Skip to main content
OpenTrials
Completed

NCT Number: NCT01774136

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

20000+ Partnership, UKZN

Durban, KwaZulu-Natal, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced HIV and MCH training for CHW

Behavioral

Primary outcomes

  1. Prevalence of antenatal booking before 20 weeks gestation

    Time frame: 1 year

  2. Prevalence of presentation for post-natal care within 7 days of delivery

    Time frame: 1 year

  3. Prevalence of exclusive breast-feeding practice at 14 weeks

    Time frame: 1 year

  4. Coverage of HIV PCR testing at 6 weeks

    Time frame: 1 year

Secondary outcomes

  1. Proportion of women who attended for antenatal care at least 4 times in pregnancy

    Time frame: 1 year

  2. Proportion of deliveries by skilled birth attendant at a health facility

    Time frame: 1 year

  3. Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months

    Time frame: 1 year

  4. Proportion of children whose growth was monitored by CCG at home

    Time frame: 1 year

  5. Prevalence of exclusive breast-feeding practice at 6 months

    Time frame: 1 year

  6. Proportion of women without known HIV-positive status who received HIV test in pregnancy

    Time frame: 1 year

  7. Proportion of women without known HIV-positive status who received HIV test result in pregnancy

    Time frame: 1 year

  8. Proportion of HIV-positive women who received CD4 test results

    Time frame: 1 year

  9. Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery

    Time frame: 1 year

  10. Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)

    Time frame: 1 year

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Institute for Healthcare Improvement
  • University of California, San Francisco
  • World Health Organization

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2013
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.