Kharitode TB: Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Study Details
Study Description
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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- Number of TB cases started on TB treatment per cluster (clinic) [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
- Acceptability of active TB case-finding strategies [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.
- Reach of active TB case-finding strategies [3.5 years]
The primary outcome will be the proportion of potentially eligible individuals who accept TB screening under each ACF strategy.
- Comparative costs and cost-effectiveness of active TB case finding strategies [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.
- Representativeness of those screened in active TB case finding [3.5 years]
In each arm, investigators will examine predictors of accepting screening using logistic regression.
- Predictors of high reach [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Facility-based screening arm
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Age 0-99 years
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Informed consent provided (or assent plus parent/guardian consent)
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Attending any of the study 28 study clinics in the facility-based screening arm
Contact tracing arm- Index Case
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Age 0-99 years
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Informed consent provided (or assent plus parent/guardian consent)
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Newly diagnosed (last 2 months) with TB at any of the 28 study clinics in the contact tracing arm
Contact tracing arm- Household Contact
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Age 0-99 years
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Informed consent provided (or assent plus parent/guardian consent)
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Living in the same household as an enrolled Index case (see above)
Contact tracing arm- Non-household Close Contact
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Age 0-99 years
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Informed consent provided (or assent plus parent/guardian consent)
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Referred to the study as a close contact of an enrolled Index case (see above)
Exclusion Criteria (all arms):
- Unable to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vhembe health subdistrict | Louis Trichardt | Limpopo | South Africa | |
| 2 | Waterberg health subdistrict | Mokopane | Limpopo | South Africa |
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
- Principal Investigator: David Dowdy, MD, PhD, Johns Hopkins Bloomberg School of Public Health
Study Documents (Full-Text)
More Information
Publications
None provided.- 15-0005
- R01AI116787-02