Trial Outcomes & Findings for Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa (NCT NCT02808507)
NCT ID: NCT02808507
Last Updated: 2024-09-05
Results Overview
The primary analysis was based on the facility- level rate ratio, and we first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% confidence interval (CI). We then adjusted for any residual confounding by district stratification and the historical annual number of people started on TB following a two-stage approach. The first step of this approach fits a Poisson regression to the facility-level counts and the district and historical volume covariates irrespective of study arm. The residuals ratios, calculated as the ratio of the observed over the expected counts, are then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.
COMPLETED
NA
4852 participants
18 months
2024-09-05
Participant Flow
Participant milestones
| Measure |
Facility-based Screening Arm
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 our 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.
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Contact Tracing Household-based Sub-arm
This strategy will be implemented for 18 months at half of the clinics within the contact tracing arm (n=14) and, after a six-month washout period, for 18 months in the other half of the clinics in that arm (n = 14). All adults (and guardians for children) with newly diagnosed pulmonary TB will be approached for enrolment as described above. Consenting patients (estimated as 1,575 subjects) will be asked for a home address (with landmarks), mobile phone number, and convenient time for a household visit. A mobile field team consisting of a nurse and lay health worker (both research staff) will circulate between the 14 primary care clinics, with notifications of all new TB cases made from the clinic to the team by mobile phone. The field team will visit the household of each consenting index case within two weeks of notification; each visit will consist of a household census (including demographic data), consent of all eligible household members for questioning and TB screening, administration of a brief questionnaire (including symptomatology, self-reported HIV and TB history, care-seeking behavior, and acceptability of the intervention), and sputum collection for testing with Xpert MTB/RIF. Each participant will also be offered voluntary HIV counselling and testing. The team will make up to three visits to each household as needed in order to approach all household contacts for study enrolment.
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Contact Tracing Incentive-based Sub-arm
This strategy will be implemented in the opposite half of the clinics randomized to contact investigation. All adults (and guardians of children) with newly diagnosed active TB will be identified and approached for enrolment as described above. However, rather than a household visit, each consenting individual will be provided with a set of 10 coupons to give to household members and close contacts whom the index case believes may be at greatest risk. These coupons will contain instructions on how to come to the clinic for free TB screening (e.g., when the study team will be at each clinic), and will have an expiration date of 2 months from the time of initial TB diagnosis. When a contact presents at the clinic with the coupon, the contact will receive a small amount of money and a transport allowance based on the distance travelled to the clinic. If the contact is diagnosed with active TB and starts treatment, the contact will receive an additional larger amount of money. Study staff will document which index case the contact is linked to, and whether the contact is diagnosed with active TB. At the end of the 2 month period in which the coupons are valid the index will receive a grocery voucher for the total incentive earned (e.g., total amount for contact(s) who presented for screening + total amount for contact(s) diagnosed with active TB and starting treatment).
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|---|---|---|---|
|
Overall Study
STARTED
|
1929
|
1413
|
1510
|
|
Overall Study
COMPLETED
|
1929
|
1413
|
1510
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Facility-based Screening Arm
n=1929 Participants
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 our 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.
|
Contact Tracing Household-based Sub-arm
n=1413 Participants
This strategy will be implemented for 18 months at half of the clinics within the contact tracing arm (n=14) and, after a six-month washout period, for 18 months in the other half of the clinics in that arm (n = 14). All adults (and guardians for children) with newly diagnosed pulmonary TB will be approached for enrolment as described above. Consenting patients (estimated as 1,575 subjects) will be asked for a home address (with landmarks), mobile phone number, and convenient time for a household visit. A mobile field team consisting of a nurse and lay health worker (both research staff) will circulate between the 14 primary care clinics, with notifications of all new TB cases made from the clinic to the team by mobile phone. The field team will visit the household of each consenting index case within two weeks of notification; each visit will consist of a household census (including demographic data), consent of all eligible household members for questioning and TB screening, administration of a brief questionnaire (including symptomatology, self-reported HIV and TB history, care-seeking behavior, and acceptability of the intervention), and sputum collection for testing with Xpert MTB/RIF. Each participant will also be offered voluntary HIV counselling and testing. The team will make up to three visits to each household as needed in order to approach all household contacts for study enrolment.
|
Contact Tracing Incentive-based Sub-arm
n=1510 Participants
This strategy will be implemented in the opposite half of the clinics randomized to contact investigation. All adults (and guardians of children) with newly diagnosed active TB will be identified and approached for enrolment as described above. However, rather than a household visit, each consenting individual will be provided with a set of 10 coupons to give to household members and close contacts whom the index case believes may be at greatest risk. These coupons will contain instructions on how to come to the clinic for free TB screening (e.g., when the study team will be at each clinic), and will have an expiration date of 2 months from the time of initial TB diagnosis. When a contact presents at the clinic with the coupon, the contact will receive a small amount of money and a transport allowance based on the distance travelled to the clinic. If the contact is diagnosed with active TB and starts treatment, the contact will receive an additional larger amount of money. Study staff will document which index case the contact is linked to, and whether the contact is diagnosed with active TB. At the end of the 2 month period in which the coupons are valid the index will receive a grocery voucher for the total incentive earned (e.g., total amount for contact(s) who presented for screening + total amount for contact(s) diagnosed with active TB and starting treatment).
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Total
n=4852 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Customized
Age
|
38 years
n=1929 Participants
|
39 years
n=1413 Participants
|
38 years
n=1510 Participants
|
38 years
n=4852 Participants
|
|
Sex: Female, Male
Female
|
794 Participants
n=1929 Participants
|
582 Participants
n=1413 Participants
|
630 Participants
n=1510 Participants
|
2006 Participants
n=4852 Participants
|
|
Sex: Female, Male
Male
|
1135 Participants
n=1929 Participants
|
831 Participants
n=1413 Participants
|
880 Participants
n=1510 Participants
|
2846 Participants
n=4852 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
1929 participants
n=1929 Participants
|
1413 participants
n=1413 Participants
|
1510 participants
n=1510 Participants
|
4852 participants
n=4852 Participants
|
|
HIV status
HIV positive
|
1161 Participants
n=1929 Participants
|
797 Participants
n=1413 Participants
|
902 Participants
n=1510 Participants
|
2860 Participants
n=4852 Participants
|
|
HIV status
HIV negative
|
562 Participants
n=1929 Participants
|
340 Participants
n=1413 Participants
|
373 Participants
n=1510 Participants
|
1275 Participants
n=4852 Participants
|
|
HIV status
HIV status unknown
|
205 Participants
n=1929 Participants
|
274 Participants
n=1413 Participants
|
235 Participants
n=1510 Participants
|
714 Participants
n=4852 Participants
|
|
HIV status
HIV status missing
|
1 Participants
n=1929 Participants
|
2 Participants
n=1413 Participants
|
0 Participants
n=1510 Participants
|
3 Participants
n=4852 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The population for this outcome consists of a sub-group of the total study population (those enrolled during the intervention period of July 18,2015 - January 17, 2018). All participants from the facility-based screening arm are included (n=1929), and the participants of the contact screening arm (n=1726) are included (this is a combination from the household-based and incentive-based screening arms).
The primary analysis was based on the facility- level rate ratio, and we first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% confidence interval (CI). We then adjusted for any residual confounding by district stratification and the historical annual number of people started on TB following a two-stage approach. The first step of this approach fits a Poisson regression to the facility-level counts and the district and historical volume covariates irrespective of study arm. The residuals ratios, calculated as the ratio of the observed over the expected counts, are then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.
Outcome measures
| Measure |
Facility-based Screening
n=1929 Participants
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.
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.
|
Contact Screening
n=1726 Participants
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.
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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|---|---|---|
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Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics
|
1929 Participants
|
1726 Participants
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PRIMARY outcome
Timeframe: 36 monthsPopulation: This analysis population includes all participants enrolled in the two contact tracing sub-arms during the total study period of 36 months. It excludes participants from the facility-based screening arm. A total of 2,923 patients were started on TB treatment during the study period: 1,413 in clinics allocated to household-based contact investigation and 1,510 in clinics allocated to incentive-based contact investigation.
The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics in the two contact tracing arms, excluding the six-month washout period.
Outcome measures
| Measure |
Facility-based Screening
n=1413 Participants
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.
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.
|
Contact Screening
n=1510 Participants
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.
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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|---|---|---|
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Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms
|
1413 Participants
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1510 Participants
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SECONDARY outcome
Timeframe: 36 monthsPopulation: The number of TB contacts screened in each contact investigation arm.
The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts ("secondary cases") by arm.
Outcome measures
| Measure |
Facility-based Screening
n=1413 Participants
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.
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.
|
Contact Screening
n=1510 Participants
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.
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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|---|---|---|
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Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing
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17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: This population includes all enrolled index participants with TB and their enrolled contacts, per arm.
This measure is the total cost of household contact investigation in both the household-based and incentive-based arms in 2018 United States dollar (USD) collected from the societal perspective (including both health systems and patient-level costs). As these are actual measured (not estimated) costs, no 95% confidence interval is reported.
Outcome measures
| Measure |
Facility-based Screening
n=2664 Participants
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.
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.
|
Contact Screening
n=2720 Participants
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.
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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|---|---|---|
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Total Cost of Household Contact Investigation Strategies
|
48760 2018 US dollars
|
58070 2018 US dollars
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: These populations include all contact persons enrolled into each arm.
These are estimated costs in 2018 USD for the cost per contact person screened in each arm, collected from the societal perspective including health system and patient-level costs.
Outcome measures
| Measure |
Facility-based Screening
n=1882 Participants
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.
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.
|
Contact Screening
n=1940 Participants
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.
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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|---|---|---|
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Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms
|
26.44 2018 US dollars
Interval 15.17 to 102.28
|
29.93 2018 US dollars
Interval 20.32 to 114.66
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Individuals included in this population were the total number of secondary TB cases identified among contacts enrolled in each arm.
Cost were measured in 2018 US dollars from the societal perspective, including both health systems and patient level costs. Total costs per arm were divided by the number of secondary TB cases identified among contacts in that arm.
Outcome measures
| Measure |
Facility-based Screening
n=17 Participants
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.
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.
|
Contact Screening
n=17 Participants
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.
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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|---|---|---|
|
Cost Per Secondary Case of TB Identified Among Contacts, Per Arm
|
2927 2018 US dollars
Interval 1680.0 to 11323.0
|
2416 2018 US dollars
Interval 2319.0 to 13085.0
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Though the difference in total costs by arm is positive, the difference in effectiveness by arm is zero, therefore we cannot calculate the incremental cost effectiveness ratio as it would require dividing by zero.
(Total costs of incentive-based contact investigation-total costs of household-based contact investigation)/(effectiveness of incentive-based contact investigation-effectiveness of household-based contact investigation)
Outcome measures
Outcome data not reported
Adverse Events
Facility-based Screening Arm
Contact Tracing Household-based Sub-arm
Contact Tracing Incentive-based Sub-arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Colleen Hanrahan
Johns Hopkins Bloomberg School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place