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Knowledge, Attitudes, PracticeNCT03774602

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

A study testing Health promotion and provision of RMNCH services in people with Knowledge, Attitudes, Practice and Gender Issues, run by Jhpiego at 21 sites in Mozambique.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Knowledge, Attitudes, Practice, Gender Issues
What is being tested?
Health promotion and provision of RMNCH services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,767 participants
Where
21 sitesMozambique
Study dates
22 Nov 2018to 22 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
  • 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
Show all 10Show fewer
  • Exclusion Criteria (Provider interviews): Has been working in the facility for < 6 months
  • 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

Who cannot join

None listed.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Mozambique21 sites

  • Angoche District, Community Setting

    Angoche, Nampula

  • Beira City, Community Setting

    Beira, Sofala

  • Buzi District, Community Setting

    Búzi, Sofala

  • Centro de Saude Ampara

    Búzi, Sofala

  • Centro de Saude Bandua

    Búzi, Sofala

  • Dondo District, Community Setting

    Dondo, Sofala

  • Meconta District, Community Setting

    Meconta, Nampula

  • Mecuburi District, Community Setting

    Mecubúri, Nampula

  • Moma District, Community Setting

    Moma, Nampula

  • Monapo District, Community Setting

    Monapo, Nampula

  • Mossuril District, Community Setting

    Mossuril, Nampula

  • Centro de Saude Ontupaia

    Nacala, Nampula

  • Centro de Saude Quissinmanjulo

    Nacala, Nampula

  • Nacala Porto District, Community Setting

    Nacala, Nampula

  • Erati District, Community Setting

    Namapa-erati, Nampula

  • Centro de Saude Metuchira

    Nhamatanda, Sofala

  • Hospital Rural de Nhamatanda

    Nhamatanda, Sofala

  • Nhamatanda District, Community Setting

    Nhamatanda, Sofala

  • Centro de Saude Iapala Sede

    Ribáuè, Nampula

  • Hospital Rural de Ribaue

    Ribáuè, Nampula

  • Ribaue District, Community Setting

    Ribáuè, Nampula

Other trials in Mozambique

About this study

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.

Read the 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.

Being tested
Health promotion and provision of RMNCH services
Medical subject headings
Behavior, Sexism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health promotion and provision of RMNCH servicesBehavioural

    Implementation of quality, high-impact interventions at institutional and community levels to increase access to and utilization of RMNCH services

Study groups in NCT03774602
Study groupRoleWhat they receive
MCSP package of interventionsExperimentalMCSP package of interventions for health promotion and provision of RMNCH services
Receives: Behavioral: Health promotion and provision of RMNCH services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Institutional delivery rate

    Percentage of last-born children age 0-23 months who were born in a health facility

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. 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

    Measured: 2 years

Secondary outcomes (2)

  1. 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

    Measured: 2 years

  2. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2018
  2. Study start22 Nov 2018
  3. Primary completion22 Dec 2018
  4. Study completion22 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,767 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03774602
Sponsor's protocol ID
IRB 8902
Status last verified
Feb 2019
First submitted
11 Dec 2018
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Health promotion and provision of RMNCH services in people with Knowledge, Attitudes, Practice and Gender Issues, run by Jhpiego at 21 sites in Mozambique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Institutional delivery rate (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03774602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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