Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand

NCT02073240 | Completed DMC

• 1 other identifier: CDC-DTBE-6498
• Study Type: observational
• Target: 22
• Locations: 2 countries
• Sites: 22

Brief Summary

Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated. Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention. Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).

Conditions

Tuberculosis

Keywords

Tuberculosis; Infection Control

Outcome Measures

Primary Outcomes (1)

• Change in prevalence and incidence of latent Tuberculosis infection in healthcare workers

  Measured by an interferon gamma release assay, QuantiFERON-TB Gold In-Tube

  0 months, 12 months, 24 months

Secondary Outcomes (2)

• Change in institutional safety culture

  0 months and 24 months

• Adherence to recommended TB Infection Control practices

  0 months, 6 months, 12 months, 18 months, 24 months

Other Outcomes (1)

• Cost data

  0 months, 6 months, 12 months, 18 months, 24 months

Study Arms (2)

Enhanced TB IC Package

Facilities randomized to the intervention group will receive the following: 1. Skills-based training for TB IC focal points 2. Audits and Feedback of performance data 3. TB IC collaborative (including mentoring) 4. Checklists

Behavioral: Enhanced TB IC Package

Usual Care Group

Usual Care group will receive available TB IC training/education alone.

Interventions

Enhanced TB IC Package BEHAVIORAL

Facilities randomized to the intervention group will receive: 1. Skills-based training addressing the hierarchy of TB IC measures, how to conduct a facility TB IC /risk assessment; and development, implementation, and monitoring of an operational TB IC plan for the facility 2. Audits and Feedback of performance 3. A TB IC collaborative membership 4. A standardized unit-level daily checklist of critical IC activities

Enhanced TB IC Package

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will be conducted at 22 hospitals, 10 in Thailand and 12 in Vietnam. The study facilities will be hospitals that typically provide care to patients with confirmed or suspected TB, namely TB or general hospitals.

You may qualify if:

• General provincial or regional hospital of at least 300 beds OR
• TB or Respiratory hospitals of at least 100 beds
• Geographic location that allows for ground transport of blood specimens to a designated reference laboratory within 16 hours of blood draw
• Hospital director is willing to commit staff time to study participation, including designating personnel to oversee TB IC and EnTIC study activities, as evidenced by a letter of support for the study

You may not qualify if:

• Specialty hospitals (such as, pediatric, infectious diseases, maternity)
• Recent (within the past 3 years) or current participation in a TB IC initiative

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• United States President's Emergency Plan for AIDS Relief: collaborator

Study Sites (22)

Buddhasothorn Hospital

Maruphong, Cha Cherng Sao, Thailand

Location

Chaiyaphum Hosptial

Nai Mueang, Changwat Chaiyaphum, 36000, Thailand

Location

Nakhon Nayok Hospital

Mueang Nakhonnayok, Changwat Nakhon Nayok, 26000, Thailand

Location

Nan Hospital

Nai Wiang, Mueang Nan, Changwat Nan, 55000, Thailand

Location

Chao Phraya Abhaibhubejhr Hosptial

Mueang Prachinburi, Changwat Prachin Buri, 25000, Thailand

Location

Banpong Hospital

Ban Pong, Changwat Ratchaburi, 70110, Thailand

Location

Singburi Hospital

Mueang Singburi, Changwat Sing Buri, 16000, Thailand

Location

Chumponkhetudomsak Hospital

Mueang, Chumpon, Thailand

Location

Pichit Hospital

Nai Mueang, Pichit, 66000, Thailand

Location

Praputtabat Hosptial

Changwat Sara Buri, Praputtabat, Thailand

Location

Hai Duong TB Hospital

Hải Dương, Hai Duong, Vietnam

Location

Binh Phuoc General Hospital

Bình Phước, Vietnam

Location

Dong Thap TB Hospial

Dong Thập, Vietnam

Location

Hoa Binh General Hospital

Hòa Bình, Vietnam

Location

Hung Yen Provincial Hospital

Hưng Yên, Vietnam

Location

Long An General Hospital

Long An, Vietnam

Location

Nam Dinh General Hospital

Nam Định, Vietnam

Location

Quang Ninh TB Hospital

Quang Ninh, Vietnam

Location

Tien Giang General Hospital

Tiền Giang, Vietnam

Location

Vinh Long General Hosptial

Vĩnh Long, Vietnam

Location

Vinh Phuc General Hospital

Vĩnh Phúc, Vietnam

Location

Dong Nai TB Hospital

Đông Nãi, Vietnam

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Michele L Pearson, MD

  Centers for Disease Control and Prevention, Center for Global Health, Division of Global HIV and TB

  PRINCIPAL INVESTIGATOR

• Sara J Whitehead, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 27, 2014
• Study Start: February 17, 2014
• Primary Completion: November 18, 2016
• Study Completion: November 18, 2016
• Last Updated: February 2, 2021

Record last verified: 2020-12

Locations

VN (12); TH (10)