Condition category
Pregnancy and Childbirth
Date applied
07/05/2018
Date assigned
11/05/2018
Last edited
11/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Tanzania struggled to meet its Millennium Development Goal of reducing the number of maternal deaths down to 193 per 100,000 live births before the 2015 deadline. As part of the country's initiatives to improve maternal health outcomes, CARE Canada has been working in one of the poorest, most rural regions, Tabora, since 2012. The Tabora Maternal and Newborn Health Initiative (TAMANI) represents the second stage of reproductive, maternal, and newborn health (RMNH) programming, and will span from 2017-2021.
The protocol aims to evaluate the impact of the TAMANI program on reproductive, maternal and newborn health outcomes in Tabora. The key measures are the quality of health services around the time of birth, contraceptive use, and adolescent birth rate.
Due to practical constraints, TAMANI will be rolled out in phases. Each phase will move two districts paired together from untreated to treated status, and whose healthcare workers and community health workers will have received training. After each crossover period, a household survey will be given to eligible participants in randomly selected households in the community to collect data on RMNH experiences.

Who can participate?
The target population for the household survey are the community members benefiting from the interventions. Eligible participants are women aged 15-49 in selected households, as well as men also aged 15-49 in the same household.

What does the study involve?
The project aims to train health care workers to deliver basic and comprehensive emergency obstetric and newborn care in public health facilities, and train community health workers to deliver RMNH education and promote use of health care services in the community.

What are the possible benefits and risks of participating?
There are no direct benefits for a participant in the study. The results from the study will be used to assess how the project did over time and whether it achieved its goals. The information can be used to improve the delivery of services in the region. The risks of participation are minimal as the information provided in the survey is kept private. During the survey, some questions or topics may be considered sensitive or uncomfortable by the participant.

Where is the study run from?
Tabora, Tanzania

When is the study starting and how long is it expected to run for?
November 2017 to July 2021.

Who is funding the study
Government of Canada - Global Affairs Canada

Who is the main contact
Dr Sam Harper, sam.harper@mcgill.ca
Dr Arijit Nandi, arijit.nandi@mcgill.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sam Harper

ORCID ID

Contact details

Department of Epidemiology
Biostatistics and Occupational Health
McGill University
Purvis Hall
Room 34B
1020 Pine Avenue West
Montreal
H3A1A2
Canada
514-398-2856
sam.harper@mcgill.ca

Type

Scientific

Additional contact

Dr Arijit Nandi

ORCID ID

Contact details

Institute for Health and Social Policy
McGill University
Charles Meredith House
1030 Pine Avenue West
Montreal
H3A1A3
Canada
514-398-7849
arijit.nandi@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D-003063

Study information

Scientific title

An evaluation of the Tabora Maternal and Newborn Health Initiative Protocol for a stepped-wedge cluster-randomized trial

Acronym

TAMANI

Study hypothesis

It is hypothesized the project will have a positive impact on reproductive, maternal and newborn health outcomes.

Ethics approval

McGill University Faculty of Medicine Institutional Review Board, 03/11/2017, A10-B50-17B.

Study design

Stepped-wedge cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Effect of community health worker training on reproductive, maternal and newborn health

Intervention

The stepped wedge cluster randomized controlled trial design allows for a phased-in approach of interventions for districts. A pair of districts serves as a cluster. At specified periods of time, a cluster will cross-over from control status to treatment status. Treatment status refers to the implementation of specific intervention activities in those districts.
The intervention is two-pronged and targets both the supply and demand side of health care provision in Tabora.
1. The supply side focuses on training and mentoring of health care workers in basic and comprehensive emergency obstetric and newborn health and reproductive health services (e.g. family planning, respectful maternity care, adolescent friendly health services). Selected health professionals are trained within a 3-month period and returned to their health facilities to implement their skills along with provided job aids. Supportive supervision and mentoring activities take place post-training at specified 6-month and 12-month intervals.
2. The demand side focuses on training and equipping a total of 1,000 community health workers to provide quality maternal and newborn health education in their communities as well as promote utilization of health care services. The training period coincides with the same period interval as healthcare worker training.
The remaining districts or clusters serve as controls, where no intervention activities occur. By the end of the last intervention period, all districts will be considered treated.
The intervention activities take place for 3-month intervals in randomly selected clusters, followed by a 3-month data collection period (‘step’) in all districts. Data collection is through a household survey in random sample of Tabora households in all districts. Participants meeting eligibility criteria in selected households will be asked to participate in the face-to-face survey on reproductive and maternal health and healthcare experiences. All intervention activities will have been completed in the July-September 2019 interval, with the final round of recruitment and data collection (‘step 4’) in October-December 2019.
The total duration of intervention implementation and follow-up time is 2 years, each consisting of 12 months of combined activity.


Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Availability of maternal and newborn health services as measured by the followed two indicators:
1.1 Percentage of women with unmet needs for family planning
1.2. Percentage of deliveries with a skilled birth attendant present
2. Increased utilization of maternal and newborn health services as measured by the following two indicators:
2.1. Percentage of women 15-49 with live birth attending antenatal care 4 or more times
2.2. Contraceptive prevalence rate, assessed as the proportion of women currently using, or whose sexual partner is currently using, at least one method of contraception, regardless of the method used
3. Adolescent birth rate as defined as number of births per 1,000 women aged 15-19 years
All outcomes will be measured by household survey (direct, face-to-face interviews) at baseline and measured again at each step in the stepped wedge design (the final step takes place approximately 2 years after the baseline survey).

Secondary outcome measures

Secondary outcomes will also be assessed among men. Specifically among men the outcomes are perceptions of women’s health and reproductive rights, including: whether a woman is justified in refusing to have sex with her husband or partner in various situations (e.g., if she knows he has sex with other women, if she is tired or not in the mood); whether a woman has the right to go to the health facility without her husband’s permission; and whether a woman can use family planning without her husband’s permission.

Overall trial start date

06/01/2017

Overall trial end date

31/07/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. All women aged 15-49 years residing in Tabora region throughout the TAMANI project lifespan (2017-2021)
2. All men aged 15-49 years residing in Tabora region throughout the TAMANI project lifespan (2017-2021)

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

The total sample size expected is N=8000 women over 6400 households across 5 rounds of data collection (4 intervention steps + baseline). The number of households/district at each step is n=160 for a total of n=320 households per cluster of 2 districts.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

13/11/2017

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Tanzania

Trial participating centre

Ifakara Health Institute
Ifakara Health Institute Plot 463, Kiko Avenue Mikocheni Dar es Salaam P.O. Box 78 373 Dar es Salaam
Dar es Salaam
PO Box 78373
Tanzania

Sponsor information

Organisation

CARE Canada

Sponsor details

9 Gurdwara Road
Ottawa
K2E7X6
Canada

Sponsor type

Charity

Website

https://care.ca

Funders

Funder type

Not defined

Funder name

Global Affairs Canada

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The individual-level data, anonymized and stripped of any identifying information, will be published in a publicly available repository (https://dataverse.harvard.edu/dataverse/3po) after the trial has ended, approximately August 1, 2021.

Intention to publish date

31/07/2022

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes