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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Dr. Jennifer Reddy, University of KwaZulu.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774136
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Disease Control and Prevention
World Health Organization
Institute for Healthcare Improvement
University of California, San Francisco
Information provided by (Responsible Party):
Dr. Jennifer Reddy, University of KwaZulu
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Dr. Jennifer Reddy, University of KwaZulu:

Primary Outcome Measures:
  • Prevalence of antenatal booking before 20 weeks gestation [ Time Frame: 1 year ]
  • Prevalence of presentation for post-natal care within 7 days of delivery [ Time Frame: 1 year ]
  • Prevalence of exclusive breast-feeding practice at 14 weeks [ Time Frame: 1 year ]
  • Coverage of HIV PCR testing at 6 weeks [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Proportion of women who attended for antenatal care at least 4 times in pregnancy [ Time Frame: 1 year ]
  • Proportion of deliveries by skilled birth attendant at a health facility [ Time Frame: 1 year ]
  • Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months [ Time Frame: 1 year ]
  • Proportion of children whose growth was monitored by CCG at home [ Time Frame: 1 year ]
  • Prevalence of exclusive breast-feeding practice at 6 months [ Time Frame: 1 year ]
  • Proportion of women without known HIV-positive status who received HIV test in pregnancy [ Time Frame: 1 year ]
  • Proportion of women without known HIV-positive status who received HIV test result in pregnancy [ Time Frame: 1 year ]
  • Proportion of HIV-positive women who received CD4 test results [ Time Frame: 1 year ]
  • Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery [ Time Frame: 1 year ]
  • Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate) [ Time Frame: 1 year ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Centers for Disease Control and Prevention
World Health Organization
Institute for Healthcare Improvement
University of California, San Francisco
Investigators
Principal Investigator: Jennifer Reddy, MBChB 20,000+ Partnership, University of KwaZulu-Natal
  More Information

Responsible Party: Dr. Jennifer Reddy, Director, University of KwaZulu
ClinicalTrials.gov Identifier: NCT01774136     History of Changes
Other Study ID Numbers: Nompilo
First Submitted: January 20, 2013
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Dr. Jennifer Reddy, University of KwaZulu:
community health workers
HIV
PMTCT
antenatal
postnatal
breastfeeding
South Africa


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