Effect of Community Mobile Outreach Approach Compared to Facility Based Directly Observed Treatment Short Course on Treatment Outcome Among Tuberculosis Patients in Jeddah: A Randomized Controlled Trial

NCT03787914 | Completed DMC

• 1 other identifier: H-02-J-002-00877
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among tuberculosis patients with those being treated with facility based directly observed treatment short course (DOTS) in Jeddah region.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Treatment Success rate

  6 to 8 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention arm patients were served by outreach mobile teams for oral anti-TB treatment under DOTS at the place of their convenience by health care professionals

Procedure: Mobile Outreach Approach

Control arm

ACTIVE COMPARATOR

Control arm patients were given the traditional facility based DOTS treatment. Control arm was not served by the outreach mobile teams.

Procedure: Mobile Outreach Approach

Interventions

Mobile Outreach Approach PROCEDURE

TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision

Control arm; Intervention arm

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed TB cases

You may not qualify if:

• Visitors having TB especially pilgrims

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Study Sites (1)

Ministry of Health

Jeddah, Mecca Region, 21577, Saudi Arabia

Location

Related Publications (1)

• Al-Sahafi A, Al-Sayali MM, Mandoura N, Shah HBU, Al Sharif K, Almohammadi EL, Abdul-Rashid OA, Assiri M, Buksh MF, Alali MM, Al-Garni A, Al-Garni F, Al-Zahrani A, Khalawi A, Alawi M, Moawwad AL, Almalki AIA, Al-Osaimi MM. Treatment outcomes among tuberculosis patients in Jeddah, Saudi Arabia: Results of a community mobile outreach directly observed Treatment, Short-course (DOTS) project, compared to a standard facility-based DOTS: A randomized controlled trial. J Clin Tuberc Other Mycobact Dis. 2020 Dec 31;22:100210. doi: 10.1016/j.jctube.2020.100210. eCollection 2021 Feb.

  PMID: 33490640 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdullah AlSahafi, MBBS, SBFM

  Director of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Specialist

Model Details: The investigators conducted a two-arm, parallel design\[1:1\], single blind randomized control trial in 200 newly diagnosed TB patients

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: December 26, 2018
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)