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Trial registered on ANZCTR


Registration number
ACTRN12620001014943
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
7/10/2020
Date last updated
7/10/2020
Date data sharing statement initially provided
7/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Mbereko+Men Model: Evaluating the effect of a community based, gender synchronised parenting intervention with mothers and fathers on maternal mental health, care-seeking for maternal, newborn and child health services, and care and support in the home for mothers and infants in Manicaland, Zimbabwe
Scientific title
The Mbereko+Men Model: Evaluating the effect of a community based, gender synchronised parenting intervention with mothers and fathers on maternal mental health, care-seeking for maternal, newborn and child health services, and care and support in the home for mothers and infants in Manicaland, Zimbabwe
Secondary ID [1] 301482 0
None
Universal Trial Number (UTN)
U1111-1253-3546
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal depression 317808 0
Postnatal anxiety 317809 0
Pregnancy 317810 0
Childbirth 317811 0
Infant health 317812 0
Intimate partner violence 318137 0
Condition category
Condition code
Public Health 315866 315866 0 0
Health promotion/education
Mental Health 315868 315868 0 0
Depression
Mental Health 315869 315869 0 0
Anxiety
Reproductive Health and Childbirth 315870 315870 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 315871 315871 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mbereko+Men intervention is delivered through two gender synchronised components. The first component (Mbereko), delivered with women who are pregnant or have a child aged up to 2 years, is monthly facilitated participatory learning and action (PLA) cycles, complemented by saving and lending clubs formed by PLA group members. The second component (+Men), delivered with men resident in the same community, is monthly education and dialogue forums, complemented by a participatory charter developed by men through the dialogue forums that focuses on how men can support family health through their actions. To enable these two components, monthly Health Centre Committees are held that bring together community leaders and health facility staff (for 1-2 hours per month for 18 months) to review clinic performance and community health outcomes, and improve community-facility linkages.

The intervention is delivered across 8 sites (4 intervention, 4 control). Each site is the catchment area of a Rural Health Clinic (a primary health facility in rural Zimbabwe), and intervention activities are implemented in collaboration with rural health clinic staff.

The intervention is delivered primarily through facilitated group discussion. Physical materials required are minimal, and comprise:
(a) Mbereko (women's) component: Action Birth Cards (one per woman) provided to women participating in group education sessions that support women to reflect and plan how to follow the health advice discussed in each group education session; flip chart with information about reproductive, maternal, newborn and child health that is used by the health facility staff member facilitating the women's group discussion session. The Action Birth Card and flip chart have been developed for previous programs led by OPHID Trust and are available for purchase on request to OPHID Trust.
(b) +Men component: flip chart with information about reproductive, maternal, newborn and child health that is used by the project staff member facilitating the men's group discussion session. The flip chart has been developed for a previous program led by OPHID Trust and is available for purchase on request to OPHID Trust.

Content included in the education modules is the same for women and men, and comprises: services provided during antenatal care, safe childbirth and facility birth, maternal rest during pregnancy and lactation, breastfeeding, prevention of couple or mother-to-child transmission of HIV and sexually transmitted infections during pregnancy and postpartum, family planning and modern methods of contraception, maternal and neonatal danger signs, child immunisation, and recognition of child illness.

The Mbereko component is delivered by trained female local health workers under the supervision of a trained female project staff member with minimum 3 years' experience in facilitating women's participatory learning and action (PLA) groups. The +Men component is delivered by a trained male project staff member who is also a trained nurse.

The intervention is delivered face to face once per month, through facilitated discussion groups, for 18 months. The Mbereko (women's) component is delivered at local rural health centres, with PLA sessions delivered approximately one hour per month for 18 months, and the saving and lending clubs initiated with a two-hour training followed by meetings at club members' discretion (these subsequent saving and lending club meetings are held either at the local rural health centre or another location at the discretion of club members). The +Men (men's) component is delivered at men's workplaces or accessible community sites, for approximately one hour each month for 18 months. After 18 months, the intervention will be delivered in control sites for a minimum of 12 months during the 3-year study implementation period.

The intervention is participatory. The group discussions with women and men are influenced by participants' perspectives and experiences. Beyond this, however, there is no adaption of the intervention.

Intervention exposure and effects (primary and secondary outcomes) will be assessed through repeat cross-sectional community based surveys, conducted in intervention and control sites at baseline and after the intervention has concluded in intervention sites. The surveys are to be conducted by trained field researchers who have not been involved in intervention delivery. Intervention adherence and fidelity will not be assessed. Community members' awareness of or satisfaction with the study intervention will not be assessed.
Intervention code [1] 317792 0
Behaviour
Intervention code [2] 317999 0
Lifestyle
Comparator / control treatment
Women receive free antenatal and maternal and child health services in Zimbabwe. The intervention supports women and their families to tackle demand-side barriers that prevent many women and newborns from accessing these services. The intervention did not change the structure or content of health care offered to women at health facilities, but rather generated the provision of information, household support and facility outreach for optimal uptake of recommended services across the maternal health cascade.

The recommended maternal and newborn health services that comprise standard of care are delivered by facility-based nurses and are described below. These are the same services that are promoted through the intervention.
1. Early antenatal care (before 14 weeks gestational age)
2. Both partners HIV test in antenatal care
3. Attend 4 or more antenatal care appointments
4. Develop a birth plan and deliver at a health facility
5. Early postnatal care for mothers AND babies (within 2 days of birth)
6. Make use of postnatal HIV services for mothers, fathers, children and infants – e.g. HIV retesting for HIV negative mothers/fathers, promotion of exclusive breastfeeding
7. Identity documents obtained
8. Post-partum family planning
9. Baby check-ups and immunisations up to date
10. Identification and early treatment of infections

Standard of care does not include outreach from facility-based nurses, or individual-level monitoring of uptake of services (by facility-based nurses working with community-based health workers) with individual- and community-level follow-up. These were included in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 324077 0
Women's mean score on the Edinburgh Postnatal Depression Scale (EPDS) (validated Shona-language version), indicating symptoms of depression and anxiety.
Timepoint [1] 324077 0
At baseline, and after 18 months of intervention implementation.
Secondary outcome [1] 383689 0
Proportion of women with clinically significant symptoms of depression and anxiety, indicated by a score of 12 or more (cutoff 11/12) on the EPDS. Measured through the repeat cross-sectional community-based surveys, using a validated Shona-language version of the EPDS.
Timepoint [1] 383689 0
At baseline, and after 18 months of intervention implementation.
Secondary outcome [2] 383690 0
Proportion of women not involved in any of three key measures of household decision-making (major household purchases, visiting family, or health visits for woman), measured separately among men and women. Measured through the repeat cross-sectional community-based surveys, using an established Demographic and Health Surveys measure, as defined by DHS-7 (https://dhsprogram.com/data/Guide-to-DHS-Statistics/Participation_in_Decision_Making.htm).
Timepoint [2] 383690 0
At baseline, and after 18 months of intervention implementation.
Secondary outcome [3] 383691 0
Men's mean score of gender-inequitable attitudes. Measured through the repeat cross-sectional community-based surveys, using the validated Gender Equitable Men (GEM) measure.
Timepoint [3] 383691 0
At baseline, and after 18 months of intervention implementation.
Secondary outcome [4] 383692 0
Proportion of men who provide pre-defined support to mother-baby pairs, measured separately among men and women. Measured through the repeat cross-sectional community-based surveys, using a 15-item study-specific measure developed based on a 2015 systematic review of male involvement, a previous qualitative study in Zimbabwe focused on male involvement, and a study in Vietnam exploring postpartum women's experiences including the impact of male partner support. The 15 items included in the measure encompass men's financial, instrumental and emotional support during pregnancy, childbirth and the postnatal period (e.g. support to access essential MNCH services, support for maternal nutrition, and contribution to household chores and baby care).
Timepoint [4] 383692 0
At baseline, and after 18 months of intervention implementation.
Secondary outcome [5] 383693 0
Proportion of women accessing pre-defined essential maternal, newborn and child health (MNCH) services: at least four antenatal care visits, commencing antenatal care in the first trimester, facility birth, couples HIV testing during pregnancy, postnatal care for baby within 72 hours from birth, and postnatal care for mother within 6 weeks from birth. Measured through the repeat cross-sectional community-based surveys using a study-specific measure developed based on World Health Organization guidance on essential MNCH services, as well as guidance from Zimbabwean stakeholders on locally-specific priority services (e.g. HIV testing).
Timepoint [5] 383693 0
At baseline, and after 18 months of intervention implementation.

Eligibility
Key inclusion criteria
Women participating in the intervention:
• Currently resident in study site;
• Pregnant and/or has a child aged 0-2 years.

Men participating in the intervention:
• Currently resident in the study site.

Women participating in the repeat cross-sectional community based surveys:
• Has given birth within the previous 0-6 months;
• Resident in study site for a minimum of 12 months;
• Aged 16 years and older; and
• Able to give informed consent.

Men participating in the repeat cross-sectional community based surveys:
• Has a child aged 0-6 months, or female partner has given birth within the previous 0-6 months;
• Resident in study site for a minimum of 12 months;
• Aged 16 years and older;
• Able to give informed consent; and
• Female partner or mother of his child has provided consent for the man to be surveyed.

Married and unmarried women and men will be eligible to participate. Women and men who are no longer in an ongoing relationship with the father or mother of their child will be eligible to participate.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was conducted by an external researcher, not connected to the trial, who generated a random number sequence that allocated study sites to intervention and control arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Microsoft Excel).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a study population of women who have given birth within 0-6 months prior to data collection (n=55 per cluster, 220 per arm), the study is powered to detect a difference in mean EPDS score of 3.5 points between the two study arms. A difference of 3.5 points is likely to be 44% of 1 standard deviation of EPDS score for this population.

EPDS is a reasonable measure for the study population. EPDS can measure perinatal common mental disorders (CMD), defined as CMD during pregnancy or in the year after giving birth. EPDS detects but does not distinguish between symptoms of depression and anxiety, so can be considered a marker for CMD. Prevalence of EPDS >11 has been measured as stable within a cohort between 6-8 weeks and 6 months postpartum, which suggests that it is meaningful to measure EPDS among women who have given birth within 0-6 months prior to data collection. A Shona-language version of the EPDS has been validated among HIV-positive and HIV-negative women aged 18 years and over in urban Zimbabwe. Mean EPDS score for a cohort of 210 women in urban Zimbabwe with a child aged 6-7 weeks (women aged 18 years and over, including both HIV-positive and HIV-negative women, recruited when attending 6-week postnatal check-up) was 10.41 (SD, 7.9). The prevalence of perinatal CMD among women in urban Zimbabwe has previously been measured at 33% (women at 6-7 weeks postpartum assessed with DSM-IV).

It is reasonable to expect that the intervention will have a moderate-to-large effect on maternal mental health. A large cluster randomised controlled trial in India (36 clusters, total 19,030 births) tested the effect of women’s participatory learning and action groups on birth outcomes and maternal depression, and found significant differences in the third year: significant increase in no or mild depression (95% intervention, 90% control, AOR 2.33 (1.25–4.38) and significant decrease in moderate depression (5% intervention, 10% control, AOR 0.43 (0.23–0.80)). Additionally, a small cohort study (27 women) of a six-week group counselling intervention for postpartum women with moderate depression found a change from mean EPDS score of 17.3 (SD, 3.7) at baseline (6-7 weeks postpartum) to 8.22 (SD, 3.6) after the six-week intervention. One aspect of this intervention was to improve the quality of intimate partners’ support to women (as in the proposed study), although this component was not separately assessed.

A detailed statistical analysis plan will be developed to guide analysis to be conducted for baseline and midline survey data. A statistician with substantial expertise in data-analysis using STATA, including advanced skills in the analysis of datasets using cluster sampling designs, will contribute to and have oversight of the final data analysis plans. Statistical analyses will be appropriately adjusted for the cluster sampling design and small number of clusters. Analysis will be conducted using STATA 12.1 or similar software and developed using verifiable syntax records (do-files).

Analysis of baseline data will assess the associations between socio-demographic characteristics, indicators of women’s empowerment, indicators of male engagement in family health and MNCH outcomes. Univariate exploratory and descriptive analyses will be undertaken to estimate prevalence and distributions of key factors both overall and by study arm. This will produce a basic description of the key variables of interest. Cross tabulations (bivariate analysis) will be used to explore whether there are significant associations among variables of interest.

Analysis of midline data will compare indicators of women’s empowerment, indicators of male engagement in family health and MNCH outcomes across study arms, controlled for potential confounders. Baseline data will be used to inform statistical adjustment for potential confounders at cluster level. This analysis will be used to assess the effect of the Mbereko+Men Model on maternal mental health, care-seeking for MNCH services, and care and support in the home.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/07/2016
Date of last participant enrolment
Anticipated
Actual
15/09/2017
Date of last data collection
Anticipated
Actual
30/11/2017
Sample size
Target
1408
Accrual to date
Final
1405
Recruitment outside Australia
Country [1] 22665 0
Zimbabwe
State/province [1] 22665 0
Manicaland Province

Funding & Sponsors
Funding source category [1] 305920 0
Government body
Name [1] 305920 0
Australian Government Department of Foreign Affairs and Trade
Country [1] 305920 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Macfarlane Burnet Institute for Medical Research and Public Health (Burnet Institute)
Address
85 Commercial Rd, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 306375 0
Charities/Societies/Foundations
Name [1] 306375 0
Organization for Public Health Interventions and Development (OPHID)
Address [1] 306375 0
20 Natal Rd, Harare
Country [1] 306375 0
Zimbabwe

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306169 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 306169 0
Ethics committee country [1] 306169 0
Australia
Date submitted for ethics approval [1] 306169 0
04/08/2015
Approval date [1] 306169 0
13/01/2016
Ethics approval number [1] 306169 0
394/15
Ethics committee name [2] 306171 0
Medical Research Council of Zimbabwe
Ethics committee address [2] 306171 0
Ethics committee country [2] 306171 0
Zimbabwe
Date submitted for ethics approval [2] 306171 0
07/10/2015
Approval date [2] 306171 0
28/03/2016
Ethics approval number [2] 306171 0
MRCZ/A/2006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102954 0
Prof Stanley Luchters
Address 102954 0
Department of Population Health, Faculty of Health Sciences, Aga Khan University, Sunny Plaza, 4th Parklands Avenue off Wangapala Rd, Nairobi, Kenya
Country 102954 0
Kenya
Phone 102954 0
+254 20 366 1132
Fax 102954 0
Email 102954 0
[email protected]
Contact person for public queries
Name 102955 0
Liz Comrie-Thomson
Address 102955 0
Burnet Institute, 85 Commercial Rd, Melbourne VIC 3004
Country 102955 0
Australia
Phone 102955 0
+61 438671143
Fax 102955 0
Email 102955 0
[email protected]
Contact person for scientific queries
Name 102956 0
Liz Comrie-Thomson
Address 102956 0
Burnet Institute, 85 Commercial Rd, Melbourne VIC 3004
Country 102956 0
Australia
Phone 102956 0
+61 438671143
Fax 102956 0
Email 102956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing was not included in the study protocol or PICFs used with participants.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.