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

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.

Study Overview

• Status: Unknown
• Conditions: Reproductive, Maternal, Newborn, and Child Health; Integrated, Community-Health Systems
• Intervention / Treatment: Other: Community Health Worker; Other: Continuous Surveillance; Other: CB-Integrated Management of Newborn and Childhood Illness; Other: Group Antenatal and Postnatal Care; Other: Balanced Post-Partum Contraceptive Counseling

• Study Type: Interventional
• Enrollment (Anticipated): 12000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duncan Maru, MD, PhD; Email: duncan@possiblehealth.org
• Study Contact Backup: Name: Scott Halliday, MS; Email: scott@possiblehealth.org

Study Locations

• Nepal
  • Achham
    • Sanfebagar, Achham, Nepal
      • Recruiting
      • Bayalpata Hospital
      • Contact: Aradhana Thapa, MPH; Email: aradhana@possiblehealth.org
      • Principal Investigator: David Citrin, PhD, MPH
      • Contact: Santosh Dhungana, MD-GP; Email: santosh@possiblehealth.org
  • Dolakha
    • Bhimeshwor, Dolakha, Nepal
      • Recruiting
      • Charikot Primary Health Center
      • Contact: Aradhana Thapa, MPH; Email: aradhana@possiblehealth.org
      • Principal Investigator: David Citrin, PhD, MPH
      • Contact: Binod Dangal, MD-GP; Email: binod@possiblehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 47 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bundled RMNCH Intervention; Stepped wedge, cluster-controlled implementation science trial of 5 bundled intervention components (1. Community Health Worker, 2, Continuous Surveillance, 3. CB-Integrated Management of Newborn and Childhood Illness, 4. Group Antenatal and Postnatal Care, and 5. Balanced Post-Partum Contraceptive Counseling) implemented across 40 village clusters in Achham District, Nepal and 40 village clusters in Dolakha District, Nepal (covering a total population of approximately 300,000) in coordination with district authorities and study staff. The investigators anticipate the experimental arm will enroll approximately 12,000 women and their children over the 18mo enrollment period.

Other: Community 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; Other: Continuous 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.; Other: CB-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.; Other: Group 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.; Other: Balanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Institutional Birth Rate	The percentage of births in a healthcare facility with a healthcare professional present.	3 years
Under-Two Mortality Rate	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.	3 years
Post-Partum Contraceptive Prevalence Rate	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Visit Coverage	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).	3 months
Group Care Content Fidelity	The percentage of topics covered and completed out of total planned topics	3 months
Group Participation	The percentage of participants completing group sessions out of total scheduled participants	3 months
Session Completion	The percentage of group sessions completed out of total appropriate number of group sessions	3 months
First-Trimester Pregnancies Identified	The percentage of pregnancies identified at less than 12 weeks	3 months
Antenatal Care Completion	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	3 months
Pediatric Pneumonia Incidence	The number of new cases of pneumonia in catchment area in children under age of two/month	1 month
Pediatric Diarrhea Incidence	The number of new cases of diarrhea in catchment area in children under age of two/month	1 month
Pediatric Stunting Prevalence	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	1 month
Exclusive Breastfeeding Prevalence	The number of infants in catchment area age zero-five months who are exclusively breastfed/total infants in catchment area age zero-five months	1 month
Percent of postpartum women with unmet need for contraception	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	3 years
Contraceptive Method Mix	The percentage of women using each method of modern contraception out of total number of women using modern contraception	3 months
Total Intervention Cost	The total sum costs of each intervention component	3 years
Cost-Effectiveness of Bundled Intervention	The total sum costs of each intervention component over under-2 deaths averted by intervention	3 years

Collaborators and Investigators

• Sponsor: Possible
• Collaborators: Planned Parenthood League of Massachusetts; National Institutes of Health (NIH); United States Agency for International Development (USAID); Ministry of Health and Population, Nepal
• Investigators: Principal Investigator: Sheela Maru, MD, MPH, Possible; Principal Investigator: Pushpa Chaudhari, MD, Ministry of Health and Population, Nepal

Publications and helpful links

General Publications

• Maru S, Nirola I, Thapa A, Thapa P, Kunwar L, Wu WJ, Halliday S, Citrin D, Schwarz R, Basnett I, Kc N, Karki K, Chaudhari P, Maru D. An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol. Implement Sci. 2018 Mar 29;13(1):53. doi: 10.1186/s13012-018-0741-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Implementation Research; Health Systems Strengthening; Community Health Workers; Maternal Mortality and Morbidity; Neonatal Mortality and Morbidity; Infant Mortality and Morbidity; Child Mortality and Morbidity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: RMNCHnyaya; 1DP5OD019894-01 (U.S. NIH Grant/Contract); AID-OAA-A-11-0001 (Other Grant/Funding Number: United States Agency for International Development)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No