Home-based Care and Hand Hygiene Interventions in Honduras

NCT04886414 | Completed

• 1 other identifier: 2021P001143
• Study Type: interventional
• Target: 1,821
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to enroll patients with acute infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) who do not meet criteria for hospital admission according to protocols developed by the Honduras Ministry of Health (MOH). Patients who are triaged to home must also be over the age of 60 years or have one high risk comorbidity and be over 45 years in order to meet inclusion criteria. These patients will be randomly assigned to one of four home-based care strategies, which may or may not include regular blood oxygenation monitoring and provision of alcohol-based hand-rub. Patients will be followed until resolution of their acute illness, and data will be collected on feasibility, impact and acceptance of the intervention. Some patients will be followed for up to one year to monitor for post-Coronavirus Disease 2019 (COVID-19) symptoms.

Conditions

Covid19

Keywords

Home-Based Care; Water, Sanitation and Hygiene; Alcohol-Based Hand Sanitizer; Triage; Post-Covid Syndrome; Community Health Workers

Outcome Measures

Primary Outcomes (4)

• Disposition after referral

  Disposition (home, admission, other) for those referred to a higher level of care

  28 days

• Duration of hospitalization

  Duration of hospitalization (days) for those who are admitted

  90 days

• Duration of ICU and/or ventilator requirement

  Duration of ICU and/or ventilator requirement (days) for those requiring critical care

  90 days

• Mortality

  Death prior to discharge from acute COVID-19 monitoring

  90 days

Other Outcomes (11)

• Proportion that receive the prescribed follow-up plan

  28 days

• Proportion with complete pulse oximetry data

  28 days

• Loss to follow-up

  90 days

Study Arms (4)

Phone-based monitoring without blood oxygenation monitoring with ABHS

EXPERIMENTAL

Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features will be documented on a phone-based patient monitoring form. Subjects will received a home-based care kit that contains alcohol-based hand sanitizer (ABHS).

Other: Phone-based monitoring; Other: Alcohol-based hand sanitizer

Phone-based monitoring without blood oxygenation monitoring without ABHS

EXPERIMENTAL

Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features will be documented on a phone-based patient monitoring form. Subjects will received a home-based care kit that does not contain alcohol-based hand sanitizer.

Other: Phone-based monitoring

Phone-based monitoring with blood oxygenation monitoring with ABHS

EXPERIMENTAL

Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features and oxygen saturation levels will be documented on a phone-based patient monitoring form. Oxygen saturation level will be assessed four times per day (morning, midday, evening, plus during the phone-based assessment) by the patient and/or family member and the lowest stable (i.e. without substantial fluctuations) level recorded during a monitoring period of one minute will be recorded and registered. Patient's will be provided monitoring sheets to record the times and dates of the oxygen saturation levels. Subjects will received a home-based care kit that contains alcohol-based hand sanitizer.

Other: Phone-based monitoring; Other: Oxygen saturation monitoring; Other: Alcohol-based hand sanitizer

Phone-based monitoring with blood oxygenation monitoring without ABHS

EXPERIMENTAL

Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features and oxygen saturation levels will be documented on a phone-based patient monitoring form. Oxygen saturation level will be assessed four times per day (morning, midday, evening, plus during the phone-based assessment) by the patient and/or family member and the lowest stable (i.e. without substantial fluctuations) level recorded during a monitoring period of one minute will be recorded and registered. Patient's will be provided monitoring sheets to record the times and dates of the oxygen saturation levels. Subjects will received a home-based care kit that does not contain alcohol-based hand sanitizer.

Other: Phone-based monitoring; Other: Oxygen saturation monitoring

Interventions

Phone-based monitoring OTHER

Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features will be documented on a phone-based patient monitoring form.

Phone-based monitoring with blood oxygenation monitoring with ABHS; Phone-based monitoring with blood oxygenation monitoring without ABHS; Phone-based monitoring without blood oxygenation monitoring with ABHS; Phone-based monitoring without blood oxygenation monitoring without ABHS

Oxygen saturation monitoring OTHER

Oxygen saturation will be monitored and recorded at regular intervals.

Phone-based monitoring with blood oxygenation monitoring with ABHS; Phone-based monitoring with blood oxygenation monitoring without ABHS

Alcohol-based hand sanitizer OTHER

Alcohol-based hand sanitizer will be distributed to subjects.

Phone-based monitoring with blood oxygenation monitoring with ABHS; Phone-based monitoring without blood oxygenation monitoring with ABHS

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with acute infection with SARS-CoV-2.
• Patients test positive for SARS-CoV-2 with rapid antigen test.
• Patients triaged to HBC by SESAL clinicians according to existing SESAL policies and protocols.
• Greater than 60 years of age OR greater than 45 years AND at least one comorbidity which increases risk for poor outcomes due to COVID-19.
• Live or work in the city where the study is being implemented
• Agrees to participate and signs informed consent

You may not qualify if:

• Less than 45 years of age
• Incapable of giving assent to participate due to medical condition at the time of enrollment

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Honduras: collaborator

Study Sites (1)

COVID-19 Triage Centers

Tegucigalpa, Francisco Morazán Department, Honduras

Location

Related Publications (1)

• Roberts KW, Alvarez B, de St Aubin M, Diaz O, Garnier S, Schnorr CD, Cruz S, Pavon L, Ochoa A, See R, Medice S, Santos HM, Ochoa J, Solis S, Dumas D, Baldwin M, Martinez A, Hakim A, Nilles E. Impact of self-administered pulse oximetry among non-hospitalized patients at risk of severe COVID-19 in Honduras: A pragmatic, cluster-randomized trial with temporal clustering. PLOS Glob Public Health. 2025 Nov 7;5(11):e0004618. doi: 10.1371/journal.pgph.0004618. eCollection 2025.

  PMID: 41202024 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be block randomized to one of four possible home-based care strategies.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: March 31, 2022
• Primary Completion: January 15, 2023
• Study Completion: February 28, 2023
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

HO (1)