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

Infant Feeding Practices Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774136
• Other study ID #: Nompilo
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2019
• Source: University of KwaZulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1342
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Antenatal Health Care Utilization
• Infant Feeding Practices
• Postnatal Health Care Utilization
• Prevention of Mother-to-child Transmission of HIV

Intervention

Behavioral:
• Enhanced HIV and MCH training for CHW

Locations

Country	Name	City	State
South Africa	20000+ Partnership, UKZN	Durban	KwaZulu-Natal

Sponsors (5)

Lead Sponsor	Collaborator
University of KwaZulu	Centers for Disease Control and Prevention, Institute for Healthcare Improvement, University of California, San Francisco, World Health Organization

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of antenatal booking before 20 weeks gestation		1 year
Primary	Prevalence of presentation for post-natal care within 7 days of delivery		1 year
Primary	Prevalence of exclusive breast-feeding practice at 14 weeks		1 year
Primary	Coverage of HIV PCR testing at 6 weeks		1 year
Secondary	Proportion of women who attended for antenatal care at least 4 times in pregnancy		1 year
Secondary	Proportion of deliveries by skilled birth attendant at a health facility		1 year
Secondary	Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months		1 year
Secondary	Proportion of children whose growth was monitored by CCG at home		1 year
Secondary	Prevalence of exclusive breast-feeding practice at 6 months		1 year
Secondary	Proportion of women without known HIV-positive status who received HIV test in pregnancy		1 year
Secondary	Proportion of women without known HIV-positive status who received HIV test result in pregnancy		1 year
Secondary	Proportion of HIV-positive women who received CD4 test results		1 year
Secondary	Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery		1 year
Secondary	Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)		1 year
Secondary	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		1 year
Secondary	Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival		1 year