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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list