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

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

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.

Study Overview

• Status: Completed
• Conditions: Infant Feeding Practices; Prevention of Mother-to-child Transmission of HIV; Antenatal Health Care Utilization; Postnatal Health Care Utilization
• Intervention / Treatment: Behavioral: Enhanced HIV and MCH training for CHW

• Study Type: Interventional
• Enrollment (Actual): 1342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa
      • 20000+ Partnership, UKZN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Proportion of women without known HIV-positive status who received HIV test in pregnancy	1 year
Proportion of women without known HIV-positive status who received HIV test result in pregnancy	1 year
Proportion of HIV-positive women who received CD4 test results	1 year
Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery	1 year
Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)	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	1 year
Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival	1 year

Collaborators and Investigators

• Sponsor: University of KwaZulu
• Collaborators: University of California, San Francisco; Centers for Disease Control and Prevention; World Health Organization; Institute for Healthcare Improvement
• Investigators: Principal Investigator: Jennifer Reddy, MBChB, 20,000+ Partnership, University of KwaZulu-Natal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 20, 2013
• First Submitted That Met QC Criteria: January 20, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: HIV; breastfeeding; South Africa; community health workers; PMTCT; postnatal; antenatal
• Other Study ID Numbers: Nompilo