Intervention Zambia Rural L&D Infection Study

NCT ID: NCT03809741

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2019-09-16

Brief Summary

This is the intervention phase of a study to investigate the impact of low-cost bundled interventions on improving the infection control practices in the labor and delivery units in rural healthcare settings in Zambia. A baseline observational phase of the health care providers' infection control procedures was done. In this intervention phase, low-cost bundle of interventions, including health care provider education, behavior feedback, visual and Short Message Service (SMS)/text message reminders, and provision of alcoholic hand rubs, will be implemented at 5 study sites. 12 weeks after the initiation of interventions, endline data will be collected. The data from endline after interventions will be compared with baseline data from observational phase to detect changes in infection control practices at each study site after the interventions.

Detailed Description

The total duration of the intervention phase is estimated to be 4 months. During this time, the investigators will collaborate with the healthcare workers (HCWs) at each study site and the district pharmacist.

The study team will visit each site separately and administer the training modules on-site during the first month of the research until all of the modules have been completed for all of the Labor and Delivery (L&D) staff, which usually consist of about 2-3 people. A quiz will be administered before and after the training session to assess change in knowledge after the training.

SMS reminders will be sent every weekday to promote best infection control practices in the L&D. Posters will also be posted for visual reminders of best practices around the health center.

After the initial training, each health centers will be visited twice a month by a study team member to assess alcohol rubs (AHR) stock, gather feedback and comments, and evaluate postpartum maternal and neonatal infectious complications and hospital outcomes. Infection and outcome data will be shared with each site monthly. About 2 months after initial training, a refresher education and training course will be held at each study site. A quiz will be administered before and after the refresher course to assess knowledge.

The investigators will collaborate with the district pharmacy for production and distribution of AHR. The pharmacists will receive training on how to combine and mix the hand rub components per WHO guidelines, and test batches will be made prior to distribution to study sites to ensure familiarity of the pharmacy staff with its production. Quality control with an alcoholmeter will be performed with the alcohol ingredient and with the finished product, as per World Health Organization (WHO) recommendation. Afterwards, the head pharmacist will be consulted biweekly by study team member to document AHR production, budget, distribution, and any other issues.

Endline data collection will occur 12 weeks after initiation of intervention implementation. During data collection period, a study team member will meet with a L&D floor administrator in a private setting at a time convenient to the administrator to go through the questionnaire portion of the ICAT together.

Eligible pregnant women will primarily be recruited and consented outside the facility in the waiting area where they congregate prior to admission for delivery. Women who are consented will be given a "consent card" in addition to a copy of the consent form. This card will state that they have previously consented to the study, and can then be presented once they are admitted for delivery. A member of the research team will accompany the primary care provider during their provision of care and patient contact during first, second, and third stages of labor to observe, assess and document infection control behaviors and practices by the providers, using the ICAT.

A retrospective review of the logbook will be done to assess for rates of postpartum maternal and neonatal infectious complication and outcomes for participants.

During the endline data collection, an anonymous, self-administered survey will be administered to the study site HCWs to assess the knowledge, attitudes and practices of the study site HCWs towards the implemented study interventions.

Conditions

Postpartum Infection; Neonatal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Preventing L&D Infections

Low-cost bundled L\&D infection prevention interventions will be implemented, including education, visual reminders, feedback, and alcoholic hand rub supply. Infection control practices and child delivery outcomes will be assessed after implementation of these interventions.

Group Type: EXPERIMENTAL

Bundled L&D Infection Prevention Interventions

Intervention Type: OTHER

The following bundle of infection prevention interventions will be implemented at each study site for 12 weeks:

Education: 2 day module of Infection Prevention and Control (IPC) training and education at the beginning of the period, with specific information pertaining to labor and delivery. A refresher course will be administered at week 6.

Feedback: Monthly feedback sessions detailing IPC practices

Reminders: Visual poster reminders on hand hygiene and daily SMS reminders on best practices for peripartum and postnatal care.

Alcohol Hand Rub (AHR) supply: Provision of AHR, produced by WHO standards and guides in collaboration with district pharmacy

Interventions

Bundled L&D Infection Prevention Interventions

The following bundle of infection prevention interventions will be implemented at each study site for 12 weeks:

Education: 2 day module of Infection Prevention and Control (IPC) training and education at the beginning of the period, with specific information pertaining to labor and delivery. A refresher course will be administered at week 6.

Feedback: Monthly feedback sessions detailing IPC practices

Reminders: Visual poster reminders on hand hygiene and daily SMS reminders on best practices for peripartum and postnatal care.

Alcohol Hand Rub (AHR) supply: Provision of AHR, produced by WHO standards and guides in collaboration with district pharmacy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women of age > 15 in early first stage of labor (cervical dilation ≤ 6cm) at the study sites during the study period
• If woman is 15 to 17 must have a guardian present
• Planned vaginal delivery
• Any healthcare workers providing direct patient care to women delivering at the study sites during study period

• Women who delivered their baby at the study sites during the study period
• Newborns who were born at the study sites during the study period

Exclusion Criteria

• Any eligible woman who presents past the early first stage of labor (cervical dilation > 6cm)
• Woman under 18 years old without a guardian present

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Right to Care

OTHER

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davison Hamer, MD

Role: STUDY_DIRECTOR

Boston University School of Public Health, Center for Global Health

Locations

Mangunza Rural Health Facility

Choma, Southern Province, Zambia

Masuku Mission Rural Health Facility

Choma, Southern Province, Zambia

Mbabala Rural Health Facility

Choma, Southern Province, Zambia

Mochipapa Rural Health Facility

Choma, Southern Province, Zambia

Simakutu Rural Health Facility

Choma, Southern Province, Zambia

Countries

Zambia

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

H-38261

Identifier Type: -

Identifier Source: org_study_id