Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
- Conditions
- Reproductive, Maternal, Newborn, and Child HealthIntegrated, Community-Health Systems
- Registration Number
- NCT03371186
- Lead Sponsor
- Possible
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 12000
- Reproductive aged women 15-49;
- Reproductive aged women 15-49; recently delivered in past two years;
- Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
- Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
- 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
- Must reside in either Achham or Dolakha District, Nepal.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Institutional Birth Rate 3 years The percentage of births in a healthcare facility with a healthcare professional present.
Under-Two Mortality Rate 3 years The 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 Rate 3 years The 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 Outcome Measures
Name Time Method Home Visit Coverage 3 months The 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 Fidelity 3 months The percentage of topics covered and completed out of total planned topics
Group Participation 3 months The percentage of participants completing group sessions out of total scheduled participants
Session Completion 3 months The percentage of group sessions completed out of total appropriate number of group sessions
Pediatric Stunting Prevalence 1 month The 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
First-Trimester Pregnancies Identified 3 months The percentage of pregnancies identified at less than 12 weeks
Antenatal Care Completion 3 months The 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 Diarrhea Incidence 1 month The number of new cases of diarrhea in catchment area in children under age of two/month
Total Intervention Cost 3 years The total sum costs of each intervention component
Cost-Effectiveness of Bundled Intervention 3 years The total sum costs of each intervention component over under-2 deaths averted by intervention
Pediatric Pneumonia Incidence 1 month The number of new cases of pneumonia in catchment area in children under age of two/month
Exclusive Breastfeeding Prevalence 1 month The 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 contraception 3 years The 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 Mix 3 months The percentage of women using each method of modern contraception out of total number of women using modern contraception
Trial Locations
- Locations (2)
Bayalpata Hospital
🇳🇵Sanfebagar, Achham, Nepal
Charikot Primary Health Center
🇳🇵Bhimeshwor, Dolakha, Nepal
Bayalpata Hospital🇳🇵Sanfebagar, Achham, NepalAradhana Thapa, MPHContactaradhana@possiblehealth.orgSantosh Dhungana, MD-GPContactsantosh@possiblehealth.orgDavid Citrin, PhD, MPHPrincipal Investigator