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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Active TB case finding

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02808507

R01AI116787-02 (U.S. NIH Grant/Contract)

15-0005

Details and patient eligibility

About

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.

Enrollment: 4,852 patients

Sex: All

Ages: Under 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,852 participants in 2 patient groups

Facility-based screening

Experimental group

Description:

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.

Treatment:

Other: Active TB case finding

Contact screening

Experimental group

Description:

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.

Treatment:

Other: Active TB case finding