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Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03371186
Enrollment
12000
Registered
2017-12-13
Start date
2016-02-29
Completion date
2021-02-28
Last updated
2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Integrated, Community-Health Systems, Reproductive, Maternal, Newborn, and Child Health

Keywords

Implementation Research, Maternal Mortality and Morbidity, Neonatal Mortality and Morbidity, Infant Mortality and Morbidity, Child Mortality and Morbidity, Community Health Workers, Health Systems Strengthening

Brief summary

The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the golden 1000 days from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the golden 1000 days from conception to age two; and 5) Balanced counseling to increase post-partum contraception.

Interventions

OTHERCommunity Health Worker

The intervention is designed to address these primary drivers of underutilization of reproductive, maternal, newborn, and child health services in rural Nepal, namely: poverty, lack of social support, and poor birth planning. The investigators have worked with a cadre of Community Healthcare Workers who, in addition to the responsibilities of local community health volunteers, have added responsibilities, training, and managerial support. These women support their community members in their homes to identify and overcome social barriers and plan for emergency healthcare needs. The goals are to increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers

OTHERContinuous Surveillance

Each patient identified by a Community Health Worker will undergo a complete diagnostic evaluation by the hospital-based clinicians and will be enrolled in the study only if they are identified as currently pregnant, have recently given birth, or have a child under the age of 24 months. Continuous surveillance systems ensure that the entire population is surveyed every three months and has a three month touchpoint with a Community Health Worker.

OTHERCB-Integrated Management of Newborn and Childhood Illness

Safe delivery care; effective neonatal resuscitation; management of childhood diarrhea, malnutrition, and pneumonia; and treatment of traumatic and congenital surgical conditions can reduce child mortality. Community Based Integrated Management of Newborn and Child Illness (CB-IMNCI) has shown substantial reductions in neonatal and early child mortality. Community Health Workers will use CB-IMNCI as the clinical protocol for ongoing care to the community.

OTHERGroup Antenatal and Postnatal Care

The proposed model will change antenatal and pediatric care in three major ways: 1) conduct care in a group setting, 2) provide expert and facilitated peer counseling, and 3) incorporate emergency planning. The group setting is designed to create a supportive social network among women facing similar challenges. The opportunity for counseling beyond the current standard will promote detailed emergency planning and the sharing of context-specific advice from peers to overcome barriers to access care. This intervention draws on the strength within communities of women to change health-seeking behaviors.

OTHERBalanced Post-Partum Contraceptive Counseling

Research on interventions to improve postpartum contraception suggest strategies that bridge the continuum of reproductive health care-antenatal care, labor and delivery, postnatal care, and infant care-are more effective than short term, stand-alone counseling sessions. The structured counseling module incorporated in the intervention will be partially adapted from the Balanced Counseling Strategy, an interactive contraceptive counseling method developed by the Population Council in accordance with the World Health Organization's tiered effectiveness guidelines. Prior studies in clinical settings in Nepal have demonstrated increased uptake of modern contraceptive methods, especially of long-acting reversible contraceptives with use of balanced counseling.

Sponsors

United States Agency for International Development (USAID)
CollaboratorFED
National Institutes of Health (NIH)
CollaboratorNIH
Ministry of Health and Population, Nepal
CollaboratorOTHER_GOV
Planned Parenthood League of Massachusetts
CollaboratorOTHER
Possible
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped wedge, cluster-controlled implementation science trial

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

1. Reproductive aged women 15-49; 2. Reproductive aged women 15-49; recently delivered in past two years; 3. Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village 4. Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above); 5. Healthcare staff; CHWs serving village clusters, CHW Leaders serving one of the village clusters, Nyaya Health Nepal and Government of Nepal employees involved in study design, program implementation, data collection, or data analysis processes; and 6. Must reside in either Achham or Dolakha District, Nepal.

Exclusion criteria

Patients meeting inclusion criteria and consenting to study enrollment, as stated above, will be included in the study unless 1) patients migrate from the study are before completion of any of the bundled interventions; 2) patients request exclusion from the study at any point during the bundled intervention.

Design outcomes

Primary

MeasureTime frameDescription
Institutional Birth Rate3 yearsThe percentage of births in a healthcare facility with a healthcare professional present.
Under-Two Mortality Rate3 yearsThe under-2 mortality rate is the probability (expressed as a rate per 1,000 live births) of a child born in a specified year dying before reaching the age of two if subject to current age-specific mortality rates.
Post-Partum Contraceptive Prevalence Rate3 yearsThe post-partum contraceptive prevalence rate is number of married reproductive aged women (15-49) in the study population who delivered in the past two years who are using a modern contraceptive method out of the total number of married reproductive aged women (15-49) in the study population who delivered in the past two years.

Secondary

MeasureTime frameDescription
Home Visit Coverage3 monthsThe percentage of children under 2 receiving monthly home based care by a CHW out of total number of children under 2 (aggregated by the percentage of pregnant women and reproductive-aged women).
Group Care Content Fidelity3 monthsThe percentage of topics covered and completed out of total planned topics
Group Participation3 monthsThe percentage of participants completing group sessions out of total scheduled participants
Session Completion3 monthsThe percentage of group sessions completed out of total appropriate number of group sessions
First-Trimester Pregnancies Identified3 monthsThe percentage of pregnancies identified at less than 12 weeks
Antenatal Care Completion3 monthsThe percentage of women who have had 4 or more antenatal care visits and are eligible for the government financial incentive out of total number of women delivered
Pediatric Pneumonia Incidence1 monthThe number of new cases of pneumonia in catchment area in children under age of two/month
Pediatric Diarrhea Incidence1 monthThe number of new cases of diarrhea in catchment area in children under age of two/month
Pediatric Stunting Prevalence1 monthThe number of cases children in catchment area under age of two whose length-for height or height-for-age is two SDs below WHO Child Growth Standards median/total number of children in catchment area under age of two
Exclusive Breastfeeding Prevalence1 monthThe number of infants in catchment area age zero-five months who are exclusively breastfed/total infants in catchment area age zero-five months
Percent of postpartum women with unmet need for contraception3 yearsThe number of reproductive age women within the first year following the birth of their most recent child who desire to either stop or postpone childbearing for the next 2 years who are not currently using a contraceptive method or have a repeat unintended pregnancy while not using contraception/Total number of women who are up to one year postpartum, excluding women who declare that they are infecund, have had a hysterectomy, or are in menopause
Contraceptive Method Mix3 monthsThe percentage of women using each method of modern contraception out of total number of women using modern contraception
Total Intervention Cost3 yearsThe total sum costs of each intervention component
Cost-Effectiveness of Bundled Intervention3 yearsThe total sum costs of each intervention component over under-2 deaths averted by intervention

Countries

Nepal

Contacts

Primary ContactDuncan Maru, MD, PhD
duncan@possiblehealth.org
Backup ContactScott Halliday, MS
scott@possiblehealth.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026