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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03774602
Other study ID # IRB 8902
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2018
Est. completion date December 22, 2018

Study information

Verified date February 2019
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2767
Est. completion date December 22, 2018
Est. primary completion date December 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Mozambique Angoche District, Community Setting Angoche Nampula
Mozambique Beira City, Community Setting Beira Sofala
Mozambique Buzi District, Community Setting Buzi Sofala
Mozambique Centro de Saude Ampara Buzi Sofala
Mozambique Centro de Saude Bandua Buzi Sofala
Mozambique Dondo District, Community Setting Dondo Sofala
Mozambique Meconta District, Community Setting Meconta Nampula
Mozambique Mecuburi District, Community Setting Mecuburi Nampula
Mozambique Moma District, Community Setting Moma Nampula
Mozambique Monapo District, Community Setting Monapo Nampula
Mozambique Mossuril District, Community Setting Mossuril Nampula
Mozambique Centro de Saude Ontupaia Nacala Nampula
Mozambique Centro de Saude Quissinmanjulo Nacala Nampula
Mozambique Nacala Porto District, Community Setting Nacala Nampula
Mozambique Erati District, Community Setting Namapa-erati Nampula
Mozambique Centro de Saude Metuchira Nhamatanda Sofala
Mozambique Hospital Rural de Nhamatanda Nhamatanda Sofala
Mozambique Nhamatanda District, Community Setting Nhamatanda Sofala
Mozambique Centro de Saude Iapala Sede Ribaue Nampula
Mozambique Hospital Rural de Ribaue Ribaue Nampula
Mozambique Ribaue District, Community Setting Ribaue Nampula

Sponsors (4)

Lead Sponsor Collaborator
Jhpiego Ministry of Health, Mozambique, Save the Children, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Mozambique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Institutional delivery rate Percentage of last-born children age 0-23 months who were born in a health facility 2 years
Primary Percentage of pregnant women who had four or more ANC visits 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
Primary Percentage of children under 2 years of age who received Penta 1 vaccination but did not receive Penta 3 (Drop out rate) 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
Primary Percentage of mothers who made birth preparations before giving birth Percentage of mothers of children age 0-23 months who made birth preparations before the birth of their youngest child 2 years
Secondary Percentage of women who have discussed FP use with her partner Percentage of women of reproductive age who have discussed with her partner whether to use a FP method 2 years
Secondary Percent of infants under 6 months of age who are exclusively breastfed Percentage of infants 0-5 months of age who are fed exclusively with breast milk 2 years
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