Improving Newborn Survival In Southern Tanzania (INSIST)

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

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.

Study Overview

• Status: Completed
• Conditions: Newborn Health
• Intervention / Treatment: Behavioral: Home-based counselling

• Study Type: Interventional
• Enrollment (Actual): 47688
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Mtwara and Lindi Regions
    • Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa, Mtwara and Lindi Regions, Tanzania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pregnant women living in the study area

Exclusion Criteria:

• Unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based counselling visits by volunteers; Home-based counselling in pregnancy and the first few days of life to encourage women and families to adopt key newborn care behaviours	Behavioral: Home-based counselling; Other Names: Mtunze Mtoto Mchanga
No Intervention: Standard care through existing health system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Newborn survival (to 28 days)	July 2010 to June 2013

Secondary Outcome Measures

Outcome Measure	Time Frame
Household behaviours for essential newborn care	July 2010 to June 2013

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: 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

Publications and helpful links

General Publications

• Hanson C, Manzi F, Mkumbo E, Shirima K, Penfold S, Hill Z, Shamba D, Jaribu J, Hamisi Y, Soremekun S, Cousens S, Marchant T, Mshinda H, Schellenberg D, Tanner M, Schellenberg J. Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania. PLoS Med. 2015 Sep 29;12(9):e1001881. doi: 10.1371/journal.pmed.1001881. eCollection 2015 Sep.
• Penfold S, Manzi F, Mkumbo E, Temu S, Jaribu J, Shamba DD, Mshinda H, Cousens S, Marchant T, Tanner M, Schellenberg D, Schellenberg JA. Effect of home-based counselling on newborn care practices in southern Tanzania one year after implementation: a cluster-randomised controlled trial. BMC Pediatr. 2014 Jul 22;14:187. doi: 10.1186/1471-2431-14-187.
• Mkumbo E, Hanson C, Penfold S, Manzi F, Schellenberg J. Innovation in supervision and support of community health workers for better newborn survival in southern Tanzania. Int Health. 2014 Dec;6(4):339-41. doi: 10.1093/inthealth/ihu016. Epub 2014 Apr 7.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 27, 2009
• First Submitted That Met QC Criteria: November 27, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 5316