Natal
Institute for Healthcare Improvement
University of California, San Francisco
Investigators
Principal Investigator: Jennifer Reddy, MBChB 20,000+ Partnership, University of KwaZulu-Natal
  More Information

No publications provided

Responsible Party: Dr. Jennifer Reddy, Director, University of KwaZulu
ClinicalTrials.gov Identifier: NCT01774136     History of Changes
Other Study ID Numbers: Nompilo
Study First Received: January 20, 2013
Last Updated: January 20, 2013
Health Authority: United States: Federal Government

Keywords provided by University of KwaZulu:
community health workers
HIV
PMTCT
antenatal
postnatal
breastfeeding
South Africa

ClinicalTrials.gov processed this record on October 23, 2014