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Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa (Kharitode TB)

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ClinicalTrials.gov Identifier: NCT02808507
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Perinatal HIV Research Unit of the University of the Witswatersrand
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
The purpose of this study is to compare three strategies for finding TB cases in a rural Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2) Conducting household contact investigations of newly diagnosed TB cases; 3) Providing incentives to newly diagnosed TB cases and their contacts to promote contact screening for TB. For each intervention, investigators will measure comparative effectiveness in terms of cases identified as well as the cost-effectiveness and feasibility of implementation.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: Active TB case finding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Actual Study Start Date : July 18, 2016
Actual Primary Completion Date : January 17, 2018
Estimated Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Facility-based screening
This strategy will be implemented at all clinics (n=28) within this arm for 18 months. Study staff will encourage providers at each of the clinics to screen all consenting patients attending the clinic, regardless of the original reason for clinic presentation. Upon presenting for care (e.g., while waiting for their healthcare provider), patients will be informed about the study and screened for cough of any duration, fever, weight loss, or night sweats. Participants who are symptomatic and provide a sputum specimen (according to the clinic standard of care) will be given a study flyer informing them that they may be contacted by study staff, and a brief summary of the study. Per standard of care, all sputum samples will be sent to the local National Health Laboratory Service laboratory for Xpert testing.
Other: Active TB case finding
Active TB case finding (ACF) refers to any number of strategies used to identify individuals with active TB disease, outside of passive case finding. In passive case finding, individuals with symptoms present at health centers for diagnosis. In active case finding, the health system makes an effort to identify TB cases before they present passively.

Experimental: Contact screening

This arm is comprised of two sub-arms:

In the household contact screening sub-arm, a mobile field team visits the household of each consenting newly diagnosed pulmonary TB index case. Each visit consists of a household census, consent of all eligible household members for TB screening, administration of a brief questionnaire, sputum collection for testing with Xpert Mycobacterium tuberculosis (MTB)/rifampin (RIF) and the offer of HIV testing.

In the incentive-based contact screening sub-arm, all consenting newly diagnosed active TB cases are provided with 10 coupons for free TB screening to give to close contacts. When a contact presents at clinic with a coupon, they and the index case each receive a small amount of money. If the contact is diagnosed with active TB and starts treatment, the index case receives an additional larger amount of money. Each contact receives a brief questionnaire, TB symptom screen, optional HIV testing, and sputum sample collection for Xpert MTB/RIF.

Other: Active TB case finding
Active TB case finding (ACF) refers to any number of strategies used to identify individuals with active TB disease, outside of passive case finding. In passive case finding, individuals with symptoms present at health centers for diagnosis. In active case finding, the health system makes an effort to identify TB cases before they present passively.




Primary Outcome Measures :
  1. Number of TB cases started on TB treatment per cluster (clinic) [ Time Frame: 1.5 years ]
    The primary outcome measure for the analysis will be the number of TB cases in each cluster started on TB treatment. If necessary (i.e., if constrained randomization does not result in balanced groups in terms of pre-intervention patient volume), this number will be adjusted for the number of TB cases started on treatment in each cluster before the intervention was implemented.


Secondary Outcome Measures :
  1. Acceptability of active TB case-finding strategies [ Time Frame: 6 months ]
    The measure for this outcome will come from a series of in-depth interviews (IDIs) with key informants, including TB health care workers and patients and community members who comprise the target populations of interest, including: (1) index TB patients who would be given vouchers; (2) household members of TB patients; (3) community members of high-TB-incidence neighborhoods;(4) individuals presenting to study clinics for routine care; and (5) health care workers involved in TB service provision. Investigators plan to conduct up to 5 IDIs per each of these 5 subgroups for a total of 25 IDIs. Each semi-structured, in-depth interview will be approximately 45 minutes in length and will cover the following domains: individual experiences with TB symptoms prior to diagnosis, the TB diagnostic process, clinic experiences and quality of TB care, feasibility and acceptability of different methods of ACF in early case detection and perceived benefits.

  2. Reach of active TB case-finding strategies [ Time Frame: 3.5 years ]
    The primary outcome will be the proportion of potentially eligible individuals who accept TB screening under each ACF strategy.

  3. Comparative costs and cost-effectiveness of active TB case finding strategies [ Time Frame: 3.5 years ]
    The primary outcome for this analysis will be the incremental cost-effectiveness ratio, defined as (cost of ACF strategy 2 - cost of ACF strategy 1 [or no ACF])/(effectiveness of ACF strategy 2 - effectiveness of ACF strategy 1 [or no ACF]), where effectiveness is modeled as the number of disability-adjusted life years (DALYs) averted by the intervention.

  4. Representativeness of those screened in active TB case finding [ Time Frame: 3.5 years ]
    In each arm, investigators will examine predictors of accepting screening using logistic regression.

  5. Predictors of high reach [ Time Frame: 3.5 years ]
    Clinics will be define as though achieving high reach of ACF acceptance (>75% of eligible patients), and investigators will compare clinic-level factors to evaluate predictors of high reach.



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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Facility-based screening arm

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Attending any of the study 28 study clinics in the facility-based screening arm

Contact tracing arm- Index Case

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Newly diagnosed (last 2 months) with TB at any of the 28 study clinics in the contact tracing arm

Contact tracing arm- Household Contact

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Living in the same household as an enrolled Index case (see above)

Contact tracing arm- Non-household Close Contact

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Referred to the study as a close contact of an enrolled Index case (see above)

Exclusion Criteria (all arms):

  • Unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808507


Contacts
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Contact: David Dowdy, MD, PhD 410-614-5022 ddowdy1@jhmi.edu
Contact: Colleen Hanrahan, PhD 410-502-9289 chanrah1@jhu.edu

Locations
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South Africa
Vhembe health subdistrict Recruiting
Louis Trichardt, Limpopo, South Africa
Contact: Lesego Mmolawa    +27 73 732 2696    mmolawal@phru.co.za   
Waterberg health subdistrict Recruiting
Mokopane, Limpopo, South Africa
Contact: Lesego Mmolawa    +27 73 732 2696    mmolawal@phru.co.za   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Perinatal HIV Research Unit of the University of the Witswatersrand
Investigators
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Principal Investigator: David Dowdy, MD, PhD Johns Hopkins Bloomberg School of Public Health
  Study Documents (Full-Text)

Documents provided by Johns Hopkins Bloomberg School of Public Health: