Chepetsa TB - Reducing TB Among HIV-Infected Malawians

NCT01450085 | Completed DMC

• 1 other identifier: 1R01AI093316-01A1
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

The specific aims of this project are: (1) to compare the impact of using the routine screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a "disruptive technology"10 that could allow TB/HIV programs in resource-limited settings to leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key barrier to scale up of ICF and IPT.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Survival of newly-diagnosed HIV-infected patients at 1 year

  4 years

Study Arms (2)

GeneXpert

ACTIVE COMPARATOR

Point of care GeneXpert

Other: GeneXpert; Other: LED Microscopy

LED Microscopy

ACTIVE COMPARATOR

Point of care LED Microscopy

Other: LED Microscopy

Interventions

GeneXpert OTHER

Point of care GeneXpert

GeneXpert

LED Microscopy OTHER

Point of care LED Microscopy

GeneXpert; LED Microscopy

Eligibility Criteria

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

You may qualify if:

• All HIV-infected men and women \> 18 years of age with newly diagnosed HIV at the 12 study clinics will be asked to participate in the study.

You may not qualify if:

• Patients will be excluded from participation if they have a current diagnosis of TB and/or if they are currently taking IPT, TB treatment and/or ART.
• Patients will also be excluded from participation if they cannot speak English or Chichewa;
• if they have a language or hearing impairment; or
• if they are prisoners.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Unknown Facility

Blantyre, Thyolo District, Malawi

Location

Unknown Facility

Blantyre, Malawi

Location

Related Publications (2)

• Ngwira LG, Corbett EL, Khundi M, Barnes GL, Nkhoma A, Murowa M, Cohn S, Moulton LH, Chaisson RE, Dowdy DW. Screening for Tuberculosis With Xpert MTB/RIF Assay Versus Fluorescent Microscopy Among Adults Newly Diagnosed With Human Immunodeficiency Virus in Rural Malawi: A Cluster Randomized Trial (Chepetsa). Clin Infect Dis. 2019 Mar 19;68(7):1176-1183. doi: 10.1093/cid/ciy590.

  PMID: 30059995 DERIVED

• Ngwira LG, Dowdy DW, Khundi M, Barnes GL, Nkhoma A, Choko AT, Murowa M, Chaisson RE, Corbett EL, Fielding K. Delay in seeking care for tuberculosis symptoms among adults newly diagnosed with HIV in rural Malawi. Int J Tuberc Lung Dis. 2018 Mar 1;22(3):280-286. doi: 10.5588/ijtld.17.0539.

  PMID: 29471905 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

• Elizabeth Corbett, MD

  Malawi Liverpool Wellcome Trust

  PRINCIPAL INVESTIGATOR

• David Dowdy, MD. PhD

  Johns Hopkins Unviversity

  STUDY DIRECTOR

• Lawrence Moulton, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 30, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

MA (2)