Clinical trial NCT01774136: Effectiveness of an HIV-adapted IMCI Training and Supervision Programme for Community Health Workers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Mother-to-child Transmission of HIV
Antenatal Health Care Utilization
Postnatal Health Care Utilization
Infant Feeding Practices
Keywords: community health workers
HIV
PMTCT
antenatal
postnatal
breastfeeding
South Africa
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: World Health Organization
name: Institute for Healthcare Improvement
name: University of California, San Francisco
First posted: 2013-01-23
Enrollment: 1342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility 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

Primary outcomes:
measure: Prevalence of antenatal booking before 20 weeks gestation
timeFrame: 1 year
measure: Prevalence of presentation for post-natal care within 7 days of delivery
timeFrame: 1 year
measure: Prevalence of exclusive breast-feeding practice at 14 weeks
timeFrame: 1 year
measure: Coverage of HIV PCR testing at 6 weeks
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of women who attended for antenatal care at least 4 times in pregnancy
timeFrame: 1 year
measure: Proportion of deliveries by skilled birth attendant at a health facility
timeFrame: 1 year
measure: Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months
timeFrame: 1 year
measure: Proportion of children whose growth was monitored by CCG at home
timeFrame: 1 year
measure: Prevalence of exclusive breast-feeding practice at 6 months
timeFrame: 1 year
measure: Proportion of women without known HIV-positive status who received HIV test in pregnancy
timeFrame: 1 year
measure: Proportion of women without known HIV-positive status who received HIV test result in pregnancy
timeFrame: 1 year
measure: Proportion of HIV-positive women who received CD4 test results
timeFrame: 1 year
measure: Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery
timeFrame: 1 year
measure: Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: 20000+ Partnership, UKZN
state: KwaZulu-Natal
Study officials:
affiliation: 20,000+ Partnership, University of KwaZulu-Natal
name: Jennifer Reddy, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.