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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Enhanced HIV and MCH training for CHW


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced HIV and MCH training for CHW<br>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<br> <br> |
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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community health workers, HIV, PMTCT, antenatal, postnatal, breastfeeding, South Africa