Improving Newborn Survival In Southern Tanzania (INSIST)
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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
- 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 .
- To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
- To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
- 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.
- 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
- To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
- 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 |
- Newborn survival (to 28 days) [ Time Frame: July 2010 to June 2013 ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- Pregnant women living in the study area
Exclusion Criteria:
- Unwilling to participate
Contacts and Locations| Tanzania | |
| Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa, Mtwara and Lindi Regions, Tanzania | |
| 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