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Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods

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ClinicalTrials.gov Identifier: NCT03774602
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Ministry of Health, Mozambique
United States Agency for International Development (USAID)
Save the Children
Information provided by (Responsible Party):
Jhpiego

Brief Summary:
This study evaluates changes in knowledge, attitudes, practices and coverage of key reproductive, maternal, newborn, and child health (RMNCH) areas, including malaria, family planning (FP), nutrition, water, sanitation and hygiene (WASH), and gender equity among the population in Nampula and Sofala provinces targeted by the Maternal and Child Survival Program (MCSP) in Mozambique.

Condition or disease Intervention/treatment Phase
Knowledge, Attitudes, Practice Gender Issues Behavioral: Health promotion and provision of RMNCH services Not Applicable

Detailed Description:

The specific objectives of the study are to:

  1. 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;
  2. 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;
  3. Determine the feasibility and acceptability of male engagement interventions on RMNCH services for clients and providers;
  4. Explore how decisions between couples are made and what may influence their decisions about seeking RMNCH services; and
  5. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2767 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods
Actual Study Start Date : November 22, 2018
Actual Primary Completion Date : December 22, 2018
Actual Study Completion Date : December 22, 2018

Arm Intervention/treatment
Experimental: MCSP package of interventions
MCSP package of interventions for health promotion and provision of RMNCH services
Behavioral: 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




Primary Outcome Measures :
  1. Institutional delivery rate [ Time Frame: 2 years ]
    Percentage of last-born children age 0-23 months who were born in a health facility

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774602


Locations
Show Show 21 study locations
Sponsors and Collaborators
Jhpiego
Ministry of Health, Mozambique
United States Agency for International Development (USAID)
Save the Children
Investigators
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Principal Investigator: Connie Lee, MPH, MIA Jhpiego

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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03774602    
Other Study ID Numbers: IRB 8902
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No