NCT01022788

Brief Summary

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. 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. 2.To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
  3. 3.To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
  4. 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. 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. 6.To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
  7. 7.To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47,688

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

3.9 years

First QC Date

November 27, 2009

Last Update Submit

April 27, 2015

Conditions

Newborn Health

Outcome Measures

Primary Outcomes (1)

  • Newborn survival (to 28 days)

    July 2010 to June 2013

Secondary Outcomes (1)

  • Household behaviours for essential newborn care

    July 2010 to June 2013

Study Arms (2)

Home-based counselling visits by volunteers

EXPERIMENTAL

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

Standard care through existing health system

NO INTERVENTION

Interventions

Home-based counsellingBEHAVIORAL
Also known as: Mtunze Mtoto Mchanga
Home-based counselling visits by volunteers

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women living in the study area

You may not qualify if:

  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

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

Location

Related Publications (3)

  • 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.

    PMID: 26418813DERIVED

  • 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.

    PMID: 25052850DERIVED

  • 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.

    PMID: 24711599DERIVED

Study Officials

  • David Schellenberg

    London School of Hygiene and Tropical Medicine

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology and International Health

Study Record Dates

First Submitted

November 27, 2009

First Posted

December 1, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

TA(1)