Improving Newborn Survival In Southern Tanzania (INSIST)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Save the Children
UNICEF
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01022788
First received: November 27, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

  1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
  2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
  3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
  4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
  5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
  6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
  7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design & methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Condition Intervention
Newborn Health
Behavioral: Home-based counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Newborn survival (to 28 days) [ Time Frame: July 2010 to June 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Household behaviours for essential newborn care [ Time Frame: July 2010 to June 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25000
Study Start Date: January 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home-based counselling visits by volunteers Behavioral: Home-based counselling
Other Name: Mtunze Mtoto Mchanga
No Intervention: Standard care through existing health system

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women living in the study area

Exclusion Criteria:

  • Unwilling to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022788

Locations
Tanzania
Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa, Mtwara and Lindi Regions, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Save the Children
UNICEF
Investigators
Principal Investigator: David Schellenberg LSHTM
Principal Investigator: Hassan Mshinda Ifakara Health Institute and COSTECH
Principal Investigator: Marcel Tanner Swiss Tropical & Public Health Institute
Principal Investigator: Fatuma Manzi, PhD Ifakara Health Institute, Tanzania
  More Information

No publications provided

Responsible Party: Joanna Schellenberg, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01022788     History of Changes
Other Study ID Numbers: 5316
Study First Received: November 27, 2009
Last Updated: February 11, 2013
Health Authority: Tanzania: National Institute for Medical Research

ClinicalTrials.gov processed this record on June 18, 2013