Project to Use Community Health Workers to Reduce Maternal Deaths

Study Overview
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Brief Summary
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The purpose of this trial is to establish if several interventions will help women in rural Tanzania access health care services during pregnancy and at the time of delivery. The interventions include education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and supplies to be used either at the health facility, or on route if the women does not make it to the health facility.

Detailed Description
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In order to reduce the number of women dying in childbirth and to improve women's health in pregnancy, this trial is designed to assess if several interventions combined can increase the number of women delivering in health care facilities. The design of the study is Multiple Baseline Design. Community health workers are trained to collect baseline data on women using mobile phones in one rural district in Tanzania. The district has four distinct divisions. After 6 months of baseline data in the district, one division will experience the interventions. The interventions are education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and birthing supplies to be used either at the health facility, or on route if the women does not make it to the health facility. The intervention will be begun in each of the other divisions in 3 month intervals (i.e. the second division starts to experience the interventions 3 months after the first, the third, 3 months after the second and the fourth 3 months after the third). The trial will continue for a total of 27 months including the baseline period.

Official Title
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Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania

Conditions
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Maternal Mortality, Access to Health Care

Intervention / Treatment
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* Behavioral: Village meeting and travel vouchers
* Device: Birth kit with misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women must be pregnant. Women must live in Rorya District, but not in Shirati Town. Women must deliver in Rorya District . Exclusion Criteria: Women who live outside or deliver outside of Rorya District. Women who deliver preterm, before they have exposure to all the interventions.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Division 1<br>The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial. Interventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage). | Behavioral: Village meeting and travel vouchers<br>* The interventions are: Village meetings by community health workers to educate women and their families about safe birthing. Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.<br>Device: Birth kit with misoprostol<br>* Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).<br>|
| Experimental: Division 2<br>The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial. Interventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage). | Behavioral: Village meeting and travel vouchers<br>* The interventions are: Village meetings by community health workers to educate women and their families about safe birthing. Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.<br>Device: Birth kit with misoprostol<br>* Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).<br>|
| Experimental: Division 3<br>The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial. Interventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage). | Behavioral: Village meeting and travel vouchers<br>* The interventions are: Village meetings by community health workers to educate women and their families about safe birthing. Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.<br>Device: Birth kit with misoprostol<br>* Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).<br>|
| Experimental: Division 4<br>The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial. nterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery. Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage). | Behavioral: Village meeting and travel vouchers<br>* The interventions are: Village meetings by community health workers to educate women and their families about safe birthing. Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.<br>Device: Birth kit with misoprostol<br>* Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facility births | Number of women attending health facilities for delivery | During baseline vs during intervention periods until end of study (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antenatal Care visits | Number of times women attend health facility for antenatal visits | During baseline vs during intervention until end of study (2 years) | 
| Postpartum visits | Number of women attending health facility for postpartum visits | During baseline vs during intervention until end of study (2 years) | 
| Use of transport intervention | Number of women using the free transport intervention | During Intervention until end of study (2 years) | 
| Use of birth kit | Number of women using the birth kit | During Intervention until end of study (2 years) |