- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03774602
Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific objectives of the study are to:
- Assess changes in knowledge, attitudes, practices and coverage (KAPC) of high-impact interventions related to MNCH (antenatal care, delivery, post-partum/natal care, and sick child care), immunization, family planning and reproductive health, nutrition, WASH and malaria among mothers and fathers of children age 0-23 months in MCSP supported areas;
- Evaluate the effectiveness of male engagement interventions that encourage couples communication at increasing antenatal care (ANC) attendance, joint birth preparedness and complication readiness (BPCR) plans, institutional birth, and use of modern FP;
- Determine the feasibility and acceptability of male engagement interventions on RMNCH services for clients and providers;
- Explore how decisions between couples are made and what may influence their decisions about seeking RMNCH services; and
- Explore the experiences of women who were referred to a health facility for themselves or their child for obstetric, newborn or child health complications, and examine the factors contributing to whether and how those referrals were completed in Nampula Province.
This study is a final program evaluation that will use a mixed methods approach, including both quantitative and qualitative data collection.
Quantitative data will be collected through a cross-sectional KAPC household survey of mothers and fathers of children age 0-23 months, replicating the same KAPC questionnaire that was conducted at baseline in 2016 in the same geographic areas. Questions were harmonized with the DHS and MICS where appropriate. Findings from the endline KAPC survey will be compared to findings from the baseline survey to assess changes over time in the primary outcomes of interest.
Qualitative data will be collected through focus group discussions (FGDs) and in-depth interviews (IDIs) with clients (mothers and fathers of children age 0-23 months) and health providers in MCSP-supported areas. The qualitative component will be conducted to help us gain a more in-depth understanding of the influence of male engagement interventions on couples' decision-making and care-seeking related to RMNCH as well as the barriers and facilitators that affected the experience of identified women who were referred to health facilities for obstetric or newborn complications. We will explore both client and provider experiences with gender-equitable male engagement practices, as well as individual client referral narratives related to obstetric or newborn complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nampula
-
Angoche, Nampula, Mozambique
- Angoche District, Community Setting
-
Meconta, Nampula, Mozambique
- Meconta District, Community Setting
-
Mecuburi, Nampula, Mozambique
- Mecuburi District, Community Setting
-
Moma, Nampula, Mozambique
- Moma District, Community Setting
-
Monapo, Nampula, Mozambique
- Monapo District, Community Setting
-
Mossuril, Nampula, Mozambique
- Mossuril District, Community Setting
-
Nacala, Nampula, Mozambique
- Centro de Saude Ontupaia
-
Nacala, Nampula, Mozambique
- Centro de Saude Quissinmanjulo
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Nacala, Nampula, Mozambique
- Nacala Porto District, Community Setting
-
Namapa-erati, Nampula, Mozambique
- Erati District, Community Setting
-
Ribaue, Nampula, Mozambique
- Centro de Saude Iapala Sede
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Ribaue, Nampula, Mozambique
- Hospital Rural de Ribaue
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Ribaue, Nampula, Mozambique
- Ribaue District, Community Setting
-
-
Sofala
-
Beira, Sofala, Mozambique
- Beira City, Community Setting
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Buzi, Sofala, Mozambique
- Buzi District, Community Setting
-
Buzi, Sofala, Mozambique
- Centro de Saude Ampara
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Buzi, Sofala, Mozambique
- Centro de Saude Bandua
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Dondo, Sofala, Mozambique
- Dondo District, Community Setting
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Nhamatanda, Sofala, Mozambique
- Nhamatanda District, Community Setting
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Nhamatanda, Sofala, Mozambique
- Centro de Saude Metuchira
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Nhamatanda, Sofala, Mozambique
- Hospital Rural de Nhamatanda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (KAPC survey):
- Women 15 years and older who have had a live birth in the 2 years preceding the survey and the child is living at the time of the interview
- Male partners (age 18 and older) of women 15 years and older who have had a live birth in the 2 years preceding the survey and the child is living at the time of the interview
Exclusion Criteria (KAPC survey): Women 15-17 years without parent permission to participate in study
Inclusion Criteria (Referral narrative interviews): Women who: a) delivered in the last 12 months who experienced obstetric complications; b) whose newborn experienced complications in the last year; c) whose child 0-59 months experienced an illness in the last year
Inclusion Criteria (Provider interviews):
- Facility managers working in selected primary health care centers
- Health care workers who provide RMNCH services in MCSP-supported facility in one of these six areas: ANC, maternity, postnatal care, FP, sick child, or well-child
Exclusion Criteria (Provider interviews): Has been working in the facility for < 6 months
Inclusion Criteria (Male engagement FGDs):
- Women 18-49 years of age who delivered in the last 12 months
- Male partner (age 18 and older) of a woman 18-49 years of age who delivered in the last 12 months
- Participated in a community dialogue
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MCSP package of interventions
MCSP package of interventions for health promotion and provision of RMNCH services
|
Implementation of quality, high-impact interventions at institutional and community levels to increase access to and utilization of RMNCH services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Institutional delivery rate
Time Frame: 2 years
|
Percentage of last-born children age 0-23 months who were born in a health facility
|
2 years
|
Percentage of pregnant women who had four or more ANC visits
Time Frame: 2 years
|
Percentage of mothers of children age 0-23 months who had four or more antenatal care visits while pregnant with their youngest child
|
2 years
|
Percentage of children under 2 years of age who received Penta 1 vaccination but did not receive Penta 3 (Drop out rate)
Time Frame: 2 years
|
Percentage of children age 12-23 months who received a Penta 1 vaccination but did not receive a Penta 3 vaccination according to or card verified at the time of the survey
|
2 years
|
Percentage of mothers who made birth preparations before giving birth
Time Frame: 2 years
|
Percentage of mothers of children age 0-23 months who made birth preparations before the birth of their youngest child
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of women who have discussed FP use with her partner
Time Frame: 2 years
|
Percentage of women of reproductive age who have discussed with her partner whether to use a FP method
|
2 years
|
Percent of infants under 6 months of age who are exclusively breastfed
Time Frame: 2 years
|
Percentage of infants 0-5 months of age who are fed exclusively with breast milk
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Connie Lee, MPH, MIA, Jhpiego
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB 8902
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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